Energy Automation - Management Manual Energy Automation - Management Manual

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Energy Automation – Management Manual
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Version 1.0 July 2005
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Management Manual Page 2 / 101
PTD EA Quality, Environment, Safety
This document is property of Siemens PTD EA

Copying the document or parts thereof is not permitted.
Enquiries for this document can be addressed to the following place:
Siemens AG
PTD EA QES
Humboldtstrasse 59
D-90459 Nürnberg
Fon: +49-911-433-7498
Fax: +49-911-433-8435
Gerhard.K.Stich@siemens.com
The issue levels of this document are listed below. Modifications to the previous versions are docu-
mented in condensed form under “Comments.”
Issue Date Name Department Telephone Comments

V 1.0 01.07.05 Stich, Majoor, PTD EA QES N 7498 First issue
Schaub
1. Update
2. Update
Version 1.0 dated 01.07.05 A53600-I4200-M800-01-76A1

Note: The electronic file is the valid version and replaces every paper copy.
Copyrights © Siemens AG 2005 All Rights Reserved For Internal Use Only
0 Preamble
The Business Division PTD EA (Energy Automation) is a business unit embedded in the goals and strat-
egy of the PTD Business Group, with responsibilities to customers, stakeholders and employees as well
as society and the environment. This sets the framework in which PTD EA has to develop optimal busi-
ness activities.
The PTD EA mission covers the entire spectrum of products, systems and solutions for energy automa-
tion of energy suppliers and industrial enterprises, for railway transport companies and energy market
management companies.
This includes:
Protection technology
Telecontrol technology
Substation automation
Power Quality
Energy management systems
Energy information systems in the area of network control technology
Communication and switching systems
Integrated IT-solutions for energy and network management
PTD EA is responsible for the distribution, planning, consulting, development, production, delivery, instal-
lation, commissioning and service of these products, systems and solutions. This encompasses world-
wide business responsibility for these activities.
As the leading supplier of this technology we are especially obligated to our customers to guarantee
them a high customer benefit and thus have installed a comprehensive management system to ensure
the required quality. This system reflects our responsibility towards society, environment as well as our
employees, especially regarding their occupational safety and health. This Management Manual de-
scribes the standards applied, demonstrating that PTD EA utilizes all necessary procedures to continu-
ally ensure and realize quality, environment protection and occupational safety and health. Our approach
is: the greatest possible customer satisfaction together with the best trained and motivated employees,
together with efficient processes that result in the best cost position.
The PTD EA supports an integrated management system for quality, environmental protection and oc-
cupational safety and health in order to achieve its objectives. All organizational units are responsible to
support and constantly improve this management system. Our employees are trained and directed to
follow the policies of this integrated management system.

1 Objectives
1.1 Scope
This Management Manual is valid for the Business Division PTD EA of Siemens AG. It covers the refer-
ences from the requirements of ISO 9001:2000, ISO14001:2004, DIN EN 13980:2002, the guidelines for
occupational safety of the German Federal Ministry of Finance and the specific processes and proce-
dures of the PTD EA. This document is structured according to the Quality Standard ISO 9001:2000.
This structure also includes the environment protection standard ISO 14001:2004 and the guideline for
occupational safety and health from the German Federal Ministry of Finance.
The organization structure of PTD EA is described in the Business Regulations.
1.2 Release
The Management Manual explains how the requirements of these standards and guidelines for occupa-
tional safety are implemented at PTD EA . The contents were approved and released by PTD EA Top-
Management and by the management system representatives. Documents were prepared by the func-
tional department “Management Systems for Quality, Environment and Safety” (PTD EA QES).
1.3 Introduction
This Management Manual is valid for all PTD Energy Automation employees, starting as of July 1, 2005.
Nuremberg
................................................. ..................................................
Armin Bruck, PTD EA Gerhard-Kurt Lübke, PTD EA BA

1.4 Contents
0 Preamble 3
1 Objectives 4
1.1 Scope 4
1.2 Release 4
1.3 Introduction 4
1.4 Contents 5
1.5 Distribution 7
1.6 Paper copies 7
1.7 Maintenance 7
2 References 7
2.1 Standards 7
2.2 Management system documents 7
2.3 Environment protection documents 7
2.4 Occupational safety and health documents 8
2.5 Other references 8
3 Mapping of the Organization to the Reference Process House 9
4 Integrated quality, environment and safety management system 11
4.1 General requirements 11
4.2 Documentation requirements 15
5 Management responsibility 21
5.1 Management commitment 21
5.2 Customer focus 23
5.3 Quality, environment protection and occupational safety and health policy 24
5.4 Planning 26
5.5 Responsibility, authority and communication 29
5.6 Management review 33
6 Resource Management 40
6.1 Provision of resources 40
6.2 Human resources 41
6.3 Infrastructure 44
6.4 Work environment 45
7 Product realization 46
7.1 Planning of product realization 46
7.2 Customer-related processes 49
7.3 Design and Development 54
7.4 Purchasing 60
7.5 Production and service provision 67
7.6 Control of monitoring and measuring devices 71
8 Measurement, analysis and improvement 73
8.1 General 73
8.2 Monitoring and measurement 75
8.3 Control of nonconforming product 82

8.4 Analysis of data 86

8.5 Improvement 86
9 Appendix 94
9.1 Cross reference DIN EN ISO 9001:2000 and PTD EA Process Instructions 94
9.2 Cross reference DIN EN ISO 14001:2004 and DIN EN ISO 9001:2000 97
9.3 Index 99

1.5 Distribution
Every PTD EA employee has access to the current version of the Management Manual over the Intranet.
1.6 Paper copies

Individual paper copies of the Management Manual can be obtained at the functional department “Qual-
ity, Environment, Safety – Management Systems”:
Siemens AG
PTD EA QES
Humboldtstrasse 59
D-90459 Nuremberg
1.7 Maintenance
The Management System Representative is responsible for maintaining the Management Manual.
2 References
2.1 Standards
• ISO / 9000:2000 - Quality Management Systems -
Fundamentals and Vocabulary
Requirements
Guidelines for performance improvements
• EN 13980, Version 02/03 in regard to ATEX – Licensing of products per guidelines 94/9/EWG.
All requirements and documents for this standard in mention are shown in italic print.
• ISO / 14001:2004 - Environmental management systems –
Requirements with guidance for use.
When only partial requirements are relevant, these are shown in bold print.
• SN 36350 Environmentally compatible products, Part 1, Part 2
2.2 Management system documents

• Siemens AG Corporate Principles, Quality management guidelines
• PTD Management Policy
• Energy Automation – Business Regulations
• Energy Automation – Quality Declaration
• Process Instructions, Work Instructions, Templates
2.3 Environment protection documents
• Siemens Principles for Environmental Protection Technical Safety, Version 1998
• PTD Environment Protection Guidelines 0-001: Organization of PTD UWS - Guidelines
• PTD Environment Protection Guidelines 1-001: Organization of company environment protection

2.4 Occupational safety and health documents

• PTD QM-Guidelines Nr. 7-01 „Occupational safety and health management at PTD“
• PTD QM-Guidelines Nr. 7-02 „Occupational safety and health – work instructions“
• PTD QM-Guidelines Nr. 7-03 „Occupational safety and health at PTD-construction sites”
2.5 Other references

• Work Instruction „Abbreviations, concepts and definitions“

3 Mapping of the Organization to the Reference Process House

Manage Customer Supply Product Support
ment Relation- Chain Lifecycle Processes
ship Man- Management Management
Proc- agement
esses (CRM) (SCM) (PLM) (SUP)
(MAN)
1 2 3 1 2 3 4 1 2 3 4 5 1 2 3 4 5 6 1 2 3 4 5 6 7 8 9
Process & Information Management

Intellectual Capital Management
Financial Planning & Controlling
Strategic Planning & Controlling
Product Portfolio Management
Environment, Health & Safety
Real Estate Management

Financial Management
Quality Management
Human Resources
Communication
Commercialize
Internal Audits
Procurement
Understand
Phase out
Organizational
Realize
Source
Deliver
Return
Define
Make
unit
Care
Plan
Plan
Plan
Sell
PTD EA Ltg./BA v v f*) v

PTD EA 1 f v v v f f f v f v v
PTD EA 2 f f f f f f f f
PTD EA 3 f f f f f f f f
PTD EA 4 f f f f f f f f f f f f f f f
PTD EA D f v v v v v f v
PTD EA P f v v v v v f f f f f f f f f
PTD EA BS f v
PTD EA IM f v f f v f
PTD EA QES v v v V
PTD EA BE f f
PTD EA PMO f f f f v v v v F
PTD EA I f
PTD EA GPP f f f f f f v
PTD EA GPM f f v
PTD EA ECC f f f f f
PTD EA C f f
PTD EA A f f f
PTD EA OI f f f f f f f v f
PTD HR f f v
Frankendata v
SRE f v
Base: Reference Process House V2.2
v = is functionally responsible for process management (process owner)
f = implements process management (process experts), supports the process owner
*) EA BA ST function in the process „Internal Audits“ as process experts for internal and external audits, IKS and SOA 404.
There are two process owners for the following processes due to the different types of business:
SCM: EA P is responsible for the product business, EA PMO is responsible for the system business.
Frankendata is responsible for Return in the System business.

PLM (PPM and Phase Out): EA 1 is responsible for the product business and EA IM is responsible
for the system business.
PLM (Commercialize): EA 1 is responsible for sales activities for market introduction and product
support. EA D is responsible for operative product support, i.e. repair and maintenance.
Procurement: EA GPP is responsible for project purchasing while EA GPM is responsible for prod-
uct procurement.
Process & Information Management: EA QES is responsible for process management while EA OI
is responsible for information management.

4 Integrated quality, environment and safety management system
4.1 General requirements

Quality management
ISO 9001
Respon-
Version Required Actions Process Actions described in Comments
sibility
‘00
4.1 The organization shall establish, docu- EA, MAN, Business Regulations Norms and Standards
ment, implement and maintain a quality EA BA CRM, A53600-Q4100-P800-01 Process Siemens-Company-quality
management system and continually SCM, Management
improve its effectiveness in accordance PLM, A53600-Q4210-P800-01 Documenta- Management policy PTD
with the requirements of this Interna- SUP tion of the Integrated management Quality management
tional Standard. System guidelines PTD
The organization shall
a) identify the processes needed for VA Q7410 Supplier qualifications
the quality management system and evaluation
and their application throughout the
organization (see 1.2),
b) determine the sequence and inter-
action of these processes,
c) determine criteria and methods
needed to ensure that both the op-
eration and control of these proc-
esses are effective,
d) ensure the availability of resources
and information necessary to sup-
port the operation and monitoring of
these processes,
e) monitor, measure and analyze
these processes, and
f) implement actions necessary to
achieve planned results and con-
tinual improvement of these proc-
esses.
g) These processes shall be managed
by the organization in accordance
with the requirements of this Inter-
national Standard.
Where an organization chooses to out-
source any process that affects product
conformity with requirements, the or-
ganization shall ensure control over such
processes. Control of such outsourced
processes shall be identified within the
quality management system.
The quality system shall ensure compli-

ance of the product with the type de-
scribed in the EC type-examination
certificate..
Comment: Due to the merger of the Business Divisions PTD EM and PTD PA into PTD EA, documents from three systems are
referenced in these tables: A53600-... refers to a PTD EA document, QS-PR-... refers to a PTD EM document and VA Q... refers
to a PTD PA document. These documents are accessible over the respective Intranet pages. Step by step, the EM and PA
documents are being replaced by the EA documents. The scope of the former documents is outlined in the PTD EA circular
01/2005. Requirements printed in italics are those of EN 13890. In the case of environment management requirements,
the relevant requirements appear respectively in bold print in the respective sections.

Environment management
ISO 14001 Respon-
Required Actions Process Actions described in Comments
Vers. ‘04 sibility
4.1 The organization shall establish, docu- EA, MAN,
ment, implement, maintain and continu- EA BA CRM,
ally improve an environmental manage- SCM,
ment system in accordance with the PLM,
requirements of this International Stan- SUP
dard and determine how it will fulfill
these requirements.
The organization shall define and docu-
ment the scope of its environmental
management system.
Occupational safety and health management

Guidelines
Respon-
H&S Required Actions Process Actions described in Comments
sibility
Mgmt.
2.11., (Establish work, sequences and proc- EA, MAN, A53600-Q4100-P800-01 Process Quality management
2.11.1. esses (planning)) EA BA CRM, management guidelines PTD
The organization should introduce and SCM, A53607-E4310-P800-01 Considera-
maintain procedures for continuous PLM, tion of environment and occupational
establishment of work and business SUP safety and health aspects in proc-
related sequences and processes, esses, products and services
where, according to experience, perils PTD QM-Guideline Nr. 7-02 „Work-
and related risks for employees and place protection – work instructions“
people on company premises may be
expected. PTD QM-Guideline Nr. 7-03 „Occupa-
tional safety and health at PTD-
construction sites“
2.11.2 The organization should take into con- EA, MAN, A53600-Q4100-P800-01 Process Quality management-
sideration when establishing company EA BA CRM, management guidelines PTD
sequences and processes: SCM, A53607-E4310-P800-01 Considera-
a) The planning, construction and start PLM, tion of environment and occupational
up of workplaces, installations and SUP safety and health aspects in proc-
facilities including providing services esses, products and services
as well as the introduction of work PTD QM-Guideline Nr. 7-02 „Work-
materials, place protection – work instructions“
b) The normal operation with the PTD QM-Guideline Nr. 7-03 „Occupa-
respective servicing (maintenance, tional safety and health at PTD-
inspection, repair), the set-up opera- construction sites“
tion, the test operation, and the de-
livery and removal of installations
including installations and equip-
ment used for services, the contact
with work materials and tools,
c) Technical and organizational modi-
fications, including expansions and
renovations,
d) The termination and removal of
equipment and installations as well
as work materials and
e) The contract acquisition and con-
tract acceptance as well as bid in-
formation.
PTD EA supports an integrated management system that describes the organization, processes and
safety measures that are provided for the implementation of the business strategy, so that the respec-
tive organizational units attain their annual objectives. The effectiveness of the integrated management
system is constantly being improved.
Site-specific laws, regulations and instructions are taken into consideration when establishing proc-
esses.

The establishing of processes in which perils and related risks are expected for employees and other
individuals (visitors etc.) is considered in the process planning. The process owner and other participat-
ing leaders are made aware of the danger potential during the process creation whereby necessary
measures for occupational safety and health are planned. Routine review of the processes also includes
occupational safety.
Our processes are derived from the Siemens Reference Process House. The Reference Process House
presents the entire group of processes, which are assigned to the various units within a Business Divi-
sion. The assignment within PTD EA is found in Chapter 3.
Figure 1: Siemens Reference Process House (V2.2)

We place special attention to the sequence and interaction of processes. Figure 2 presents an overview
of business process interaction. The detailed assignment of business process within the organizational
units is shown in Chapter 3.
Figure 2: Process Interaction
The description of process interfaces is found in the respective Process Instructions and Work Instruc-
tions. PTD EA QES provides a list with all process and work instructions.
As a rule, the process instructions contain criteria and methods needed to ensure the effectiveness and
supervision of the processes. Furthermore, the availability of information and resources for process exe-
cution and supervision is well established.
The organizational units are responsible for promoting the continuous improvement of processes.

4.2 Documentation requirements
4.2.1 General
Quality management
ISO 9001 Respon-
4.2.1 The quality management system docu- EA MAN, Business Regulations Management policy PTD
mentation shall include EA BA CRM, Quality Declaration Quality management-
a) documented statements of a quality SCM, Guidelines PTD
PLM, Process Instructions
policy and quality objectives,
SUP Work Instructions
b) a quality manual,
Templates
c) documented procedures required by
this International Standard, A53600-Q4210-P800-01 Documenta-
tion of the integrated Management
d) documents needed by the organiza- system
tion to ensure the effective planning,
operation and control of its proc-
esses, and
e) records required by this Interna-
tional Standard (see 4.2.4).
ISO 14001 Respon-
4.4.4 The environmental management system EA MAN, Business Regulations
documentation shall include EA BA CRM, Process Instructions
a) the environmental policy, objectives SCM,
PLM, Work Instructions
and targets,
SUP Guidelines
b) description of the scope of the
environmental management system, Organizational unit (OE) – specific
instructions
c) description of the main elements of
the environmental management
system and their interaction, and
reference to related documents,
d) documents, including records,
required by this International Stan-
dard, and
e) documents, including records,
determined by the organization to
be necessary to ensure the effective
planning, operation and control of
processes that relate to its signifi-
cant environmental aspects.
Workplace safety management

Guideline
Respon-
sibility
Mgmt.
2.7.1 H&S Mgmt. documentation is to be in- EA, MAN, Business Regulations
troduced and maintained in considera- EA BA CRM, Quality Declaration
tion of the size and nature of the organi- SCM,
zation activities. This is to include the PLM, PTD QM-Guideline 7-01 „Workplace
following, for example: SUP Protection-Management at PTD“
a) the occupational safety and health QM-Guideline Nr. 7-02 Work protec-
policy and the occupational safety tion - work instructions
and health goals of the organiza- A53600-Q4230-W800-01 Document
tion; control
b) the result of the testing of H&S A53600-Q4240-W800-01 Records of
Mgmt. performance and effective- the Management system
ness;

Workplace safety management

Guideline
Respon-
sibility
Mgmt.
c) a proof that these obligations were VA Q5100: Establishing the Division
complied with (e.g., results of a risk strategy
evaluation, a list of hazardous ma-
terial, noise level register),
d) the allocation of key functions and
responsibilities for implementing
H&S Mgmt.;
e) the characteristic perils and related
risks to safety and health that arise
based on the organizational activi-
ties, as well as actions that avoid or
minimize these perils;
f) Commitments, procedures, instruc-
tions or other internal documents
that are used within the H&S Mgmt.
framework.
2.7.2 The H&S Mgmt. documentation must be EA, MAN, Business Regulations
clearly composed and easily understood EA BA CRM, Quality Declaration
by those who use it. It must be so con- SCM,
structed that documents and records are PLM, PTD QM-Guideline 7-01 „Occupa-
timely and easily accessible. It must be SUP tional safety and health-Management
routinely reviewed and updated when at PTD“
needed. The organization should intro- QM-Guideline Nr. 7-02 Occupational
duce and maintain procedures for all safety and health Work instructions
necessary and productive control of all A53600-Q4230-W800-01 Control of
necessary documents and records and documents
should assure the relevance, accessibil-
ity, distribution and safe keeping through A53600-Q4240-W800-01 Records to
competencies and procedural methods. the Management system
VA Q5100: Establishing the Division

Strategy
The documentation structure of the EA Management system is shown in the following figure:

Figure 3: Management system documentation

In addition to those requirements shown in Figure 3, site-specific laws, regulations and procedures are
also considered in the documentation.
Guidelines serve as support documents, that are used during schooling and training. These documents
are not controlled.
The following documents contain the binding policy and objectives for PTD EA :
• Siemens Quality Management (principles)
• Siemens PTD Management Policy (Guidelines)
• Energy Automation – Quality Declaration (Management policy)
This is achieved by the documentation, implementation and support of an integrated management sys-
tem in accordance with ISO 9001, ISO 14001 and the guideline for occupational safety and health. In
this manner, the company objectives
• Customer satisfaction
• Compliance with regulations, laws and standards
• Positive business results
are attained.
In addition we establish yearly quality and environmental goals within the organizational units. These are
conveyed in writing to all employees and made known during all communication meetings and events.
The degree to which these objectives are realized is monitored by the responsible leaders and those
with the assigned responsibility, and this is reported to the Division management.
4.2.2 Management Manual
The Management Manual describes the integrated management system.
Quality management
ISO 9001 Respon-
4.2.2 The organization shall establish and EA, MAN, A53600-Q4100-P800-01 Process Management policy PTD
maintain a quality manual that includes EA BA CRM, management Quality management-
a) the scope of the quality manage- SCM, A53600-Q4210-P800-01 Documenta- Guidelines PTD
ment system, including details of PLM, tion of the integrated management
and justification for any exclusions SUP system
b) the documented procedures estab-
lished for the quality management
system, or reference to them, and
c) a description of the interaction
between the processes of the qual-
ity management system.

4.2.3 Control of documents

Quality management
ISO 9001 Respon-
4.2.3 Documents required by the quality man- EA, MAN, A53600-Q4230-W800-01 Document Guidelines for Information
agement system shall be controlled. EA BA CRM, control security
Records are a special type of document SCM,
and shall be controlled according to the PLM,
requirements given in 4.2.4. SUP
A documented procedure shall be estab-
lished to define the controls needed
a) to approve documents for adequacy
prior to issue,
b) to review and update as necessary
and re-approve documents,
c) to ensure that changes and the
current revision status of documents
are identified,
d) to ensure that relevant versions of
applicable documents are available
at points of use,
e) to ensure that documents remain
legible and readily identifiable,
f) to ensure that documents of exter-
nal origin are identified and their dis-
tribution controlled, and
g) to prevent the unintended use of
obsolete documents, and to apply
suitable identification to them if they
are retained for any purpose.
a) Equipment documents and manu-

facturer's documents shall be con-
trolled;
b) Documented procedures shall
ensure that information contained
within manufacturer's documents is
compatible with equipment docu-
ments. The manufacturer shall not
initially approve or subsequently
amend related drawings unless they
are in compliance with the schedule
drawings;
c) The quality system shall ensure that
no factor (type, characteristic, posi-
tion etc.) defined within the EC type-
examination certificate and technical
documentation (e.g. schedule draw-
ings) is modified;
d) There shall be a documented sys-
tem that refers all related drawings
to the relevant schedule drawings;
e) Where there are common schedule
drawings associated with more than
one EC type-examination certificate,
there shall be a documented system
to ensure simultaneous supplemen-
tary action in the event of an
amendment to such drawings;
f) Where a manufacturer also has
drawings for products not intended
for use in potentially explosive at-
mospheres then the manufacturer
shall have a system that enables
both the related drawings and
schedule drawings to be clearly

Quality management
ISO 9001 Respon-
identified;
g) The manufacturer shall document
which notified body is responsible
for the quality system notification for
each EC type-examination certifi-
cate;
h) Where equipment documents or
manufacturer's documents are
passed to a third party, they shall be
provided in a way that is not mis-
leading.
ISO 14001 Respon-
4.4.5 Documents required by the environ- EA, MAN, Management policy PTD
mental management system and by this EA BA CRM, Environment manage-
International Standard shall be con- SCM, ment –guidelines PTD
trolled. Records are a special type of PLM,
document and shall be controlled in SUP
accordance with the requirements given
in 4.5.4.
The organization shall establish, imple-
ment and maintain a procedure(s) to
a) approve documents for adequacy
prior to issue,
b) review and update as necessary
and reapprove documents,
c) ensure that changes and the current
revision status of documents are
identified,
d) ensure that relevant versions of
applicable documents are available
at points of use,
e) ensure that documents remain
legible and readily identifiable,
f) ensure that documents of external
origin determined by the organiza-
tion to be necessary for the planning
and operation of the environmental
management system are identified
and their distribution controlled, and
g) prevent the unintended use of
obsolete documents and apply suit-
able identification to them if they are
retained for any purpose.
4.2.4 Control of records

Quality management
ISO 9001 Respon-
4.2.4 Records shall be established and main- EA, MAN, A53600-Q4230-W800-01 Document Examples:
tained to provide evidence of conformity EA BA CRM, control Review-Protocols
to requirements and of the effective SCM, A53600-Q4240-W800-01 Records for Test protocols
operation of the quality management PLM, the Management system Training certificates
system. Records shall remain legible, SUP QM-control card in SAP
readily identifiable and retrievable. A Memorandum SG-Nr. 383
documented procedure shall be estab-
lished to define the controls needed for
the identification, storage, protection,
retrieval, retention time and disposition

Quality management
ISO 9001 Respon-
of records.
ISO 14001 Respon-
4.5.4 The organization shall establish and EA SUP(2)
maintain records as necessary to dem- EA BA
onstrate conformity to the requirements
of its environmental management sys-
tem and of this International Standard,
and the results achieved.
ment and maintain a procedure(s) for the
identification, storage, protection, re-
trieval, retention and disposal of records.
Records shall be and remain legible,
identifiable and traceable.

5 Management responsibility
5.1 Management commitment

Quality management
ISO 9001 Respon-
5.1 Top management shall provide evidence EA, MAN, Business Regulations Norms and Standards
of its commitment to the development EA BA CRM, Quality Declaration Siemens-Corporate-Quality
and implementation of the quality man- SCM,
agement system and continually improv- PLM, Protocols for Management-Reviews Management policy PTD
ing its effectiveness by SUP VA Q6100 Accountancy Quality management-
a) communicating to the organization Guidelines PTD
the importance of meeting customer
as well as statutory and regulatory
requirements,
b) establishing the quality policy,
c) ensuring that quality objectives are
established,
d) conducting management reviews,
and
e) ensuring the availability of re-
sources.
ISO 14001 Respon-
4.4.1 Management shall ensure the availability EA MAN, Norms and Standards
of resources essential to establish, im- EA BA CRM, Management policy PTD
plement, maintain and improve the envi- SCM,
ronmental management system. Re- PLM, Environment manage-
sources include human resources and SUP ment –Guidelines PTD
specialized skills, organizational infra-
structure, technology and financial re-
sources.
Roles, responsibilities and authorities
shall be defined, documented and
communicated in order to facilitate
effective environmental management.
The organization's top management
shall appoint a specific management
representative(s) who, irrespective of
other responsibilities, shall have defined
roles, responsibilities and authority for
a) ensuring that an environmental
management system is established,
implemented and maintained in ac-
cordance with the requirements of
this International Standard,
b) reporting to top management on the
performance of the environmental
management system for review, in-
cluding recommendations for im-
provement.
The entire team of executives is responsible to develop and implement a management system and
should improve the effectiveness by using the following measures:
• Meaningful communication as needed in order to fulfill customer requests and the requirements of
legal and normative demands

• Formation of a quality, environment protection and occupational safety and health policy
• Establishing and following the quality, environment protection and occupational safety and health
goals.
• Carry out management reviews
• Guarantee availability of resources
An overview of the improvement process is found in the following illustration.
Figure 4: Improvement process of the PTD EA Management System

5.2 Customer focus

Quality management
ISO 9001 Respon-
5.2 Top management shall ensure that cus- EA CRM, Business Regulations
tomer requirements are determined and SCM, Quality Declaration
are met with the aim of enhancing cus- PLM,
tomer satisfaction (see 7.2.1 and 8.2.1). SUP(3, 8) VA Q5110 Strategic Marketing
VA Q7100 Portfolio management
and product definition
VA Q7200 Business Development
ISO 14001 Respon-
4.3.1 The organization shall establish, imple- EA CRM, A53600-E4310-P800-01 Environ-
ment and maintain a procedure(s) SCM, mental aspects
a) to identify the environmental PLM, PTD ETS 1-0002 Dealing with envi-
aspects of its activities, products SUP(3, 8) ronmentally relevant documents
and services within the defined
scope of the environmental man-
agement system that it can con-
trol and those that it can influ-
ence taking into account planned
or new developments, or new or
modified activities, products and
services, and
b) to determine those aspects that
have or can have significant im-
pact(s) on the environment (i.e. sig-
nificant environmental aspects).
The organization shall document this
information and keep it up to date.
The organization shall ensure that the
significant environmental aspects are
taken into account in establishing, im-
plementing and maintaining its environ-
mental management system.
4.3.2 The organization shall establish, imple- EA CRM, A53600-E4320-P800-01 Study of

ment and maintain a procedure(s) SCM, environmentally relevant requirements
a) to identify and have access to the PLM, A53600-E4320-W800-01 Legal and
applicable legal requirements and SUP(3, 8) other requirements for environment
other requirements to which the or- protection
ganization subscribes related to its X27 Dealing with environmen-
environmental aspects, and tally relevant documents
b) to determine how these require- X22 Dealing with hazardous
ments apply to its environmental materials
aspects.
X25 Utilization of waste prod-
The organization shall ensure that these ucts
applicable legal requirements and other
requirements to which the organization
subscribes are taken into account in
establishing, implementing and maintain-
ing its environmental management sys-
tem.
Management ensures that the customer requirements are taken into consideration and fulfilled in keep-
ing with the objective of increasing customer satisfaction. Customer and market requirements for the
basic products are handled with the customer processes (PLM, CRM). Requirements of customer pro-
jects are handled using the offer process (CRM) and the project development process (SCM). Manage-
ment ensures that these processes are constantly controlled and improved. Further details are found in
Chapter 7.2.1.

We offer our customers products that support the conservation of natural resources and that guarantee a
great degree of safety and health protection during transport and energy distribution.
Our products and production process are so designed as to avoid negative effects on the environment
and any perils to safety and health. Our efforts for environmental protection surpass the legal and corpo-
rate guidelines.
5.3 Quality, environment protection and occupational safety and health policy
Quality management
ISO 9001 Respon-
5.3 Top management shall ensure that the EA, MAN, Business Regulations Management policy PTD
quality policy EA BA CRM, Quality Declaration Quality management-
a) is appropriate to the purpose of the SCM, guidelines PTD
PLM, A53600-Q4100-P800-01 Process
organization, management
SUP
b) includes a commitment to comply
with requirements and continually
improve the effectiveness of the VA Q5100 Establishment of the
quality management system, Division strategy
c) provides a framework for establish- VA Q6200 Employee development
ing and reviewing quality objectives, at PTD PA
d) is communicated and understood
within the organization, and
e) is reviewed for continuing suitability.
ISO 14001 Respon-
4.2 Top management shall define the or- EA MAN, Quality Declaration Norms and Standards
ganizations environmental policy and EA BA CRM, Management policy PTD
ensure that, within the defined scope of SCM,
its environmental management system, PLM, Environment manage-
it SUP ment –Guidelines PTD
a) is appropriate to the nature, scale
and environmental impacts of its ac-
tivities, products and services,
b) includes a commitment to continual
improvement and prevention of pol-
lution,
c) includes a commitment to comply
with applicable legal requirements
and with other requirements to
which the organization subscribes
which relate to its environmental
aspects,
d) provides the framework for setting
and reviewing environmental objec-
tives and targets,
e) is documented, implemented and
maintained,
f) is communicated to all persons
working for or on behalf of the or-
ganization, and
g) is available to the public.
.


Guidelines
Respon-
sibility
Mgmt.
2.1.1 Top management must establish the EA, MAN, Business Regulations
occupational safety and health policy in EA BA CRM, Quality Declaration
writing, which SCM,
PLM, VA Q5100 Establishment of the
a) is based on the principles of pre- Division strategy
vention and constant improvement; SUP
b) is calculated according to the size
of the organization, its type of ac-
tivities, the perils present and the
risks involved;
c) is formulated clearly and precisely,
dated and signed or placed into ef-
fect with their consent;
d) the respective objectives become
binding for all members of the or-
ganization;
e) all members of the organization are
duly informed thereof and have
easy access;
f) is routinely tested for suitability and
updated;
g) is made known to relevant external
bodies whenever appropriate.
2.1.2. The participation by employees is an EA, MAN, Business Regulations
important element of H&S Mgmt. within EA BA CRM, Quality Declaration
an organization. SCM,
PLM,
SUP
2.1.3. The occupational safety and health EA, MAN, Business Regulations
policy should contain at least the follow- EA BA CRM,
ing basic principles and objectives: Quality Declaration
SCM,
PLM, VA Q5100 Establishment of the
a) Protection and improvement of the SUP Division strategy
safety and health of organization
members through preventing acci-
dents at the workplace, through
avoiding or minimizing perils and
related risks to safety and health as
well as measures for the fair and
just composition of work;
b) Compliance with relevant occupa-
tional safety and health procedures,
wage and company agreements,
voluntary programs for occupational
safety and health and other re-
quirements to which the organiza-
tion is bound, as well as observing
the degree of technology, work-
place medicine and hygiene and
other guaranteed ergonomic find-
ings;
c) Including employees and their
representatives in counseling as
well as employee motivation to ac-
tively participate in all H&S Mgmt.
elements;
d) Continued improvements of the
AMS performance.
2.1.4. The H&S Mgmt. should already be com- EA, MAN, Business Regulations
patible with the current management EA BA CRM, Quality Declaration
system of the organization or be inte- SCM,
grated into this system. PLM,
SUP

The quality, environment protection and occupational safety and health policies are defined in the PTD
EA Quality Declaration.
5.4 Planning
5.4.1 Objectives
Quality management
ISO 9001 Respon-
5.4.1 Top management shall ensure that qual- EA, MAN, Quality Declaration
ity objectives, including those needed to EA BA CRM, A53600-Q4100-P800-01 Process
meet requirements for product (see SCM, management
7.1a)), are established at relevant func- PLM,
tions and levels within the organization. SUP
The quality objectives shall be measur- VA Q5100 Establishment of the
able and consistent with the quality Division strategy
policy. VA Q6100 Accountancy
ISO 14001 Respon-
4.3.3 The organization shall establish, imple- EA, MAN, Business Regulations Norms and Standards
ment and maintain documented envi- EA BA CRM, Quality Declaration Management policy PTD
ronmental objectives and targets, at SCM,
relevant functions and levels within the PLM, A53600-E4330-P800-01 Environment Environment manage-
organization. SUP program ment –Guidelines PTD
The objectives and targets shall be
measurable, where practicable, and
consistent with the environmental policy,
including the commitments to prevention
of pollution, to compliance with applica-
ble legal requirements and with other
subscribes, and to continual improve-
ment.
When establishing and reviewing its
objectives and targets, an organization
shall take into account the legal re-
quirements and other requirements to
which the organization subscribes, and
its significant environmental aspects. It
shall also consider its technological
options, its financial, operational and
business requirements, and the views of
interested parties.
ment and maintain a program(s) for
achieving its objectives and targets.
Program(s) shall include
a) designation of responsibility for
achieving objectives and targets at
relevant functions and levels of the
organization, and
b) the means and time frame by which
they are to be achieved.

Guidelines
Respon-
sibility
Mgmt.


Guidelines
Respon-
sibility
Mgmt.
2.2.1 In concurrence with occupational safety EA, MAN, Business Regulations
and health policy and based on the initial EA BA CRM, Quality Declaration
test or further test data (see 2.9), top SCM,
management should set measurable PLM, PTD QM-Guideline Nr. 7-01 „Occupa-
occupational safety and health objec- SUP tional safety and health management
tives that relate to the specific organiza- at PTD
tion, that VA Q5100 Establishment of Division
a) are appropriate for the organization strategy
regarding its size, type of activities, QS-PR-QM-009-N Corrective and
the perils present and the risks in- preventive actions
volved; QS-PR-QM-010-N Measurement,
b) are in concurrence with the relevant Analysis and Improvement
occupational safety and health pro- A53600-Q4100-P800-01 Process
cedures as well as the technical management
and business obligations of the or-
ganization regarding occupational
safety and health;
c) are aimed at continually improving
the safety and health protection of
employees, in order to achieve the
best possible occupational safety
and health performance;
d) are realistic and attainable;
e) are documented and communicated
to all relevant officials within the or-
ganization;
f) are evaluated and when needed
updated on a routine basis.
2.2.2. The following must be determined in EA, MAN, Business Regulations
order to achieve the occupational safety EA BA CRM, Quality Declaration
and health objectives, based on results SCM,
from the initial test, subsequent tests, PLM, PTD QM-Guideline Nr. 7-01 „Occupa-
e.g., internal audits or other data: SUP tional safety and health management
at PTD
a) a definition of the organizational
occupational safety and health ob- A53600-Q4100-P800-01 Process
jectives and an adequate quantifi- management
cation of the objectives; VA Q5100 Establishment of Division
b) a plan to achieve the individual strategy
objectives, e.g., such as goal QS-PR-QM-009-N Corrective and
agreements in which responsibili- preventive actions
ties are defined and transparent QS-PR-QM-010-N Measurement,
performance criteria are estab- Analysis and Improvement
lished and that indicates who is to
do what and when;
c) Measurement criteria to use for
testing to ascertain whether the
objectives have been attained.
Quality, environment protection and occupational safety and health goals are established within the or-
ganizational units and then examined and released in the management review. The consistency with
policy and strategy is hereby assured. The quality, environment protection and occupational safety and
health goals for products and services are defined in the management system documents as well as
specifications and planning documents for customer and development projects. The quality plan is a
fixed component of every planning document for a project.
5.4.2 Management system planning

Quality management
ISO 9001 Respon-
5.4.2 Top management shall ensure that EA, MAN, A53600-Q4100-P800-01 Process Management policy PTD
EA BA CRM, management

Quality management
ISO 9001 Respon-
a) the planning of the quality manage- SCM, Quality management-
ment system is carried out in order PLM, Guidelines PTD
SUP VA Q7350 Technical modifications
to meet the requirements given in
4.1, as well as the quality objec- VA Q7410 Supplier qualification and
tives, and evaluation
b) the integrity of the quality manage-
ment system is maintained when
changes to the quality management
system are planned and imple-
mented
The quality system shall ensure that the

product conforms to the type described
in the EC type-examination certificate.
All the elements, requirements and pro-
visions adopted by the manufacturer
shall be documented in a systematic and
orderly manner in the form of written
policies, procedures and instructions. the
quality system documentation shall
permit a consistent interpretation of
quality programmes, plans, manuals and
records.´
The manufacturer shall facilitate an
arrangement whereby the notified body
may audit aspects of the suppliers op-
erations that affect the type of protection.
Planning and enhancement of the management system take place in the management review and in
other meetings of the PTD EA senior management. Decisions are recorded in the meeting minutes and
in action item lists. In case of modifications, the process owners and the management of the organiza-
tional units are responsible for maintaining the management system during the planning and implemen-
tation.
ISO 14001 Respon-
4.3.3 The organization shall establish, imple- EA, MAN, Quality Declaration
ment and maintain documented envi- EA BA CRM, A53600-E4330-P800-01 Environment
ronmental objectives and targets, at SCM, program
relevant functions and levels within the PLM,
organization. SUP
ment.
interested parties.
The organization shall establish, im-
plement and maintain a program(s)
for achieving its objectives and tar-

ISO 14001 Respon-
gets. Program(s) shall include
achieving objectives and targets
at relevant functions and levels of
the organization, and
b) the means and time frame by
which they are to be achieved.
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority

Quality management
ISO 9001 Respon-
5.5.1 Top management shall ensure that the EA, MAN, Business Regulations
responsibilities and authorities are de- EA BA CRM, Organization and work plans VZM-
fined and communicated within the or- SCM, Overview
ganization. PLM,
SUP Job description for former responsible
parties
Responsibilities and authority for the
following shall be defined:
a) the effective co-ordination of activi-
ties with respect to products in-
tended for use in explosive atmos-
pheres;
b) the need to liaise with the notified
body responsible for the issue of the
EC type-examination certificate and
the technical documentation;
c) the need to liaise with the notified
body responsible for the assess-
ment of the quality system with re-
spect to intended updating of the
quality system;
d) the authorizing of initial approval
and changes to related drawings,
where appropriate;
e) the authorizing of concessions;
f) informing the customer of any appli-
cable special conditions for safe use
and any schedules of limitations.
ISO 14001 Respon-
4.4.1 Management shall ensure the availability EA MAN, Business Regulations Norms and Standards
of resources essential to establish, im- EA BA SUP(5) X2 Signature authorizations Management policy PTD
plement, maintain and improve the envi-
ronmental management system. Re- QS-WI-FA-019-N Signature regula- Environment manage-
sources include human resources and tions ment –Guidelines PTD
sources.
shall be defined, documented and
communicated in order to facilitate
effective environmental management.


provement.

Guidelines
Respon-
sibility
Mgmt.
2.4.1 Top management should establish the EA, MAN, Business Regulations
competencies, responsibilities and au- EA BA CRM, QM-Guideline Nr. 7-01: Occupational
thorities for the development, implemen- SCM, safety and health management at
tation and performance of H&S Mgmt. PLM, PTD
and for attaining the established occupa- SUP
tional safety and health objectives.
2.4.2 Structures and procedures must be set, EA, MAN, Business Regulations
that EA BA CRM, QM-Guideline Nr. 7-01: : Occupational
a) guarantee that occupational safety SCM, safety and health management at
and health is known and accepted PLM, PTD
at all levels and is anchored in the SUP
VAQ5530: Communication
responsibility area of line manage-
ment; QS-PR-QM-012-N internal Communi-
cation
b) define the competencies, responsi-
bilities and authorities of those per- ZP-Memorandum Nr. 28/95 Occupa-
sons who tional safety and health / promoting
company health
- identify and evaluate perils and re-
lated risks to safety and health,
- plan and implement the relevant ac-
tions and supervise their execution or
- perform consulting functions,
c) and report this to all members of the
organization;
d) fulfill H&S Mgmt.-principles of the
guidelines, of the specific handling
aids or voluntary programs to which
the organization has committed;
e) support prevention and action pro-
grams for promoting health;
f) establish and implement the neces-
sary company committees and work
groups for promoting safety and
health protection;
2.5 / 2.5.1. (Participation, rights and obligations of EA, MAN, Business Regulations
employees) EA BA CRM, Work Regulations
The organization should establish and SCM,
introduce appropriate procedures as well PLM,
as make available time and resources in SUP
order to involve employees in the im-
provement of safety and health protec-
tion. This should also be established for
their participation in the development
and enhancement of H&S Mgmt. as well
as the prevention and elimination of
perils. Existing committees and work
groups within the company are to be


Guidelines
Respon-
sibility
Mgmt.
used for this purpose.
Responsibility and competency of the organization units in PTD EA are thoroughly described in the
Business Regulations. Work plans relate to the respective employee allocation in the organizational
units and when needed are published by PTD EA management. The organization structure is made
available to all employees in the system Siemens Corporate Organization (SCO). The list of PTD EA
organizational units is found in Chapter 3 of the Management Manual.
The rights and obligations of employees are expressed in legal as well as Siemens internal regulations
such as Work Regulations. Employees bear the responsibility for implementing the occupational safety
and health policy of PTD EA in their area of responsibility as well as participating in its constant im-
provement.
Since we consider environment and occupational safety and health to be a community effort, our leaders
encourage employees to actively participate therein; they commit all employees to environment and oc-
cupational safety and health and challenge them to be constantly aware of environment and occupa-
tional safety. In this manner we anchor and promote conscientious responsibility for the environment and
workplace on all levels.
Furthermore, employees participate actively in this implementation in that they are involved personally,
either as being a safety representative, first aid assistant or fire-fighting assistant. In addition, every em-
ployee is to bring to the attention of the responsible leader, the safety representative or safety specialist
any suggestions for improving the environment or occupational safety and health, which in turn will be
evaluated and placed into practice or passed on to management.
5.5.2 Management representative

Quality management
ISO 9001 Respon-
5.5.2 Top management shall appoint a mem- EA MAN, Business Regulations Management policy PTD
ber of management who, irrespective of CRM,
other responsibilities, shall have respon- SCM,
sibility and authority that includes PLM,
a) ensuring that processes needed for SUP
the quality management system are
established, implemented and main-
tained,
performance of the quality man-
agement system and any need for
improvement, and
c) ensuring the promotion of aware-
ness of customer requirements
throughout the organization.
ISO 14001 Respon-

ISO 14001 Respon-
4.4.1 Management shall ensure the availability EA MAN, Business Regulations Norms and Standards
of resources essential to establish, im- EA BA SUP(5) Management policy PTD
plement, maintain and improve the envi-
ronmental management system. Re- Environment manage-
sources include human resources and ment –Guidelines PTD
sources.
shall be defined, documented and com-
municated in order to facilitate effective
environmental management.
other responsibilities, shall have
defined roles, responsibilities and
authority for
management system is estab-
lished, implemented and main-
tained in accordance with the re-
quirements of this International
Standard,
b) reporting to top management on
the performance of the environ-
mental management system for
review, including recommenda-
tions for improvement.

Guidelines
Respon-
sibility
Mgmt.
2.4.3 Top management should designate a EA MAN, Business Regulations Management policy PTD
representative for H&S Mgmt. who is CRM, QM-Guideline Nr. 7-01: Occupational
required to make reports. The represen- SCM, safety and health management at
tative must be responsible for PLM, PTD
a) the development, implementing, SUP
maintenance and support of H&S
Mgmt.;
b) routine reporting to top manage-
ment regarding H&S Mgmt. per-
formance and need for improve-
ments;
c) encouraging the participation of all
organization members.
Division management will designate a management system representative who will coordinate all three
work areas of the integrated management system. He will work as a partner together with the environ-
ment protection management system representative and with the occupational safety and health man-
agement system representative.
5.5.3 Internal communication

Quality management

ISO 9001 Respon-

5.5.3 Top management shall ensure that ap- EA, MAN, Business Regulations
propriate communication processes are EA BA CRM, VA Q5530 Communication
established within the organization and SCM,
that communication takes place regard- PLM, QS-PR-QM-012-N Internal Communi-
ing the effectiveness of the quality man- SUP cation
agement system.
ISO 14001 Respon-
4.4.3 With regard to its environmental aspects EA, MAN, Business Regulations Norms and Standards
and environmental management system, EA BA CRM, Quality Declaration Management policy PTD
the organization shall establish, imple- SCM, Intranet.
ment and maintain a procedure(s) for PLM, Environment manage-
SUP See Chapter 7.2.3. ment –Guidelines PTD
a) internal communication among the
various levels and functions of the
organization,
b) receiving, documenting and re-
sponding to relevant communication
from external interested parties.
The organization shall decide whether to
communicate externally about its signifi-
cant environmental aspects, and shall
document its decision. If the decision is
to communicate, the organization shall
establish and implement a method(s) for
this external communication.

Guidelines
Respon-
sibility
Mgmt.
2.8., (Communication and cooperation) EA, MAN, Business Regulations
2.8.1. Top management should establish pro- EA BA CRM, ZP-Memorandum Nr. 28/95 Occupa-
cedures for internal communication, i.e., SCM, tional safety and health / company
for information flow within the organiza- PLM, health promotion
tion – and for cooperation. These proce- SUP
VA Q5530 Communication
dures should ensure and promote infor-
mation flow and cooperation QS-PR-QM-012-N Internal Communi-
cation
a) between managers and their em-
ployees and vice-versa,
b) between persons with consulting
functions and those employed,
managers and functional depart-
ments,
c) between company committees or
work groups that are involved in the
area of safety and health protec-
tion,
d) between these company commit-
tees or work groups and managers,
employees and persons in consult-
ing as well as
e) between (same level) employees.
5.6 Management review
5.6.1 General

Quality management
ISO 9001 Respon-
5.6.1 Top management shall review the or- EA, MAN, Business Regulations
ganization’s quality management sys- EA BA CRM, A53600-Q4240-W800-01 Records of
tem, at planned intervals, to ensure its SCM, the Management system
continuing suitability, adequacy and PLM,
effectiveness. This review shall include SUP
assessing opportunities for improvement VA Q5530 Communication
and the need for changes to the quality QS-PR-QM-012-N Internal Communi-
management system, including the qual- cation
ity policy and quality objectives.
Records from management reviews shall
be maintained (see 4.2.4).
a) the maximum intervals between

reviews should normally be 12
months and shall not exceed 14
months;
b) top management shall chair the
review;
c) the person(s) responsible for the
activities as detailed in 5.5.1 shall
participate in the review.
ISO 14001 Respon-
4.6 Top management shall review the or- EA MAN, Business Regulations Norms and Standards
ganization's environmental management EA BA SUP(5) PTD ETS 0-002 Environment man- Management policy PTD
system, at planned intervals, to ensure agement- Audit
its continuing suitability, adequacy and Environment manage-
effectiveness. Reviews shall include ment –Guidelines PTD
assessing opportunities for improvement
and the need for changes to the envi-
ronmental management system, includ-
ing the environmental policy and envi-
ronmental objectives and targets. Re-
cords of the management reviews shall
be retained.
Input to management reviews shall in-
clude
a) results of internal audits and evalua-
tions of compliance with legal re-
quirements and with other require-
ments to which the organization
subscribes,
b) communication(s) from external
interested parties, including com-
plaints,
c) the environmental performance of
the organization,
d) the extent to which objectives and
targets have been met,
e) status of corrective and preventive
actions,
f) follow-up actions from previous
management reviews,
g) changing circumstances, including
developments in legal and other re-
quirements related to its environ-
mental aspects, and
h) recommendations for improvement.
The outputs from management reviews
shall include any decisions and actions

ISO 14001 Respon-
related to possible changes to environ-
mental policy, objectives, targets and
other elements of the environmental
management system, consistent with the
commitment to continual improvement.
.

Guidelines
Respon-
sibility
Mgmt.
2.18., (Evaluation performed by top manage- EA, MAN, Business Regulations
2.18.1. ment) EA BA CRM, PTD QM-Guideline Nr. 7-01 Work-
Top management should SCM, place Protection-Management at PTD
PLM,
a) evaluate the overall strategy of H&S SUP A53600-Q4100-P800-01 Process
Mgmt. in order to ascertain if the management
planned performance goals have A53600-Q4240-W800-01 Records to
been reached; the Management system
b) evaluate the capability of H&S
Mgmt. to fulfill the safety and health
protection requirements of the or- QS-PR-QM-009-N Corrective and
ganization; preventive actions
c) evaluate the necessity for modifica- QS-PR-QM-010-N Measurement,
tions in H&S Mgmt., including occu- Analysis and Improvement
pational safety and health policy
and occupational safety and health
objectives;
d) check to see which improvements
are necessary in an appropriate
time period,
e) in view of a meaningful planning
and continuous improvement, indi-
cate the addressees for feedback,
including setting priorities;
f) evaluate progress regarding occu-
pational safety and health objectives
of the organization and of the cor-
rection actions;
g) evaluate the effectiveness of follow-
up actions based on earlier evalua-
tions made by top management.
2.18.2. The frequency and scope of routine EA, MAN, Business Regulations
evaluations made by top management EA BA CRM, PTD QM-Guideline Nr. 7-01 Occupa-
should depend on the needs and re- SCM, tional safety and health-Management
quirements of the organization. The PLM, at PTD
intervals between evaluations should not SUP
influence the effectiveness of H&S A53600-Q4100-P800-01 Process
Mgmt. performance management
A53600-Q4240-W800-01 Records for
the Management system
QS-PR-QM-009-N Corrective and

preventive actions
QS-PR-QM-010-N Measurement,
Analysis and Improvement
Division management and the management of individual organizational units execute at least yearly a
management review in order to verify that the integrated management system is up-to-date and effective
and to assure that needed improvement measures are implemented. The suitability, adequacy and effec-

tiveness of the management system are reviewed as well. Opportunities for further improvements and
need for modifications are determined.
Results of the management review are recorded in a protocol that serves to attest to the fulfillment of the
corporate guidelines for guaranteeing process and product quality.
5.6.2 Review input

Quality management
ISO 9001 Respon-
5.6.2 The input to management review shall EA, MAN, Business Regulations
include information on EA BA CRM, A53600-Q4240-W800-01 Records for
a) results of audits, SCM, the Management system
PLM,
b) customer feedback, SUP
c) process performance and product Audits
conformity, Customer surveys, CSI
d) status of preventive and corrective Balanced Scorecards
actions, Self evaluations
Management-Reviews
e) follow-up actions from previous Q-Days
management reviews,
f) changes that could affect the quality
management system, and
g) recommendations for improvement.
The review shall include the overall

effectiveness of the quality management
system with respect to products intended
for use in potentially explosive atmos-
pheres
ISO 14001 Respon-
4.6 Top management shall review the or- EA MAN, Business Regulations Norms and Standards
ganization's environmental management EA BA SUP(5) Management policy PTD
system, at planned intervals, to ensure
its continuing suitability, adequacy and Environment manage-
effectiveness. Reviews shall include ment –Guidelines PTD
be retained.
Input to management reviews shall
include
a) results of internal audits and
evaluations of compliance with
legal requirements and with other
requirements to which the or-
ganization subscribes,
interested parties, including
complaints,
c) the environmental performance
of the organization,
d) the extent to which objectives
and targets have been met,
e) status of corrective and preven-
tive actions,

ISO 14001 Respon-
management reviews,
g) changing circumstances, includ-
ing developments in legal and
other requirements related to its
environmental aspects, and
h) recommendations for improve-
ment.
The outputs from management reviews
shall include any decisions and actions
related to possible changes to environ-
mental policy, objectives, targets and
other elements of the environmental
management system, consistent with the
commitment to continual improvement.

Guidelines
Respon-
sibility
Mgmt.
2.18.3. The evaluation made by top manage- EA, MAN, Business Regulations
ment should consider: EA BA CRM, PTD QM-Guideline Nr. 7-01 „Occupa-
a) the results from investigating SCM, tional safety and health management
work-related injuries, illnesses, PLM, at PTD“
accidents and near miss- SUP
accidents, health impairments as preventive actions
well as supervision and measure-
ments of performance and audit-
ing actions;
b) additional internal and external
influences and changes, including
organizational changes that could
impact H&S Mgmt..
The basis for the management review is formed by the analysis of audit reports and other records, e.g.,
test reports, project status reports, error reports, error statistics and the analysis of routine departmental
meetings. An important part of the management review is the evaluation of the implementing of impor-
tant preventive actions and the effectiveness of executed corrective actions.
In addition, information regarding customer satisfaction and customer feedback as well as data on the
effectiveness of the main processes is used. Implementation of actions originating from prior manage-
ment reviews is verified. Modifications that could impact the management system are presented, and
recommendations for improvements from various sources are taken into consideration.
5.6.3 Review output

Quality management
ISO 9001 Respon-
5.6.3 The output from the management review EA, MAN, Business Regulations
shall include any decisions and actions EA BA CRM, Audits
related to SCM, Customer surveys
a) improvement of the effectiveness of PLM, Self evaluations
the quality management system and SUP Management-Reviews
its processes, Q-Days
b) improvement of product related to Budget planning
customer requirements, and
c) resource needs.

ISO 14001 Respon-
4.6 Top management shall review the or- EA, MAN, Business Regulations Norms and Standards
ganization's environmental management EA BA CRM, A53600-E4460-P800-01 sequence Management policy PTD
system, at planned intervals, to ensure SCM, control environmental aspects
its continuing suitability, adequacy and PLM, Environment manage-
effectiveness. Reviews shall include SUP ment –Guidelines PTD
be retained.
Input to management reviews shall in-
clude
a) results of internal audits and evalua-
tions of compliance with legal re-
quirements and with other require-
ments to which the organization
subscribes,
interested parties, including com-
plaints,
c) the environmental performance of
the organization,
d) the extent to which objectives and
targets have been met,
e) status of corrective and preventive
actions,
management reviews,
g) changing circumstances, including
developments in legal and other re-
quirements related to its environ-
mental aspects, and
h) recommendations for improvement.
The outputs from management re-
views shall include any decisions and
actions related to possible changes
to environmental policy, objectives,
targets and other elements of the
environmental management system,
consistent with the commitment to
continual improvement.

Guidelines
Respon-
sibility
Mgmt.
2.18.4. Results of the evaluation as ascertained EA, MAN, Business Regulations
by top management should be recorded EA BA CRM, A53600-Q4240-W800-01 Records for
and reported to the H&S Mgmt. repre- SCM, the Management system
sentative. Organization members should PLM,
be informed thereof in an appropriate SUP
manner. VA Q5530 Communication
QS-PR-QM-012-N Internal Communi-
cation
The results of the management review are documented in a report, in updates of the continuously main-
tained list of action items and in the published quality, environment and occupational safety and health
objectives. The results contain decisions and measures for
Improving the effectiveness of the management system and its processes

Improvement of products based on customer requirements

Need for resources

6 Resource Management
6.1 Provision of resources

Quality management
ISO 9001 Respon-
6.1 The organization shall determine and EA, MAN, Business Regulations Management policy PTD
provide the resources needed EA BA CRM, VA Q6100 Accountancy Quality management
a) to implement and maintain the SCM, Guidelines PTD
PLM, VA Q6300 Establishment and sup-
quality management system and port of the infrastructure
continually improve its effective- SUP
ness, and QS-PR-DE-001-G Development Pro-
cess
b) to enhance customer satisfaction
QS-PR-OP-001-G Project Delivery
by meeting customer requirements.
Process
ISO 14001 Respon-
4.4.1 Management shall ensure the avail- EA, MAN, Business Regulations Norms and Standards
ability of resources essential to es- EA BA CRM, Quality Declaration Management policy PTD
tablish, implement, maintain and SCM,
improve the environmental manage- PLM, Environment manage-
ment system. Resources include SUP ment –Guidelines PTD
human resources and specialized
skills, organizational infrastructure,
technology and financial resources.
provement.

Guidelines
Respon-
sibility
Mgmt.

2.3 The formation of occupational safety and EA, MAN, PTD QM-Guideline Nr. 7-01 „Occupa- Management policy PTD
health planning should encompass the EA BA CRM, tional safety and health-Management
availability of sufficient financial, person- SCM, at PTD
nel, technical and timely resources PLM, PTD QM-Guideline Nr. 7-02 „Occupa-
including necessary information for all SUP tional safety and health-Work instruc-
organization members. tions“
A53607-E4310-P800-01 Considera-
tion of environmental and occupa-
tional safety and health aspects in
processes, products and services
All employees who participate in the business processes CRM, SCM and PLM are in a position where
they can influence customer satisfaction and are thus responsible for the improvement of customer satis-
faction. The necessary resources are determined in the planning documents.
The management of an organizational unit is fundamentally responsible for the resource planning in their
area of responsibility. Unless additional resources are needed from other organizational units, the re-
source planning is carried by the own organization’s management.
6.2 Human resources
6.2.1 General
Quality management
ISO 9001 Respon-
6.2.1 Personnel performing work affecting EA, MAN, VA Q6200 Employee development
product quality shall be competent on EA BA CRM, at PTD PA
the basis of appropriate education, train- SCM,
ing, skills and experience. PLM,
SUP
ISO 14001 Respon-
4.4.1 Management shall ensure the availability EA, MAN, Business Regulations Norms and Standards
of resources essential to establish, im- EA BA CRM, Management policy PTD
plement, maintain and improve the envi- SCM,
ronmental management system. Re- PLM, Environment manage-
sources include human resources SUP ment –Guidelines PTD
and specialized skills, organizational
infrastructure, technology and finan-
cial resources.
provement.


Guidelines
Respon-
sibility
Mgmt.
2.6. Qualification and training EA, MAN, See 6.2.2.
EA BA CRM,
SCM,
PLM,
SUP
Management of an organizational unit together with the personnel organization is responsible for hiring
and further competency training of all employees. Personnel must have the necessary competence that
is to be achieved through education, training, skills, and experience.
6.2.2 Competence, awareness and training

Quality management
ISO 9001 Respon-
6.2.2 The organization shall EA, MAN, A53607-Q6220-P800-01 Compe-
EA BA CRM, tence, awareness and training
a) determine the necessary compe-
SCM,
tence for personnel performing
PLM,
work affecting product quality,
SUP
b) provide training or take other ac-
tions to satisfy these needs,
c) evaluate the effectiveness of the
actions taken,
d) ensure that its personnel are aware
of the relevance and importance of
their activities and how they con-
tribute to the achievement of the
quality objectives, and
e) maintain appropriate records of
education, training, skills and ex-
perience (see 4.2.4).
ISO 14001 Respon-
4.4.2 The organization shall ensure that any EA MAN Business Regulations Norms and Standards
person(s) performing tasks for it or on its EA BA Management policy PTD
behalf that have the potential to cause a
significant environmental impact(s) iden- Environment management
tified by the organization is (are) compe- –Guidelines PTD
tent on the basis of appropriate educa-
tion, training or experience, and shall
retain associated records.
The organization shall identify training
needs associated with its environmental
aspects and its environmental manage-
ment system. It shall provide training or
take other action to meet these needs,
and shall retain associated records.
ment and maintain a procedure(s) to
make persons working for it or on its
behalf aware of
a) the importance of conformity with
the environmental policy and pro-
cedures and with the requirements
of the environmental management
system,
b) the significant environmental as-

ISO 14001 Respon-
pects and related actual or potential
impacts associated with their work,
and the environmental benefits of
improved personal performance,
c) their roles and responsibilities in
achieving conformity with the re-
quirements of the environmental
d) the potential consequences of
departure from specified proce-
dures.

Guidelines
Respon-
sibility
Mgmt.
2.6., (Qualification and training) EA, MAN, PTD QM-Guideline Nr. 7-02 „Occupa-
2.6.1. Top management should define the EA BA CRM, tional safety and health- Work instruc-
necessary qualification requirements SCM, tions“
and set and maintain commitments that PLM, A53607-Q6220-P800-01 Compe-
ensure that all organization members SUP tence, awareness and training
are sufficiently qualified and competent
in order to comply with their obligations
and responsibilities for safety and health
protection.
2.6.2 The qualification should be guaranteed EA, MAN,
through appropriate training and infor- EA BA CRM, PTD QM-Guideline Nr. 7-02 „Occupa-
mation programs, that cover the follow- SCM, tional safety and health - work in-
ing: PLM, structions“
a) the occupational safety and health SUP
A53607-Q6220-P800-01 Compe-
policy as committed in the organi- tence, awareness and training
zation and the respective objec-
tives
b) the organization structure and
sequence and the respective re-
sponsibilities within the organiza-
tion;
c) the perils and related risks to
safety and health;
d) measures to be taken.
2.6.3. Training and information programs as EA, MAN, PTD QM-Guideline Nr. 7-02 „Occupa-
presented in paragraph 2.6.1 should EA BA CRM, tional safety and health - work in-
a) be carried out by qualified indi- SCM, structions“
viduals; PLM, A53600-Q4240-W800-01 Records for
SUP the Management system
b) encompass effective and timely
initial instruction and provide in A53607-Q6220-P800-01 Compe-
appropriate intervals repeated in- tence, awareness and training
struction;
c) contain an evaluation of the train-
ing by the participants regarding
comprehensibility and retention;
d) include an evaluation of training
success by the immediate super-
visors based on the employee
level of knowledge and perform-
ance:
e) be reviewed in routine intervals
and changed if needed in order to
guarantee relevancy and effec-
tiveness. Existing company com-
mittees and work groups, per
2.5.1 should be included in the
evaluation where appropriate;


Guidelines
Respon-
sibility
Mgmt.
f) be adequately documented. The
size and type of activities of the
organization must be taken into
consideration;
g) must be free of cost for all partici-
pants and whenever possible,
take place during work hours.
Necessary personnel resources are provided by GG or OE/OTE for the planning and implementing of
occupational safety and health. These resources are the management representatives and safety spe-
cialists supplied by GG or the appropriate representative, while the safety representative, first aid assis-
tants and those trained in fire fighting are supplied by OE/OTE. OT/OTE provides these individuals with
sufficient free time for the occupational safety and health needs and cover all personnel and additional
expenses. This is also for time and financial expenditures necessitated by including other employees
(e.g., for information, instruction or evacuation drills, etc).
Employees are informed and instructed by their supervisors before beginning work in their area or at
process modifications and later at least once annually regarding occupational safety and health at their
workstation and in general in the company. This instruction should encompass the:
- Environment policy of PTD EA
- Occupational safety and health policy of PTD EA and the respective objectives;
- The organizational structure and sequence of occupational safety and health and the related re-
sponsibilities of PTD EA;
- The perils and related risks to safety and health;
- Actions to be taken;
- Further instructions as per the PTD QM-Guideline 7-02, Chap. 4.2
In addition, those employees who have a special function in occupational safety and health receive spe-
cial training:
- Safety representatives:
after their assignment, they are trained by safety specialists (e.g., at PS UAS or BGFE). This train-
ing includes yearly refresher courses offered by the safety specialists. Safety representatives par-
ticipate in the routine meetings of the occupational safety committee (ASA).
- First Aid assistants:
are provided with a 2-day basic training through the safety specialist (e.g., from the German Red
Cross). A refresher course is offered every two years, while annually such courses are offered by
PS UAS. This is also brought about by the safety specialist.
- Those trained in fire fighting (fire fighter aids)
receive a one-day training which is repeated on an annual basis whereby participation is at the dis-
cretion of the fire fighter aid. These repeat courses should not be taken at intervals greater than 3
to 5 years. The training is documented by the safety specialist.
The information, instruction and training provided should be evaluated by the participants regarding
comprehensibility and retention. Execution of training is documented by the safety specialist.
Management encourages timely continued training of employees.
6.3 Infrastructure
Quality management
ISO 9001 Respon-
6.3 The organization shall determine, pro- EA, MAN, VA Q6300 Establishment and main-
vide and maintain the infrastructure EA BA CRM, tenance of infrastructure

Quality management
ISO 9001 Respon-
needed to achieve conformity product SCM, Work instructions
requirements. Infrastructure includes, as PLM,
applicable SUP QS-PR-MIS-002 Infrastructure and
Work Environment
a) buildings, workspace and associ-
ated utilities,
b) process equipment (both hardware
and software), and
c) supporting services (such as trans-
port or communication).
ISO 14001 Respon-
4.4.1 Management shall ensure the avail- EA, MAN, R2 Proposal and approval of
ability of resources essential to es- EA BA CRM, investments and com-
tablish, implement, maintain and SCM, pany efforts in construc-
improve the environmental manage- PLM, tion and purchasing pro-
ment system. Resources include SUP posals
human resources and specialized
provement.

Guidelines
Respon-
sibility
Mgmt.
2.3 Availability of resources See 6.1
6.4 Work environment

Quality management
ISO 9001 Respon-
6.4 The organization shall determine and EA CRM(4), VA Q7540 Customer property –
manage the work environment needed PLM, Product conservation
to achieve conformity to product re- SUP(3); QS-PR-MIS-002 Infrastructure and
quirements. SCM Work Environment
PTD QM-Guideline Nr. 7-02

ISO 14001 Respon-
4.4.1 Management shall ensure the avail- EA MAN, Business Regulations Norms and Standards
ability of resources essential to es- EA BA SUP(5) R2 Proposal and approval of Management policy PTD
tablish, implement, maintain and investments and com-
improve the environmental manage- Environment manage-
pany efforts in building ment –Guidelines PTD
ment system. Resources include and purchasing propos-
human resources and specialized als
provement.

Guidelines
Respon-
sibility
Mgmt.
2.3. Availability of resources See 6.1
7 Product realization
7.1 Planning of product realization

Quality management
ISO 9001 Respon-
7.1 The organization shall plan and develop EA, MAN, A53600-Q4100-P800-01 Process Quality management-
the processes needed for product reali- EA BA CRM, management Guidelines PTD
zation. Planning of product realization SCM, A53600-Q4240-W800-01 Records for
shall be consistent with the requirements PLM, the Management system
of the other processes of the quality SUP
management system (see 4.1).
In planning product realization, the or- VA Q7100 Portfolio management
ganization shall determine the following, and Product definition
as appropriate: QS-PR-MA-001-G Product Manage-
a) quality objectives and requirements ment Process
for the product; QS-PR-DE-001-G Development Pro-
b) the need to establish processes, cess
documents, and provide resources QS-PR-OP-001-G Project Delivery
specific to the product; Process
c) required verification, validation, QS-PR-CS-001-G Communication
monitoring, inspection and test ac- Solution Delivery Process

Quality management
ISO 9001 Respon-
tivities specific to the product and QS-PR-OP-009-G Services & Solu-
the criteria for product acceptance; tions Sub Process
d) records needed to provide evidence
that the realization processes and
resulting product meet requirements
(see 4.2.4).
The output of this planning shall be in a
form suitable for the organization’s
method of operations.
ISO 14001 Respon-
4.4.6 The organization shall identify and plan EA, MAN, Business Regulations Norms and Standards
those operations that are associated EA BA CRM, A53600-E4320-W800-01 Legal and Management policy PTD
with the identified significant environ- SCM, other requirements for environment
mental aspects consistent with its envi- PLM, Environment management
protection –Guidelines PTD
ronmental policy, objectives and targets, SUP
in order to ensure that they are carried A53600-E4460-P800-01 Sequence
out under specified conditions, by control environmental aspects
a) establishing, implementing and
maintaining a documented proce-
dure(s) to control situations where
their absence could lead to devia-
tion from the environmental policy,
objectives and targets, and
b) stipulating the operating criteria in
the procedure(s), and
c) establishing, implementing and
maintaining procedures related to
the identified significant environ-
mental aspects of goods and ser-
vices used by the organization and
communicating applicable proce-
dures and requirements to suppli-
ers, including contractors.

Guidelines
Respon-
sibility
Mgmt.
2.11. Establishing work, sequences and proc- EA, MAN, see 4.1.
esses (planning) EA BA CRM,
SCM,
PLM,
SUP
2.12., (Evaluation of perils) EA, MAN, PTD QM-Guideline Nr. 7-01 Occupa-
2.12.1. The organization should determine and EA BA CRM, tional safety and health management
evaluate perils and related risks for SCM, at PTD
safety and health at the workplace in PLM, PTD QM-Guideline Nr. 7-02 „Occupa-
order to derive necessary measures for SUP tional safety and health – work instruc-
occupational safety and health. The tions“
evaluation should be undertaken based PTD QM-Guideline Nr. 7-03 „Occupa-
on the type of activity. In case of identi- tional safety and health at PTD con-
cal work conditions, the evaluation of struction sites“
one workplace or activity is sufficient.
2.12.2 For determination of perils, the organiza- EA, MAN, PTD QM-Guideline Nr. 7-01
tion should introduce and maintain pro- EA BA CRM, Occupational safety and health man-
cedures for evaluating perils originating SCM, agement at PTD
at workplaces, sequences, processes PLM,
and installations that involve expected SUP PTD QM-Guideline Nr. 7-02 „Occupa-
risks for employees and persons on tional safety and health – work instruc-


Guidelines
Respon-
sibility
Mgmt.
organization premises. tions“
PTD QM-Guideline Nr. 7-03 „Occupa-
tional safety and health at PTD con-
struction sites“
2.12.3. In the evaluation of perils that cannot be EA, MAN, PTD QM-Guideline Nr. 7-01 Work
ruled out for employees and persons on EA BA CRM, protection management at PTD
the organization premises, the risks SCM, PTD QM-Guideline Nr. 7-02 „Work
associated with these perils regarding PLM, protection - work instructions“
safety and health should be evaluated SUP
and taken into consideration for the PTD QM-Guideline Nr. 7-03 „Work
company in question as well for the protection at PTD construction sites“
other companies involved.
2.13.1 Actions for avoiding or minimizing perils see 8.5.3
2.14., (Change management) EA, MAN, A53607-E4310-P800-01
2.14.1. Impact of internal modifications (e.g., in EA BA CRM, Consideration of environment and
personnel, or due to new procedures, SCM, occupational safety and health as-
work sequences, organization structures PLM, pects in processes, products and
or acquisitions) and external modifica- SUP services
tions (e.g., resulting from changes in
legal provisions and developments in the
area of occupational safety and health
knowledge and technology) at the work-
place should be studied and evaluated.
The impact of H&S Mgmt. should also
be secured during a modification phase.
2.14.2. A perils evaluation for the workplace EA, MAN, PTD QM-Guideline Nr. 7-01 Work
should be made before any change or EA BA CRM, protection management at PTD
introduction of new work procedures, SCM, A53607-E4310-P800-01 Considera-
work sequences, materials or machin- PLM, tion of environment and occupational
ery. SUP safety and health aspects in proc-
esses, products and services
2.14.3. When implementing change measures, it EA, MAN, PTD QM-Guideline Nr. 7-01 Work
must be assured that all organization EA BA CRM, protection management at PTD
members concerned have been suffi- SCM, A53607-E4310-P800-01 Considera-
ciently instructed and that they are quali- PLM, tion of environment and occupational
fied. SUP safety and health aspects in proc-
esses, products and services
Quality, environment and occupational safety and health objectives are documented in records and
planning documents. Additional requirements can be determined by the market and customers, and
these are noted in the specifications. Records of verification, validation, observation, test activities and
release criteria are filed within the projects, in order to show that the realization process and the resulting
product fulfill the requirements.
The perils evaluation is performed according to type of activity. In case of identical work conditions, the
evaluation of one workplace or activity is sufficient. The handling intended as well as the handling not
intended is appraised and considered. Required Actions for environment and occupational safety and
health are derived from the perils evaluation.
When executing modifications (internal such as in personnel, or due to new procedures, work se-
quences, organization structures or installations or external such as changes in legal provisions and de-
velopments in the area of occupational safety and health knowledge and technology), the impact on the
workplace should be studied and evaluated by the responsible management. If necessary, management
takes measures to assure the effectiveness of the environment and occupational safety and health man-
agement system during the modification phase.
A perils evaluation for the workplace should be executed before any change or introduction of new work
procedures, work sequences, materials or machinery.

7.2 Customer-related processes

Guidelines
Respon-
sibility
Mgmt.
2.11. Establishing work, sequences and proc- See 7.1
esses (planning)
2.12 Evaluation of perils see 7.1

2.13.1 Actions for avoiding or minimizing perils see 8.5.3
7.2.1 Determination of requirements related to the product

Quality management
ISO 9001 Respon-
7.2.1 The organization shall determine EA CRM, A53600-Q7300-P600-01 Product Quality management-
a) requirements specified by the cus- SCM, Development Guidelines PTD
tomer, including the requirements PLM, VA Q7100 Portfolio management
for delivery and post-delivery activi- SUP(3, 8) and Product definition
ties, –––––– -–––––––
EA BA PLM3, VA Q7200 Business Development
b) requirements not stated by the SUP6 VA Q7201 Preparation of bids, Pro-
customer but necessary for speci- ject handling
fied or intended use, where known,
QS-PR-SA-001-G CAP Process
c) statutory and regulatory require-
ments related to the product, and QS-PR-MA-001-G Product Manage-
ment Process
d) any additional requirements deter-
QS-PR-CS-001-G Communication
mined by the organization.
Solution Delivery Process
Ex-Manual for each Z-Version
The product category and marking shall
be included .
ISO 14001 Respon-
4.3.1 The organization shall establish, imple- EA CRM, Business Regulations Norms and Standards
ment and maintain a procedure(s) SCM, Management policy PTD
a) to identify the environmental PLM,
SUP(3, 8) Environment management
aspects of its activities, products –Guidelines PTD
and services within the defined –––––– -–––––––
scope of the environmental man- EA BA PLM(3),
agement system that it can con- SUP(6)
trol and those that it can influ-
ence taking into account planned
or new developments, or new or
modified activities, products and
services, and
taken into account in establishing, im-
plementing and maintaining its environ-
mental management system.

ISO 14001 Respon-
4.3.2 The organization shall establish, im- EA QES SUP(2) A53600-E4320-W800-01 Legal and
plement and maintain a procedure(s) other requirements for environment
a) to identify and have access to the protection
applicable legal requirements and
other requirements to which the
organization subscribes related
to its environmental aspects, and
b) to determine how these require-
ments apply to its environmental
aspects.
The organization shall ensure that these
applicable legal requirements and other
subscribes are taken into account in
establishing, implementing and maintain-
ing its environmental management sys-
tem.
4.4.6 The organization shall identify and plan EA CRM, Norms and Standards
those operations that are associated SCM, Management policy PTD
with the identified significant environ- PLM,
mental aspects consistent with its envi- SUP(3, 8) Environment management
ronmental policy, objectives and targets, –––––– -––––––– –Guidelines PTD
in order to ensure that they are carried EA BA PLM(3),
out under specified conditions, by SUP(6)
.

Guidelines
Respon-
sibility
Mgmt.
2.10. Establishing obligations EA CRM,
The organization should introduce and SCM,
maintain procedures in order to routinely PLM(3,4),
establish and implement relevant legal SUP(2,6)
provisions. Documents here result from, –––––– -–––––––
e.g., authorizations, permits from au- EA BA PLM(3),
thorities, from expert testing or from SUP(6)
official company reviews. Also, wage
contracts, technical control work, norms
etc can be included herein.
Requirements are systematically established and contain:

• Customer requirements that can also include requirements for delivery and for activities in the start-
up phase
• Requirements that are not stipulated by the customer but are crucial for the specified or intended
application
• Legal and official product-specific requirements

• Requirements that have been additionally established by the organization

Requirements undergoing modifications regarding legal procedures, wage contracts, technical control
work, norms etc. are determined by the safety specialist and communicated either directly or through
routine ASA meetings (ASA=Occupational safety and health committee) to PTD EA.
Additional requirements that result from new or modified tasks or task areas are to be determined in ad-
vance by the responsible management together with PTD QES, if needed with consultation with the
safety specialist.
7.2.2 Review of requirements related to the product

Quality management
ISO 9001 Respon-
7.2.2 The organization shall review the re- EA CRM, A53600-Q7300-P600-01 Product BAV-Guidelines
quirements related to the product. This SCM, Development Quality management-
review shall be conducted prior to the PLM, A53600-Q4240-W800-01 Records for Guidelines PTD
organization’s commitment to supply a SUP(3, 8) the Management system
product to the customer (e. g. submis- –––––– -–––––––
sion of tenders, acceptance of contracts EA BA PLM(3),
or orders, acceptance of changes to SUP(5, 6) VA Q7201 Bid preparation, Project
contracts or orders) and shall ensure handling
that QS-PR-SA-001-G CAP Process
a) product requirements are defined, QS-PR-MA-001-G Product Manage-
b) contract or order requirements ment Process
differing from those previously ex- QS-PR-CS-001-G Communication
pressed are resolved, and Solution Delivery Process
c) the organization has the ability to
meet the defined requirements.
Records of the results of the review and
actions arising from the review shall be
maintained (see 4.2.4).
Where the customer provides no docu-
mented statement of requirement, the
customer requirements shall be con-
firmed by the organization before accep-
tance.
Where product requirements are
changed, the organization shall ensure
that relevant documents are amended
and that relevant personnel are made
aware of the changed requirements.
The review shall ensure that any stated

customer requirement is compatible with
the EC type-examination certificate e.g.
ambient temperature range.
ISO 14001 Respon-
4.3.1 The organization shall establish, imple- EA CRM, Norms and Standards
ment and maintain a procedure(s) SCM, Management policy PTD
a) to identify the environmental as- PLM,
SUP(3, 8) Environment management
pects of its activities, products and –Guidelines PTD
services within the defined scope of –––––– -–––––––
the environmental management EA BA PLM(3),
system that it can control and those SUP(5, 6)
that it can influence taking into ac-
count planned or new develop-
ments, or new or modified activities,
products and services, and

ISO 14001 Respon-
taken into account in establishing,
implementing and maintaining its
environmental management system.
4.4.6 The organization shall identify and plan EA CRM, A53600-E4320-W800-01 Legal and Norms and Standards
those operations that are associated SCM, other requirements for environment Management policy PTD
with the identified significant environ- PLM, protection
A53600-E4460-P800-01 Sequence –Guidelines PTD
ronmental policy, objectives and targets, –––––– -––––––– control environmental aspects
in order to ensure that they are carried EA BA PLM(3),
out under specified conditions, by SUP(5, 6)

7.2.3 Customer Communication

Quality management
ISO 9001 Respon-
7.2.3 The organization shall determine and EA, MAN, A53600-Q7300-P600-01 Product Quality management-
implement effective arrangements for EA BA CRM, Development Guidelines PTD
communicating with customers in SCM, VA Q7100 Portfolio management
relation to PLM, and Product definition
SUP
a) product information, VA Q7200 Business Development
b) enquiries, contracts or order VA Q7201 Bid preparation, Project
handling, including amendments, handling
and VA Q7230 Customer Care
c) customer feedback, including QS-PR-MA-003-G Product Portfolio
customer complaints. Management Process
QS-PR-OP-001-G Project Delivery
Process
QS-PR-CS-001-G Communication
Solution Delivery Process
QS-PR-OP-009-G Services & Solu-
tions Sub Process
ISO 14001 Respon-
4.4.3 With regard to its environmental aspects EA, MAN, Business Regulations Norms and Standards
and environmental management system, EA BA CRM, Quality Declaration Management policy PTD
the organization shall establish, imple- SCM,
ment and maintain a procedure(s) for PLM, Environment management
SUP –Guidelines PTD
a) internal communication among the
various levels and functions of the
organization,
b) receiving, documenting and re-
sponding to relevant communication
from external interested parties.
The organization shall decide whether to
communicate externally about its signifi-
cant environmental aspects, and shall
document its decision. If the decision is
to communicate, the organization shall
establish and implement a method(s) for
this external communication
One of the main success factors for products and solutions from PTD EA is the communication of prod-
uct information to the customer. The information flow for the basic product is part of the Product Portfolio
Management Process.
Communication with the customer is also an essential requirement for successful customer projects.
This concerns all phases from acquisition through delivery, up to the guarantee and servicing phase.
Guidelines
Respon-
sibility
Mgmt.
2.8.2. Management should establish proce- EA, SUP(8) VAQ5530: Communication
dures for communication with external EA BA QS-PR-QM-012-N Internal Communi-
sites, especially authorities, accident cation
insurance carriers, experts and test sites
as well as with the public.
Communication regarding occupational safety and health with external sites is covered by PS UAS that
has the technical responsibility for occupational safety and health.


Guidelines
Respon-
sibility
Mgmt.
2.8.3. In the case of employees from other EA, SUP(6,8) See 7.4
organizations (such as contractors) who EA BA
perform in joint workplaces within their
own organization or are employed in the
same work spheres, procedures for
communication with these other organi-
zations must be established in order to
determine actions for safety and health
protection.
7.3 Design and Development

Guidelines
Respon-
sibility
Mgmt.
2.11. Establishing work, sequences and proc- EA, MAN, see 7.1
SCM,
PLM,
SUP
2.12 Evaluation of perils EA, MAN, see 7.1
EA BA CRM,
SCM,
PLM,
SUP
2.13.1 Actions for avoiding or minimizing perils EA, MAN, see 8.5.3
EA BA CRM,
SCM,
PLM,
SUP
7.3.1 Design and Development planning

Quality management
ISO 9001 Respon-
7.3.1 The organization shall plan and control EA CRM, A53600-Q7300-P600-01 Product Quality management-
the design and development of product. SCM, Development Guidelines PTD
During the design and development PLM, Development Guidelines F+E-Controlling PTD
planning, the organization shall deter- SUP3
mine
a) the design and development stages,
b) the review, verification and valida-
tion that are appropriate to each de-
sign and development stage, and
c) the responsibilities and authorities
for design and development.
The organization shall manage the inter-
faces between different groups involved
in design and development to ensure
effective communication and clear as-
signment of responsibility.
Planning output shall be updated, as
appropriate, as the design and develop-
ment progresses.

ISO 14001 Respon-
4.4.6 The organization shall identify and plan EA CRM, Business Regulations Norms and Standards
those operations that are associated SCM, Management policy PTD
ronmental policy, objectives and targets, –––––– -––––––– –Guidelines PTD
in order to ensure that they are carried EA BA PLM(3)
out under specified conditions, by SUP(5, 6)
b) stipulating the operating criteria
in the procedure(s), and
PTD EA creates a mid-term and long-term planning of product strategy. A product roadmap is made for
each product line.
These documents contain the announced releases, release contents and release schedules. This plan-
ning also includes R&D budget planning.
7.3.2 Design and Development inputs

Quality management
ISO 9001 Respon-
7.3.2 Inputs relating to product requirements EA CRM, Management-Manual PTD PA Quality management-
shall be determined and records main- SCM, A53600-Q7300-P600-01 Product Guidelines PTD
tained (see 4.2.4). PLM, Development
These inputs shall include SUP(3, 8)
–––––– -––––––– VA Q5110 Strategic Marketing
a) functional and performance re- EA BA PLM(3), VA Q7100 Portfolio management
quirements, SUP(5, 6) and Product definition
b) applicable statutory and regulatory Development Guidelines
requirements,
Requirement specifications with re-
c) where applicable, information de- quirement tables
rived from previous similar designs,
QS-PR-MA-001-G Product Manage-
and
ment Process
d) other requirements essential for
design and development.
These inputs shall be reviewed for ade-
quacy. Requirements shall be complete,
unambiguous and not in conflict with
each other.

ISO 14001 Respon-
4.4.6 The organization shall identify and plan EA QES SUP(2) Business Regulations Quality management-
those operations that are associated A53600-E4320-W800-01 Legal and Guidelines PTD
with the identified significant environ- other requirements for environment
mental aspects consistent with its envi- protection
ronmental policy, objectives and targets,
in order to ensure that they are carried
out under specified conditions, by
the identified significant envi-
ronmental aspects of goods and
services used by the organization
and communicating applicable
procedures and requirements to
suppliers, including contractors.
7.3.3 Design and Development outputs

Quality management
ISO 9001 Respon-
7.3.3 The outputs of design and development EA CRM, A53600-Q7300-P600-01 Product Quality management-
shall be provided in a form that enables SCM, Development Guidelines PTD
verification against the design and de- PLM, VA Q7100 Portfolio management
velopment input and shall be approved SUP(3) and Product definition
prior to release. –––––– ––––––
EA BA SUP(7) QS-PR-PUR-002-G Hardware Support
Design and development outputs shall Process
a) meet the input requirements for Development Guidelines
design and development,
Test concepts
b) provide appropriate information for
purchasing, production and for ser-
vice provision,
c) contain or reference product accep-
tance criteria, and
d) specify the characteristics of the
product that are essential for its safe
and proper use.
ISO 14001 Respon-
4.4.6 The organization shall identify and plan EA CRM, Establishment and mainte-
those operations that are associated SCM, nance of documented
with the identified significant environ- PLM, objectives regarding the
mental aspects consistent with its envi- SUP(3) environment for each
ronmental policy, objectives and targets, –––––– ––––––– relevant function and level.
in order to ensure that they are carried EA BA SUP(7)

ISO 14001 Respon-
maintaining procedures related
to the identified significant envi-
services used by the organiza-
tion and communicating applica-
ble procedures and requirements
to suppliers, including contrac-
tors.
7.3.4 Design and Development review

Quality management
ISO 9001 Respon-
7.3.4 At suitable stages, systematic reviews of EA CRM, A53600-Q7300-P600-01 Product Quality management-
design and development shall be per- SCM, Development Guidelines PTD
formed in accordance with planned PLM, VA Q7100 Portfolio management
arrangements (see 7.3.1) SUP(3) and Product definition
a) to evaluate the ability of the results –––––– –––––––
Development Guidelines
of design and development to meet EA BA SUP(7)
requirements, and Design reviews, Tests
b) to identify any problems and pro-
pose necessary actions.
Participants in such reviews shall include
representatives of functions concerned
with the design and development
stage(s) being reviewed. Records of the
results of the reviews and any necessary
actions shall be maintained (see 4.2.4).
ISO 14001 Respon-
4.4.6 The organization shall identify and plan EA CRM, Quality management-
those operations that are associated SCM, Guidelines PTD
mental aspects consistent with its envi- SUP(3)
ronmental policy, objectives and targets, –––––– –––––––
maintaining a documented pro-
cedure(s) to control situations
where their absence could lead
to deviation from the environ-
mental policy, objectives and
targets, and

ISO 14001 Respon-
7.3.5 Design and Development verification

Quality management
ISO 9001 Respon-
7.3.5 Verification shall be performed in accor- EA CRM, A53600-Q7300-P600-01 Product Quality management-
dance with planned arrangements (see SCM, Development Guidelines PTD
7.3.1) to ensure that the design and PLM, Development Guidelines
development outputs have met the de- SUP(3)
sign and development input require-
ments. Records of the results of the
verification and any necessary actions
shall be maintained (see 4.2.4).
ISO 14001 Respon-
tors.
7.3.6 Design and Development validation

Quality management
ISO 9001 Respon-

7.3.6 Design and development validation shall EA CRM, A53600-Q7300-P600-01 Product Quality management-
be performed in accordance with SCM, Development Guidelines PTD
planned arrangements (see 7.3.1) to PLM, Development Guidelines
ensure that the resulting product is ca- SUP(3)
pable of meeting the requirements for Delivery release
the specified application or intended use,
where known. Wherever practicable,
validation shall be completed prior to the
delivery or implementation of the prod-
uct. Records of the results of validation
and any necessary actions shall be
ISO 14001 Respon-
tion and communicating appli-
cable procedures and require-
ments to suppliers, including
contractors.

7.3.7 Control of design and development changes

Quality management
ISO 9001 Respon-
7.3.7 Design and development changes EA CRM, A53600-Q7300-P600-01 Product Quality management-
shall be identified and records main- SCM, Development Guidelines PTD
tained. The changes shall be re- PLM, VA Q7531 Configuration manage-
viewed, verified and validated, as SUP(3) ment / Data Management
appropriate, and approved before –––––– –––––––
implementation. EA BA SUP(7) VA Q7350 Technical changes
The review of design and development Development Guidelines
changes shall include evaluation of the
effect of the changes on constituent
parts and product already delivered.
Records of the results of the review of
changes and any necessary actions
shall be maintained (see 4.2.4).
ISO 14001 Respon-
ronmental policy, objectives and targets, –––––– –––––––
targets, and
7.4 Purchasing
Guidelines
Respon-
sibility
Mgmt.
SCM,
PLM,
SUP


EA BA CRM,
SCM,
PLM,
SUP
2.13.1 Actions for avoiding or minimizing perils EA, MAN, see 8.5.3
EA BA CRM,
SCM,
PLM,
SUP
2.13.4., (Cooperation with contractors) EA BA SUP(6) VA Q7400 Purchasing marketing
2.13.4.1. Procedures must be established and QS-PR-QM-001-G Procurement Proc-
maintained to ensure that safety and ess Procedure
health protection requirements of the
organization or at least equivalent re-
quirements are also in force for contrac-
tors and their employees.
When ordering services, it must be noted that the subcontractor must arrange for his employees to have
the same or at least equivalent safety and health protection requirements that are in force at PTD EA.
Guidelines
Respon-
sibility
Mgmt.
2.13.4.2. Agreements for local contractors should EA, SCM, VA Q7410 Supplier qualification and
a) Include effective communication EA BA SUP(6) evaluation
and coordination between the re- QS-PR-QM-001-G Procurement Proc-
sponsible organization level and the ess Procedure
contractor. Determinations must be
made regarding information on per-
ils and such actions for avoiding
and lessening of these;
b) Make known regulations for report-
ing workplace accidents and ill-
nesses that occur among the con-
tractor’s employees while they are
working for the organization;
c) Inform contractors or their employ-
ees regarding relevant perils and
risks to safety and health and if
necessary require that the contrac-
tor provide respective training for
his employees before they com-
mence work and if necessary con-
tinue training while on the job;
d) Observe the right of the principal to
monitor the occupational safety and
health measures taken by the con-
tractor;
e) Require that the local occupational
safety and health procedures and
agreements be maintained by the
contractor.
The contractor should enter into equiva-
lent agreements with subcontractors.
Locally employed subcontractors are made aware of occupational safety and health and advised that
local occupational safety and health procedures and agreements are to be upheld by the subcontractor.
Guidelines
Respon-
sibility
Mgmt.
2.13.3 Procurement EA, SCM, VA Q7410 Supplier qualification and
Procedures must be introduced and EA BA SUP(6) evaluation


Guidelines
Respon-
sibility
Mgmt.
maintained to ensure that QS-PR-QM-001-G Procurement Proc-
a) before procurement of goods and ess Procedure
services, determinations are made
regarding the pertinent legal provi-
sions regarding safety and health
protection as well as respective re-
quirements by the organization;
b) fulfillment of relevant safety and
health protection requirements of
the organization are included in
procurement and lease specifica-
tions;
c) the requirements for procured
goods and services are fulfilled be-
fore these are installed or utilized;
d) occupational safety and health
criteria are to be used when evalu-
ating and selecting contractors.
Current legal provisions regarding safety and health protection as well as the company’s own require-
ments must be made known before the procurement of goods and services. This also applies to the
evaluation and selection of subcontractors, whereby occupational safety and health criteria are to be
used.
7.4.1 Purchasing process

Quality management
ISO 9001 Respon-
7.4.1 The organization shall ensure that pur- EA CRM, VA Q7400 Purchasing marketing
chased product conforms to specified SCM, VA Q7410 Supplier qualification and
purchase requirements. The type and PLM, evaluation
extent of control applied to the supplier SUP(3)
and the purchased product shall be –––––– ––––––– QS-PT-PUR-001-G Procurement
dependent upon the effect of the pur- EA BA SUP(7) Process
chased product on subsequent product P18 Use of non-company
realization or the final product. workers
The organization shall evaluate and
select suppliers based on their ability to
supply product in accordance with the
organization’s requirements. Criteria for
selection, evaluation and reevaluation
shall be established.
Records of the results of evaluations and
any necessary actions arising from the
evaluation shall be maintained (see
4.2.4).
a) While manufacture, test and final

inspection may be sub-contracted,
the responsibility for ensuring con-
formance with the EC type-
examination certificate shall not be
sub-contracted;
b) Suppliers providing a product,
process or service that can affect
the product's compliance with the
EC type-examination certificate
shall only be selected after an
evaluation has demonstrated that
they have the capability of ensuring
compliance with all specified re-
quirements:

Quality management
ISO 9001 Respon-
1. The evaluation shall be made
by one or more of the following
methods:
• The supplier has third
party quality system certi-
fication to the appropriate
standard and scope is-
sued by an accredited
body which can demon-
strate that it operates in
compliance with EN
45012. This can be
achieved by an accredited
certification;
• a documented evaluation
which provides objective
evidence that the supplier
can provide product,
process or service that
are fit for purpose;
• a documented site as-
sessment to ensure that
all relevant controls are
available, documented,
understood and effective.
NOTE: The evaluation should
take the following in account:
• criticality of the product,
process or service;
• degree of difficulty, or
variability in the manufac-
turing process;
• location of the supplier
and hence the effective-
ness of communications;
• does the supplier, in turn
sub-contract the product,
process or service;
2. Suppliers providing calibration
services shall be evaluated on
their ability to meet stated re-
quirements;
3. where the features affecting
the type of protection can not
be verified at a later stage e.g.
encapsulated intrinsically safe
circuits, then the evaluation
shall include initial and periodic
site assessments at the suppli-
ers premises to ensure rele-
vant controls are available,
documented, understood and
effective;
c) Suppliers not used for a period
exceeding one year shall be re-
evaluated prior to the placing of the
contract;
d) Requirements b) and c) are not
mandatory for products, processes
or services where the manufacturer
fully verifies each item for confor-
mance;
e) The ongoing ability of the supplier to
provide conforming product, proc-
ess or service shall be reviewed at

Quality management
ISO 9001 Respon-
periods not exceeding one year.
ISO 14001 Respon-
4.4.6 The organization shall identify and plan EA, CRM, Business Regulations Norms and Standards
those operations that are associated EA BA SCM, Quality Declaration Management policy PTD
mental aspects consistent with its envi- SUP(3, 5, Environment management
ronmental policy, objectives and targets, 6) –Guidelines PTD
7.4.2 Purchasing information

Quality management
ISO 9001 Respon-
7.4.2 Purchasing information shall describe EA, CRM, VA Q7400 Purchasing marketing
the product to be purchased, including EA BA SCM, VA Q7410 Supplier qualification and
where appropriate PLM, evaluation
a) requirements for approval of prod- SUP(3, 5,
6) SAP-User information
uct, procedures, processes and
equipment, L24 Reference to printer
accessories, office mate-
b) requirements for qualification of rials, cleaning products,
personnel, and work uniforms and other
c) quality management system re- useful items.
quirements.
The organization shall ensure the ade-
quacy of specified purchase
a) The purchasing documents shall

clearly describe the specific re-
quirements pertaining to subcon-
tracted product set out in the EC
type-examination certificate and the
equipment documents (e.g. for
process control, testing or inspec-

Quality management
ISO 9001 Respon-
tion);
b) For items where conformance
cannot be verified after manufacture
(e.g. encapsulated intrinsically safe
circuits), the purchasing information
shall set out the specific quality pro-
cedures, resources and sequence
of activities relevant to the particular
item;
c) The manufacturer shall define the
method by which documents e.g.
technical specifications, stated in a
particular purchase order remain
traceable to the order.
ISO 14001 Respon-
4.4.6 The organization shall identify and plan EA, CRM,
those operations that are associated EA BA SCM,
mental aspects consistent with its envi- SUP(3, 5,
ronmental policy, objectives and targets, 6)
7.4.3 Verification of purchased products

Quality management
ISO 9001 Respon-
7.4.3 The organization shall establish and EA, CRM, VA Q7400 Purchasing marketing
implement the inspection or other EA BA SCM, VA Q8240 Product monitoring and
activities necessary for ensuring that PLM, measuring
purchased product meets specified SUP
purchase requirements. SAP-User information
Where the organization or its customer VA Q7410 Supplier qualification and
intends to perform verification at the evaluation
supplier’s premises, the organization VA Q6200 Employee development
shall state the intended verification at PTD PA
arrangements and method of product QS-PR-PUR-001-G Procurement
release in the purchasing information. Process
QS-PR-PUR-002-G Hardware Support

Quality management
ISO 9001 Respon-
a) For purchased products that can Process
comprise the type of protection the
manufacturer shall determine and
implement verification arrangements
which demonstrate the product's
compliance with the EC type-
examination certificate, taking into
account the nature of the product
and the nature of the supplier;
b) When deciding what type of verifica-
tion is required for a particular pur-
chased product, the manufacturer
shall consider the nature of the pur-
chased product, the supplier, and
how critical it is to the type of pro-
tection;
c) Where the supplier has been evalu-
ated and documented objective evi-
dence demonstrate the supplier to
be fully capable of producing and
verifying the product or service, no
further verification of the product or
service is required, if a declaration
of conformity according to EN
45014 is supplied with each batch
or product;
d) Where the EC type-examination
certificate specifies routine tests or
inspections these shall be carried
out on each and every product.
They may be carried out by either
the supplier or the manufacturer.
When carried out by the supplier
they shall be specified on the pur-
chasing documents, e.g. by a qual-
ity plan, and confirmed by the sup-
plier e.g. declaration of conformity
according EN 45014;
e) Where verification of a product
cannot be carried out after manufac-
ture, e.g. the internal parts of an en-
capsulated intrinsically safe circuit,
then the product shall only be ac-
cepted if supplied with a declaration
of conformity according to EN
45014. This shall specifically state
compliance to the purchase docu-
ments, e.g. a quality plan, that lists
the factors that together demon-
strate conformity of the product;
f) Where sample inspections or tests
are permitted they shall be con-
ducted in a manner which demon-
strates conformity of the entire
batch;
g) Where either the supplier or the
manufacturer requires training or
specialist skill or knowledge to carry
out a verification they shall be
documented and training records
maintained;
h) Where the manufacturer chooses
not to carry out inspections and
tests at its own premises, then in-
spections and tests shall be per-
formed on the suppliers premises
under the responsibility of the
manufacturer;

Quality management
ISO 9001 Respon-
i) Where a supplier provides product
with evidence of conformity (e.g. EC
type-examination certificate, quality
assurance notification), then further
verification is not required unless
the manufacturer considers it nec-
essary.
ISO 14001 Respon-
4.4.6 The organization shall identify and plan EA, CRM, Quality management-
those operations that are associated EA BA SCM, Guidelines PTD
mental aspects consistent with its envi- SUP
tors.
7.5 Production and service provision

Guidelines
Respon-
sibility
Mgmt.
SCM,
PLM,
SUP
EA BA CRM,
SCM,
PLM,
SUP
2.13.1 Actions for avoiding or minimizing perils EA, MAN, see 8.5.3 PTD QM-Guideline 7-03
EA BA CRM,
SCM,
PLM,
SUP

7.5.1 Control of production and service provision

Quality management
ISO 9001 Respon-
7.5.1 The organization shall plan and carry out EA SCM VA Q7500 Production
production and service provision under VA Q8240 Product monitoring and
controlled conditions. Controlled condi-
tions shall include, as applicable VA Q7540 Customer property –
Product maintenance
a) the availability of information that
describes the characteristics of the VA Q7230 Customer Care
product, QS-PR-OP-001-G Project Delivery
b) the availability of work instructions, Process
as necessary, QS-PR-CS-001-G Communication
c) the use of suitable equipment, Solution Delivery Process
d) the availability and use of monitor- QS-PR-OP-009-G Service & Solution
ing and measuring devices, Sub Process
e) the implementation of monitoring SAP-User information
and measurement, and Manufacture and test plans
f) the implementation of release,
delivery and post-delivery activi-
ties.
The manufacturer shall consider the

requirements contained in the EC type-
examination certificate
ISO 14001 Respon-
4.4.6 The organization shall identify and plan EA SCM
those operations that are associated
with the identified significant environ-
mental aspects consistent with its envi-
7.5.2 Validation of processes for production and service provision

Quality management
ISO 9001 Respon-
7.5.2 The organization shall validate any EA SCM A53600-Q8230-P800-01 Monitoring PI Process Management

Quality management
ISO 9001 Respon-
processes for production and service and measurement of processes
provision where the resulting output QS-PR-OP-001-G Project Delivery
cannot be verified by subsequent moni- Process
toring or measurement. This includes
any processes where deficiencies be- QS-PR-CS-001-G Communication
come apparent only after the product is Solution Delivery Process
in use or the service has been delivered. QS-PR-OP-009-G Service & Solution
Validation shall demonstrate the ability Sub Process
of these processes to achieve planned Process capability and machinery
results. capability investigations (PFU, MFU)
The organization shall establish ar-
rangements for these processes includ-
ing, as applicable
a) defined criteria for review and ap-
proval of the processes,
b) approval of equipment and qualifi-
cation of personnel,
c) use of specific methods and proce-
dures,
d) requirements for records (see
4.2.4), and
e) revalidation.
ISO 14001 Respon-
4.4.6 The organization shall identify and plan EA SCM
those operations that are associated
with the identified significant environ-
tors.
7.5.3 Identification and traceability

Quality management
ISO 9001 Respon-
7.5.3 Where appropriate, the organization EA CRM, VA Q7530 Identification and trace-
shall identify the product by suitable SCM, ability

Quality management
ISO 9001 Respon-
means throughout product realization. PLM, VA Q7531 Configuration management
The organization shall identify the prod- SUP(3) / Data Management
uct status with respect to monitoring and QS-PR-OP-001-G Project Delivery
measurement requirements. Process
Where traceability is a requirement, the QS-PR-CS-001-G Communication
organization shall control and record the Solution Delivery Process
unique identification of the product (see
4.2.4). QS-PR-DE-001-G Development Pro-
cess
SAP-User information
a) The manufacturer shall establish
and maintain procedures for prod- MLFB, part number, manufacture
uct identification during all stages of number, product level
production, testing, final inspection
and placing on the market;
b) traceability is required with respect
to the final product and its signifi-
cant parts.
7.5.4 Customer property

Quality management
ISO 9001 Respon-
7.5.4 The organization shall exercise care with EA SCM VA Q7540 Customer property –
customer property while it is under the Product maintenance
organization’s control or being used by QS-PR-OP-003-G Identification and
the organization. The organization shall Control of Products
identify, verify, protect and safeguard
customer property provided for use or
incorporation into the product. If any
customer property is lost, damaged or
otherwise found to be unsuitable for use,
this shall be reported to the customer
and records maintained (see 4.2.4).
It is the responsibility of the manufac-

turer to verify the compatibility of cus-
tomer-supplied product with the re-
quirements of the EC type-examination
certificate.
The exact contents, scope and effort timewise of customer participation during software development
and/or preparation of parameter documents as well as the preparation of data for the generating and
testing are all included in the contract. Unless there are special agreements, the customer is integrated
according to the PTD AE Process.
7.5.5 Preservation of product

Quality management
ISO 9001 Respon-

7.5.5 The organization shall preserve the EA SCM VA Q7540 Customer property –
conformity of product during internal Product maintenance
processing and delivery to the intended QS-PR-PUR-002-G Hardware Support
destination. This preservation shall in- Process
clude identification, handling, packaging,
storage and protection. Preservation QS-PR-DE-001-G Development Proc-
shall also apply to the constituent parts ess
of a product.
The manufacturer shall provide its cus-

tomers with the instructions as described
in Annex II of the Directive 94/9/EC.
ISO 14001 Respon-
4.4.6 The organization shall identify and plan EA SCM, A53600-E4320-W800-01 Legal and
those operations that are associated SUP(2) other requirements for environment
with the identified significant environ- protection
targets, and
7.6 Control of monitoring and measuring devices

Quality management
ISO 9001 Respon-
7.6 The organization shall determine the EA SCM, VA Q7600 Control of monitoring and
monitoring and measurement to be CRM(4), measuring devices
undertaken and the monitoring and PLM,
measuring devices needed to provide SUP(3)
evidence of conformity of product to
determined requirements (see 7.2.1).
The organization shall establish proc-
esses to ensure that monitoring and
measurement can be carried out and are
carried out in a manner that is consistent
with the monitoring and measurement
requirements.
Where necessary to ensure valid results,
measuring equipment shall
a) be calibrated or verified at specified
intervals, or prior to use, against
measurement standards traceable
to international or national meas-
urement standards; where no such

Quality management
ISO 9001 Respon-
standards exist, the basis used for
calibration or verification shall be
recorded;
b) be adjusted or re-adjusted as nec-
essary;
c) be identified to enable the calibra-
tion status to be determined;
d) be safeguarded from adjustments
that would invalidate the measure-
ment result;
e) be protected from damage and
deterioration during handling, main-
tenance and storage.
In addition, the organization shall assess
and record the validity of the previous
measuring results when the equipment
is found not to conform to requirements.
The organization shall take appropriate
action on the equipment and any product
affected.
Records of the results of calibration and
verification shall be maintained (see
4.2.4).
When used in the monitoring and meas-
urement of specified requirements, the
ability of computer software to satisfy the
intended application shall be confirmed.
This shall be undertaken prior to initial
use and reconfirmed as necessary.
a) Where a calibration certificate does

not bear the accreditation logo of a
national accreditation authority,
each calibration certificate shall in-
clude at least the following informa-
tion:
• an unambiguous identification
of the item calibrated;
• evidence that the measure-
ments are traceable to na-
tional or international stan-
dards;
• the method of calibration;
• a statement of compliance
with any relevant specification;
• the calibration results;
• the uncertainty of measure-
ment, where necessary;
• the environmental conditions,
where relevant;
• the date of calibration;
• the signature of the person
under whose authority the cer-
tificate was issued;
• the name and address of the
issuing organization and the
date of issue of the certificate;
• a unique identification of the
calibration certificate.
b) Where a calibration certificate does
not bear the accreditation logo of a
national accreditation authority or
does not contain the information

Quality management
ISO 9001 Respon-
listed in a), the manufacturer shall
demonstrate a valid relationship to
international or national measure-
ment standards by other means
(e.g. a documented site assess-
ment).
ISO 14001 Respon-
4.5.1 The organization shall establish, imple- EA SCM,
ment and maintain a procedure(s) to CRM(4),
monitor and measure, on a regular PLM,
basis, the key characteristics of its op- SUP(3)
erations that can have a significant
environmental impact.
The procedure(s) shall include the
documenting of information to monitor
performance, applicable operational
controls and conformity with the organi-
zation's environmental objectives and
targets.
The organization shall ensure that
calibrated or verified monitoring and
measurement equipment is used and
maintained and shall retain associ-
ated records.

Guidelines
Respon-
sibility
Mgmt.
2.15. Monitoring performance and measuring EA SCM, see 8.2.3.
CRM(4),
PLM,
SUP(3)
All verification and test instruments are prepared, examined and maintained based on the standards for
their application. We differentiate between
• Measuring instruments,
• Test and diagnosis software
• Verification and test sequences
8 Measurement, analysis and improvement
8.1 General
Quality management
ISO 9001 Respon-

8.1 The organization shall plan and imple- EA, MAN, Business Regulations EFQM
ment the monitoring, measurement, EA BA CRM, A53600-Q4100-P800-01 Process
analysis and improvement processes SCM, management
needed PLM,
SUP A53600-Q8230-P800-01 Monitoring
a) to demonstrate conformity of the and measuring of processes
product,
b) to ensure conformity of the quality
c) to continually improve the effective- Self evaluation
ness of the quality management
system.
This shall include determination of appli-
cable methods, including statistical tech-
niques, and the extent of their use.
ISO 14001 Respon-
4.5.1 The organization shall establish, EA, MAN, Business Regulations
implement and maintain a proce- EA BA CRM,
dure(s) to monitor and measure, on a SCM,
regular basis, the key characteristics PLM, PTD Environment protection Guideline
of its operations that can have a SUP 0-003 Documentation for
significant environmental impact. Environment manage-
ment- Audits
The procedure(s) shall include the
documenting of information to moni- QS-WI-QM-010-N Measurement,
tor performance, applicable opera- Analysis and Improve-
tional controls and conformity with ment
the organization's environmental
objectives and targets.
The organization shall ensure that cali-
brated or verified monitoring and meas-
urement equipment is used and main-
tained and shall retain associated re-
cords.

Guidelines
Respon-
sibility
Mgmt.
2.9., (Initial test) EA, MAN, Business Regulations
2.9.1. The H&S Mgmt. used in the organization EA BA CRM, PTD QM-Guideline 7-01 „Occupa-
and relevant determinations should be SCM, tional safety and health-Management
tested by a procedure to be established. PLM, system“
SUP
A53600-Q4100-P800-01 Process
management
QM-009-N Corrective and preventive
actions
2.9.2. The results of this initial test should EA, MAN, Business Regulations
a) be documented; EA BA CRM, PTD QM-Guideline 7-01 „Work protec-
SCM, tion management at PTD“
b) serve as the basis for decisions PLM,
made for H&S Mgmt. implementa- SUP QM-Guideline Nr. 7-02 Work protec-
tion; tion - work instructions
c) form a starting point from which A53600-Q4230-W800-01 Document


Guidelines
Respon-
sibility
Mgmt.
continuous improvements of the or- control
ganization H&S Mgmt. can be A53600-Q8230-P800-01 Monitoring
measured. and measuring of processes
QM-009-N Corrective and preventive

actions
The occupational safety and health management system, once defined and implemented, is subject by
PTD IHS to an audit per the audit checklist compliance (MIPAS). The results of this examination are
documented and serve as the basis and starting point for further continuous improvements of the occu-
pational safety and health management system.
8.2 Monitoring and measurement
8.2.1 Customer satisfaction

Quality management
ISO 9001 Respon-
8.2.1 As one of the measurements of the EA, MAN, Business Regulations
performance of the quality management EA BA CRM, A53600-Q8230-P800-01 Monitoring
system, the organization shall monitor SCM, and measuring of processes
information relating to customer percep- PLM,
tion as to whether the organization has SUP QS-PR-MA-002-G Tactical Marketing
met customer requirements. The meth- Self evaluations
ods for obtaining and using this informa-
tion shall be determined
For the purpose of this European Stan-

dard "customer satisfaction" shall be in
relation to the product's compliance with
the EC type-examination certificate.
PTD EA follows up on information that reveals the customer’s sense to the fulfillment of customer re-
quirements by the organization.
8.2.2 Internal audit

Quality management
ISO 9001 Respon-
8.2.2 The organization shall conduct internal EA, MAN, A53600-Q8220-P800-01 Internal
audits at planned intervals to determine EA BA CRM, Audits
whether the quality management system SCM,
a) conforms to the planned arrange- PLM,
ments (see 7.1), to the requirements SUP
of this International Standard and to
the quality management system re-
quirements established by the or-
ganization, and
b) is effectively implemented and
maintained.
An audit program shall be planned,
taking into consideration the status and
importance of the processes and areas

Quality management
ISO 9001 Respon-
to be audited, as well as the results of
previous audits. The audit criteria,
scope, frequency and methods shall be
defined. Selection of auditors and con-
duct of audits shall ensure objectivity
and impartiality of the audit process.
Auditors shall not audit their own work.
The responsibilities and requirements for
planning and conducting audits, and for
reporting results and maintaining records
(see 4.2.4) shall be defined in a docu-
mented procedure.
The management responsible for the
area being audited shall ensure that
actions are taken without undue delay to
eliminate detected nonconformities and
their causes. Follow-up activities shall
include the verification of the actions
taken and the reporting of verification
results (see 8.5.2).
The audit programme shall address the

effectiveness of the elements of the
quality system as described in this stan-
dard to ensure that the products are in
conformity with the EC type-examination
certificate. The maximum period be-
tween audits should normally be 12
months and shall not exceed 14 months.
ISO 14001 Respon-
4.5.5 The organization shall ensure that inter- EA, MAN, PTD ETS 0-002 Environment ma-
nal audits of the environmental man- EA BA CRM, nagement Audit
agement system are conducted at SCM, PTD ETS 0-003 Documentation of
planned intervals to PLM, the Environment mana-
a) determine whether the environ- SUP gement- Audit
mental management system
1. conforms to planned arrange-
ments for environmental man-
agement including the re-
quirements of this Interna-
tional Standard, and
2. has been properly imple-
mented and is maintained,
and
b) provide information on the results of
audits to management.
Audit programme(s) shall be planned,
established, implemented and main-
tained by the organization, taking into
consideration the environmental impor-
tance of the operation(s) concerned and
the results of previous audits.
Audit procedure(s) shall be established,
implemented and maintained that ad-
dress
• the responsibilities and re-
quirements for planning and
conducting audits, reporting
results and retaining associ-
ated records,
• the determination of audit cri-
teria, scope, frequency and

ISO 14001 Respon-
methods.
Selection of auditors and conduct of
audits shall ensure objectivity and the
impartiality of the audit process.

Guidelines
Respon-
sibility
Mgmt.
2.17, (Internal Audits) EA, MAN, A53600-Q8220-P800-01 Internal
2.17.1. Regularly held internal audits must also EA BA CRM, Audits
be established in order to ascertain if the SCM,
H&S Mgmt. is suitable for effectively PLM,
protecting the safety and health of em- SUP
ployees and preventing accidents and
near miss-accidents.
2.17.2. An auditing program and auditing proce- EA, MAN, A53600-Q8220-P800-01 Internal
dure must be developed. The qualifica- EA BA CRM, Audits
tions of the auditors as well as the SCM,
scope, frequency, audit methods and PLM,
audit reporting will be determined. SUP
2.17.3. The audit evaluates the H&S Mgmt. EA, MAN, A53600-Q8220-P800-01 Internal
elements of the organization or a special EA BA CRM, Audits
part thereof. It should include a systems SCM,
section and a compliance section. It PLM,
should examine: SUP
a) the suitability of the current policy
and strategy for safety and health
protection within the H&S Mgmt.
framework,
b) the suitability of the selected
objectives as well as the necessary
measures in the operative area,
c) the configuration, procedures and
performance of H&S Mgmt.,
d) preservation of legal and other
obligations and
e) the practical implementation of H&S
Mgmt..
2.17.4. The audit report should reveal whether EA, MAN, A53600-Q4230-W800-01 Document
H&S Mgmt., its elements or parts thereof EA BA CRM, control
implement the organization policy and SCM, A53600-Q4240-W800-01 Records for
thus guarantee achievement of organi- PLM, the Management system
zation objectives; SUP
A53600-Q8220-P800-01 Internal
a) describe how the employees Audits
actively participate in occupational
safety and health and how the
necessary company committees
and work groups are set up and
how the representatives were des-
ignated;
b) Refer to results from prior evalua-
tions of H&S Mgmt. performance
and prior audits;
c) Enable the organization to ob-
serve relevant legal provisions for
safety and health protection, and
d) Fulfill the objective of continuous
improvement.
2.17.5. Audits should be executed by qualified EA, MAN, A53600-Q8220-P800-01 Internal
individuals from inside the company or EA BA CRM, Audits
outside that are also independent from SCM,


Guidelines
Respon-
sibility
Mgmt.
the organizational area to be audited. PLM,
SUP
2.17.6. Results of the audit and the ensuing EA, MAN, A53600-Q4240-W800-01 Records for
conclusions should be reported to those EA BA CRM, the Management system
parties responsible for corrective ac- SCM, A53600-Q8220-P800-01 Internal
tions. PLM, Audits
SUP
8.2.3 Monitoring and measurement of processes

Quality management
ISO 9001 Respon-
8.2.3 The organization shall apply suitable EA, MAN, A53600-Q4100-P800-01 Process
methods for monitoring and, where ap- EA BA CRM, management
plicable, measurement of the quality SCM, A53600-Q8230-P800-01 Monitoring
management system processes. These PLM, and measuring of processes
methods shall demonstrate the ability of SUP
the processes to achieve planned re-
sults. When planned results are not
achieved, correction and corrective
action shall be taken, as appropriate, to
ensure conformity of the product.
Where a process can affect the integrity

of a type of protection, and where the
resulting integrity cannot be verified after
manufacture (e.g. the environmental
conditions required for curing an encap-
sulation), the specific process shall be
measured or monitored and documen-
tary evidence shall be maintained to
demonstrate compliance with required
parameters.
ISO 14001 Respon-
4.5.2 Consistent with its commitment to com- EA, MAN,
pliance, the organization shall establish, EA BA CRM,
implement and maintain a procedure(s) SCM,
for periodically evaluating compliance PLM,
with applicable legal requirements. SUP
The organization shall keep records of

ISO 14001 Respon-
the results of the periodic evaluations.
The organization shall evaluate compli-

ance with other requirements to which it
subscribes. The organization may wish
to combine this evaluation with the
evaluation of legal compliance referred
to in 4.5.2.1 or to establish a separate
procedure(s).

Guidelines
Respon-
sibility
Mgmt.
2.15., (Performance monitoring and measur- EA SCM, A53600-Q4100-P800-01 Process
2.15.1. ing) CRM(4), management
Procedures must be developed, intro- PLM, A53600-Q4230-W800-01 Document
duced and routinely checked for monitor- SUP(3) control
ing, measuring and recording occupa- A53600-Q4240-W800-01 Records for
tional safety and health performance. the Management system
VA Q7600 Control of monitoring and

measuring devices
preventive actions
QS-PR-QM-010 Measurement, Analy-
sis and Improvement
2.15.2. The selection of performance indicators EA SCM, A53600-Q4100-P800-01 Process
should correspond to the organization CRM(4), management
size, type of activities, perils present and PLM, A53600-Q4230-W800-01 Document
their related risks as well as the occupa- SUP(3) control
tional safety and health objectives.
VA Q7600 Control of monitoring and

measuring devices
preventive actions
QS-PR-QM-010 Measurement, Analy-
sis and Improvement
2.15.3. Qualitative as well as quantitative ac- EA SCM, A53600-Q4100-P800-01 Process
tions should also be taken into consid- CRM(4), management
eration, in keeping with organization PLM, A53600-Q4230-W800-01 Document
needs. These should SUP(3) control
a) be based on the perils and their A53600-Q4240-W800-01 Records for
related risks for the organization, the the Management system
obligations in view of occupational
safety and health policy and occupa-
tional safety and health objectives; VA Q7600 Control of monitoring and
and support as far as possible the measuring devices
evaluation procedures of the organiza- QS-PR-QM-009-N Corrective and
tion, including the evaluation by top preventive actions
management. QS-PR-QM-010 Measurement, Analy-
sis and Improvement
2.15.4. Performance monitoring and measure- EA SCM, A53600-Q4100-P800-01 Process
ment should CRM(4), management
a) be a means by which to determine in PLM, A53600-Q4230-W800-01 Document
what way the occupational safety SUP(3) control


Guidelines
Respon-
sibility
Mgmt.
and health policy and objectives A53600-Q4240-W800-01 Records for
have been implemented and the per- the Management system
ils and related risks have been
avoided or minimized;
b) encompass active and reactive VA Q7600 Control of monitoring and
monitoring and should take place us- measuring devices
ing analysis of statistics on company QS-PR-QM-009-N Corrective and
disturbances, emergencies, work- preventive actions
place injuries, illnesses, accidents QS-PR-QM-010 Measurement, Analy-
and near miss- accidents, health im- sis and Improvement
pairments as well through routine
company walk-throughs;
c) be recorded.
Prospective key indicators:

An important key indicator that reveals the fulfillment of legal and other obligations is the number of
trained or assigned employees with special and relevant occupational safety and health functions:
- Safety representatives
- First aid assistant
- Fire fighter assistant
Further key indicators to be mentioned are:
- Budget / means destined for occupational safety and health (personal protection gear, protection
measures in production, especially chairs.........)
- Hours spent by the safety specialist and assistant
- Number of planned audits
- Peril analysis performed
- Refund of insurance premiums of the Employers Liability Injurance Association (as indicator of the
effectiveness of occupational safety and health)
- Degree of coverage of instruction and company walk-throughs
Retrospective key indicators:
- Accident statistics (e.g., from PS UAS)
- Downtime costs relevant to occupational safety and health
- Absence due to illness
A review of key indicators and a new definition of objective values for the next fiscal year take place an-
nually when senior management sets the strategy.
Key indicators are selected by management, reported to QES and assembled there. A further review of
the figures is performed routinely (monthly or quarterly) in senior management meetings and within the
framework of the annual management review by senior management.
Guidelines
Respon-
sibility
Mgmt.
2.15.5. Monitoring should be the basis for deci- EA, MAN, A53600-Q4100-P800-01 Process
sions to improve the following proc- EA BA CRM, management
esses: SCM, A53600-Q8230-P800-01 Monitoring
a) Identification and evaluation of PLM, and measuring of processes
perils and related risks, SUP
b) Avoiding and minimizing of perils preventive actions
and related risks, QS-PR-QM-010-N Measurement,
c) Occupational safety and health per- Analysis and Improvement
formance in the organization.
2.15.6. Active monitoring should include the EA, MAN, PTD QM-Guideline Nr. 7-01 Work


Guidelines
Respon-
sibility
Mgmt.
following elements needed for a config- EA BA CRM, protection management
ured system: SCM, at PTD
a) Monitoring whether established PLM, PTD QM-Guideline Nr. 7-02 Work
plans, accepted performance crite- SUP protection - work instruc-
ria and objectives have been at- tions
tained; A53600-Q8230-P800-01 Monitoring
b) Systematic investigation whether and measuring of processes
possible perils and related risks for QS-PR-QM-009-N Corrective and
safety and health of the employees preventive actions
are found in work systems, work-
places, installations, and equip- QS-PR-QM-010-N Measurement,
ment; Analysis and Improve-
ment
c) Monitoring of the work environment
including the work organization;
d) Monitoring of the employees’ health
through required workplace medical
examinations in order to determine
the effectiveness of the preventive
actions;
e) Preservation of prescribed legal
provisions, voluntary programs,
wage agreements, company
agreements and other occupational
safety and health regulations to
which the organization has commit-
ted.
2.15.7. Reactive monitoring should encompass EA, MAN, PTD QM-Guideline Nr. 7-01 Work
the identification, study and reporting of EA BA CRM, protection management
a) Job-caused injuries, illnesses, acci- SCM, at PTD
dents and near miss-accidents and PLM, PTD QM-Guideline Nr. 7-02 Work
health impairments (including moni- SUP protection - work instruc-
toring of absences due to illness tions
statistics) A53600-Q8230-P800-01 Monitoring
b) Material damages relevant to occu- and measuring of processes
pational safety and health QS-PR-QM-009-N Corrective and
c) Insufficient occupational safety and preventive actions
health and H&S Mgmt. perform- QS-PR-QM-010-N Measurement,
ance. Analysis and Improve-
ment
8.2.4 Monitoring and measurement of product

Quality management
ISO 9001 Respon-

8.2.4 The organization shall monitor and EA SCM VA Q8240 Product monitoring and
measure the characteristics of the prod- measuring
uct to verify that product requirements QS-PR-DE-001-G Development Pro-
have been met. This shall be carried out cess
at appropriate stages of the product
realization process in accordance with QS-PR-OP-001-G Project Delivery
the planned arrangements (see 7.1). Process
Evidence of conformity with the accep- QS-PR-CS-001-G Communication
tance criteria shall be maintained. Re- Solution Delivery Process
cords shall indicate the person(s) author- QS-PR-OP-009-G Service & Solution
izing release of product (see 4.2.4). Process
Product release and service delivery Test protocols
shall not proceed until the planned ar-
rangements (see 7.1) have been satis-
factorily completed, unless otherwise
approved by a relevant authority and,
where applicable, by the customer
Where routine tests are required by the

EC type-examination certificate and the
equipment documents, then those tests
shall be performed as specified with no
sampling techniques being permitted.
Where practicable, the label bearing the
marking data shall not be affixed until
the final inspection and testing has been
satisfactory completed.
ISO 14001 Respon-

procedure(s).

Guidelines
Respon-
sibility
Mgmt.
2.15. Performance monitoring and measuring EA SCM, See 8.2.3
CRM(4),
PLM,
SUP(3)
8.3 Control of nonconforming product

Quality management

ISO 9001 Respon-

8.3 The organization shall ensure that prod- EA, CRM, VA Q8300 Control of defective
uct which does not conform to product EA BA SCM, products
requirements is identified and controlled PLM, QS-PR-DE-001-G Development Pro-
to prevent its unintended use or delivery. SUP(1, 2, cess
The controls and related responsibilities 3, 5, 7)
and authorities for dealing with noncon- QS-PR-OP-001-G Project Delivery
forming product shall be defined in a Process
documented procedure. QS-PR-CS-001-G Communication
The organization shall deal with noncon- Solutions Delivery Proc-
forming product by one or more of the ess
following ways
a) by taking action to eliminate the
detected nonconformity;
b) by authorizing its use, release or
acceptance under concession by a
relevant authority and, where appli-
cable, by the customer;
c) by taking action to preclude its
original intended use or application.
Records of the nature of nonconformities
and any subsequent actions taken, in-
cluding concessions obtained, shall be
When nonconforming product is cor-
rected it shall be subject to re-verification
to demonstrate conformity to the re-
quirements.
When nonconforming product is de-
tected after delivery or use has started,
the organization shall take action appro-
priate to the effects, or potential effects,
of the nonconformity.
a) The manufacturer shall maintain a

system such that in the event of
product not complying with the EC
type-examination certificate and
having been supplied, then the
manufactures customer can be
identified;
b) The manufacturer shall take action,
appropriate too the degree of risk,
where non-conforming product has
been supplied to a customer;
c) Where unsafe, non-conforming
product has been supplied to a cus-
tomer, the manufacturer shall, in
writing, inform its customer and the
notified body responsible for the
quality system notification;
d) Where it is not possible to trace
unsafe product(e.g. product sup-
plied via a distributor, or high vol-
ume products such as cable glands)
then a notice shall be placed in ap-
propriate publications providing rec-
ommended action to be taken;
e) For all non-conforming product that
has been supplied to a customer,
the manufacturer shall maintain, for
a minimum period of 10 years, re-
cords of:
1. serial numbers or identification
of products supplied;
2. the customer who received the
product;

Quality management
ISO 9001 Respon-
3. the action taken to inform cus-
tomers and the relevant noti-
fied body in the case of unsafe
non-conforming product;
4. the action taken to implement
corrective and preventative
action;
f) Concessions for product that take
the product outside the design as
defined in the EC type-examination
certificate and technical documenta-
tion are not permitted.
ISO 14001 Respon-
4.5.3 The organization shall establish, imple- EA, CRM,
ment and maintain a procedure(s) for EA BA SCM,
dealing with actual and potential non- PLM,
conformity(ies) and for taking corrective SUP(1, 2,
action and preventive action. The pro- 3, 5, 7)
cedure(s) shall define requirements for
a) identifying and correcting noncon-
formity(ies) and taking action(s) to
mitigate their environmental im-
pacts,
b) investigating nonconformity(ies),
determining their cause(s) and tak-
ing actions in order to avoid their
recurrence,
c) evaluating the need for action(s) to
prevent nonconformity(ies) and
implementing appropriate actions
designed to avoid their occurrence,
d) recording the results of corrective
action(s) and preventive action(s)
taken, and
e) reviewing the effectiveness of
corrective action(s) and preventive
action(s) taken.
Actions taken shall be appropriate to the
magnitude of the problems and the
environmental impacts encountered.

ISO 14001 Respon-
4.4.7 The organization shall establish, imple- EA, CRM,
ment and maintain a procedure(s) to EA BA SCM,
identify potential emergency situations PLM,
and potential accidents that can have SUP(1, 2,
an impact(s) on the environment and 3, 5, 7)
how it will respond to them.
The organization shall respond to actual
emergency situations and accidents and
prevent or mitigate associated adverse
environmental impacts.
The organization shall periodically re-
view and, where necessary, revise its
emergency preparedness and response
procedures, in particular, after the oc-
currence of accidents or emergency
situations.
The organization shall also periodically
test such procedures where practicable.

Guidelines
Respon-
sibility
Mgmt.
2.13.2., (Regulations for company disturbances EA, SCM(2), Guidelines Company Catastrophe
2.13.2.1. and emergencies) EA BA SUP(2,9) Protection Organization (BKO)
Procedures must be established and Guidelines Fire protection
maintained for company disturbances PTD QM-Guideline Nr. 7-01 Work
and emergencies. These procedures protection management at PTD
should identify the potentials for distur-
bances and emergency situations and
include prevention measures to protect
the employees and other persons on
company premises from perils and re-
lated risks. These procedures
a) ensure that necessary information as
well as necessary internal communi-
cation and coordination is available
so that in case of an emergency on
company premises, all individuals
will be protected;
b) provide information and communica-
tion with government workplace
safety authorities or statutory acci-
dent insurance carriers and emer-
gency services;
c) include First Aid and medical support
as well as fire fighting and evacua-
tion of all people on company prem-
ises;
d) provide all organization members at
all levels with relevant information
and plan to offer training including
routine practice of procedures for
emergency prevention and defense.
2.13.2.2. Procedures for emergency prevention EA, SCM(2), A53600-Q4100-P800-01 Process
and defense should be established with EA BA SUP(2,9) management
the assistance of external emergency
services and with other sites if neces-
sary
The possible potentials for company disturbances and emergency situations are to be identified when
establishing measures for their prevention and emergency defense. Based on the above, measures are
defined for preventing the related safety and health risks of the employed. Measures such as First Aid

and medical support as well as fire fighting and evacuation of all individuals on company premises are
also included. Cooperation with internal and external emergency services and other sites is established.
8.4 Analysis of data

Quality management
ISO 9001 Respon-
8.4 The organization shall determine, collect EA, MAN, A53600-Q4100-P800-01 Process
and analyze appropriate data to demon- EA BA CRM, management
strate the suitability and effectiveness of SCM, A53600-Q8230-P800-01 Monitoring
the quality management system and to PLM, and measuring of processes
evaluate where continual improvement SUP
of the effectiveness of the quality man-
agement system can be made. This
shall include data generated as a result
of monitoring and measurement and
from other relevant sources.
The analysis of data shall provide infor-
mation relating to
a) customer satisfaction (see 8.2.1),
b) conformity to product requirements
(see 7.2.1),
c) characteristics and trends of proc-
esses and products including op-
portunities for preventive action,
and
d) suppliers.
ISO 14001 Respon-
procedure(s).
8.5 Improvement
8.5.1 Continuous improvement

Quality management
ISO 9001 Respon-
8.5.1 The organization shall continually im- EA, MAN, A53600-Q4100-P800-01 Process EFQM
prove the effectiveness of the quality EA BA CRM, management

Quality management
ISO 9001 Respon-
management system through the use of SCM,
the quality policy, quality objectives, PLM,
audit results, analysis of data, corrective SUP Audits
and preventive actions and management Management – Reviews
review. and Q-Days
Self evaluation
The effectiveness of the management system is continually improved based on the EFQM-model. This
is achieved through utilization of policy and strategy, quality objectives, audit results, data analysis, cor-
rective measures and management reviews.
ISO 14001 Respon-
4.3.3 The organization shall establish, imple- EA, MAN, A53600-E4460-P800-01 Sequence
ment and maintain documented envi- EA BA CRM, control environmental aspects
ronmental objectives and targets, at SCM,
relevant functions and levels within the PLM,
organization. SUP
ment.
interested parties.
ment and maintain a program(s) for
achieving its objectives and targets.
Program(s) shall include
achieving objectives and targets at
relevant functions and levels of the
organization, and
b) the means and time frame by
which they are to be achieved.

Guidelines
Respon-
sibility
Mgmt.
2.20. (Continuous improvement) EA, MAN, QS-PR-QM-009-N: Corrective and
Procedures are to be established for EA BA CRM, preventive actions
continuous improvement of H&S Mgmt. SCM, QS-PR-QM-010-N: Measurement,
as well as of safety and health protec- PLM, Analysis and Improvement
tion. These procedures take into consid- SUP
QS-PR-QM-013-N: Process Manage-
eration: ment
a) Occupational safety and health ob-
jectives of the organization,
Audits
b) Results of identifying and evaluating


Guidelines
Respon-
sibility
Mgmt.
perils and related risks; Management – Reviews
c) Results of the performance monitor- and Q- Days
ing and measurement; Self evaluations
d) Investigations of work- caused inju-
ries, illnesses, accidents and near
miss-accidents and health impair-
ments;
e) Results and recommendations from
the audits;
f) Results of evaluation by top man-
agement;
g) Suggestions for improvements
made by organization members, in-
cluding those of internal commit-
tees and work groups;
h) Modifications of occupational safety
and health regulations and volun-
tary programs, wage agreements
and company agreements;
i) New relevant information;
j) Results from programs for health
protection and promotion.
The continuous improvements of H&S Mgmt. are guaranteed by the following actions:
- Monitoring and restating of the occupational safety and health objectives at the annual strategy
conference held by senior management
- Routine (monthly or quarterly) discussions of the occupational safety and health key indicators in
the senior management meeting
- Establishing and implementing actions based on:
- Walk-throughs by managers in their areas of responsibility
- Investigations of work-caused injuries, illnesses, accidents and near miss-accidents and
health impairments
- Results and recommendations from the audits
- Results from the management reviews by senior management
- Implementation of suggestions for improvement by employees, company committees and work cir-
cles
8.5.2 Corrective actions

Quality management
ISO 9001 Respon-
8.5.2 The organization shall take action to EA, MAN, Business Regulations Product safety principles
eliminate the cause of nonconformities in EA BA CRM, VA Q7230 Customer Care for Siemens AG
order to prevent recurrence. Corrective SCM,
actions shall be appropriate to the ef- PLM, VA Q8500 Corrective and preventive Quality management-
actions / Product safety Guidelines PTD
fects of the nonconformities encoun- SUP
tered. report
A documented procedure shall be estab- QS-PR-QM-009-Corrective and pre-
lished to define requirements for ventive actions
a) reviewing nonconformities (includ- Non Conformity Reports
ing customer complaints),
b) determining the causes of noncon-
formities,
c) evaluating the need for action to
ensure that nonconformities do not
recur,
d) determining and implementing

Quality management
ISO 9001 Respon-
action needed,
e) records of the results of action
taken (see 4.2.4), and
f) reviewing corrective action taken.
ISO 14001 Respon-
4.5.3 The organization shall establish, imple- EA, MAN, Business Regulations Product safety principles
ment and maintain a procedure(s) for EA BA CRM, X26 Actions before and after for Siemens AG
dealing with actual and potential non- SCM, environmental accidents Quality management-
conformity(ies) and for taking corrective PLM, Guidelines PTD
action and preventive action. The pro- SUP
a) identifying and correcting non-
conformity(ies) and taking ac-
tion(s) to mitigate their environ-
mental impacts,
b) investigating nonconform-
ity(ies), determining their
cause(s) and taking actions in
order to avoid their recurrence,
c) evaluating the need for action(s) to
prevent nonconformity(ies) and
implementing appropriate actions
designed to avoid their occurrence,
taken, and
corrective action(s) and preventive
action(s) taken.
The organization shall ensure that any
necessary changes are made to envi-
ronmental management system docu-
mentation.

Guidelines
Respon-
sibility
Mgmt.
2.16., (Investigations) EA, SCM(3), VA Q8500 Corrective and preventive
2.16.1. When investigating causes and reasons EA BA SUP(2,7) actions / Product safety
for work-caused injuries, illnesses, acci- report
dents and near miss-accidents as well QS-PR-QM-009-N: Corrective and
as health impairment, every unsatisfac- preventive actions
tory functioning of the H&S Mgmt. must QS-PR-QM-010-N: Measurement,
be identified and documented. Analysis and Improvement
2.16.2. Such investigations are to be carried out EA, SCM(3), VA Q8500 Corrective and preventive
by qualified individuals. EA BA SUP(2,7) actions/ Product safety
report
QS-PR-QM-009-N: Corrective and
preventive actions
QS-PR-QM-010-N: Measurement,


Guidelines
Respon-
sibility
Mgmt.
2.16.3. The results of these investigations, as EA, SCM(3), VA Q8500 Corrective and preventive
long as they are not subject to data EA BA SUP(2,7) actions / Product safety
protection regulations, should be re- report
vealed to company committees or work QS-PR-QM-009-N: Corrective and
groups who should express their own preventive actions
recommendations.
2.16.4. The results of these investigations EA, SCM(3), VA Q8500 Corrective and preventive
should be revealed to the responsible EA BA SUP(2,7) actions/ Product safety
individuals in addition to all recommen- report
dations from committees and work QS-PR-QM-009-N: Corrective and
groups so that corrective actions may be preventive actions
taken. The implementation of corrective
actions must be monitored. Results QS-PR-QM-010-N: Measurement,
should be included in the evaluation by Analysis and Improvement
top management and be taken into con-
sideration under actions for continuous
improvement.
2.16.5. Reports from external institutions such EA, SCM(3), VA Q8500 Corrective and preventive
as government occupational safety and EA BA SUP(2,7) actions / Product safety
health authorities, carriers of statutory report
accident insurance or specialized or- QS-PR-QM-009-N: Corrective and
ganizations should be included in the preventive actions
investigations.
2.19. Corrective actions EA, SCM(3), see 8.5.3
EA BA SUP(2,7)
In cases of injuries, illnesses, accidents and near miss-accidents and health impairments, the causes
and reasons for unsatisfactory functioning of H&S Mgmt. are to be identified. Results are documented
and evaluated. Corrective measures are formulated using this investigation in order to prevent a repeat
of these events.
The results are fed into the evaluation of the management system and are taken into consideration for
actions towards continuous improvements.
8.5.3 Preventive actions

Quality management
ISO 9001 Respon-
8.5.3 The organization shall determine action EA, MAN, VA Q7230 Customer Care The procedure for preven-
to eliminate the causes of potential non- EA BA CRM, VA Q8500 Corrective and preventive tive actions is comparable
conformities in order to prevent their SCM, actions / Product safety to the procedure for correc-
occurrence. Preventive actions shall be PLM, report tive actions, as presented
appropriate to the effects of the potential SUP in Chapter 8.5.2, only that
problems. QS-PR-QM-009-N Corrective and it is intended for potential
preventive actions errors.
A documented procedure shall be estab-
lished to define requirements for
a) determining potential nonconform- see 8.5.2.
ities and their causes,
b) evaluating the need for action to
prevent occurrence of nonconform-
ities,
c) determining and implementing
action needed,
d) records of results of action taken
(see 4.2.4), and
e) reviewing preventive action taken.

ISO 14001 Respon-
4.5.3 The organization shall establish, imple- EA, MAN, X26 Actions before and after
ment and maintain a procedure(s) for EA BA CRM, environmental accidents
dealing with actual and potential non- SCM,
conformity(ies) and for taking corrective PLM,
action and preventive action. The pro- SUP
a) identifying and correcting noncon-
formity(ies) and taking action(s) to
mitigate their environmental im-
pacts,
b) investigating nonconformity(ies),
determining their cause(s) and tak-
ing actions in order to avoid their
recurrence,
c) evaluating the need for action(s)
to prevent nonconformity(ies)
and implementing appropriate
actions designed to avoid their
occurrence,
taken, and
corrective action(s) and preven-
tive action(s) taken.
The organization shall ensure that any
necessary changes are made to envi-
ronmental management system docu-
mentation.

Guidelines
Respon-
sibility
Mgmt.
2.13., (avoiding perils) EA, PLM(3,4), A53600-Q4100-P800-01 Process
2.13.1., Actions for avoiding and minimizing EA BA SCM(3), management
2.13.1.1 perils SUP(2,7) A53600-Q8230-P800-01 Monitoring
The organization should introduce and and measuring of processes
maintain procedures to establish and VA Q8500 Corrective and
carry out actions to avoid or minimize preventive actions / Product safety
perils and related risks for the safety and report
health of employees and persons on QS-PR-QM-009-N: Corrective and
organization premises. Priority should be preventive actions
given to technical actions over organiza-
tional or people-related actions. If cer- QS-PR-QM-010-N: Measurement,
tain residual perils and the related risks Analysis and Improve-
cannot be avoided by comprehensive ment
actions, the employer should provide
appropriate personal protection gear at
no cost and take actions to ensure its
utilization and maintenance.
2.13.1.2. The procedures for avoiding or minimiz- EA, PLM(3,4), A53600-Q4100-P800-01 Process
ing perils and related risks should be so EA BA SCM(3), management
configured that during work, in se- SUP(2,7) A53600-Q8230-P800-01 Monitoring
quences and processes, any deviations and measurement of processes
from the acceptable conditions can be
recognized in time and corrected. These VA Q8500 Corrective and preventive
procedures should actions / Product safety
report
a) be routinely evaluated and when


Guidelines
Respon-
sibility
Mgmt.
necessary modified; QS-PR-QM-009-N: Corrective and
b) ensure the observation of occupa- preventive actions
tional safety and health regulations QS-PR-QM-010-N: Measurement,
and guarantee the status of tech- Analysis and Improve-
nology, workplace medicine and ment
hygiene as well as other assured
ergonomic knowledge;
c) take into consideration the up-to-
date know-how, including informa-
tion and reports from organizations
such as government occupational
safety and health authorities, statu-
tory accident insurance carriers and
other appropriate institutions;
d) provide procedure and work in-
structions when perils cannot be
completely avoided.
Appropriate actions for occupational safety and health are taken based on the perils identified. The fol-
lowing order is to be observed for protective measures:
- avoidance or minimization of perils
has priority over
- technical / measures
have priority over
- organizational or people-related protective measures
In case of residual perils that cannot be avoided by comprehensive measures and the related risks, the
employee is to receive appropriate personal protection gear at no cost, and actions are taken to ensure
its use and maintenance.
Actions for avoiding or minimizing perils are so configured that deviations from the acceptable conditions
can be recognized on time and corrected. These are evaluated during the routine process review and
modified if needed.
Guidelines
Respon-
sibility
Mgmt.
2.13.5., (Workplace medical care, promoting EA, SCM(3,4), PTD QM-Guideline 7-01 „Occupa-
2.13.5.1 health) EA BA SUP(2) tional safety and health-Management
The organization should identify the system“
need for necessary workplace medical
care of the employed under considera-
tion of the perils and related risks to their
safety and health. They should introduce
and maintain procedures to ensure
workplace medical care as long as the
working conditions of the employed and
the current regulations so require.
2.13.5.2. In order to anchor the organization ob- EA, SCM(3,4), ZP-Memorandum Nr. 28/95 Occupa-
jectives in the area of safety and health EA BA SUP(2) tional safety and health / company
protection in the minds of the employees health promotion
and the observation of these objectives
during their work activities, even includ-
ing managers, the organization should
support measures for company health
promotion that supplement the occupa-
tional safety and health. These meas-
ures should motivate employees to ob-
serve occupational safety and health
actions and to act with awareness of
their health and safety.

Local management is to hire a company doctor to provide workplace medical care as far as working
conditions and pertinent regulations make this necessary. Routine preventive care examinations, coun-
seling for vaccinations for foreign travel, etc. are part of this service.
In order to promote the awareness of employees and management regarding safety and health, the
company doctor is a member of the working party occupational health. He counsels and supports the
working party in all questions of health promotion and the planning of the annual health day.
Guidelines
Respon-
sibility
Mgmt.
2.19., (Preventive and corrective actions) EA, EA SCM(3,4), VA Q8500 Corrective and preventive
2.19.1. Procedures must be determined and BA SUP(2) actions / Product safety
maintained for corrective and preventive report
actions, that are produced through the QS-PR-QM-009-N: Corrective and
performance monitoring and measuring preventive actions
of H&S Mgmt., the H&S Mgmt. audits QS-PR-QM-010-N: Measurement,
and the evaluations by top management. Analysis and Improvement
These procedures should include:
a) the identification and analysis of the
causes leading to non-compliance
with relevant occupational safety
and health regulations and /or
commitments of H&S Mgmt.;
b) the introduction, planning, imple-
menting, test for effectiveness and
documentation of corrective and
preventive actions, including modi-
fications to H&S Mgmt. itself.
2.19.2. If the H&S Mgmt. evaluation or that from EA, EA SCM(3,4), VA Q8500 Corrective and preventive
other sources so deems that the preven- BA SUP(2) actions / Product safety
tive and corrective actions for perils and report
their related risks are insufficient or soon QS-PR-QM-009-N: Corrective and
to become insufficient, then these ac- preventive actions
tions should be modified and docu-
mented. QS-PR-QM-010-N: Measurement,
The routinely executed process reviews serve to establish the preventive and corrective actions, since
these reviews examine whether the current occupational safety and health actions are optimum or
whether their effectiveness can be improved upon. In addition, the identification and analysis of causes
of non-compliance with relevant occupational safety and health regulations and/or commitments by AMS
is also included. The preventive and corrective actions can also refer to the introduction, planning,
implementing, test for effectiveness and documentation of corrective and preventive actions, including
modifications to the H&S Mgmt. itself.

9 Appendix
9.1 Cross reference DIN EN ISO 9001:2000 and PTD EA Process Instructions
4 Quality Management System
4.1. General requirements Business Regulations, Process management, A53600-Q4100-P800-01
Documentation of the integrated management A53600-Q4210-P800-01
system VA Q7410
4.2. Documentation requirements
4.2.1 In general Business Regulations, Quality Declaration, A53600-Q4210-P800-01
Documentation of the integrated management
system, Process Instructions, Work Instruc-
tions, Templates
4.2.2 Quality manual Process management, Documentation of the A53600-Q4100-P800-01
integrated management system A53600-Q4210-P800-01
4.2.3 Document control Document control A53600-Q4230-W800-01
4.2.4 Control of records Document control, Memorandum SG-Nr. 383 A53600-Q4230-W800-01

A53600-Q4240-W800-01
5 Responsibility of management
5.1 Obligations of management Business Regulations, Quality Declaration, VA Q6100
Protocols for management review
5.2 Customer orientation Business Regulations, Quality Declaration VA Q5110
VA Q7100
VA Q7200
A53600-E4310-P800-01
PTD ETS 1-0002
A53600-E4320-P800-01
A53600-E4320-W800-01
X27
X22
X25
5.3 Quality policy Business Regulations, Quality Declaration, A53600-Q4100-P800-01
Process management VA Q5100
VA Q6200
5.4 Planning
5.4.1 Objectives Quality Declaration, Process management A53600-Q4100-P800-01
VA Q5100
VA Q6100
A53600-E4330-P800-01
5.4.2 Planning of the Management system Process management A53600-Q4100-P800-01
VA Q7350
VA Q7410
A53600-E4330-P800-01
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority Business Regulations, work plans X2
QS-WI-FA-019-N
5.5.2 Top management representative Business Regulations
5.5.3 Internal Communication Business Regulations VA Q5530
QS-PR-QM-012-N
5.6 Management evaluation
5.6.1 In general Business Regulations A53600-Q4240-W800-01
VA Q5530
QS-PR-QM-012-N
PTD ETS 0-002
5.6.2 Input for evaluation Business Regulations VA W4240
5.6.3 Evaluation results Business Regulations A53600-E4460-P800-01
6 Resource management
6.1 Availability of resources Business Regulations VA Q6100
VA Q6300
QS-PR-DE-001-G
QS-PR-OP-008-G
6.2. Human resources
6.2.1 In general VA Q6200
6.2.2 Capability, awareness and training Capability, awareness and training A53607-Q6220-P800-01
6.3 Infrastructure VA Q6300
QS-PR-MIS-002-N
R2
6.4 Work environment VA Q7540
QS-PR-MIS-002-N
R2
7 Product realization
7.1 Planning of Product realization Process management A53600-Q4100-P800-01

A53600-Q4240-W800-01
QS-PR-MA-001-G
QS-PR-DE-001-G
QS-PR-OP-008-G
QS-PR-CS-001-G
QS-PR-OP-009-G
A53600-E4320-W800-01
A53600-E4460-P800-01
7.2 Customer related processes
7.2.1 Determination of requirements for the product VA Q7100
VA Q7200
VA Q7201
A53600-Q7300-P600-01
QS-PR-SA-001-G
QS-PR-MA-001-G
QS-PR-CS-001-G
A53600-E4320-W800-01
7.2.2 Evaluation of requirements for the product A53600-Q4240-W800-01
VA Q7201
A53600-Q7300-P600-01
QS-PR-SA-001-G
QS-PR-MA-001-N
QS-PR-CS-001-G
A53600-E4320-W800-01
A53600-E4460-P800-01
7.2.3 Communication with the customer VA Q7100
VA Q7200
VA Q7201
VA Q7230
A53600-Q7300-P600-01
VA Q4050
QS-PR-MA-003-G
QS-PR-OP-001-G
QS-PR-CS-001-G
QS-PR-OP-009-G
7.3 Development
7.3.1 Development planning A53600-Q7300-P600-01
7.3.2 Development inputs VA Q5110
VA Q7100
A53600-Q7300-P600-01
QS-PR-MA-001-G
A53600-E4320-W800-01
7.3.3 Development Results VA Q7100
A53600-Q7300-P600-01
QS-PR-PUR-002-G
7.3.4 Development evaluation VA Q7100
A53600-Q7300-P600-01
7.3.5 Development verification A53600-Q7300-P600-01
7.3.6 Development validation A53600-Q7300-P600-01
7.3.7 Control of Development modifications A53600-Q7300-P600-01
VA Q7531
VA Q7350
7.4 Procurement
7.4.1 Procurement Process VA Q7400
VA Q7410
QS-PR-PUR-001-G
7.4.2 Procurement details VA Q7400
VA Q7410
QS-PR-PUR-001-G
L24
P18
7.4.3 Verification of procured products VA Q7400
VA Q8240
VA Q7410
VA Q6200
QS-PR-PUR-001-G
QS-PR-PUR-002-G
7.5 Production and providing services
7.5.1 Control of Production and providing services VA Q7500
VA Q8240
VA Q7540
VA Q7230
QS-PR-OP-001-G
QS-PR-CS-001-G
QS-PR-OP-009-G
7.5.2 Validation of Processes for Production and Monitoring and measuring of processes A53600-Q8230-P800-01
providing services QS-PR-OP-008-G
QS-PR-CS-001-G
QS-PR-OP-009-G
7.5.3 Identification and traceability VA Q7530

VA Q7531
QS-PR-OP-001-G
QS-PR-CS-001-G
QS-PR-DE-001-G
7.5.4 Customer property VA Q7540
QS-PR-OP-003-G
7.5.5 Product preservation VA Q7540
QS-PR-PUR-002-G
QS-PR-DE-001-G
A53600-E4320-W800-01
7.6 Control and monitoring of measuring devices VA Q7600
8 Measurement, analysis and improvement
8.1 In general Business Regulations, Process management, A53600-Q4100-P800-01
Monitoring and Measurement of processes A53600-Q8230-P800-01
PTD ETS 0-003
8.2 Monitoring and measurement
8.2.1 Customer satisfaction Business Regulations, Monitoring and meas- A53600-Q8230-P800-01
urement of processes QS-PR-MA-002-G
8.2.2 Internal Audit A53600-Q8220-P800-01
PTD ETS 0-002
PTD ETS 0-003
8.2.3 Monitoring and measurement of processes Process Management, Monitoring and meas- A53600-Q4100-P800-01
urement of Processes A53600-Q8230-P800-01
8.2.4 Monitoring and measurement of the Product VA Q8240
QS-PR-DE-001-G
QS-PR-OP-001-G
QS-PR-CS-001-G
QS-PR-OP-009-G
8.3 Control of defective products VA Q8300
QS-PR-DE-001-G
QS-PR-OP-001-G
QS-PR-CS-001-G
8.4 Data analysis Process management, Monitoring and meas- A53600-Q4100-P800-01
urement of Processes A53600-Q8230-P800-01
8.5 Improvement
8.5.1 Continual Improvement Process management A53600-Q4100-P800-01
A53600-E4460-P800-01
8.5.2 Corrective actions Business Regulations VA Q7230
VA Q8500
QS-PR-QM-009-N
X26
8.5.3 Preventive actions VA Q7230
VA Q8500
QS-PR-QM-009-N
X26
Table -1: Cross reference DIN EN ISO 9001:2000 and PTD EA Process Instructions

9.2 Cross reference DIN EN ISO 14001:2004 and DIN EN ISO 9001:2000
DIN EN ISO 14001:2004 DIN EN ISO 9001:2000

Introduction - 0 Introduction
0.1 In general
0.2 Process oriented approach
0.3 relation to ISO 9004
0.4 Compatibility with other Management systems
Area of utilization 1 1 Area of utilization
1.1 In general
1.2 utilization
Normative references 2 2 Normative references
Concepts 3 3 Concepts
Demands on an environment management sys- 4 4 Quality management system
tem
General requirements 4.1 4.1 General requirements
Environment policy 4.2 5.3 Quality policy
Planning 4.3 5.4 Planning
Environmental aspects 4.3.1 5.2 Customer orientation
7.2.1 Determining requirements for the Product
Evaluation of requirements for the Product
7.2.2
Legal obligations and other requirements 4.3.2 5.2 Customer orientation
7.2.1 Determining requirement for the Product
Setting objectives, individual objectives and 4.3.3 5.4.1 Quality Objectives
program(s) 5.4.2 Planning of the Quality management system
8.5.1 Constant improvement
Realization and execution 4.4 7 Product realization
Resources, tasks, responsibility and authority 4.4.1 5.1 Responsibility of management
5.5.1 Responsibility and Authority
5.5.2 Top management representative
6.1 Availability of Resources
6.2.1 Human Resources
6.3 Infrastructure
6.4 Work environment
Capability Awareness and Training 4.4.2 6.2.2 Capability, awareness and Training
Communication 4.4.3 5.5.3 Interne Communication
7.2.3 Communication with customers
Documentation 4.4.4 4.2.1 Documentation requirements
In general
Document control 4.4.5 4.2.3 Document control
Control of sequences 4.4.6 7.1 Planning of the Product realization
7.2.1 Determining the requirements for the Product
Evaluation of the requirements of the Product
7.2.2 Development Planning
Development input
7.3.1 Development Results
7.3.2 Development Evaluation
7.3.3 Development verification
7.3.4 Development validation
7.3.5 Control of Development modifications
7.3.6
7.3.7 Procurement Process
Procurement details
7.4.1 Verification of procured Products
7.4.2
7.4.3 Control of Production and providing services
Validation of Processes for Production and provid-
7.5.1 ing services
Product preservation
7.5.2
7.5.5
Emergency care and danger defense 4.4.7 8.3 Control of defective Products
Control and corrective actions 4.5 8 Measurement, Analysis and Improvement
Monitoring and Measurement 4.5.1 7.6 Control of monitoring and measuring devices
8.1 Measurement, Analysis and Improvement

In general
Evaluation of compliance with legal regulations 4.5.2 8.2.3 Monitoring and Measurement of Processes
8.2.4 Monitoring and Measurement of Products
8.4 Data analysis
Non-conformity, corrective and preventive actions 4.5.3 8.3 Control of defective Products
8.5.2 Corrective measures
8.5.3 Preventive measures
Records 4.5.4 4.2.4 Control of Quality records
Internal Audit 4.5.5 8.2.2 Internal Audit

DIN EN ISO 14001:2004 DIN EN ISO 9001:2000

Evaluation by Management 4.6 5.6 Management Evaluation
5.6.1 In general
5.6.2 Input for the Evaluation
5.6.3 Results of the Evaluation
Table 9-2: Cross reference DIN EN ISO 14001:2004 and DIN EN ISO 9001:2000

9.3 Index
Figure 1: Siemens Reference Process House (V2.2) ...............................................................................13
Figure 2: Process Interaction....................................................................................................................14
Figure 3: Management system documentation........................................................................................17
Figure 4: Improvement process of the PTD EA Management System .....................................................22
Table 9-1: Cross reference DIN EN ISO 9001:2000 and PTD EA Process Instructions ..................... 96
Table 9-2: Cross reference DIN EN ISO 14001:2004 and DIN EN ISO 9001:2000 ............................ 98


If you have any questions about Power Transmission
and Distribution, our Customer Support Center is avail-
able around the clock.
Tel.: +49 180 / 524 7000 (Subject to changes,
e.g.. 12 ct/min.)
Fax: +49 180 / 524 2471
E-Mail: ptd.support@siemens.com
www.siemens.com/ptd-support
The information in this document contains

Siemens AG general descriptions of the technical options
Power Transmission available, which do not always have to be
present in individual cases. The required
and Distribution features should therefore be specified in
Energy Automation each individual case at the time of closing
the contract.
Humboldtstraße 59
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Energy Automation – Management Manual

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Issue Date Name Department Telephone Comments

Version 1.0 dated 01.07.05 A53600-I4200-M800-01-76A1

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8.4 Analysis of data 86

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1.6 Paper copies

2.2 Management system documents

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2.4 Occupational safety and health documents

2.5 Other references

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3 Mapping of the Organization to the Reference Process House

Process & Information Management

Product Portfolio Management

Environment, Health & Safety

Real Estate Management

PTD EA Ltg./BA v v f*) v

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4 Integrated quality, environment and safety management system

4.1 General requirements

The quality system shall ensure compli-

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Occupational safety and health management

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Figure 1: Siemens Reference Process House (V2.2)

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Figure 2: Process Interaction

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4.2 Documentation requirements

Workplace safety management

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Workplace safety management

VA Q5100: Establishing the Division

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Figure 3: Management system documentation

4.2.2 Management Manual

The Management Manual describes the integrated management system.

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4.2.3 Control of documents

a) Equipment documents and manu-

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4.2.4 Control of records

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5.1 Management commitment

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An overview of the improvement process is found in the following illustration.

Figure 4: Improvement process of the PTD EA Management System

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5.2 Customer focus

4.3.2 The organization shall establish, imple- EA CRM, A53600-E4320-P800-01 Study of

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Occupational safety and health management

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