Interpretation of The Requirements of DIN EN ISO 9001:2015

Guide to ISO 9001:2015
Interpretation of the requirements of

DIN EN ISO 9001:2015
TÜV NORD GROUP

Foreword
Dear Reader,
Quality and customer satisfaction are vital factors

when it comes to success on the competitive market.
For many years now, the internationally recognised
standard ISO 9001 has provided the basis for efficient
quality management in a large number of organizations.
The environment in which companies and other

organizations have to work has become much more
complex in the past few years. This fact, which also
has a decisive impact on all aspects of management,
is taken into account by the new version of the
Standard. This new version is to be adapted to present
and future developments in such a way that it can
retain its validity for a period of ten years. But one thing Dr. Klaus Oberste Lehn
will not change — ISO 9001 will remain the only cross-
sector certification standard for quality management In view of the transitional period of three years, you
systems. will have sufficient time to consider future planning for
your quality management system and to discuss the
We would like to keep you informed at all times about transition to ISO 9001:2015 at leisure with our auditors.
the latest developments, and so this Guide has been
created to answer the most important questions We are looking forward to speaking to you!
regarding the new ISO 9001.
Some practical examples of interpretation of the

Standard, along with suitable system documents and
Dr. Klaus Oberste Lehn
key indicators, will show how you can meet the Head of Certification Body
changed requirements. TÜV NORD CERT GmbH
Rev. 02 / 11.15 2
Contents
1. The Learning Organization 4. ISO 9001:2015 – Interpretation of

the requirements
1.1. How quality management helps 04
organizations to progress 4.1. Notes for the user 15
1.2. History of ISO 9001 04 4.2. Interpretation of the requirements 16
1.3. From draft to final standard: 05 of ISO 9001:2015 clauses
The schedule for the changeover following
publication of ISO 9001:2015
5. Annexes
2. What’s new? The main changes Answers to important questions about the 46
in ISO 9001:2015 New Versions of ISO 9001 and ISO 14001

2.1. Introduction of a “High Level 07
Structure”
2.2. Concept of risk-based thinking 09
2.3. More freedom for documentation 09
2.4. Greater relevance of the standard 09
for service providers
2.5. Concept of “interested parties” 09
2.6. Tasks of management, absence of 09
quality management representative
2.7. Improvement of customer satisfaction 09
3. Comparison of 10
ISO 9001:2015 – ISO 9001:2008
Rev. 02 / 11.15 3
1. The Learning Organisation
1.1. H
ow quality management helps subjected to thorough revision and updating in order to
organizations to progress reflect changed conditions. Since its introduction in 1987,
ISO 9001 has been through several stages on the way
Quality management is a development concept for to its current form. This evolution is also connected with
companies and other organizations. Development the development of TÜV NORD CERT: the certification
means the ability to adequately meet changing challenges. unit for quality management at TÜV NORD was estab-
Many requirements, such as technological change lished in 1986.
or increasing competitive pressure, mean that organiza-
tions have to change continuously in order to adapt The first version of ISO 9001 was based on one British and
to their markets as effectively as possible. As important one US-American military standard. It provided for three
as it is to adapt, ongoing development of know-how different quality management systems, depending on the
is essential – for this is the prerequisite for growth and business activities of the organization to be certified.
improvement in market position. However, this develop-
ment is not simply a reaction to short-term crises, but is The first revision took place in 1994: it placed particu-
always a longer-term process. Therefore well-functioning lar emphasis on the theme of quality assurance and
quality management creates the necessary structure recommended preventive measures, instead of merely
for continual development, in order to enhance customer checking the end product. Organizations were still
satisfaction and therefore success on the market. structured in terms of individual departments and organi-
zational units.
International Standard ISO 9001 is an internationally-
recognised, reliable and tried and tested basis for such The year 2000 brought a radical revision and adaptation
quality management. All over the world, it promotes of the standard to modern management methods.
further development of organizations and creates trust In place of quality assurance and control, concepts for
in the relationships between companies, their customers quality management and process management at a
and their suppliers. The numbers speak for themselves: deeper and more cross-departmental level were intro-
in 2013 there were a total of 1,129,446 certificates to duced; in addition, continual improvement of customer
ISO 9001 spread over 187 countries. This amounts to satisfaction came to the fore. Analysis of requirements,
nearly three quarters of all ISO certificates – and the the process approach and the linking of different work
numbers are still rising. processes became the focus of attention. Mere con-
centration on individual units within the organization
Next to China and Italy, Germany is one of the countries gave way to a process-based way of seeing things, or
in which most certificates have been issued. However, in other words to an overall process landscape.
there is also increasing demand for ISO 9001 certifications
in India and the USA. The new edition of 2008 did not bring about such far-
reaching changes, but simply clarified some aspects
of the standard. In the course of this, ISO 9001 was
brought closer to Standard ISO 14001, which deals with
1.2. History of ISO 9001 environmental management. Even if an increasing trend
towards sector-specific standards has been seen since
Just as companies develop as they base their quality the turn of the millennium, ISO 9001 remains the pree-
management on ISO 9001, so does the Standard minent quality standard: no other standard is so wides-
itself develop: around every five years, the Standard is pread throughout the world, and no other standard is
Rev. 02 / 11.15 4
1. The Learning Organization
so well able to combine generally applicable principles of all sectors and types, not only in order to determine
for establishing and maintaining quality throughout the requirements of their customers, but also to fulfil
an organization under one umbrella. This means that them in the best possible way through provision of
ISO 9001 continues to be the main guide for organizations products and services.
1.3. The schedule for the changeover

following publication of ISO 9001:2015
Publication Transition period End of

of the standard Transition period
Publication of 3 years until the Transition period

the standard on changeover ends on
22/09/2015 15/09/2018
15/09 /15 3 Jahre 14 / 09/2018
Planning phase Transition phase End of the transition phase
n
Get to know the content n onsider the required
C n uccessive implemen-
S
of the new standar changes with regard to tation of the planned
their usefulness for your actions by summer
Client n peak to the auditor
S own organisation 2018 at the latest
organisation during the next audit
n n upgrade audit is
A
n ake note of information
T recommended within
from the certificationbody the framework of a
recertification audit
n raw up a plan for the
D
work needed for the n erform Delta or GAP
P
changeover audits beforehand in order
to identify any gaps in the
management system
Figure 1 – ISO 9001 timeline
The three-year transition period for ISO 9001:2015 Following the changeover, new certificates will be
begins on 15/9/2015 and ends on 14/09/2018. Certificates issued based on ISO 9001:2015 for the remaining
according to ISO 9001:2008 that are still in circulation validity period of the old certificates (or based on the
have a validity of three years provided that within the corresponding issue of the DIN EN ISO-standards).
(aforementioned) transition period, the changeover is Since the publication of ISO 9001:2015, audits can
made to ISO 9001:2015 by means of an upgrade audit. also be performed according to ISO 9001:2015.
Rev. 02 / 11.15 5
1. The Learning Organization
Audits according to the former DIS (Draft Standard) will Delta or GAP audits. GAP audits make it possible to
not be recognised. Companies and other organisations identify the gaps in the management system in advance.
that are already certified then have the possibility to The GAP audit can be added, for example, to the next
change over by 14. September 2018. An upgrade audit surveillance or recertification audit. This means that
within the framework of recertification is recommended. there will be sufficient time for the transition phase.
In order to achieve successful recertification according Simply contact us or send us a message if you require
to the new standard, we recommend performance of further information or an offer.
Rev. 02 / 11.15 6
2. What’s new?
The main changes in ISO 9001:2015
2.1. Introduction of a “High Level Structure” information security. However, despite their close relation-
ship with each other, these standards up to now did not
The most important new aspect of ISO 9001:2015 share a common structure. In order to make harmonised
regards the establishment of the so-called High Level structure and wording possible for all the relevant
Structure. The background is that all management standards, a structure with identical chapter structures,
systems are based on certain basic elements – including texts, terms and definitions has now been established
ISO Standards such as ISO 9001, ISO 14001 for for all future management standards. This represents a
environmental management, BS OHSAS 18001 for very important step forward along the path to integrated
occupational health and safety and ISO 27001 for management systems.
4 Context
of the 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance
evaluation 10 Impro-
vement
organisation
Understanding Management Risks and Resources Operational Measurement, Nonconformity

of and opportunities planning and analysis, ealua- and corrective
organisation commitment control tion action
Expectations (Quality) Policy Quality Competences Requirements Internal audits Improvement

of interested objectives for products
parties/ and services
stakeholders
Scope Tasks, Planning of Awareness Design and Management

Responsibilities, changes development of review
Authorities products and
services
Quality Communication Control of exter-

management nally provided
system and its processes, prod-
processes ucts and services
Documented Production
Information and service
provision
Release of
products and
services
Control of non-
conforming out-
puts (products
and services)
Figure 2 – Overview of the High Level Structure
Rev. 02 / 11.15 7
2. What’s new? The main changes in ISO 9001:2015
Schedule for the changeover of all management systems to the new structure:
Already changed
over to High Changeover Changeover
Standard
Level Structure 2016 2017
ISO 27001 X
ISO 9001 X
ISO 14001 X
BS OHSAS 18001 X
ISO 22000
ISO 22301
ISO/TS 16949 X
ISO 50001 X
ISO 13485
Rev. 02 / 11.15 8
2. What’s new? The main changes in ISO 9001:2015
2.2. Concept of risk-based thinking respective organization. Although this requirement

also existed before, this aspect is now accorded greater
ISO 9001:2015 assumes that a basic understanding emphasis. In concrete terms this means that the
of (product- or service-related) risk assessment is organization should not only consider statutory and
increasingly important for organizations of all kinds. regulatory requirements and the needs of their customers,
For this reason, the concept of risk-based thinking but should also consistently think about their relation-
is being introduced for the first time. Although no ships with their employees, partners, suppliers and
risk management as such is required, organizations other parties who are relevant for their quality manage-
should identify risks and be able to take them ment system, such as banks, local authorities or even
appropriately into consideration. In return, there is competitors.
no specific requirement for preventive measures.
2.6. Tasks of management, absence of

2.3. More freedom for documentation qualitiy management representative
The minimum six documented procedures are no longer Assignment of roles and tasks has been overhauled;
required; instead of documents and proofs, the only there is now a clearer requirement for acknowledgement
mention is of documented information. This makes of management responsibility and commitment.
handling of documents more flexible. Based on its own Instead of a separate quality management representa-
specific competences and structures, the organization tive, in future a member of the company or organization
can decide for itself what it wishes to document and management will fulfil this role. The management
to what extent. This decision must be justified to the review is extended to include aspects of strategic
auditor within the framework of the certification. focus, consideration of stakeholders and strategic risk
assessment.
2.4. Greater relevance of the standard for

service provide 2.7. Improvement of customer satisfaction
The fact that the service sector is growing is also The new version of the standard requires that necessary
reflected in ISO 9001:2015. Although it was possible to inputs and expected outputs must be specified and
implement the standard across sectors in the past, measured for each process. KPIs (Key Process Indicators)
the new version is more strongly focussed on the needs were not so clearly required before. This means that
and interests of service providers. Among other things, ISO 9001:2015 is driving forward consideration, moni-
the term “products” has now been expanded to become toring and measurement of processes.
“products and services”.
For more detailed information, an overview of the

2.5. Concept of “interested parties” clauses in the Standard and a summary of the
requirements and possible evidences that can be
At two points in the new version, reference is made provided by your organization, please see the
to so-called “interested parties” (stakeholders), whose interpretation of the requirements given in Chapter 4
interests must be taken into consideration by the of this document.
Rev. 02 / 11.15 9
3. Comparison of
ISO 9001:2015 – ISO 9001:2008
The table below shows the difference between the structure
of ISO 9001:2008 and the new version, ISO 9001:2015.
Clause Clause
9001:2008 Basic ISO structure 9001:2015
1 Scope 1
2 Normative references 2
3 Terms and definitions 3
1 Context of the organization 4
1.1 Understanding the organization and its context 4.1
Understanding the needs and expectations

New 4.2
of interested parties
1.2 / 4.2.2 Determining the scope of the quality management system 4.3
4 / 4.1 Quality management system and its processes 4.4
5 Leadership 5
5.1 Leadership and commitment 5.1
5.2 Customer focus 5.1.2
5.2 / 5.3 Policy 5.2
4.2.1a / 5.3 Development of quality policy 5.2.1
5.3 d Communication of quality policy 5.2.2
5.5.1 / 5.5.2 Roles, responsibilities and authorities in the organization 5.3
5.4.2 Planning 6
New Actions to address risks and opportunities 6.1
Rev. 02 / 11.15 10
3. Comparison of ISO 9001:2015 – ISO 9001:2008
Clause Clause
4.2.1a / 5.4.1 Quality objectives and planning to achieve them 6.2
New Planning of changes 6.3
6 Support 7
6 Resources 7.1
6.1 General 7.1.2
6.2 People 7.1.2
6.3 Infrastructure 7.1.3
6.4 Environment for the operation of processes 7.1.4
6.2 / 8.2 Monitoring and measuring resources 7.1.5
7.6 / 8.2 Traceability of measurements 7.1.5.2
New Organizational knowledge 7.1.6
6.2.1 / 6.2.2 Competence 7.2
6.2.2 d Awareness 7.3
5.5.3 Communication 7.4
4.2 Documented information 7.5
4.2.1 General 7.5.1
4.2.3 / 4.2.4 Creating and updating 7.5.2
4.2.3 / 4.2.4 Control of documented information 7.5.3

(Documented information required) 7.5.3.1
(Control of documented information) 7.5.3.2
Rev. 02 / 11.15 11
Clause Clause
7 Operation 8
7.1 / 7.5.1 Operational planning and control 8.1
7.2 Requirements for products and services 8.2
7.2.3 Customer communication 8.2.1
Determination of requirements related

7.2.1 8.2.2
to products and services
7.2.2 Review of requirements related to products and services 8.2.3
7.2.2 Changes of requirements related to products and services 8.2.4
7.3 Design and development of products and services 8.3
7.3 General 8.3.1
7.3.1 Design and development planning 8.3.2
7.3.2 Design and development inputs 8.3.3
7.3.1 Design and development controls 8.3.4
7.3.3 Design and development outputs 8.3.5
7.3.7 Design and development changes 8.3.6
4.1 / 7.5.4 Control of externally provided products and services 8.4
4.1 / 7.5.4 General 8.4.1
4.1 / 7.5.4 Type and extent of control of external provision 8.4.2
7.4.2 Information for external providers 8.4.3
7.5 Production and service provision 8.5
Rev. 02 / 11.15 12
Clause Clause
7.5.1 Control of production and service provision 8.5.1
7.6 Means of measurement 8.5.1
7.5.3 Identification and traceability 8.5.2
7.5.4 Property belonging to customers or external providers 8.5.3
7.5.5 Preservation 8.5.4
7.2.1 / 7.5.1 Post-delivery activities 8.5.5
7.2 / 7.3.7 / 8.2 Control of changes 8.5.6
7.4.3 / 8.2.4 Release of products and services 8.6
Control of nonconforming process outputs,

8.3 8.7
products and services
8.1 Performance evaluation 9
8.1 Monitoring, measurement, analysis and evaluation 9.1
8.1 General 9.1.1
5.2 / 8.2.1 Customer satisfaction 9.1.2
8.4 Analysis and evaluation 9.1.3
8.2.2 Internal audit 9.2 / 9.2.1 / 9.2.2
5.6 Management review 9.3
5.6.1 General 9.3.1
5.6.2 Outputs of the management review 9.3.2
5.6.3 Outputs of the management review 9.3.3
8.5 Improvement 10
Rev. 02 / 11.15 13
Clause Clause
8.5.1 General 10.1
8.3 / 8.5.2 Nonconformity and corrective action 10.2

(Actions) 10.2.1
(Documented information) 10.2.2
8.5.1 Continual improvement 10.3
Rev. 02 / 11.15 14
4. ISO 9001: 2015 –
Interpretation of the requirements
4.1. Notes for the user
In the following sections of this brochure we use a consistent presentation scheme. Each clause or sub-clause of the
Standard will be shown in the following form.
Requirement of Interpretation / Examples of docu- Examples of

the Standard Activities mentation / Evidences Key Indicators
The column Requirement of the Standard contains The fourth column lists some practical examples of
the basic requirements of the respective clause or Key Process Indicators. However, the examples do
subclause of the Standard. not claim to be exhaustive, as in practice different
KPIs or KPI systems are used in different organizations.
Under the heading Interpretation /Activities, examples
are given of activities for practical implementation
within a process-orientated framework in companies
and organizations.
The column regarding Examples of documentation/

Evidences shows some documents which can provide
evidence of fulfilment of the requirements of the Standard.
Rev. 02 / 11.15 15
4. ISO 9001:2015 – Interpretation of the requirements
4.2. Interpretation of the requirements of ISO 9001:2015 clauses

Clause 4 – Context of the organization
4.1 Understanding the organization and its context
Understand the organization Determine external and n analysis of the

and its context internal issues that are influencing factors
important for the objectives
and strategy of the orga- External themes:
nization, and continuously n List of the laws, changes
observe them. and planned changes

n technical developments
The aim is to define the n market analyses
themes and evaluate which n economic changes
ones influence the capability n strategy papers
of the QM system and

aretherefore relevant to the Internal themes:
results to be achieved, n mission statement
e.g. fulfilment of customer n performance,
requirements. key indicators

n cultural themes
(e.g. China)
4.2 Understanding the needs and expectations of interested parties
Understand the needs and Determination: List of interested parties

expectations of interested and their requirements:
parties n of the interested parties
who are relevant for the QM n customers
systems n owners
n and the requirements and n suppliers
expectations of the interested n banks
parties that are relevant for n partners
the QM system n official bodies /
authorities
The aim is to monitor and n universities
check the information supplied n associations,
to the interested parties federations

along with the requirements n development centres
and expectations of the

interested parties. This is in
order to determine the effect
on the capability to provide
products and services which
fulfil customer requirements
and legal requirements.
Rev. 02 / 11.15 16

4.3 Determining the scope of the quality management system
Determine the scope of the n Determine the boundaries n scope

quality management system and scope of the QM system n description of the
n Determine the scope, taking processes within the
the internal and external scope, including
themes into consideration, outsourced processes
and also the requirements of n geographical and technical
the interested parties scope

n Documented scope, stating n justification of exclusion of
the products and services requirements

which fall under the QM
system products and services
supplied by the organization.
4.4 Quality management system and its processes
Quality management system The aim is to determine, use, n description of the interac- n customer satisfaction
and its processes monitor, assess and improve tions of the processes, e.g. indicators
the processes of the QM process model n process quality
Requirements for the quality system that are needed to n list of process owners indicators
management system: achieve the intended results. n tasks, function/job n process performance
n structure, implementation, The following must be taken description of the process indicators
maintenance and continual into consideration: owners n process cost
improvement of the QM n process indicators for indicators

system n inputs and outputs measuring effectiveness of n resource indicators
n determination and use of n sequence and interaction of processes n target achievement
the necessary processes and processes n assignment of the indicators

their interactions n criteria, methods, process indicators to n business management
measurement of performance the processes indicators

Documented information that indicators for ensuring effective n measurement,
is needed in order to support implementation and control monitoring and evaluation

the processes and carry of the processes of the processes
them out as planned must be n resources needed and n linking of the processes
updated and kept. available with further documents

n responsibilities for (documented procedures,
processes work instructions)
n risks and opportunities n available resources
n necessary changes n analysis of processes with
n opportunities for regard to risks and oppor-

improvement tunities and associated
planning, implementation
and assessment of actions
n list of the documents
needed for implementation

of the processes, document
control and storage
Rev. 02 / 11.15 17

Clause 5 – Leadership
5.1 Leadership and commitment
5.1.1 Leadership and The top management n written quality policy n rate of target fulfilment
commitment for the shall demonstrate leadership and objectives n rate of meeting deadlines
quality management and commitment by taking n evidence of training on n customer satisfaction
system responsibility for the effective- quality policy/informative index

ness of the QMS events n complaint rate
n statements of top n qualification index of
n establish quality policy and management personnel

objectives that are appropriate n evidence of attainment n return on Investment (Rol)
to the strategy and context of targets (BSC) n benchmark hit list
of the organization n improvement projects (ranking)

n communicate quality policy n results from top n profit margin (genera)
and ensure that it is under- management meetings n implementation rate of
stood and implemented in n management review training budget

the organization n performance charts n investment implementa-
n ensure integration of the n reaction plans if results/ tion rate

QMS into business processes targets not achieved n employee fluctuation rate
n promote awareness of n training plans/evidences n employee satisfaction
the process approach and regarding process approach, index

risk-based thinking and processes, methods
communicate importance of n communication with
fulfilment of the requirements employees (notices, agendas

of the QM system of information events)
n ensure necessary availability regarding effectiveness of
of resources the QM system
n ensure that the desired n personnel development
QMS plans
n support employees and n employment of personnel
others, in order to ensure the n protocols regarding targets
effectiveness of the QMS n project plans
n promote the continual n investment plans
improvement process n training budget
n support others in their n factory agreements with
management activities employees

n continual improvement
projects
n results from top
management meetings
n corporate policies
n mission statement
Rev. 02 / 11.15 18

5.2 Customer focus
5.2 Customer focus Leadership and commitment n analysis of customer n customer satisfaction
The top management for customer satisfaction satisfaction index
shall demonstrate leader- through n SWOT analysis n complaint rate
ship and responsibility n action plans n new products/time unit
for customer satisfaction n communication, under- n list of customer requirements n break even point for
standing and fulfilment of n list of statutory and new products

customer requirements regulatory requirements n life cycle of products
and the currently valid n assessment of fulfilment n number of product
statutory and regulatory of customer requirements liability cases

requirements n action plans n key indicators for
n determination of risks and n analysis of customer production risk

opportunities concerning surveys n field failure rate
product and service n market analyses
compliance n analysis of complaints
n focus on improvement of documentation

customer satisfaction
5.2 Policy
5.2.1 Development of The top management shall n written statement of

quality policy determine, implement, monitor Q policy
and maintain a Q policy. The n review of Q policy for
quality policy must appropriateness
n be appropriate for the

objective and the context of
the organization
n create a framework for
determination and review of

Q objectives
n contain the obligation to
fulfil appropriate requirements

n contain the obligation to
undertake continual impro-

vement
5.2.2 C
ommunicating the The quality policy must: n written version of Q policy
quality policy n documentation from
n be available as documented informative events, Intranet
information entries etc. for employees,
n be communicated, under- printed versions for stake-
stood and applied within the holders of the organization,
organization possibly publish on the
n be available to relevant Internet
interested parties, as
appropriate
Rev. 02 / 11.15 19

5.3 Organizational roles, responsibilities and authorities
5.3 Organisational roles, Assignment, communication n organisation charts n key indicators regarding
responsibilities and authorities and understanding of res- n job/function descriptions the effectiveness of the
ponsibilities and authorities n definition of members of QM system
for relevant roles within the management and top n rate of fulfilment of per-
organization, in order to management formance assessments

ensure that n letters of appointment n rate of fulfilment of
n control rights Q objectives

n the QM system n contracts with third parties n rate of fulfilment of
fulfils the requirements of n budget process results

ISO 9001:2015 n requirement profiles n employee fluctuation rate
n the processes provide the n process owners
intended result n key accounts, customer
n the performance of the support staff

QMS and potentials for n change management
improvement are reported to n communication rules
the top management n status reports/Q-analyses
n customer focus is n reports on internal audits
promoted n reports regarding
n the integrity of the QMS is Q situation

maintained, even if changes n statistical evaluations
occur n management review
n innovation projects
n project planning for change
Clause 6 – Planning for the quality management system
6.1 Actions to address risks and opportunities
6.1.1 The objective is to plan the n project plan for change

QM system so that, taking projects with inputs
into consideration the internal n list of external themes
and external themes, the n list of internal themes
requirements of the interes- n list of risks
ted parties and the risks and n list of opportunities
opportunities that have n investment plans
been determined, n strategy plans
n QM plans
n the QM System achieves n production plans
the intended results, n resource plans/evidences
n undesired effects are
prevented or reduced
n desired effects are
strengthened
n continual improvement is
achieved and maintained,

even if changes occur
Rev. 02 / 11.15 20

6.1 Actions to address risks and opportunities
6.1.2 Measures for handling risks n list of risks nrisk priority number
and opportunities shall be n list of opportunities nimplementation rate
planned, integrated into the n FMEAs of actions
QM system, implemented n risk analyses
and assessed for effective- n action plans
ness. n QM plans
n production plans
Determination of risks and n resource plans/evidences
opportunities is related to n process descriptions
creation of products and n work and test plans
services. Determination of
the measures is orientated
on the possible influence
on conformity.
6.2 Quality objectives and planning to achieve them
6.2.1 Q objectives shall be specified n Q objectives and n implementation rate of

and maintained in written their determination and Q objectives
form for relevant functions, communication n customer-related quality
levels and processes. n internal/external target objectives: fulfilment of

Quality objectives shall agreements (business delivery dates, complaint
plans, project plans, rate, customer satisfaction
n be consistent with the qualify agreements) index
Q policy n organization-related, n product-related quality
n be measurable product-related, customer- objectives: tonnage,

n take appropriate require- related objectives internal production times,
ments into consideration n employee information OEE, machinery utilisation
n be relevant for product and n rules regarding updating rate, rework rate, scrap
service and also relevant to n rules regarding control rate, stocks, key indicators
increase of customer satis- n harmonisation with for process quality, cpk
faction Q policy values, throughput times,
n be monitored n level of achievement and processing times,
n be communicated trends n external providers:
n be updated when necessary complaint rate, adherence

n must be documented and to delivery deadlines
the documentation must be
kept
6.2.2 When planning how to n action plans

achieve its quality objectives, n results of evaluations
the organization shall define
n what will be done
n what resources will be
required
Rev. 02 / 11.15 21

6.2 Quality objectives and planning to achieve them
6.2.2 n who will be responsible

n when it will be completed
n how the results will be
evaluated
Clause 7 – Support
7.1 Resources
7.1.1 General The organization shall n requirement profile n extent of resources

determine and provide the (employees, infrastructure) n capacity utilisation of
necessary resources for the resource planning (internal persons involved
QMS. The following must be and external) n risk assessment/planning
taken into consideration: n project management of redundancies

n availability (personnel, n sickness rate
n capabilities and limitations of infrastructure)

the existing internal resources n job or function descriptions
n what information has to be n service/quality agreement
gathered from external (if using external resources)

providers
7.1.2 People The organization shall provide n personnel, staff position n qualification index
the persons necessary for planning n rate of further training
effective implementation of n definition of key undertaken (qualification
the QMS qualifications index)
n status of available qualified
staff and qualifications

n qualification plan
n staff deployment planning
7.1.3 Infrastructure The organization shall deter- n investment plans navailability of plant and
mine, provide and maintain n resource planning machinery
the infrastructure necessary n material flow analyses
for operation of its proces- n warehouse capacity
ses to achieve conformity assessment

of products and services. n process capability studies
Examples are buildings, n measuring instrument
tools, equipment, software, capability studies

hardware, transport, IT
Rev. 02 / 11.15 22

7.1 Resources
7.1.4 Environment for the The organization shall deter- n handling and storage n implemented training
operation of processes mine, provide and maintain conditions (temperature, air courses
the environment necessa- humidity, cleanliness, identifi- n employee satisfaction
ry for the operation of its cation, traceability etc.) index

processes and to achieve n servicing and maintenance n employee fluctuation rate
conformity of products plans n accident statistics
and services, e.g. physical, n risk and hazard assessment
social, psychological and n factory tour reports/logs
environmental factors and

other factors such as
temperature, humidity,
ergonomics and cleanliness)
7.1.5 Monitoring and Where monitoring and mea- n test planning concept n rate of tests not OK (to
measuring resources surements are necessary for n test planning assess process capability)
the conformity of the product n qualification requirements n proportion of measuring
7.1.5.1 General or the service, the organisation for testers devices with calibration
shall determine the resources n test instructions results not OK
needed to ensure valid, n determination or resource n accumulated use times of
reliable monitoring and reliable requirements a measuring instrument

measurement. n measuring equipment n calibration times (available/
capability studies non-available periods)

nMeasuring instruments shall n validation of test software n set/actual stock of
be regularly maintained in n register of measuring instruments

order to ensure continuous equipment and standards n proportion of measuring
availability for use in n evidences of calibration instruments which could

accordance with the intended n reference to international not be located at the plan-
purpose, and corresponding standards ned time of calibration
documented information n corrective actions in case n time/cost for re-testing
must be available. of defective measuring and further actions (e.g.

instruments recall), if defective measuring
instruments were used
7.1.5.2 Measurement Where measurement n test planning concept
traceability traceability is a statutory or n test planning
regulatory requirement, n qualification requirements
a customer or relevant for testers

interested party expectation, n test instructions
or considered by the organi- n dermination of resource n rate of tests not OK

zation to be an essential part requirements (assessment of process
of providing confidence in n measuring equipment capability)
the validity of measurement capability studies n propertion of measuring
results, measuring instruments n validation of test software instruments with calibration

shall be verified or calibra- n register of measuring result not OK
tedat specified intervals or instruments and standards n accumulated use times of
prior to use against measu- n evidences of calibration a measuring instrument

rement standards traceable n reference to international n calibration times (available/
to international or national standards non-available periods)
Rev. 02 / 11.15 23

7.1 Resources
7.1.5.2 Measurement measurement standards. (If n corrective actions in n set/actual stock of

traceability no standards exist the basis case of defective measuring instruments
for calibration or verification instruments n proportion of measureing
must be retained in docu- instruments which could not

mented form) be located at the planned
n identified in order to deter- time of calibration
mine their calibration status n time/cost for re-testing
n safeguarded from and further actinos (e.g.

adjustments, damage or recall), if defective measuring
deterioration that would instruments were used
invalidate the calibration
status and subsequent
measurement results.
If a defective measuring
instrument is identified, the
organization shall review
the validity of the previous
measurement results.
Corrective action must be
taken.
7.1.6 Organizational The organization shall n information entry and n current nature of list of
knowledge determine the knowledge onwards transfer points relevant legislation on a
necessary for the operation (´knowledge hierarchy´) defined date
of its processes and to n list of relevant legislation n proportion of obsolete
achieve conformity of n knowledge database standards in use at the time

products and services. This n customer database of the document review
knowledge shall be maintai- n analysis of product n number of proposals for
ned and made available to management reviews improvement

the extent necessary. When n complaint database n number of implemented
addressing changing needs n employee competence improvements

and trends, the organization matrix
shall consider its current n training plans
knowledge and determine n resource plans/project
how to acquire or access management

the necessary additional n FMEAs
knowledge.
Rev. 02 / 11.15 24

7.2 Competence
The organization shall: n qualification requirement n implementation rate rela-

profiles ted to training requirement
n determine the necessary n qualification matrix n number of training units
competence of employees/ n job/function descriptions per year and employee

person(s) doing work that af- n employee meetings (rate)
fects its quality performance n initial instruction plans n analyses to evaluate the
n ensure that these employees/ n mentoring programmes effectiveness of training or

persons are competent on n evidences of training mentoring programmes
the basis of appropriate edu- n assessment of effectiven- n training costs (rate)
cation, training or experience ess of training or mentoring n proportion of external/
n where applicable, take actions programmes internal training

to acquire the necessary n see previous section, 7.1.6 n employee satisfaction
competence, and evaluate index

the effectiveness of the
actions taken
n retain appropriate do-
cumented information as
evidence of competence.
7.3 Awareness
Persons doing work under n minutes of meetings n level of implementation

the organization’s control regarding performance and
shall be aware of effectiveness of the system
n evidences of initial instruc-
nThe Q policy tion and training

nThe relevant Q objectives n participation in complaint
Their contribution to the meetings, Q circles

effectiveness of the quality n evidences regarding
management system, inclu- knowledge of Q policy and

ding the benefits of improved objectives
quality performance
7.4 Communication
The organization shall deter- n communication plans n analysis and evaluation of

mine the internal and external (internal communication customer portfolio
communications relevant guidelines) n analysis of number of
to the quality management n job/function descriptions customer visits/surveys

system, including n meeting hierarchy n participation rate in
n PR plans continual improvement pro-

n On what it will communicate n marketing concepts cess or suggestion system
n When to communicate n meeting reports n participation rate in
n With whom to communicate employee surveys

n How to communicate
Rev. 02 / 11.15 25

7.5 Documented information
7.5.1 General The QMS shall include: At least:
n the documented informa- 4.3 Scope and exclusions

tion required by this Standard 4.4 Process model and
n further information interactions, process
considered by the organization responsibilities, performance
to be necessary for the effec- indicators, risks, opportuni-
tiveness of the QMS. ties, resources, input, out-
put, resources, necessary
instructions like test instruc-
tions, work instructions,
documented procedures
5.2.2 Q policy
6.2.1 Q objectives
7.1.5 calibration, verification
7.2 evidences of competence
7.5 rules regarding creation,
updating and control of
documented information
8.1 evidences of process
control measures (e.g. cpk
values, test logs, machine
setting releases, product
releases…)
8.2.3 assessment results
of offer/contract review,
including new and changed
requirements
8.3.2 evidence of the
fulfilment of requirements for
development
8.3.5 development results
8.3.6 development changes
8.4.1 results of performance
monitoring and new
assessment
8.5.1 instructions for ensu-
ring controlled conditions
8.5.2 storage of documented
information for identification
with regard to traceability
8.5.6 changes and results
of the assessment and
monitoring for unplanned
changes to production/
service provision
Rev. 02 / 11.15 26

- Documented information
7.5
8.6 evidences regarding

conformity with requirements
must be kept (release), with
traceability to the person
responsible for the release
8.7 the activities and deci-
sions which were undertaken
in relation to the nonconfor-
ming products/services shall
be kept as documented
information
9.1.1 suitable documented
information shall be kept as
evidence of results of
monitoring and measurement
9.2.2 documented informa-
tion as evidence of realisation
of the audit programme shall
be kept
9.3.2 the results of the
management review shall
be kept in the form of
documented information
7.5.2 Creation and updating Documented information n coding or number key

shall be n rules on format
n establishment of
n identifiable and assignable responsibilities for review

(title, date, author, reference and approvals
number etc.)
n have an appropriate format
(language, software com-

patibility and graphics) and
medium (paper or electronic)
n be subject to appropriate
review and approval
7.5.3 Control of documented The documented information n list(s) of valid documents nreview cycle
information shall be monitored and n distribution keys/lists ninformation acquisition
controlled to ensure that it n revision lists costs (laws, directives, stan-
7.5.3.1 n change procedures dards and other regulations)
n is available where needed n release procedures
n is adequately protected n authority and access
(confidentiality, integrity and concept

use for intended purpose) n rules of behaviour
n security concept
n archiving rules
Rev. 02 / 11.15 27

7.5 Documented information
7.5.3.2 Document control shall n list of necessary external

include the following activities documents
(in so far as applicable): n control and identification of
external documents, e.g.

n idistribution, access, easy – laws, standards
location and use – customer specifications,
n filing/storage and preserva- drawings
tion – requirements/contract
n monitoring of changes specifications
(e.g. follow-up of versions) – datasets
n archiving period,
disposalreview and approval
Clause 8 – Operation
8.1 Operational planning and control
8.1 Operational planning and Control processes shall be n Control process planning, n number of processes
control planned, implemented and controlling documents n process cycle time
monitored. The following n Evidence of product/ n process capability index
shall be considered: service acceptances from n customer satisfaction
customers index
n requirements for the product n complaint rate
and services n customer loyalty rate
n process criteria and n key indicators for
acceptance criteria for the process resources

products and services n energy saving key
n resources needed to achieve indicators (e.g. reduction

conformity of products and of consumption figures)
services n further key indicators
n control of the processes in are given in the following

accordance with the defined paragraphs
criteria
n internal documentation that
is necessary in order to have

confidence in the control
processes and to demonstrate
conformity of products and
services to requirements.
The output of the planning

shall be suitable for the
organization’s operations.
Planned changes shall be
controlled and consequences
of unintended changes shall
also be reviewed.
Rev. 02 / 11.15 28

8.1 Operational planning and control
Outsourced processes shall

be controlled in accordance
with 8.4.
8.2 Determination of requirements for products and services
8.2.1 Customer Processes of customer n product catalogues and n number of enquiries

communication communication shall be lists, product descriptions to customers regarding
established in relation to: n complaint management clarification of product
n contingency plans requirements
n information relating to n order documentation, n reaction time regarding
products and services contract documentation faults, nonconformities,

n enquiries, contracts, order n results of customer surveys complaints and claims
handling, including requests n customer satisfaction
for changes index

n customer views, perceptions,
complaints
n handling of customer
property, if applicable
n contingency actions, where
relevant
8.2.2 Determination of A process shall be estab- n project plans n product indicators (e.g.
requirements related to lished, implemented and n tender and performance price, performance, lifetime,
products and services maintained to determine the specifications technical features, service
requirements for the products n statutory and regulatory supply capability)
and services to be offered to requirements n requirements regarding
potential customers. It must key indicators arising from

be ensured that statutory and regulatory
requirements
n product and service
requirements, including those
considered necessary by the
organization, and applicable
statutory and regulatory
requirements, are fulfilled
n the organization can fulfil

these requirements and
substantiate the claims for the
products and services it offers
Rev. 02 / 11.15 29

8.2 Determination of requirements for products and services
8.2.3 Review of requirements The following shall be n contracts n key indicators regarding
in relation to products reviewed as applicable: n order confirmations testing time and costs
and services n communication in case n (e.g. duration of testing,
n customer requirements, of changes frequency of testing,

including for delivery and n see also 8.2.1 n scope of testing)
post-delivery activities n production costs
• requirements not stated by n production time
the customer but necessary n time needed for feasibility
for the customer’s specified study

or intended use
• statutory and legal
requirements
• contract or order require-
ments differing from those
previously expressed
Requirements can also arise

from the interested parties.
The review shall be conducted
prior to the commitment to
supply products and services
and must ensure that diffe-
rences from the previously-
defined requirements are
resolved.
Where the customer does

not provide a documented
statement of their require-
ments, the requirements shall
be confirmed in writing by
the organization prior to
acceptance.
This documented information

shall be retained.
Changes in the requirements

shall also be included in the
documented information and
the relevant personnel shall
be made aware.
Rev. 02 / 11.15 30

8.3 Design and development of products and services
8.3.1 General A design and development n project plans n number of development

process shall be established, n development plans/ plans per time period
implemented and maintained, flowcharts n fulfilment rate of customer
which is suitable to make the n milestone plans requirements

subsequent production or n measurement and test n fulfilment rate of customer
service provision reliable and plans expectations

secure. n verification and validation n number of existing patents
rules n lifetime key indicators
n rules for release/sign-off n design and development
n responsibility matrix times

n risk assessment
8.3.2 Design and When specifying develop- n documented procedures n number of development
development planning ment stages and control, the for design and development plans per time period
following shall be taken into n process landscape for n fulfilment rate of customer
consideration: design and development requirements

n project plans n fulfilment rate of customer
n nature, duration and n development plans/ expectations

complexity of activities flowcharts n number of existing patents
n requirements that specify n milestone plans n lifetime key indicators
particular process stages, n measurement and test n design and development
including reviews plans times

n design and development n verification and validation
verification and validation rules

n responsibilities and n release specifications
authorities n responsibility matrix
n need for internal and n risk assessment
external resources
n interface control
n need to involve clients or
users in the development

process
n requirements for
subsequent production or
service provision
n the control level expected
by customers and other

relevant interested parties
n documentation that is
required in order to evidence

fulfilment of the requirements
8.3.3 Design and The organisation shall deter- n tender specifications/task

development inputs mine the requirements set
essential for the specific type n performance specifications
of products and services being (as written by supplier)

designed and developed.
Rev. 02 / 11.15 31

The following must be taken n statutory and/or regulatory n rate of fulfilment of require-
into consideration: implementation guidelines ments and expectations in %
n reports of results from n number of projects to be
n functional and performance previous developments of processed

requirements the same kind n number of statutory and/or
n information gained from n evaluation of customer regulatory requirements

previous comparable need evaluations n fulfilment rate of needs
development activities n patent searches and expectations in %

n statutory and regulatory n release documents n number of projects to be
requirements n complaints analysis processed

n standards and procedural n warranty analysis n number of legal and/or
rules of the organization itself n FMEAs statutory requirements

n consequences of defective n index for ease of repair
products and services n test cost index
n training and further training
Inputs must be appropriate costs for the designers and

for the development objecti- developers
ves, and must be complete n design and development
and clear. Conflicts among costs

inputs shall be resolved. n material cost index
n cost index for possible
Documentation of design cooperation partners

and development inputs shall
be retained.
8.3.4 Design and The controls shall ensure that n performance specifications n number of necessary tests
development controls n results of product quality n fulfilment rate of develop-
n the results to be achieved in controls ment rules and specifications
the development are clearly n verification logs n rate of fulfilment of
defined n validation records process requirements

n the design and development n number of follow-up actions
reviews are conducted as n disposal costs
planned n duration of development
n verification is conducted to n fulfilment rate of statutory
ensure that the results of the and regulatory requirements:

design and development n environment
have met the input require- n occupational health and
ments safety
n validation is conducted to n health
ensure that the resulting n product liability etc.
products and services are n costs of testing time
suitable for the intended use n testing costs
n fulfilment rates for specified
characteristics
n time and cost of follow-up
actions
Rev. 02 / 11.15 32

8.3.5 Design and The design and development n evidences from Clause 8.3
development outputs outputs shall
n meet the input requirements

for design and development
n be adequate for the
subsequent processes for

the provision of products
and services
n include or reference
monitoring and measuring

requirements and acceptance
criteria as applicable
n ensure that products or
services are fit for the intended

purpose and their safe and
proper use
Documented information
regarding the development
outputs shall be retained.
8.3.6 Design and Changes that are made dur- n written change requests n number of development
development changes ing development or subse- (e.g. of the customer, from changes
quently to design inputs and production) n new verification and
outputs shall be determined, n new revision status of validation time/cost

reviewed and controlled tender specification, draw- n cost index for development
so that there is no negative ings, process descriptions, changes

impact on products on test procedures, test n savings rate
conformity to requirements. equipment etc.

Documented information n comments/test reports
regarding changes to design regarding changes

inputs and outputs shall be n release documents regard-
retained, including results of ing changes implemented

reviews and the authority to n communications sent to
make changes and instigate customers and departments

necessary actions. regarding changes
n withdrawn documents
n change history
Rev. 02 / 11.15 33

8.4 Control of externally-provided processes, products and services
8.4.1 General The organization shall ensure n supplier assessment n complaints regarding
that external processes, pro- n product specifications suppliers
ducts and services conform n QM documentation of the n delivery reliability
to the specified requirements. supplier

Control is necessary when n checklist
external providers supply n evidences from supplier
products and services which assessment

n list/database of approved
n are incorporated into the suppliers

organization’s own products n assessment criteria
and services n complaints
n products and services are n ppm statistics
provided directly to the n quality agreements
customer(s) by external n performance specifications
providers on behalf of the

organization
n are provided by an external
provider as a result of
decision by the organization
Criteria for the evaluation,

selection and monitoring of
performance of external
providers must exist and be
applied. The most important
aspect is conformity with the
specified requirements.
The organisation shall retain

documented information re-
garding the resulting activities
and actions.
8.4.2 Type and extent of Externally provided processes, n supplier management

control products and services shall n results of supplier audits
not have an adverse effect n own complaints issued to
on the ability of the organiza- suppliers

tion to consistently deliver n results from receiving
conforming products and inspection

services to its customers.
Externally provided proces-

ses shall remain under the
control of the QMS of the
organization.
In order to define external

provision, the following shall
be taken into consideration:
Rev. 02 / 11.15 34

8.4 Control of externally-provided processes, products and services
n what influence do the

externally-provided processes,
products and services have
on the conformity of the
products/services supplied
by the organization
n how effective are the con-
trol measures taken by the

external provider him/herself
Verifications and other activi-

ties must be correspondingly
introduced and implemented
in order to ensure conformity.
8.4.3 Information for Applicable requirements n evidences of communica-

external providers for the following shall be tions with external suppliers
communicated to external n overviews of requirements
providers: n internal evaluations/reports
regarding suitability of the

n the products, services or requirements
processes to be provided n audit programme for
or performed supplier audits

n approval and release of
products and services,

methods, processes or
equipment
n competence and
qualifications of personnel
n interactions with the QMS
of the organization
n control and monitoring
of the external provider’s

performance by the
organization
n verfication activities that the
organization or its customer

intends to perform at the
external provider’s premises
The adequacy of specified

requirements shall be ensured
prior to their communication
to the external provider.
Rev. 02 / 11.15 35

8.5 Production and service provision
8.5.1 Control of production Conditions for production and n written releases from n process performance
and service provision provision of services must be customers index
controlled. n results of internal quality n process quality index
controls n processing times (e.g.
Controlled conditions shall n test and measurement for set-up, manufacturing,

include, as applicable: results downtimes, control times,
n results from internal audits transportation times)
n availability of documented n machine flexibility rate
information regarding the n reserve capacity rate
characteristics of products n equipment level of
and services, activities to be machinery

carried out and results to be n tool utilisation rate
achieved n proportion of optimum
n availability and application of batch sizes

suitable resources for n order processing time to
monitoring and measurement completion

n performance of monitoring n number of completed
and measurement activities orders

n suitable infrastructure and n scrap rate
process environment n machine downtimes
n competence and qualifica- n process qualification rate
tion requirements for persons n proportion of special
n validation and regular new processes

validation of the processes n energy cost rate
when the resulting output n process control costs
cannot be verified by means

of monitoring or measurement
n measures to prevent human
error
n release of products,
services, delivery activities,

post-delivery activities
8.5.2 Identification and Where necessary, identity n work instructions nidentification costs
traceability and traceability shall be n accompanying documents, ntime and cost for
ensured. The status of process e.g. process slip/routing card preparation of recalls
outputs (e.g. intermediate n production plans
products, parts or services) n EDP records
shall be identified during the n marking on products
entire production process or n evidences of testing
service provision with respect n blocking notes
to monitoring and measure- n releases
ment requirements.
Where traceability is a
requirement, it shall be main-
tained by means of suitable
documented information.
Rev. 02 / 11.15 36

8.5.3 Property belonging Property belonging to the n work instruction regarding n costs due to reduction in
to customers or customer or external provi- handling of customer quality of customer property
external providers ders shall be handled with property n proportion of storage costs
care, identified, verified and n list of customer property for customer property
protected. n identification marking n costs for maintaining
(labels, engraving, storage quality of customer property

If the property is damaged, and warehouse lists etc.)
lost or incorrectly used, this n correspondence with the
shall be communicated to the customer

customer or external provider. n records of verification and
maintenance that have been

performed
n receiving inspections
8.5.4 Preservation Process outputs shall be n packaging, storage, n Number of times MSL
preserved during production preservation and despatch (minimum shelf life)
and service provision to the rules is exceeded
extent necessary to ensure n parts lists n costs for packaging,
conformity with the require- n storage lists storage and preservation

ments. n stock location and removal n transportation cost index
plans n process performance
Preservation can include n rules regarding storage index

identification, handling, periods and any necessary n process quality index
packaging, storage, trans- segregation of items n processing times (e.g.
mission or transportation and n despatch labelling for set-up, manufacturing,

protection. n shelf life monitoring downtimes, control times,
n assembly/operating transportation times)
instructions n machine flexibility rate
n reserve capacity rate
n equipment level of
8.5.5 Post-delivery activities The requirements for post- n warranty rules machinery
delivery activities shall also n obligations regarding n tool utilisation rate
be met as applicable. disposal n proportion of optimum

n maintenance
batch sizes
The following shall be taken n servicing
n order processing time to
into consideration in order to completion

determine these:
n statutory and regulatory

requirements
n possible undesired n product indicators (e.g.:
consequences in connection price, performance, lifetime,
with products and services technical characteristics,
n nature, use and lifetime of service capability)
the products and services n key indicator rules from
n customer requirements statutory and regulatory

n customer feedback requirements
Rev. 02 / 11.15 37

8.5.6 Control of changes Unplanned changes shall be n evidences regarding n number of development
reviewed and controlled with changes in the monitoring changes
regard to product/service activities n new verification and
conformity. n job descriptions for veto validation time and costs

persons n cost index for
Documented information n documented procedure for development changes

regarding the results of release/change management n savings index
the review of changes, the

personnel authorizing the
change and any necessary
actions related to change
control shall be retained.
8.6 Release of products and services
8.6 Release of products Release of products and n internal evidences regar- n number of articles that
and services services shall be implemented ding release and evidences should be supplied with
in stages. Evidence of con- from the customer certificates
formity with the acceptance n number of deliveries con-
criteria shall be retained. formant with specification

n testing time/costs in
Release of products and ser- receiving inspection area

vices to the customer shall n fulfilment of delivery times
not proceed until product by suppliers

conformity has been n inspection time and costs
satisfactorily verified and also n nonconformity rate
approved by the customer. n scrap rate
n costs for repair/rework
Documented information n testing time
shall provide traceability to n complaint rate
the person(s) authorizing

release.
Rev. 02 / 11.15 38

8.7 Control of nonconforming process outputs, products and services
8.7 Control of non-confor- Process outputs, products n blocked goods store n number of defects
ming process outputs, and services which do not n blocking notes, reminders according to type
products and services fulfil the requirements shall n evidences, see 8.6 n number of defects in
be identified and controlled, specific areas/departments/

so that they are not used or groups
delivered unintentionally. n costs of defects
n status of corrective and
Suitable corrective actions preventive actions

should be taken also for n costs of corrective and
nonconforming products preventive actions

and services that are only
detected after delivery of
the product or during the
provision of the service.
The organization can deal

with nonconforming products
and services in one or more
of the following ways:
n correction
n segregation, retention,
return or suspension of provi-
sion of products and services
n informing the customer
n obtaining release for use
as is or continuation, or
reprovision
n acceptance under
concession
The conformity shall be

verified again following the
corrections.
regarding these activities
shall be retained.
Rev. 02 / 11.15 39

Clause 9 – Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General The organization shall n test planning concept n KPIs regarding quality
determine n test plans status
n sampling plans n process capabilities
n what needs to be monito- n test instructions n key indicators for lifetime
red and measured n analysis procedures n comparative figures with
n the methods for monitoring, n analyses (failure/scrap competitors (benchmark)

measurement, analysis and rates, most frequent failures n scrap and rework costs
evaluation (to ensure valid and defects, trends) and times

results) n reporting (quality reports,
n when the monitoring and review reports)

measuring are to be perfor-
med
n the time when the analysis
and evaluation should be

performed
Monitoring and measuring

activities shall be performed
shall be retained as evidence
of the results.
The quality performance and

effectiveness of the QMS
shall be evaluated.
9.1.2 Customer satisfaction The organization shall n customer satisfaction n customer satisfaction
surveys (user surveys) index
n monitor customer percep- n reports of visits to n complaint rate, penalties,
tions of the degree to which customers goodwill and guarantee

requirements have been met n analysis of traders’ costs
n obtain information regarding statements n proportion of established
the impressions and opinions n market surveillance and to new customers

of customers observation n customer loyalty rate
n determine the methods n customer satisfaction n customer structure
for obtaining and using this analyses (proportion of large-scale

information n analysis of market shares customers)
n complaint reports n rate of orders won
n spontaneous expressions
of satisfaction
n benchmarking
Rev. 02 / 11.15 40

9.1 Monitoring, measurement, analysis and evaluation
9.1.3 Analysis and evaluation Data and information from n risk analyses (FMEA) n quality-relevant key
monitoring, measurement n quality records indicators (including failure
and other sources shall be n test logs rate, penalties, goodwill
analysed and evaluated. n statistical analyses and guarantee costs)
n results of internal and n process capabilities
The results of the analysis external audits n customer satisfaction
and evaluation shall be used n Q reports indices

to n customer satisfaction n supplier assessment
analyses (reliability)
n demonstrate conformity n supplier assessments n benchmark comparison
of products and services to n action plan for improvement figures (quality-relevant

requirements of customer satisfaction or and economic indicators)
n assess and enhance other improvements
customer satisfaction n management review
n assess conformity and
effectiveness of the QMS

n demonstrate that planning
has been successfully

implemented
n assess the performance
of external providers
n demonstrate the need and
opportunities for improvement

in the QMS
n supply inputs to the
management review
9.2 Internal Audit
9.2.1 Internal audits shall be per- n documented procedure for ncost/benefit index
formed at planned intervals internal audits naudit times in relation to
in order to verify that the n set values, target values operational performance
organization’s own require- with regard to the require-
ments for its quality ments
management system and
the requirements of 9001-
2015 are effectively imple-
mented and maintained.
9.2.2 With regard to internal audits, n audit programme n requirement fulfilment

the organization shall n audit plans rate
n audit criteria n implementation rate of
n plan the audit programme n audit records internal audits

(frequency of audits, n audit evaluations
methods, responsibilities, n audit reports
Rev. 02 / 11.15 41

9.2 Internal Audit
planning, reporting, quality n nonconformity reports

objectives, importance of n action plans for introduction
the processes concerned, of corrective actions
customer feedback, changes n management reviews
with an impact on the n reports regarding the
organization and considera- effectiveness of corrective

tion of the results of previous and preventive actions
audits) n proofs of qualification of
n define the audit criteria and internal auditors

scope for each audit
n select auditors and conduct
audits to ensure objectivity and

impartiality of the audit process
n report results to relevant
managers
n take necessary correction
and corrective actions

without delay
n retain documented informati-
on as evidence of the
implementation of the audit
programme and the audit
results
9.3 Management review
9.3.1 General The QMS shall be assess- n management review report n see above
ed by top management at n reports of n quality-relevant key
planned intervals with the – internal audits indicators, including
aim of ensuring its continuing – process audits failure rate, complaint rate,
suitability, adequacy and – product audits penalties, goodwill and
effectiveness. n quality analyses guarantee costs)
n status of corrective and n capability of processes
The following aspects shall preventive actions n customer satisfaction
be considered: n resource requirement and indices

n status of actions from previ- use plans n supplier assessment
ous management reviews n supplier quality status (reliability)

n changes that affect the n risk analyses (technical/ n benchmark comparison
QMS, including strategic economic/business) figures (quality-relevant

direction and economic/business
n information regarding the indicators)
quality performance, in- n see previous clause,
cluding developments and 9.1 ff., for further examples

indicators in case of external
documents, e.g.
– nonconformities, corrective
actions
– monitoring and
Rev. 02 / 11.15 42

9.3 Management review
measurement results n documented procedure for

– audit results internal audits
– customer satisfaction n set values, target values
– issues concerning external with regard to the require-

providers and interested ments
parties
– adequacy of resources for
the QMS
– process performance and
conformity
n effectiveness of actions
taken to address risks and

opportunities
n new opportunities for
improvement
9.3.2 Management The input must include n Status, progress and inci-
review inputs dent reports
n Status of actions from pre- n Key process indicators
vious management reviews (KPI)

n Changes in external and in- n Risk assessments, comp-
ternal issues that are relevant laints statistics

to the quality management n Results of market obser-
system vations
n Information on the perfor- n Evaluations from internal
mance and effectiveness suggestion system

of the quality management n Evaluations of customer
system (fulfilment of quality satisfaction analyses

objectives, process perfor-
mance etc.)
n Adequacy of resources
n Effectiveness of actions
taken to address risks and

opportunities
n Opportunities for improve-
ment
9.3.3 Management The outputs of the manage- n Management review n Level of agreement
review outputs ment review shall include deci- n Status and progress (Compliance)
sions and actions related to: reports n Status of resources for
n opportunities for improvement: n List of open points (LOP) implementation of corrective

n any need for changes and n Records regarding follow- and preventive actions
resources for changes up of corrective and preven- n Time needed up to
tive actions complete implementation

The organisation shall retain of corrective and preventive
documented information as actions
evidence of the results of
management reviews
Rev. 02 / 11.15 43

Clause 10 – Improvement
10.1 General
10.1 General Opportunities for improvement n improvement projects n key indicators from the
shall be implemented and n rules for implementation of FMEA
necessary actions shall be improvement projects n trend indicators
determined in order to n continual improvement n lifetime indicators
potential database n emission indicators
n improve products and n quality management plans n disposal costs
services, taking future n project plans n unit costs
needs and expectations into n target lists and reports n risk indicators
consideration n progress reports n comparative figures with
n reduce or prevent n management reviews competitors

undesired events n corrective action plans n scrap and rework costs
n improve the performance n preventive action plans or times

and effectiveness of the QM n benchmarking results
system n total costs
n failure and fault costs
n process cycle times
n planning times
10.2 Nonconformity and corrective action n planning costs
n number of suggestions/
10.2.1 When a nonconformity n records of fault identification number of employees

occurs, the organization shall n statistical analyses n cost saving per
react and if appropriate n test/result logs and reports suggestion

n instructions for corrective n implementation costs per
n take action to control and actions suggestion

correct it n root cause analyses n fulfilment rate of
n deal with the n training plans targets in the continual

consequences n training evidences improvement process
n determine the causes and n complaint analyses n number of higher-level
take appropriate corrective n any changed supply improvement groups

actions contracts,
n determine if similar n Q agreements
nonconformities exist or n review logs
could occur n Ishikawa diagrams
n review effectiveness of any n pareto analyses

n complaint rate
corrective actions taken n histograms
n scrap, rework and
n update risks and n 5 Why
guarantee costs
n goodwill costs
opportunities n FMEA Review
n customer satisfaction
n change the QMS if n 8-d Report
appropriate index
n self-assessment index
n process performance
The aim is that nonconformities
should not recur or recur index
n process stability index
somewhere else.
Rev. 02 / 11.15 44

10.2 Nonconformity and corrective action
10.2.2 The organisation shall retain

documented information with
regard to:
n the nature of the

nonconformities and any
actions taken
n the result of any corrective
actions
10.3 Continual improvement
10.3. Continual improvement The suitability, adequacy and n project plans n rate of target achievement
effectiveness of the QMS n logs and trends regarding n number of implemented
must be continually improved. set targets improvements
The aim is to determine n progress reports n benchmarking/ranking
needs and opportunities that n management reviews index

require action as part of the n corrective action plans n saving from improvement
continual improvement pro- n preventive action plans group work

cess. Results, analyses and n system of suggestions for n cost/benefit ratio
assessments and also the improvement n reaction and
results of the management implementation time

review must be considered in
this connection.
Rev. 02 / 11.15 45
5. Annexes
ISO 9001:2015 – 5. What are the advantages of the new standards?

Questions and important perspectives The new High Level Structure creates greater harmony
from the point of view of sales between the ISO management system standards, ma-
king it easier to extend existing systems into an integra-
ted whole. The themes of user friendliness and market
orientation receive more emphasis. This means that the
standard focuses more strongly on the characteristics
and needs of service companies and that documentation
1. When will ISO 9001:2015 and ISO 14001:2015 be requirements are more flexible. The direct responsibility
published and when will DIN EN ISO 9001:2015 of organizations is emphasised much more strongly than
and DIN EN ISO 14001:2015 appear? before. The same applies to the process approach and
Following publication of the English-language version of the responsibility of top management.
ISO 9001: 2015 on 15/09/2015 and of ISO 14001:2015
on 15/09/2015, the German DIN standards DIN EN ISO 6. What is the structure of the new standards?
9001:2015 and DIN EN ISO 14001: 2015 have now also ISO 9001:2015 and ISO 14001:2015 will have a new
appeared. The Issue Status of both standards is Novem- structure, the so-called High Level Structure. This is
ber 2015. intended to provide the same binding structure for all the
management system standards, and results in two very
2. From when can the certifications be performed important benefits. Firstly, terms, definitions and struc-
according to the new standards? tures can be used for all the standards and secondly,
Audits according to ISO 9001:2015 and ISO standards are easier to understand and synergies are
14001:2015 can be carried out as from the date of their possible when different standards and certifications are
publication. Audits based on the previous DIS (DIN-ISO) combined.In detail, the current draft version indicates
standards will not be recognised. that the structure of the ten clauses will be as follows:
3. How long is the transition period? 1. Scope

ISO 9001:2015: The transition period of three years 2. Normative references
begins on 23/09/2015 and ends on 22/09/2018 for the 3. Terms and definitions
changeover to ISO 9001:2015. 4. Context of the organization
ISO 14001:2015: The transition period of three years 5. Leadership
begins on 15/09/2015 and ends on 14/09/2018 for the 6. Planning
changeover to ISO 14001:2015. 7. Support
8. Operation
4. From when can certificates 9. Performance evaluation
according to ISO 9001:2015 and 10. Improvement
ISO 14001:2015 be issued?
Due to the change in the accreditation procedure for 7. What is particularly important for the new stan-
all certification bodies by DAkkS, ISO 9001:2015 and dards with regard to consideration of risks?
ISO 14001:2015 certificates can only be issued without The treatment of risks plays a more central role than is
the addition of the letters “FDIS” starting from currently the case – amongst others in the clauses on
28/10/2015. According to a decision of DAkkS, certifi- “Leadership” and “Planning”. Although a specific risk
cates according to DIN EN may also only be issued as management system as such is not demanded, orga-
from 28/10/2015 at the earliest. nizations should be capable of identifying risks that are
Rev. 02 / 11.15 46
5. Annexes
associated with the realisation and the utilisation/usage does not change, i.e. it corresponds to the term of
of the products/the service and of taking them into validity of the original certificates.
consideration in an appropriate way. However, there is
no specific requirement for preventive measures. Com- 12. How much extra time is needed to upgrade
panies profit from this new way of seeing things, as they within the framework of the recertification audit?
have the chance to recognise risks early on and take The additional time to upgrade to the requirements of
corresponding action. ISO 9001:2015 or ISO 14001:2015 within the framework
of a recertification audit is at least 10 per cent of the
8. What is the relationship to stakeholders audit time for the recertification audit, but at least
in the new standard? 0.25 audit days on site.
In the new version of the standard, organizations not
only have to fulfil legal requirements and the expecta- 13. What must be taken into consideration regarding
tions of customers, but will also need to engage with the certificates for the upgrade during recertification?
other interested parties. This requirement means that the After completion of the recertification procedure, you will
complexity of today’s working and social environment is receive the certificates according to ISO 9001:2015 or
taken into account, and it also offers opportunities to ISO 14001:2015 with a validity of three years. The term
achieve desired improvements and minimise risks. of validity follows on from the previous certificate. This
means that the expiry date corresponds to the previous
9. Who specified the additional time needed for the threeyear time interval (expiry date of the old certificate
upgrade to DIN EN ISO 9001:2015 or DIN EN ISO plus 3 years) if the recertification procedure is performed
14001:2015? in good time or if the performance of the audit and the
The German Accreditation Body (DAkkS) has specified NC (nonconformity) management is completed in good
the additional time as standard for all certification bodies time (by the due date).
in the document regarding “Instructions for the transition
to ISO 9001:2015 and ISO 14001:2015” (Anleitung zum 14. Is a “gap audit” or preliminary audit necessary
Übergang ISO 9001:2015 und ISO 14001:2015) issued for the upgrade?
on 20/04/2015. If you are not sure what is missing from your system in
order to upgrade to the new standards, we will be happy
10. How much extra time is needed to upgrade to offer you a “gap audit” or preliminary audit. The gap
within the framework of the surveillance audit? audit can be added to the next surveillance or recertifi-
The additional time to upgrade to the requirements of cation audit, for example. Just let us know if you need
ISO 9001:2015 or ISO 14001:2015 within the framework further information or an offer for a gap audit.
of a surveillance audit is at least 20 per cent of the audit
time for the surveillance audit, but at least 0.5 audit 15. Is an upgrade within the framework of the
days on site. recertification audit more favourable?
For some sizes of organization, the additional time
11. Are certificates issued if the upgrade takes place needed can be less for a recertification audit than for a
within the framework of the surveillance audit? surveillance audit.
After the surveillance audit is complete, you receive
the certificates according to ISO 9001:2015 or An example for an organization with 80 employees
ISO 14001:2015. The term of validity of the certificate and a certificate valid until 30/04/2017:
Rev. 02 / 11.15 47
5. Annexes
- Upgrade in the recertification audit with 4.0 audit days 19. How much more expensive is first (initial) certi-
means additional time of 0.4 audit days. fication if an organization upgrades directly to the
- The new certificate is valid from 01/05/2017 – new standard?
30/04/2020. Basically the same man day table applies as before, i.e.
- Upgrade in the 2nd surveillance audit in 2016 with it is not more expensive if you undertake certification to
2.0 audit days means additional time of 0.5 audit days. the new standard in a first (initial) certification.
- The new certificate is valid from the date of the
certification decision up to 30/04/2017. 20. Is it recommended only to consider the new
standard in initial (first) certifications?
16. Why is upgrade in the recertification If the organization begins now with the implementation
audit recommended? of the quality management system, it seems useful if
The new requirements of the standard affect almost all the organisation concerns itself directly with the new
areas of the organization. This means that the extra time ISO 9001:2015 und ISO 14001:2015 standards.
needed for the organization to prepare and the number If certification is absolutely required within a short time,
of representatives that have to be present is just as great it can be helpful to undertake certification according to
as in the case of recertification. 9001:2008 or 14001:2009 and to make the upgrade in
the transition period. The transition period is three years
17. If the upgrade does not take place in the recerti- from the date when the new standard is published.
fication or the surveillance audit, what are the other
possibilities? 21. When will it no longer be possible to undertake
It is possible to carry out the upgrade in a special audit. first certifications according to the old version of the
This is an additional audit date between the regular standard?
audits. The additional time and cost is greater than for First certifications according to the old version are no
the surveillance or recertification audit. This is because of longer possible after expiry of the transition period of
the extra time needed for preparation and follow-up and three years.
possible consideration of changes since the last audit.
Travel costs are also charged. 22.What is the procedure in the case of transfer from
another certification body?
18. What must organizations do so they can upgrade It is possible to upgrade to the new standard during the
to the new standard in the next recertification audit? transfer audit. The same rules for additional time apply
The notice of the date for the recertification audit, which as for upgrade during a recertification, surveillance or
is sent to you in good time before the audit date, already special audit.
contains a reminder for the upgrade to the new stan-
dard. If you wish the upgrade to take place during a 23. Is it possible to carry out the transfer with the
surveillance audit, we ask you to let us know as soon as old version and then to upgrade in the surveillance
possible, but at the latest three months before the plan- audit?
ned audit date, as we also have to plan for the additional Yes, it is possible. It is even a good way to make the
time. Please note that we recommend that the upgrade upgrade, as the auditor, the audit procedure and many
takes place during the recertification audit. other details already change for the customer during the
transfer. If the upgrade is made in the surveillance audit,
the customer does not have to handle everything at the
same time.
Rev. 02 / 11.15 48
5. Annexes
24. Are transfer costs covered with the upgrade if management system still has to be laid down and
the company shifts within the transfer? the resources that are needed for maintenance of the
No, the times and costs have to be added together. management systems must be planned.
25. Which is easier to implement – the old or the new 28. How far is the service sector now involved?
version? The new standard can also be used across all sectors.
The advantage of the 2015 version is that the structure Service providers are not explicitly mentioned and
of the standard follows the processes in the organizati- therefore find implementation easier. Organizations
on. This means that it is easier to implement the 2015 which use a large number of outsourced processes in
version. An important advantage of the 2015 version is order to conduct their business will find that handling
the reduced requirement for documented procedures. of outsourced processes is included in the standard. If
This means that the organization can build up its own outsourced processes are used, the interfaces and the
QM system with tailormade documentation. monitoring have to be described and key indicators have
to be established for them. The outsourced processes
The main emphasis of the 2015 version is the focus on are taken into consideration in the calculation of the
results. It is no longer so important where (i.e. in which number of man-days required for the audits.
document) something is described. The most important
question is whether the process is effective. This promo- 29. Does the new version of the standard particularly
tes acceptance of the standard. address organizations which have to consider the
risks of the processes they use? Which organiza-
26. What are the most important differences between tions are they?
the old and the new versions that the customer has The standard requires risk-based thinking within the
to take into consideration in implementing the 2015 framework of the PDCA cycle. Here, it is a question of
version? process-orientated risks. Those risks must be determi-
The standard has a new structure. All clauses from ned which are present (or could be present) in connec-
4 to 10 have to be covered, with the exception of justi- tion with the realisation of the product or the provision of
fied exclusions (concessions). Some requirements are the service and whose occurrence could have a negative
new. These include risk-based thinking, consistent im- impact on customer satisfaction.
plementation of the process approach, the documented
information, the context of the organization, handling of 30. What advantages do service providers have
outsourced processes, more emphasis on management with the ISO 9001:2015 version compared with the
commitment and responsibility, quality controlling and current 2008 version?
some other requirements. When service providers implemented the ISO 9001:2008
version, they had to transfer the idea of “product” to
27. Which are the greatest traps and problems to mean “service”. This is no longer necessary, as services
be expected in recertifications according to the 2015 are explicitly mentioned in the standard.
version?
It is absolutely not recommended to “throw away” the
existing quality management system too quickly. In fu-
ture, documentation will still be required in order to provi-
de evidence of processes and process evaluation. Even
if there is no longer a requirement for a top management
representative for quality, the responsibility for the quality
Rev. 02 / 11.15 49
contact
TÜV NORD CERT GmbH

Langemarckstr. 20
45141 Essen
TÜV NORD GROUP

Interpretation of The Requirements of DIN EN ISO 9001:2015

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Interpretation of The Requirements of DIN EN ISO 9001:2015

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Guide to ISO 9001:2015

Interpretation of the requirements of

TÜV NORD GROUP

Quality and customer satisfaction are vital factors

The environment in which companies and other

Some practical examples of interpretation of the

1. The Learning Organization 4. ISO 9001:2015 – Interpretation of

1.3. The schedule for the changeover

Publication Transition period End of

Publication of 3 years until the Transition period

15/09 /15 3 Jahre 14 / 09/2018

Planning phase Transition phase End of the transition phase

Figure 1 – ISO 9001 timeline

Understanding Management Risks and Resources Operational Measurement, Nonconformity

Expectations (Quality) Policy Quality Competences Requirements Internal audits Improvement

Scope Tasks, Planning of Awareness Design and Management

Quality Communication Control of exter-

Figure 2 – Overview of the High Level Structure

2.2. Concept of risk-based thinking respective organization. Although this requirement

2.6. Tasks of management, absence of

2.4. Greater relevance of the standard for

For more detailed information, an overview of the

3 Terms and definitions 3

1 Context of the organization 4

1.1 Understanding the organization and its context 4.1

Understanding the needs and expectations

4 / 4.1 Quality management system and its processes 4.4

5.1 Leadership and commitment 5.1

5.2 Customer focus 5.1.2

5.2 / 5.3 Policy 5.2

4.2.1a / 5.3 Development of quality policy 5.2.1

5.3 d Communication of quality policy 5.2.2

5.5.1 / 5.5.2 Roles, responsibilities and authorities in the organization 5.3

New Actions to address risks and opportunities 6.1

4.2.1a / 5.4.1 Quality objectives and planning to achieve them 6.2

New Planning of changes 6.3

6.1 General 7.1.2

6.2 People 7.1.2

6.3 Infrastructure 7.1.3

6.4 Environment for the operation of processes 7.1.4

6.2 / 8.2 Monitoring and measuring resources 7.1.5

7.6 / 8.2 Traceability of measurements 7.1.5.2

New Organizational knowledge 7.1.6

6.2.1 / 6.2.2 Competence 7.2

6.2.2 d Awareness 7.3

5.5.3 Communication 7.4

4.2 Documented information 7.5

4.2.1 General 7.5.1

4.2.3 / 4.2.4 Creating and updating 7.5.2

4.2.3 / 4.2.4 Control of documented information 7.5.3

7.1 / 7.5.1 Operational planning and control 8.1

7.2 Requirements for products and services 8.2

7.2.3 Customer communication 8.2.1

Determination of requirements related

7.2.2 Review of requirements related to products and services 8.2.3

7.2.2 Changes of requirements related to products and services 8.2.4

7.3 Design and development of products and services 8.3

7.3 General 8.3.1

7.3.1 Design and development planning 8.3.2

7.3.2 Design and development inputs 8.3.3

7.3.1 Design and development controls 8.3.4

7.3.3 Design and development outputs 8.3.5

1.3. The schedule for the changeover