You are on page 1of 115

ISO/TS 16949 WORKSHOP

AGENDA
 TS 16949 Update
First Edition Review
Second Edition Review
 Highlights of IASG Sanctioned QS-9000:98
Interpretations (Nov 99 and July 01)
 ISO 14001 Update
 AQSR Overview
 Registration Process
 Question & Answer Session

2
ISO / TS 16949
Quality Systems
ISO/TS 16949
What is it?
ISO/TS 16949 is an ISO Technical Specification
prepared by the International Automotive Task
Force (IATF) and representatives from ISO/TC
176, Quality Management and Quality Assurance,
and its subcommittees.
Particular requirements for the application of ISO
9001:1994 are incorporated into ISO/TS 16949.

4
ISO/TS 16949

ISO/TS 16949 harmonizes the supplier


quality system requirements of the United
States, Germany, Italy, and France, with
the purpose of having a single document
and registration scheme that the European
and U.S. automotive industry would
accept.

5
INTERNATIONAL AUTOMOTIVE
TASK FORCE MEMBERS

Associazione Nazionale Fra Industrie Automobilistiche (ANFIA)


Automotive Industry Action Group (AIAG)
Comité des Constructeurs Français d’Automobiles (CCFA)
Fédération des Industries des Équipements pour véhicules (FIEV)
Society of Motor Manufacturers and Traders Ltd. (SMMT Ltd.)
Verband der Automobilindustrie (VDA) Qualitätsmanagement Center
(QMC)

6
Automotive Quality System Harmonization
FIAT
IVECO AVSQ

PSA (Peugot
Citoen)
RENAULT EAQF
FIEV
Technical Specification

ISO/TS 16949
ADAM OPEL
Quality Systems - Automotive
AUDI
Suppliers - Particular
BMW
requirements for the application
DAIMLER VDA 6.1
BENZ of ISO 9001:1994
FORD
WERKE
VW

CHRYSLER
FORD QS-9000
GM
7
ISO/TS 16949
This document follows the same structure as ISO
9001: 1994, with some additional requirements
drawn from the following documents:
QS-9000 Quality System Requirements, Third Edition
VDA 6, Part 1: Quality System Audit
AVSQ’94 Guida per l’applicazione (guidelines for use)
Evaluation Aptitude Qualité Fournisseur (EAQF 94)

8
ISO/ TS 16949
The elements of ISO/TS 16949 are closely aligned
with the elements of the four automotive standards.
Most of the elements can be traced to a minimum of
one of the four automotive standards - many
elements can be traced to all four standards.

9
ISO/TS 16949

The goal of this Technical Specification is the


development of fundamental quality systems that
provide for continuous improvement, emphasizing
defect prevention and the reduction of variation and
waste in the supply chain.

10
ISO/TS 16949
Why the new standard?
Create a Global Quality System Language
Create Global Recognition of Certificates
Reduction in multiple 3rd party registrations
Provide a competitive advantage
Advantages for upgrading QM-System
Advantages for global sourcing

11
IATF Communique - October 4th 2000
Implementation of certification to ISO/TS 2nd edition, relative to ISO 9001:2000 transition

Certification validity

to ISO/TS 16949 : 2002

to ISO/TS 16949 : 1999

to ISO 9001 : 2000

to ISO 9001 : 1994


3 years max (see IAF-TC176 communique)

Standards life time

ISO/TS 16949 : 1999 ISO/TS 16949 : 2002

ISO 9001 : 1994 ISO 9001 : 2000

2000 2001 2002 2003 2004 2005


12
ISO/TS 16949:1999 vs. QS-9000 3rd Edition

What's different?
Numbering (4.1-4.20) remains the same
Additional 5% requirements over a typical tier 1
QS-9000 system
Registration requirements are much “tighter” than
QS-9000

13
ISO/TS 16949:1999
Element Description Comment
4.1.2.2.2 Shift resources New
4.1.3.2 Management Review - supplemental Partly New
4.1.5 Analysis and Use of Company Level Data Paragraph c new
4.1.6 Employee motivation, empowerment and New
satisfaction
4.1.7 Impact on society Partly New
4.2.4.2 Measurements New
4.2.4.6 Computer-aided design Partly New
4.4.2.3 Research and development New
4.6.2.2 Subcontractor development Partly New

14
ISO/TS 16949:1999
Element Description Comment

4.17.2.3 Process Audit New


4.17.3 Auditor Qualification New
4.18.3 Training on the job New
4.19.3 Servicing agreement with customer New

15
ISO/TS 16949:1999
ISO 9001 vs. QS-9000:98 vs. ISO/TS 16949
Element ISO Shall QS Shall ISO/TS 16949 Shall
4.1 9 30 39
4.2 9 50 62
4.3 5 7 7
4.4 20 39 34
4.5 9 11 12
4.6 11 21 18
4.7 2 3 3
4.8 3 3 3
4.9 7 32 28
4.10 16 36 23

16
ISO/TS 16949:1999
ISO 9001 vs. QS-9000:98 vs. ISO/TS 16949
Element ISO Shall QS Shall ISO/TS 16949 Shall
4.11 16 17 20
4.12 2 3 2
4.13 7 18 18
4.14 5 12 14
4.15 9 23 24
4.16 7 12 8
4.17 6 8 12
4.18 3 5 7
4.19 1 2 3
4.20 2 5 4
Total 149 337 341

17
ISO/TS 16949:1999
4.1.1.2 Objectives
The supplier shall define goals, objectives and
measurements to deploy the quality policy.
Objectives for achieving quality shall be included in
the business plan.

NOTE The goals and objectives should address


customer expectations and be achievable within a
defined time period.
*more explicit about quality policy objectives

18
ISO/TS 16949:1999
4.1.1.4 Continuous Improvement
Continuous improvement in quality, service, cost and
technology shall be provided for in the Quality Policy.
The supplier shall identify opportunities for quality
and productivity improvement and implement
appropriate improvement projects.
The supplier shall use appropriate improvement
measures and methodologies (see 4.2.7).

19
ISO/TS 16949:1999
4.1.1.4 Continuous Improvement cont’d
NOTE 1 The following list shows examples of possible techniques
which might be used. There may be many other methods
which meet specific supplier needs more appropriately:
- control charts (variables, attributes, CUSUM),
- design of experiments (DOE),
- theory of constraints,
- overall equipment effectiveness,
- parts per million (PPM) analysis to achieve zero defects,

20
ISO/TS 16949:1999
4.1.1.4 Continuous Improvement cont’d
- value analysis,
- benchmarking,
- analysis of motion/ergonomics,
- mistake-proofing.

NOTE 2 Guidelines for quality improvement are given in


ISO 9004-4
* relocated from 4.2.5; more explicit about quality policy objectives

21
ISO/TS 16949:1999
4.1.2.1.3 Quality responsibility
Management with responsibility and authority for
corrective action shall be promptly informed of
products or processes which becomes non-compliant
with specified requirements.
Personnel responsible for quality shall have the
authority to stop production to correct quality
problems.

* note changed into a requirement


22
ISO/TS 16949:1999
4.1.2.2.2 Shift resources
Especially concerning the production process,
all the shifts shall be staffed with personnel in
charge of, or delegated responsibility for
quality.

* new requirement

23
ISO/TS 16949:1999
4.1.3.2 Management review - supplemental
These reviews shall include all elements of the quality system
and its performance (see 4.2.8) over time as an essential part
of the continuous improvement process.
Part of the management review shall be the monitoring of
strategic quality objectives, and the regular reporting and
evaluation of the cost of poor quality.
NOTE Management review should be conducted with sufficient
frequency to ensure that the established quality system is
effective.

* more explicit about what to review

24
ISO/TS 16949:1999
4.1.5 Analysis and use of company level
data
The supplier shall document trends in quality,
operational performance (productivity, costs of poor
quality, efficiency, effectiveness) and current quality
levels for key product and service features.

NOTE These should be compared with those of


competitors and/or appropriate benchmarks.

25
ISO/TS 16949:1999
4.1.5 Analysis and use of company level
data cont’d
Trends in data and information shall be compared
with progress toward overall business objectives and
lead to action to support the following:
a) development of priorities for prompt solutions to
customer-related problems;
b) determination of key customer related trends and
correlation to support status review, decision making
and longer term planning;

26
ISO/TS 16949:1999
4.1.5 Analysis and use of company level
data cont’d
c) an information system for the timely reporting of
product information arising from usage.
* item “c” is new

27
ISO/TS 16949:1999
4.1.6 Employee motivation, empowerment and
satisfaction
The supplier shall have a process for motivation of
employees to achieve quality objectives and to make
continuous improvements. The process shall include
promotion of quality awareness on all levels.
NOTE Quality reviews should be conducted to provide
appropriate information, such as “plan/actual”
comparison and improvement suggestions.

28
ISO/TS 16949:1999
4.1.6 Employee motivation, empowerment
and satisfaction cont’d
The supplier shall have a process for measurement of
employee satisfaction and employee understanding
of appropriate quality objectives.
* new sub-element

29
ISO/TS 16949:1999
4.1.7.1 Product safety
- Due care regarding product safety and means to
minimize potential risks to employees, customers,
users and the environment shall be addressed in the
supplier’s quality policy and practices, especially in
design control (see 4.4) and process control (see 4.9)
procedures and practices. The supplier shall promote
internal awareness of safety considerations relative
to the supplier’s product.
* QS-9000:98; 4.2.3.4 more explicit

30
ISO/TS 16949:1999
4.1.7.2 Regulations
- The supplier shall have a process to ensure
compliance with all applicable government, safety
and environmental regulations, including those
concerning storage, handling, recycling, eliminating
or disposing of materials.

* QS-9000:98; 4.6.1.2 more explicit

31
ISO/TS 16949:1999
Product realization
In this Technical Specification, quality planning
activities of all pre-launch phases have been
integrated under the new heading “Product
realization”.
For suppliers with product design responsibility,
product realization also includes product design (see
4.4).
Product realization in the context of quality planning
is discussed in 4.2.4. The structure is outlined on the
next slide:

32
ISO/TS 16949:1999
Product Realization cont’d
4.2.3 Quality planning
4.2.3.1 Quality planning - ISO 9001 : 1994
4.2.3.2 Quality plan requirements
4.2.4 Product realization
4.2.4.1 General
4.2.4.2 Measurements
4.2.4.3 Review cycle
4.2.4.4 Multidisciplinary approach
4.2.4.5 Tools and techniques
4.2.4.6 Computer-aided design

33
ISO/TS 16949:1999
Product realization cont’d
4.2.4.7 Special characteristics
4.2.4.8 Feasibility review
4.2.4 Product realization continued
4.2.4.9 Management of process design
4.2.4.9.1 General
4.2.4.9.2 Process design input
4.2.4.9.3 Process design output
4.2.4.9.4 Process verification
4.2.4.10 Control plan
4.2.4.11 Product approval process
*Renumbered and some new requirements

34
ISO/TS 16949:1999
4.2.8 Quality system performance
The supplier shall evaluate the performance of the quality
system to verify the effectiveness of its operation. Results shall
be recorded to provide, as a minimum, evidence of the
achievement of:
a) objectives specified in the quality policy (see 4.1.1.2),
b) objectives specified in the business plan (see 4.1.4),
c) customer satisfaction with product supplied.
The results shall be used for continuous improvement or
corrective action as appropriate.
* more explicit

35
ISO/TS 16949:1999
4.10.6 Laboratory requirements
Where inspection, testing and calibration services are
conducted by a supplier’s laboratory facility shall
comply with ISO/IEC 17025, including use of a
laboratory scope.
NOTE Accreditation of supplier facilities to ISO/IEC
17025 or national equivalent is not required by, nor
does it satisfy, all quality system requirements
specified in this Technical Specification for a
laboratory. Therefore, the laboratory should be
included in the on-site audits.

36
ISO/TS 16949:1999
4.10.6 Laboratory requirements cont’d
Commercial/independent laboratory facilities used for
inspection, test or calibration services by the supplier
shall be accredited to ISO/IEC 17025 or national
equivalent.

* new requirement with respect to ISO/IEC 17025

37
ISO/TS 16949:1999
4.17.2.3 Process audit
The supplier shall audit the product realization and
production processes to determine the effectiveness
of process performance (see A.43)

* new requirement

38
ISO/TS 16949:1999
A.43 process audit
onsite verification activity used to:
- verify conformance to specified requirements, such
as control plan, work instructions,
- ensure that quality objectives are met,
- verify that specified requirements for process
capability/performance are met,
- assess the effectiveness of activities and related
results

39
ISO/TS 16949:1999

4.17.3 Auditor qualification


The supplier shall comply with customer
requirements for internal system and process auditor
qualification.

* new requirement

40
Registration Approach

Differences from QS-9000


The registrar cannot conduct an on site Gap
Analysis
Only one Pre-audit visit is permitted
The suppliers’ quality system consultant is
not permitted to be present during any on-
site audit activity

41
Registration Approach

Differences from QS-9000


All non-conformances must be closed within 90
days of the initial audit.
Failure to do so will result in a complete re-audit
If auditor finds major non-conformances (which
likely will not be closed within 90 days) he/she
must terminate the certification process

42
Registration Approach
Additional Requirements
90 day rolling audit schedules must be submitted to
IATF
report must be submitted to IATF for any
terminated audit
IATF reserves the right to become involved with
certification decisions
Authorization to provide the final report (see Annex 1,
section 3) to the IATF shall be specified in the
certification contract between the certification body
and the supplier.

43
Audit Process

The entire quality system shall be assessed at a


minimum of once every three years.

Certification body checklists shall include all questions


contained in the “Checklist to ISO/TS 16949 if open
minor or major nonconformities to ISO/TS 16949
exist. After certification, when a nonconformity is
identified by the certification body, then the
decertification process shall be initiated.

44
Audit Process cont’d.
Each on-site audit, including initial and surveillance
audits, shall include a review of:
customer complaints and supplier response,
supplier internal audit and management review results
and actions,
progress made toward continuous improvement
targets,
effectiveness of the corrective actions and verification
since the last surveillance audit.
Elements 4.1, 4.2, and 4.4 for design responsible supplier
shall be reviewed at least once during an on-site audit
within each consecutive 12-month period.

45
Audit Team
The audit team shall provide a full report on the
operations audited consistent with the content of
Annex 1 “Rules for auditing quality systems according
to ISO/TS 16949”, to the supplier within 15 working
days of each initial and surveillance audit unless
otherwise agreed by the supplier.
Third-party auditors shall identify opportunities for
improvement, e.g., excessive scrap, as these become
evident during the audit without recommending
specific solutions. These opportunities shall be
included in the report to the supplier.

46
Other Requirements

Certification bodies shall notify the IATF of all


scheduled audits including witness audits and shall
allow IATF members, or their designates, to attend.

47
Other Requirements cont’d.
Upgrading of a current automotive certificate, AVSQ,
EAQF, QS-9000, VDA 6.1, by one of the IATF
contracted certification bodies will be taken into
account prior to the initial assessment to ISO/TS
16949, as follows:
If the scope is unchanged, at least 50% of the
required audit mandays for initial audit shall be
applied. The audit must fully include the ISO/TS
16949 elements 4.1, 4.2, and 4.14 and the customer
specific requirements, and assess the remaining
ISO/TS 16949 requirements on a sampling basis

48
ISO/TS 16949
Audit Man-days for certification to ISO/TS 16949
Audited Initial Audit Surveillance Audits Re-certification
Entity: (On-site mandays) [years 1 and 2]: Audit [year 3]:
Number of (On-site mandays (On-site mandays)
Employees within each 12
Month Period)
1-15 2 2 2
16-30 4 2 2
31-60 5 3 3
61-100 6 3 4
101-250 8 4 5
251-500 10 5 7
501-1000 12 6 8
1001-2000 15 7 10
2001-4000 18 9 12
>4001 21 11 14

49
Other Requirements cont’d.

If the scope is changed, 100% of the required audit


person days for the initial audit shall be applied. The
audit must fully include all ISO/TS 16949
requirements, including customer specific
requirements; sampling of ISO/TS 16949
requirements is not permitted.

50
Other Requirements cont’d.
IATF reserves the right to send a delegate to the
executive management committee of the certification
body concerning certification decisions regarding
ISO/TS 16949.
If a certification body places an existing ISO/TS
16949 certified company on suspension because of
quality system nonconformities or a violation of the
rules of registration, the certification body shall notify
IATF, within 10 working days.

51
Transition Planning
Review changes with top management
Determine and plan for resources
Appoint transition team and Project Leader
Provide adequate training to transition team
Contact AQSR to confirm transition policies and
timing

52
Transition Planning

Train Internal Auditors


Develop project timeline, assign tasks, personnel and
due dates
Do regular/ scheduled project review
Provide training on the changes for appropriate
personnel
Involve top management throughout the transition
process

53
ISO/TS 16949
The principles detailed in this communiqué are
supported by the following vehicle manufacturers:
BMW, Daimler-Chrysler, Fiat, Ford, General Motors
(including OpelVauxhall), PSA Peugeot-Citreon,
Renault SA, Volkswagen and the trade associations
AIAG, ANFIA, FIEV, SMMT and VDA.

54
ISO/TS 16949
Statements from OEM’s
DaimlerChrysler
Recognition of VDA 6.1 and QS-9000 Standards
Effective immediately, as part of our Global
Procurement & Supply strategy at DaimlerChrysler,
registration to either VDA 6.1 or QS-9000, including
company specific requirements, will be accepted as
quality registration from our suppliers.

55
ISO/TS 16949
DaimlerChrysler cont’d
Registrations to ISO/TS 16949, including company
specifics will also be accepted as quality registration
from our suppliers. This new Technical Specification
may become the Quality Management standard of
the future.

56
ISO/TS 16949
Ford Motor Company
October 7, 1999
For many suppliers, particularly those with multiple international
automotive customers, ISO/TS 16949 may represent substantial
efficiencies by allowing one audit to satisfy the quality system
requirements of QS-9000, VDA 6.1, AVSQ, EAQF when coupled
with individual company-specific quality requirements and the
common automotive registration scheme. The new Technical
Specification may become the single automotive industry quality
management standard of the future.

57
ISO/TS 16949
All General Motors Global Suppliers
New ISO/TS 16949 and QS-9000 GM Customer-
Specific Requirements
GM will accept, as optional to QS-9000, a third party
certification to ISO/TS 16949 that meets the
following conditions:
The certification scope must include both ISO/TS
16949 and the accompanying ISO/TS 16949 GM-
Customer Specific Requirements.

58
ISO/TS 16949
All General Motors Global Suppliers cont’d
Note that GM does NOT require you to upgrade your
QS-9000 certificate to ISO/TS 16949. However, we
strongly recommend that you use your next QS-9000
surveillance audit to upgrade to the ISO/TS 16949
with the above conditions.

59
ISO/TS 16949
General Motors European Operations
New ISO/TS 16949
November 30, 1999
Please note that GM will NOT recognize certification
to VDA 6.1, EAQF or AVSQ as equivalent to QS-9000
or to ISO/TS 16949. In order to be accepted as
supplier for GM, you must provide either a 3rd party
certification to QS-9000 or optional to ISO/TS 16949
as outlined in the attached letter.

60
ISO/TS 16949
Renault
October 20, 1999
We have agreed to a common supplier automotive
quality system requirements document, ISO/TS
16949 which meets the basic current requirements:
EAQF 94, VDA 6.1, AVSQ 94 and QS 9000.
Therefore, from next October 15, Renault recognizes
certifications carried out in third party by every IATF
certified organization as an alternative for EAQF 94,
avoiding multiple certifications to our suppliers.
We recommend you to use this new standard.

61
ISO 9001:2000
ISO/TS 16949 2 Edition
nd

Update
ISO/TS 16949 2nd Edition

The 2nd Edition of ISO/TS 16949 is


based on the 4 main clauses of ISO
9001:2000

63
ISO 9001:2000
Eight Quality Management Principles
 Customer focus: organizations depend on their customers
and therefore should understand current and future customer
needs, should meet customer requirements and strive to exceed
customer expectations.
 Leadership: leaders establish unity of purpose, direction, and
the internal environment of the organization. They create the
environment in which people can become fully involved in
achieving the organization’s objectives.
 Involvement of people: people at all levels are the essence
of an organization and their full involvement enables their
abilities to be used for the organization’s benefit.

64
ISO 9001:2000
Eight Quality Management Principles
4 Process approach: a desired result is achieved more efficiently
when related resources and activities are managed as a process.
5 System approach to management: identifying, understanding
and managing a system of interrelated processes for a given
objective contributes to the effectiveness and efficiency of the
organization.
6 Continual Improvement: a permanent objective of the
organization is continual improvement.
7 Factual approach to decision making: effective decisions are
based on the logical or intuitive analysis of data and information.
8 Mutually beneficial supplier relationships: the ability of the
organization and its suppliers to create value is enhanced by
mutually beneficial relationships.

65
ISO 9001:2000
Process Approach
ISO 9001 encourages the adoption of a
process approach to quality management.
Activity that receives inputs and converts
them to outputs can be considered as a
process.
The systematic identification and
management of the processes employed
within an organization and the interactions
between such processes may be referred to
as the ‘process approach’.
66
ISO 9001:2000 Process Model
Quality Management System
Continual Improvement

C Management C
Responsibility
R S
U U
E A
Q T
S S
U I
I S
T T
R Resource
Measurement, F
E Analysis, A
Management
O Improvement O
M C
E T
M M
N I
T O
E Input Product Output E
S and/or Service Product N
Service
Realization
R R

Figure 1 Quality Management Process Model


Source: ISO 9001:2000
February 1999

67
ISO 9001:2000
ISO 9002 and ISO 9003 withdrawn
New language compatibility with
ISO 14001:1996
TC 176 and TC 207 working
towards harmonized auditing
standards which should be
available by Q2 - 2001.

68
ISO 9001:2000
Upgrades from 1994 to 2000 version
must be complete by Dec 15, 2003

69
ISO 9001:2000 Clause Headings
Sections ISO 9001:2000
Clauses
Management Responsibility
5.0
Resource Management
6.0
Product Realization
Measurement, Analysis, 7.0
Improvement 8.0

ISO 9001:2000 clauses are integrated and linked

70
ISO 9001 : 2000
Change in Terminology
ISO 9001 : 1994
Subcontractor Supplier Customers

Supplier Organization Customers

ISO 9001 : 2000

71
TS 16949 2nd Edition
Clause 5: Management Responsibility
5.1 Management Commitment
5.1.1 Process oriented organization
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.4.1 Quality Objectives
5.4.2 Quality Management System planning
5.5 Responsibility, Authority, and Communication
5.5.1 Responsibility and authority
5.5.2 Management representative
5.6 Management Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
72
TS 16949 2nd Edition
Clause 6: Resource Management
6.1 Provision of Resources
6.2 Human Resources
6.2.1 General
6.2.2 Competence, awareness, and training
6.3 Infrastructure
6.3.1 Plant, facility and equipment planning
6.3.2 Contingency Plans
6.4 Work Environment
6.4.1 Safety
6.4.2 Cleanliness of Premises
6.5 Sourcing

73
TS 16949 2 Edition nd

Clause 7: Product Realization


7.1 Planning of Product Realization
7.1.1 Quality Plan requirements
7.1.2 Change control
7.2 Customer-related Processes
7.2.1 Determination of requirements related to the product
7.2.2 Review of requirements related to the product
7.2.3 Customer Communication
7.3 Design and Development
7.3.1 Design and Development planning
7.3.2 Design and development inputs
7.3.3 Design and development outputs
7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
7.3.7 Control of design and development changes

74
TS 16949 2 Edition nd

Clause 7: Product Realization


7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
7.5 Production and Service Operations
7.5.1 Control of production and service provision
7.5.2 Validation of processes for production and service provision
7.5.3 Identification and traceability
7.5.4 Customer property
7.5.5 Preservation of product
7.6 Control of monitoring and measuring devices
7.6.1 Measurement System Analysis
7.6.2 Calibration Records
7.6.3 (skipped?)
7.6.4 Laboratory requirements

75
TS 16949 2nd Edition
Clause 8: Measurement, Analysis and Improvement

8.1 General requirements


8.2 Monitoring and Measurement
8.2.1 Customer satisfaction
8.2.2 Internal audit
8.2.3 Monitoring and measurement of processes
8.2.4 Monitoring and measurement of product
8.3 Control of nonconforming product
8.3.1 Customer information
8.3.2 Control of reworked product
8.3.3 Customer authorization

76
TS 16949 2nd Edition
Clause 8: Measurement, Analysis and Improvement

8.4 Analysis of data


8.4.1 Analysis and use of company-level data
8.5 Improvement
8.5.1 Continual improvement
8.5.2 Corrective action
8.5.3 Preventive action

77
ISO 14001

Update…
ISO 14001
Registration Reminder
General Motors requires third-party
registration by December 31, 2002
Ford requires third-party registration by:
– December 31, 2001 (one site) and
– July 1, 2003 (balance of sites)
Daimler Chrysler requires third-party
registration by Jan 1, 2003

79
ISO 14001
An integrated auditing approach will
be made available to those
organizations that will integrate their
EMS and QMS systems.
Reduction in duplication of efforts
Potential reduction in audit time & cost

80
Enhanced Surveillance
Audit

Optional for Automotive standards


Surveillance Audit - New Requirements
Adds Value to Surveillance Audits
Proactive
Focuses surveillance audits on areas in
need of audit
Phase in period over next 6-9 months
30 days Prior to surveillance audit
• Customer to download “Customer Metrics
Summary” from AQSR web site
• Completed form to be forwarded to AQSR

82
Surveillance Audit -
New Requirements
• Your auditor reviews customer metrics and
adjusts audit plan (if needed) to focus audit.
• AQSR prepares and sends audit plan to you

NOTE: Your auditor reviews customer metrics on site during surveillance audit,
so this enhancement only brings that review forward by a month or so.

83
Surveillance Audit -
New Requirements
“Customer Metrics” will be reviewed as
part of each surveillance audit
Ford
• Delivery (P/S)
• PPM (Productivity / Service)
• Q1 Status (Either Q1 or not)
• Launch QR’s
• PSW (PPAP violations)
• PPM
84
Surveillance Audit -
New Requirements
GM
• PPM
• Delivery (SPDI Rating)
• Responsiveness rating
• PPAP rejection / interims (0)
Chrysler
• PPM
• Delivery
Other Customer requirements
85
IASG Sanctioned
Interpretations - QS-9000:1998

Third Edition Interpretations

November 1, 1999

86
IASG Sanctioned QS-9000
Interpretations
Highlights
Findings (major/minor/opportunity for
continuous improvement)
Probation
• Status with OEM
• Major NCR
• Failure to close minor NCR
• Notification of ASQ database
• Impact on “Corporate” registrations
• On-site assessment to close probationary status

87
IASG Sanctioned QS-9000
Interpretations
Highlights
Registration Transfers
CARs may be issued up to 5 days after audit

88
IASG Sanctioned QS-9000
Interpretations July 2001
Supplier Development
Subcontractors must be registered to ISO
9001 or 9002 by Dec 31, 2002
Notification of registrar within 30 days of
Closure, merger, acquisition, joint venture, site consolidation
etc.
Registrar may consider additional on site activity
Failure to do so will result in a MAJOR CAR
Probationary Status update
6 month surveillance only for a minimum of 18 months

89
AQSR
Corporate Update
AQSR Profile
International Management Systems Registrar:
Providing accredited third party management system
registration
• Core Quality
– ISO 9000 - Quality
• Automotive Quality
– QS-9000, TE Supplement, ISO TS 16949, VDA 6.1
• Aerospace Quality (AS 9000 & AS9100)
• TL-9000
• ISO 14000 - Environment

91
AQSR Profile
Over 4500 Certificates of Registration
issued Worldwide
• North America
• South America
• Europe
• Asia

92
AQSR Profile
Top 2 registrar for market growth (North America)
Ranked #4 overall (in a field of 39 North American
registrars) for the level of knowledge, service and value
provided to clients*
Ranked #1 overall for Canadian-based registrars
A “top 10” registrar for QS-9000 certificates issued
One of 31 registrars capable of providing ISO/TS 16949
registration worldwide
Automotive industry expertise

* 2000 Quality Digest survey of registered companies. July 2000 publication date

93
AQSR Profile
International AQSR Group Offices
United States - Ann Arbor, Michigan
Canada - Mississauga, Ontario
UK - Timperley
Germany - Gosheim
Mexico – Mexico City
Venezuela - Valencia
Taiwan - Taipei
China - Shanghai & Dong Guong
India - New Delhi
94
AQSR Profile
Accredited by
SCC - Canada
RAB – U.S.
SENCAMER - Venezuela
DAR/KBA - Germany

Scope of Accreditation
Broad base of experience in most IAF Scope
Categories in both Manufacturing and Service
Sectors

95
AQSR Profile
Service Experience
Engineering Services, Project Management, Airport
Management, Employment & Staffing,
Construction and Related Companies,
Transportation, Wholesale, Retail
Manufacturing Experience
Textiles, Printing, Steel, Chemical, Rubber &
Plastics, Minerals, Concrete, Basic Metals,
Fabrication, Electrical and Electronics, Aerospace,
Transportation Equipment, Aerospace

96
AQSR Profile
Client base
Hundreds of small to medium manufacturers and service providers
Larger companies include:
• Magna International (Worldwide registrar with over 100 sites)
• Honda Motor Corporation (2 sites)
• Dow Chemical (8 sites)
• General Motors (EDS – Venezuela)
• Hayes Lemmers (18 sites)
• Belle Tire (60 sites)
• General Broach (8 sites)
• Teleflex (12 sites)
• L & W Engineering (5 sites)
• Orius Corporation (20 sites)
• FCI Automotive (5 sites)
• Ventra Group (5 sites)
• Liebher (3 sites)
• LDM Technologies (9 sites)
97
                        
AQSR Profile
AQSR is affiliated with the OMNEX Group of Companies
OMNEX was established in the mid 1980’s
• Providing Quality Related “Best In Class”
– Training Services
– Publishing Services
– Quality System Related Software
– Documentation Management
– Process Management
– Audit Management
– APQP Process Management

DEMO CD’S ARE AVAILABLE

98
AQSR Profile
OMNEX training courses support our
®

clients’ quality efforts.


Essentials / Foundation Workshops
RAB Lead Auditor (QMS and EMS)
RAB Internal Auditor Training
Ford certified QOS and Global 8D
Six Sigma

99
The Registration
Process

How does it work ?


How does it work ?

New Registration
Assumption of Existing Registration
A Quality Partnership
Recommended
Aggressive Schedule
Schedule
• Initial Contact - Proposal

• Proposal acceptance (application)

Consultant
• Readiness Review (Optional - QMS)

• Document Review

5 to 6 Months
8 to 10 Months

• Pre-Audit (Optional)

• On-Site Registration Assessment

• Registration

• Surveillance Audits

102
A Quality Partnership
New Registration
Getting to know one another
Initial contact/ Site visit
AQSR prepares a quote for registration services based on
the site evaluation and or the information you provide
through our preliminary questionnaire (Request for quote)
Presentation of quotation
Beginning our formal relationship
Application for Registration is signed by the Client and the
formal registration process begins

103
A Quality Partnership
New Registration

Readiness Review
A tour of your facility
An analysis of your current management system
to the requirements of the applicable standard)
Typically informal for QMS
A verbal and written report will be presented on-
site

104
A Quality Partnership
New Registration
Document Review
A review of Levels I and II documentation.
At your place our ours
Development of On Site Checklist

Audit Plan Development


Joint development of an audit plan performed by
your auditor (typically occurs approximately two
months before the on-site audit)

105
A Quality Partnership
New Registration
Pre-Audit (Optional)
Your auditor will review the implementation of
your policies and procedures.
• This audit will use the processes identical to the
Registration Assessment.
– For QS-9000 this audit can be the first or “Initial Audit” of
a two stage audit (if requested)
Great opportunity for your staff to meet and
interact with your auditor
Confirms your readiness for the Registration
Assessment

106
A Quality Partnership
New Registration
On-Site Registration Assessment
The formal On-Site assessment is carried out at your facility
Your auditor will confirm that you are following your own
procedures and processes as described in your
documentation.
Non-adversarial approach
• Open process (no surprises)
• Your auditor guide(s) accompany the auditor(s) during all
phases of the assessment
• Ongoing dialogue with the auditor(s)
• Findings can be addressed during the assessment
Recommendations for registration are made by your
Lead Auditor at the closing meeting.
107
A Quality Partnership
New Registration
Surveillance
In order to ensure that your system continues
to meet the relevant requirements, AQSR will
conduct periodic surveillance visits.
Semi-annual and annual options are available.
AQSR’s semi-annual surveillance format does
not require a comprehensive on-site re-
assessment after 3 years.

108
A Quality Partnership
Assumption of existing registration
On-site Assumption of Registration visit
Review of System Documentation
Review of audit reports issued by current registrar
•Gain an understanding of current registrar’s approach
and general implementation status
–For QS-9000 you cannot be in probation at the time
of transfer
Small sampling of system implementation
Recommendation for AQSR registration

109
A Quality Partnership
Assumption of existing registration
Issue of AQSR Certificate of Registration
Notification to stakeholders
Notification to customers and existing registrar
•Assistance available from AQSR in this matter
Update ASQ (QS-9000)
Update international databases
•Worldpreferred
•McGraw Hill
•ASQ etc.
Welcome to the AQSR Registration Program

110
Beyond Registration
Service
AQSR WEB SITE
Corporate Overview
General information including scope, SIC codes contact info etc.
Online quote request (approx 10 per month)
Pressroom
• Offers clients up to date information on industry trends
• Newsletters
• Articles
• Press Releases
Internet based directory of all AQSR registered clients
Link to Worldpreferred.com
• E-commerce B2B listings available*

111
Marketing for
Clients The World’s Best Suppliers

AQSR’s B2B Ecommerce web partner


International Directory of Registered Companies (all standards)
• North America – 50,000 suppliers
• International (25% complete) – 15,000 suppliers
Worldpreferred.com is marketing the database to buyers worldwide
AQSR Clients
• Basic Listing – Free
• Enhanced listing - $2000 / year
– Web site “extranet” plus extensive information database on
company
– B2B e-commerce including no-fee RFQ capability offering
direct links to buyers worldwide.
• Visit http://www.worldpreferred.com or request an information
package from AQSR for more information.
112
Marketing for Clients
Service
Newsletter Program
AQSR’s quarterly newsletter provides registrants with the latest information on
what’s happening
Briefing program
Updates on industry trends, standards and general information
• Offered to client’s, non-clients (targeted markets)
Client Surveys
Review of AQSR deliverables to ensure that we continue to meet our client s needs.
• Independent evaluation during Q4-2000
Paperless Audit Management**
Electronic Audit Management
• Document Reviews
• Audit Reports
• CAR Management
• Schedules
** Should be available by July 01

113
Beyond Registration

Communication
AQSR Update sent quarterly
• Up to date industry information
• Share your experiences

114
Thank You,
are there any
Questions?

A copy of this presentation is available at


www.aqsr.com in Powerpoint 97.
Click on the “Pressroom” icon
115

You might also like