Iso16949new 121026233956 Phpapp01

Robere & Associates (Thailand) Ltd.
2002
1
To an Introduction to
ISO/TS/16949
Robere & Associates (Thailand) Ltd. 2002
2
Agenda
Company approach
The Specification
Administrative issues

3
How to Create, I mplement and
Maintain an I SO/TS16949 System that
adds value to your company..
4
Management vs Assurance
QS9000 with its foundation in ISO9001:1994 is
a Quality Assurance Customer requirement.
ISO/TS 16949 with its foundation in
ISO9001:2000 is a Quality Management System
This difference identifies the focus of our
activities.
5
Steps to transition..QS TS
- The Seven Rs -
1. Review your existing system against the new
requirements
2. Reformat the structure and the approach
3. Regulate the implementation activities
4. Renew your skills for the new system
5. Rejoice in the improvements
6. Report on the Audit activities and
7. Redo the process

6
Review your existing system
against the new requirements

The second edition of the standard is being
finalized
Look at the QS9000 requirements against
ISO/TS16949 as well as ISO9001:2000.
Determine the gap.
There have been some relaxations in the revised
requirement
7
Reformat the structure and the
approach
Existing document
structure will work
Identify new
references
ISO/TS 16949 more
prescriptive than
ISO9001:2000
8
QUALITY SYSTEM DOCUMENTATION
PROGRESSION
International Standards ISO 9001/ISO9002

Sector Requirements
ISO/TS 16949
Part and Process Approval
Procedures

Defines
international quality
system requirements
Quality
Manual
Procedures
Job Instructions
Other Documentation
Customer-supporting
reference manuals on:
(see bibliography)

Advanced
Quality Planning

Control Plan

Tools and techniques
Level 1
Defines
Approach &
Responsibility
Level 2
Defines Who
What, When
Level 3
Answers
How
Level 4
Prompts recording of
information such as forms,
tags, labels
International
automotive quality
system requirements
9
Product/
Service
QUALITY MANAGEMENT SYSTEM
CONTINUAL IMPROVEMENT
Management
responsibility
Measurement,
analysis
improvement
Resource
management
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Output
Input
Quality Management Process Model
Product
(and/or service)
Realization
5
8
7
6
10
Regulate the implementation
activities

Establish the QMR
and the team
Establish the plan
Follow the plan
Management must
lead the activities
through example
11
Renew your skills for the new
system

Ensure that all staff responsible
for the system are trained in:
Customer focused activities
Leadership
How to involve their staff in the day
to day activities
The philosophy of a process and
system approach to management
Continuous improvement tools
The methods of a factual approach to
decision making
The steps to develop supplier
relationships

12
1. Customer-Focused Organization.
2. Leadership.
3. Involvement of People.
4. Process Approach.
5. System Approach to Management.
6. Continual Improvement.
7. Factual approach to decision making.
8. Mutually beneficial supplier relationships.
Eight Quality Management Principles
13
Renew your skills for the
additional requirements
All clauses of ISO9001:2000
Many requirements were
carried over from the 1
st

edition
Helps to strengthen the
automotive QMS
Requirements
14
Rejoice in the improvements
Recognize those who have
contributed to the system
improvements
Plan other activities that
would involve more staff
Post all the improvement
activities for everyone to see.

15
Report on the Audit activities

Audits are for
improvement and for
the prevention of
non-conformances.
Use the internal
audits for continuous
improvements
16
Redo the process
Even though youve been
certified, constantly
review existing process
for improvement.
Document your
activities..they become
part of your overall
quality improvement
program
17
Part 1: Conclusion..
The new requirement
brings greater
benefits
Upgrade your system
for improvement,
using the
Quality
Management Tools
Focus on the long-
term improvement
18
THE GLOBAL QUALITY
SYSTEM SPECIFICATION FOR
THE AUTOMOTIVE INDUSTRY
19
Evolution of ISO/TS16949
International Automotive Task Force (IATF)
France (EAQF-94)
Germany (VDA 6.1)
Italy (AVSQ)
USA (QS-9000)
Peugeot / Citroen, Renault Automobiles
BMW, AUDI, Bosch, GME/Opel, Mercedes Benz, Volkswagen
Fiat, Magneti Marelli
Daimler Chrysler, Ford, General Motors, VW of America
20
Evolution of ISO/TS16949
Trade Associations supporting the IATF
AIAG, USA
ANFIA, Italy
CCFA, France
FIEV, France
SMMT Ltd., UK
VDA, Germany
21
Goal of ISO/TS 16949
The goal of this Technical Specification is the
development of a quality management system that
provide for continuous improvement, emphasizing
defect prevention and the reduction of variation
and waste in the supply chain.
22
Scope of ISO/TS16949
The Technical Specification is applicable to
production and service part supplier and
subcontractor sites providing:

Parts or Materials, or
Heat Treating, painting, plating, or other finishing services, or

other customer-specified products.
Remote Locations need to be covered too.
Remote Locations cannot obtain standalone certification
The Technical Specification can be applied throughout the

automotive supply chain.

23
How does ISO/TS16949 align with the
existing Sector Specific Standards?
The elements of the ISO/TS/are closely aligned

with the elements of the four automotive
standards
Most of the elements of ISO/TS/can be traced to

a minimum of one of the four automotive
standards.
Many of the elements can be traced to all four

standards

24
Quality Related Requirements
Part
Commodity
Division
Company
Sector
Fundamental
More
Specific
More
Generic
ISO/TS /TS16949
ISO/TS 9001:2000
25
Expected Benefits of
ISO/TS/16949
Improved product and process quality
Provide additional confidence for global sourcing
Freeing up supplier resources for other quality activities
Common quality system approach in the supply chain for

supplier/subcontractor development and consistency.
Reduction of variation and increased efficiency

26
Benefits of ISO/TS/16949
Reduction in 2nd party system audits
Reduction in multiple 3rd party registrations
Common language to improve understanding of quality

requirements
27
Foreword to the ISO/TS/16949
Based on ISO9000 - ISO 9001:2000 Text is Boxed
Shall is a mandatory requirement
Notes are for guidance in understanding
Should in a note is for guidance purposes only
Sector specific requirements are outside the boxes
The term such as is used only for guidance

28
More Requirements for
management!!
To list the goals, objectives, and measurements used to
support the quality policy
To put in place a method of determining customer
satisfaction
To develop a method of continuous improvement
To assign a customer representative (different from
management representative)
To inform management of noncompliant goods and
take corrective action
To assign quality responsible people on all shifts

29
More Requirements for
management!!
To use of project management
To use of advanced product quality planning (APQP)
To establish cost of quality as part of management
To review a detailed business plan for the company
To analyze the company data on effectiveness,
efficiency, quality, etc.
To use of benchmarking system of motivating
employees towards continuous improvement
To analyze product safety
To account for applicable regulations, including health,
safety, and the environment.

30

ISO/TS 16949
Conformance and
Guidance Standards
Foundation & Familiarization
31

The ISO/TS 16949 Conformance
standard:
Contains five primary clauses (4-8) and
23 sub-clauses
116 sub-sub clauses, 91 of which are
directly related to automotive
requirements.

Foundation & Familiarization
32
ISO/TS16949:2000 Clause - 0
Introduction
Describes the standard to address
customer satisfaction and regulatory
requirements to compliment product
technical requirements
Defines the process approach as the
systematic identification and
management of processes and their
interaction
The clause structure of
ISO/TS16949:2000 follows this process
approach

33
ISO/TS16949:2000 Clause 1
Scope (1.1)
Establishes the intent of the standard
To provide a product that meets specification
To address customer satisfaction
To ensure continual improvement
To prevent nonconformity
Additional focus on Automotive requirements
Applicable to production and service part organization
sites where customer specified products are
manufactured.
Remote locations such as design centers, corp
headquarters, but cannot obtain a stand-alone
certification
Can be applied throughout the automotive supply chain.

34
ISO/TS16949:2000 Clause
1.2 Application (Exclusions)
States the rules for permitting
exclusion of requirements of clause
7, where they do not apply because
of the nature of the organization:
For ISO/TS16949 only 7.3 (Design) can be
excluded
Cannot exclude manufacturing process
design
35
ISO/TS16949:2000 Clause
2 Normative reference
Identifies ISO 9000:2000 Quality
Management Systems
Fundamentals and Vocabulary as a
standard whose content also applies
in meeting ISO/TS16949
requirements.

36
ISO/TS16949:2000
Clause 3:Terms and definitions
Describes the change in terms:
Supplier (old) = organization (new)
Sub-contractor (old) = supplier (new)
Notes that product can apply to hardware,
software, services and processed materials.
Product can therefore be a product or
service.
37
Additional ISO/TS 16949
3.1 Terms and Definitions for the
automotive Industry
Continual Improvement
Control Plan
Design Responsible Organization
Error Proofing
Laboratory Scope
Manufacturing
Outsourcing
Predictive Maintenance
Premium freight
38
4.1 General Requirements
Shall
Establish
Document
Implement
Maintain
Continually improve the Quality
Management System (QMS)
39
4.1 General Requirements
Shall implement by;
a. Identify processes required for the QMS
b. Determine sequence & interaction of process
c. Determine criteria and methods required for effective
operation and control
d. Ensure availability of resources/information to support
operations and monitoring
e. Measure, monitor & analyse
f. Implement actions necessary to achieve planned
results & continual improvement
Note: When an organization outsources, they cannot delegate
the technical responsibility

40
4.2 General - Documentation
requirements
The QMS documentation shall include;
a. Documented statements of a quality policy and quality
objectives
b. A Quality Manual
c. Documented procedures as required by ISO/TS
9001:2000
d. Documents required by an organisation to ensure;
Effective planning/operation
Control of its processes
e. Quality records required by ISO/TS 9001:2000

41
4.2 General Documentation
requirements
Note:
The scope of the QMS shall be dependant upon
a. Size and type of the organisation
b. Complexity and interaction of the processes
c. Competence of personnel

42
4.2.2 Quality Manual
A quality manual shall be
established and maintained which
includes;
a. The scope of the QMS
Including details and justification of any exclusions
b. Documented procedures or reference to
these
c. Description of sequence & interaction of
processes included in the QMS.

43
4.2.3 Control of documents
Documents required for the QMS shall be controlled.
Documents defined as quality records shall be controlled
as per 4.2.4
A documented procedure shall be established to;
a. approve documents for adequacy prior to use
b. review, update as necessary and re-approve documents
c. To assure that changes and the current revision status of
documents are identified
d. Ensure that relevant versions of applicable documents are available
at points of use
e. Ensure that documents remain legible and readily identifiable
f. Ensure documents of external origin are identified and their
distribution controlled
g. Prevent unintended use of obsolete documents, and to apply
suitable identification to them if they are retained for any other
purpose

44
4.2.3 Control of documents
4.2.3.1 Engineering Specifications

Shall have a process to assure a timely (not
more than two weeks) review, distribution and
implementation of all customer engineering
standards/specifications and changes.
Must keep records of the change
45
4.2.4 Control of Quality Records
Quality records shall be established and maintained as
objective evidence
Quality records shall be
Legible
Readily identifiable
Retrievable
A documented procedure shall define;
Identification
Legibility
Storage
Protection
Retrieval
Retention period
Disposition of quality records
4.2.4.1: The organization shall define retention periods for QMS
related documents and records to satisfy retulatory and
customer requirements

46
TEAM EXERCISE: 15
Minutes
Summarize in your team
the preceding element of
ISO/TS16949:2001. Explain
in a short statement what
the intent of the element is
and its affect on your
management approach.
47
5.1 Management Commitment
Top management shall provide
evidence of commitment to the
development and improvement
of the QMS by;
a. Communicating the importance of meeting
Customer
Statutory
Regulatory
b. Establishing the quality policy
c. Ensuring quality objectives are established
d. Conducting management reviews
e. Ensuring the availability of resources
48
5.1.1 Process efficiency
Top management shall monitor the
product realization processes and the
support processes to assure their
effectiveness and efficiency
49
5.2 Customer Focus
Top management shall ensure
Customer requirements are determined,
then
Fulfilled, thereby,
enhancing customer satisfaction
50
5.3 Quality Policy
Top management shall ensure that the
quality policy;
a. is appropriate to the purpose of the organisation
b. Includes a commitment to comply with requirements
and continual improve the effectiveness of the QMS
c. Provides a framework for establishing and reviewing
quality objectives
d. Is communicated and understood within the
organisation
e. Is reviewed for continuing suitability
51
Planning:
5.4.1 Quality Objectives
Top Management shall ensure objectives,
including product related objectives, are
established at relevant functions and levels of the
organisation.
These objectives shall be;
Measurable
Consistent with the Quality Policy
5.4.1.1: The objectives shall be included in the
business plan and used to deploy the quality
policy
52
5.4.2 Quality Management
System Planning
Top management shall ensure that
a. The planning of the QMS is carried out
such that in meets the requirements of
General Requirements (4.1)
The stated Quality Objectives
b. The integrity of the QMS is maintained
when changes to the QMS are planned
and implemented
53
5.5.1 Responsibility,
Authority and Communication
Top management shall ensure that the
Responsibilities and the
Authorities are defined and communicated within the
organization
5.5.1.1:
Management responsible for corrective action shall be
promptly informed of non-conforming products or
processes
Personnel responsible for quality shall have the
authority to stop production to correct problems.
All shifts shall have someone responsible for quality

54
5.5.2 Management
Representative
Top Management shall appoint a member(s)
from within its management team who is
responsible for;
Ensuring the processes of the QMS are established,
implemented and maintained
Reporting to top management on the performance of the
QMS, including needs for improvement
Promoting awareness of customer requirements
throughout the organization
5.5.2.1: Customer representative: Top management
shall designate someone to represent the needs of
the customer in all areas.

55
5.5.3 Internal
Communication
Top management shall;
Ensure appropriate communication
processes are established
Ensure communication takes place
regarding the effectiveness of the QMS
56
5.6.1 Management Review:
General
Top Management shall review the organisations QMS at
planned intervals to ensure continuing;
Suitability
Adequacy
Effectiveness
The review shall include
Assessing opportunities for improvement
Need for changes to the QMS
Review of quality policy
Review of quality objectives
Records of management reviews shall be maintained
5.6.1.1: The review shall cover
all elements of the QMS and performance trends.
Cost of poor quality
The achievement of objectives in the Quality Policy, the business
plan and the level of customer satisfaction with supplied product

57
5.6.2 Review Input
The input to management review shall
include information on;
Results of audits
Customer feedback
Process performance and product conformity
Status of preventive and corrective action
Follow up actions from previous management reviews
Planned changes that could effect the QMS
Recommendations for improvement
5.6.2.1: Input shall include an analysis of actual
and potential field-failures and their impact on
quality, safety, or the environment
58
5.6.3 Review Output
The output from the management
review shall include any decisions
and actions related to;
Improvement of the effectiveness of the
QMS and its processes
Improvement of product, related to
customer requirements
Resource needs
59
TEAM EXERCISE: 15
Minutes
60
Resource Management:
6.1 Provision of resources
The organisation shall determine
and provide the resources
needed to;
a. To implement and maintain the QMS
and continually improve its
effectiveness
b. To enhance customer satisfaction

61
Human Resources:
6.2.1 General
Personnel performing work affecting
quality shall be competent on the
basis of;
Appropriate education
Training
Skills
Experience
62
6.2.2 Competence,
awareness and training
The organisation shall;
a. Determine the necessary competence for personnel
performing work affecting quality
b. Provide training or take other actions to satisfy these
needs
c. Evaluate the effectiveness of the actions taken
d. Ensure that its personnel are aware of their own
impact on quality
e. Maintain appropriate records of education/training,
skills and experience

63
Additional Automotive
Requirements for training
6.2.2.1: Product design skills: Individuals
responsible for product design must be
trained in tools and techniques
6.2.2.2: Training: Must have a
documented procedure to identify needs
and achieving competence. Applies to
everyone in the organization.
64
Requirements for training
6.2.2.3: Training on the job:Must have training
in any new or modified job affecting product
quality (includes contract or agency personnel)
6.2.2.4: Employee Motivation and
Empowerment: shall have a process to motivate
and measure the extent the employees :
achieve quality objectives,
make continual improvements and
Create an environment to promote innovation
Shall include the promotion of quality and technological
awareness throughout the whole organization.

65
6.3 Infrastructure
The organisation shall:
Determine
Provide
Maintain
The infrastructure needed to achieve conformity
to product requirements. As an example,
infrastructure might be;
a. Buildings, workspace and associated utilities
b. Process equipment, both hardware & software
c. Supporting services such as transport or
communication

66
Requirements
6.3.1 Plant, Facility and equipment planning:
Use a multidisciplinary approach
Shall optimize material travel, handling and value-
added use of floor space
Shall facilitate synchronous material flow
Methods shall be developed and implemented to
evaluate and monitor the effectiveness of existing
operations.
6.3.2 Contingency Plans:
Shall prepare contingency plans to satisfy customer
requirements in case of emergency
67
6.4 Work Environment
The organisation shall
Determine and manage the conditions of the
work environment needed to achieve
conformity to product requirements
6.4.1 Personnel safety:
The quality policy and practices shall address
activities to minimize potential risks
6.4.2 Cleanliness of premises
Shall maintain the premises in a state of order,
cleanliness and repair.
68
TEAM EXERCISE: 15
Minutes
69
Product realization:
7.1 Planning and product realization
The organisation shall plan and develop the
processes needed for product realization.
Planning of product realization shall be
consistent with the QMS
In planning product realization, the organisation
shall determine the following as appropriate
Quality objectives & requirements for the product
The need to establish processes, documents, and
provide product specific resources

Continued next slide

70
7.1 Planning and product
realization .cont
In planning product realization, the organisation shall
determine the following as appropriate..
c. Required
Verification,
Validation,
Monitoring,
Inspection and test activities specific to the product and the
criteria for product acceptance
d. Records needed to provide evidence that the realization
processes and resulting product fulfill requirements
The output of this planning shall be in a form suitable for
the organisations method of operations

71
Requirements
7.1.1 Planning of product realization:
Customer requirements and tech specs shall
be included in the planning
7.1.2 Acceptance criteria: shall be defined
by the organization and, where required, by
the customer. For attribute data sampling,
zero defects is required
72
Requirements
7.1.3 Confidentiality: Organization shall ensure
the confidentiality of customer-contracted
products and projects
7.1.4 Change Control:
Organization must have a process to control and react
to changes that impact product realization (including
the supplier).
All proprietary designs, impact on form, fit and
function shall be reviewed with the customer
If customer has additional verification/identification
requirements, they shall be met

73
Customer Related Processes:
7.2.1 Determination of requirements
related to the product
The organisation shall determine;
a. Requirements specified by customer including
Requirements for delivery and post-delivery activities*
b. Requirements not stated by the customer but
necessary for specified use or known intended use
c. Statutory and regulatory requirements related to the
product
d. Any additional requirements determined by the
organisation

* Post-delivery includes any after sales servicing
74
Requirements
7.2.1.1 Customer-designated special
characteristics: The organization shall
demonstrate conformity to customer
requirements for designation,
documentation and control of special
characteristics.
75
7.2.2 Review of requirements
related to the product
The organisation shall
Review the requirements related to the product
Conduct this review prior a commitment to supply
The review shall ensure
Product requirements are defined
Contract or order requirements differing from those
previously expressed are resolved
The organisation has the ability to meet the defined
requirements
Records of the results of the review and actions
arising from the review shall be maintained.
Continued next slide..
76
7.2.2 Review of requirements
related to the product(cont)
Where the customer provides no
documented statement of requirement, the
customer requirements shall be confirmed
by the organisation before acceptance
Where product requirements are changed,
the organisation shall ensure
that relevant documents are amended
Relevant personnel are made aware of the
changes
77
Requirements
7.2.2.1 Organization manufacturing
feasibility:
The organization shall investigate, confirm and
document the manufacturing feasibility of the
proposed products in the contract review
process including risk analysis.
78
7.2.3 Customer
Communication
The organisation shall determine
and implement effective
arrangements for customer
communication in relation to;
Product information
Enquiries, contracts or order handling,
including amendments
Customer feedback, including
customer complaints

79
Requirements
7.2.3.1 Customer communication
Supplemental
The organization shall have the ability to
communicate necessary information, including
data, in a customer-specified language and
format (e.g. computer-aided design data,
electronic data exchange).
80
Design and Development:
7.3.1 Design & Development
planning
The organisation shall plan and control the design and
development of the product.
During this stage the organisation shall determine;
The design and development staged
The review, verification and validation that are appropriate
to each design and development stage
The responsibilities and authorities for design and
development
The organisation shall manage all interfaces involved in
design and development to ensure effective
communication and clear assignment of responsibility
Planning output shall be updated, as appropriate, as the
design and development progresses.
81
Requirements
7.3.1.1 Multidisciplinary approach:
The organization shall use a multidisciplinary
approach to prepare for product realization,
including:
Development/finalization and monitoring of special
characteristics,
Development and review of FMEAs including
actions to reduce potential risks, and
Development and review of control plans
82
Inputs
Inputs relating to product requirements shall be
determined and records maintained. The shall
include;
Functional and performance requirements
Applicable statutory and regulatory requirements
Where applicable, information derived from previous
similar designs
Other requirements essential for design and
development
These inputs shall be reviewed for adequacy.
Requirements shall be complete, unambiguous
and not in conflict with each other.

83
Requirements
7.3.2.1 Product design input:
Shall identify, document and review the product design
inputs including:
Customer requirements
Use of information
7.3.2.2 Manufacturing process design input:
Shall identify, document and review the manufacturing
design inputs including:
Product design output data
Targets for productivity
Customer requirements
Experience from previous developments

84
Requirements
7.3.2.3 Special Characteristics:
The organization shall identify special
characteristics and
Include all special characteristics in the control plan
Comply with customer specified definitions and
symbols and
Identify process control documents including:
Drawings, FMEAs, control plans, and operator
instructions with customers special characteristic symbol.
85
Outputs
The outputs of design and development shall be
provided in a form that enable verification
against the design and development input and
shall be approved prior to release. Design and
development outputs shall;
a. Meet the input requirements for design and
development
b. Provide appropriate information for purchasing,
production and for service provision
c. Contain or reference product acceptance criteria
d. Specify the characteristics of the product that are
essential for its safe and proper use
86
Requirements
7.3.3.1 Product design outputs Supplemental:
Product design output shall be expressed in terms that
can be verified and validated against product design
input requirements
Shall include:
Design FMEA, reliability results,
Product special characteristics, specifications,
Product error-proofing, as appropriate,
Product definition including drawings or mathematically based
data,
Product design reviews results, and
Diagnostic guidelines where applicable.

87
Requirements
7.3.3.2 Manufacturing process design output:
The output shall be expressed in terms that can be verified.
They shall include:
Specifications and drawings,
Manufacturing process flow chart/layout,
Manufacturing process FMEAs
Control plan
Work instructions,
Process approval acceptance criteria,
Data for quality, reliability, maintainability and measurability,
Results of error-proofing activities as appropriate
Methods of rapid detection and feedback of product/manufacturing
nonconformities

88
review
At suitable stages, systematic reviews of design
and development shall be conducted;
a. To evaluate the ability of the results of design and
development to fulfill requirements
b. To identify any problems and propose necessary
actions
Participants in such reviews shall include
representatives of functions concerned I the
design and development area. Records of both
the results of the reviews and actions shall be
maintained

89
Requirements
7.3.4.1 Monitoring
Measurements at specified stages of design and
development shall be defined, analyzed and
reported with summary results as an input to
management review.
90
Verification shall be performed to
ensure;
Design & development outputs have
satisfied the design and development
inputs.
Records of the results of the
verification and any action shall be
maintained
Verification
91
validation
Design and Development validation shall be
performed in accordance with planned
arrangements to ensure
The product is capable of fulfilling the requirements for
the specified or known intended use or application.
Wherever, practical, validation shall be completed
prior to delivery or implementation of the product.
Records of the results of validation and any
necessary actions shall be maintained.

92
Requirements
7.3.6.1 Design and development validation
Supplemental:
Design and development shall be performed in
accordance with customer requirements including
timing
7.3.6.2 Prototype program:
When required, the organization shall have a prototype
program and control plan.
All testing activities shall be monitored
Must be responsible for all outsourced services
93
Requirements
7.3.6.3 Product approval process:
The organization shall conform to a product
and process approval procedure recognized by
the customer.
94
7.3.7 Control of design and
development stages
Design and development changes shall be
implemented and records maintained.
The changes shall be reviewed, verified and
validated, as appropriate, and approved prior to
implementation.
The review of design and development changes
shall include evaluation of the effect of the
changes on constituent parts and delivered
product.
Records of the result of the review of changes
and any necessary actions shall be maintained
95
Purchasing:
7.4.1 Purchasing process
The organisation shall ensure that purchased product
conforms to specified purchase requirements.
The type and extent of control applied to the supplier and
the purchased product is dependant upon the effect of the
purchased product on subsequent product realization or
the final product.
The organisation shall evaluate and select suppliers based
on their ability to supply product in accordance with the
organisation's requirements.
Criteria for selection, evaluation and re-evaluation shall be
established.
Records of the results of evaluations and any necessary
actions arising from the evaluation shall be maintained.

96
Requirements
7.4.1.1 Regulatory compliance: all products or materials
shall satisfy applicable regulatory requirements.
7.4.1.2 Supplier quality management system
development: suppliers to the organization shall be third-
party registered to ISO9001:2000 by an accredited third
party certification body
7.4.1.3 customer-approved sources: where specified by
the contract (e.g. customer engineering drawing
specification) the organization shall purchase products,
materials or services from approved sources
97
7.4.2 Purchasing
Information
Purchasing information shall describe the
product to be purchased, including where
appropriate;
a. Requirements for approval of product, procedures,
processes and equipment
b. Requirements for qualification of personnel
c. QMS requirements
The organisation shall ensure the adequacy of
specified purchase requirements prior to their
communication to the supplier
98
7.4.3 Verification of
purchased product
The organisation shall establish and implement
the inspection or other activities necessary for
ensuring that purchased product conforms to
specified requirements.
Where the organisation or the customer intends
to perform verification at the suppliers premises,
the organisation shall state the intended
verification arrangements and method of product
release in the purchasing information.

99
Requirements
7.4.3.1 Incoming product quality:
The organization shall have a proces to assure
the quality of purchased products:
Receipt of and evaluation of statistical data by the
organization
Receiving inspection and/or testing
Second or third party assessments or audits
Part evaluation by a designated laboratory
Another method agreed with the customer
100
Requirements
7.4.3.2 Supplier monitoring:
Supplier monitoring shall be monitored
through:
Delivered part quality performance
Customer disruptions including field returns
Delivery schedule performance
Special status customer notifications related to
quality or delivery issues
101
Production and service Provision:
7.5.1 Control of production & service
provision
The organisation shall plan and carry out
production and service provision under
controlled conditions that shall include, as
applicable;
a. The availability of information that describes the
characteristics of the product
b. The availability of work instructions
c. The use of suitable equipment
d. The availability and use of monitoring and measuring
devices
e. The implementation of monitoring and measurement
f. The implementation of release, delivery and post delivery
activities
102
Requirements
7.5.1.1 Control Plan
Organization shall:
Develop control plans
Have a control plan for pre-launch and production
The control plan shall:
List the controls used for the manufacturing process
Include methods for monitoring special characteristics
Include customer required information
Initiate the specified reaction plan when the process is
unstable.
103
Requirements
7.5.1.2 Work Instructions: The organization
shall prepare documented work instructions for all
employees having responsibilities for the
operation of the processes.
7.5.1.2 Verification of Job set-ups
Shall be verified whenever performed
Work instructions shall be available for set-up
personnel
104
Requirements
7.5.1.4 Prevention and predictive maintenance:
The organization shall identify key process equipment
and provide a planned preventive maintenance system:
Planned maintenance activities
Packaging and preservation of equipment, tooling
Availability of replacement parts for key manufacturing
equipment
Documenting, evaluating and improving maintenance
objectives.

105
Requirements
7.5.1.5 Management of production tooling:
Shall provide resources for tool and guage design, fabrication and
verification
Shall establish a system for production tooling management:
Maintenance and repair facilities and personnel
Storage and recovery
Set-up
Tool-change programs for perishable tools
Tool design modification documentation
Tool modification and revision to documentation
Tool identification, defining the status, production repair or
disposal
Shall implement a system to monitor these activities if any work is
outsourced
106
Requirements
7.5.1.6 Production scheduling: shall be
scheduled to meet customer requirements
7.5.1.7 Feedback of Information from service: a
process for communication of information shall be
established and maintained
7.5.1.8 Servicing agreement with customer: if
there is a servicing agreement with the customer
the organization shall verify the effectiveness of:
Organization service centers,
Any special purpose tools or measurement equipment
The training of servicing personnel

107
7.5.2 Validation of processes
for product and service
provision
The organisation shall validate any processes for
production and service provision where the
resulting output cannot be verified by subsequent
monitoring or measurement.
This includes any processes where deficiencies
become apparent only after the product is in use
or the service has been delivered.
Validation shall demonstrate the ability of these
processes to achieve planned results

108
7.5.2 Validation of processes for
product and service provision..cont
The organisation shall establish
arrangements for these processes
including, as applicable;
Defined criteria for review and approval of
processes
Approval of equipment and qualification of
personnel
Use of specific methods and procedures
Requirements for records
Re-validation
109
7.5.3 Identification &
Traceability
The organisation shall identify, where
appropriate*, the product by suitable means
through product realization
The organisation shall identify the product status
with respect to monitoring and measuring
requirements
Where traceability is a specified requirement, the
organisation shall control and record the unique
identification of the product.
7.5.3.1: the words where appropriate do not apply
110
7.5.4 Customer property
The organisation shall exercise care with
customer property while it is under the
organisations control.
The organisation shall;
Identify
Verify
Protect
Safeguard customer property
If any customer property is lost, damaged or
otherwise found to be unsuitable for use, this
shall be reported to the customer and records
maintained
7.5.4.1 Customer-owned production tooling: shall be
permanently marked so that the ownership is visible and can
be determined.
111
7.5.5 Preservation of product
The organisation shall preserve the conformity of
product during internal processing and delivery
to the intended destination.
This preservation shall include;
Identification
Handling
Packaging
Storage
Protection
Preservation shall also apply to the constituent
parts of a product
7.5.5.1 Storage and Inventory: stock shall be assessed at
appropriate intervals. Organization shall use a stock rotation
system like FIFO. Obsolete material shall be controlled.
112
7.6 Control of Monitoring and
measuring devices
The organisation shall determine the monitoring
and measurement to be taken and the monitoring
and measuring devices needed to provide
evidence of conformity of product to determined
requirements
The organisation shall establish processes to
ensure that monitoring and measurement can be
carried out and are carried out in a manner that is
consistent with the monitoring and measurement
requirements

113
measuring devices.cont
Where necessary to ensure valid results,
measuring equipment shall;
a. Be calibrated or verified at specified intervals or prior to
use, against national or international standards
Where no such standards exist, the basis used for
calibration or verification shall be recorded
b. Be adjusted or re-adjusted as necessary
c. Be identified to enable calibration status to be determined
d. Be safeguarded from adjustments that would invalidate the
measurement result
e. Be protected from damage and deterioration during
handling, maintenance and storage


114
measuring devices.cont
Additionally, that organisation shall assess and record the
validity of previous measuring results when equipment is
found not to conform to specified requirements.
The organisation shall take appropriate action on the
equipment and any product affected.
Records of the results of calibration and verification shall
be maintained.
When used in the monitoring and measurement of
specified requirements, the ability of computer software
to satisfy the intended application shall be confirmed.
This shall be undertaken prior to initial use and
reconfirmed as necessary

115
Requirements
7.6.1 Measurement system analysis:
statistical studies shall be conducted to analyze
the variation in each type of measuring and test
equipment
Shall apply to measurement systems referenced
in the control plan
Shall conform to those in customer reference
manuals
116
Requirements
7.6.2 Calibration records:
Records of the calibration shall include:
Equipment identification
Revisions from engineering changes
Any out-of-specification readings
An assessment of the impact of the out-of-
specification
Statements of conformance to spec
Notification to the customer is suspect product has
been shipped.
117
Additional Automotive Requirements
7.6.3 Laboratory Requirements
7.6.3.1 Internal Laboratory:
Shall have a defined scope that includes its capability to
perform the required inspection, test or calibration
services.
Scope shall be included in the QMS documentation
Shall comply with:
Adequacy of laboratory procedures
Qualifications of the laboratory personnel conducting tests
Testing of the commodities
Capability to performs tests correctly traceable to standard
Review of related quality records

118
7.6.3 Laboratory Requirements
7.6.3.2 External Laboratory:
Shall have a defined scope that includes its
capability to perform the required inspection,
test or calibration services.
Shall be accredited to ISO/IEC 17025 or equivalent
or
Shall be evidence that the lab is acceptable to the
customer

119
TEAM EXERCISE: 15
Minutes
120
Measurement, Analysis and
Improvement:
8.1 General
1. The organisation shall plan and implement
the monitoring, measurement, analysis and
improvement processes needed;
a. To demonstrate conformity of the product
b. To ensure conformity of the QMS
c. To continually improve the effectiveness of the
QMS
2. This shall include determination of
applicable methods, including statistical
techniques and the extent of their use.

121
Requirements
8.1.1 Identification of statistical tools:
appropriate tools for each process shall be
determined during advanced quality
planning and included in the control plan
8.1.2 Knowledge of basic statistical
concepts: shall be understood and utilized
throughout the organization
122
Monitoring and measurement:
8.2.1 Customer satisfaction
The organisation shall monitor
information relating to customer
perception as to whether the
organisation has fulfilled customer
requirements.
The methods for obtaining and using
this information shall be determined
123
Requirements
Customer satisfaction Supplemental:
shall be continually evaluated. Performance
indicators include
Delivered part quality performance
Customer disruptions including field returns
Delivery schedule performance
Customer notification related to quality or
delivery issues
124
8.2.2 Internal Audit
The organisation shall conduct internal
audits at planned intervals to determine
whether the QMS;
a. Conforms to planned arrangements, to the
requirements of this international standard
and to the QMS requirements established by
the organisation
b. Is effectively implemented and maintained


125
8.2.2 Internal Audit cont..
An audit program shall be planned, taking into
consideration;
The status of the importance of the activity being audited
Results of previous audits
The audit criteria, scope, frequency and methods shall be
defined
The process of selection of auditors and auditors
themselves shall ensure objectivity and impartiality of the
audit process.
Auditors shall not audit their own work.


126
8.2.2 Internal Audit cont..
The responsibilities and requirements for
planning and conducting audits, and for
reporting results and maintaining records shall
be defined in a documented procedure.
The management responsible for the area being
audited shall ensure that actions are taken
without undue delay to eliminate detected
nonconformities and their causes.
Follow up activities shall include the
verification of the actions taken and the
reporting of verification results.

127
Requirements
8.2.2.1 Quality management system audit: shall
audit the QMS to verify compliance with this TS
and additional QMS requirements
8.2.2.2 Manufacturing process audit: shall audit
each manufacturing process to determine
effectiveness
8.2.2.3 Product audit: shall audit products at
appropriate stages of production and delivery to
very conformance to all specified requirements
(e.g.dimensions, functionality, packaging and
labeling)
128
Requirements
8.2.2.4 Internal Audit plans: audits shall
cover quality management related
processes, activities and shifts, and shall be
scheduled according to an annual plan
8.2.2.5 Internal auditor qualification:
auditors shall be qualified to audit the
requirements of this technical specification
129
8.2.3 Monitoring &
Measurement of processes
The organisation shall apply suitable methods for
monitoring and, where applicable, measurement
of the QMS processes.
These methods shall demonstrate the ability of
the processes to achieve planned results
When planned results are not achieved,
correction and preventive action shall be taken,
as appropriate, to ensure conformity of product
130
8.2.3.1 Monitoring and measurement of
manufacturing processes:
Shall perform process studies on all new manufacturing
Shall maintain manufacturing process capability or
performance as specified by the customer
Measurement techniques
Sampling plans
Acceptance criteria, and
Reaction plans when acceptance criteria are not met
Significant process events shall be noted on control
charts
Shall initiate a reaction plan for unstable or non-capable
characteristics

131
8.2.4 Monitoring &
measurement of product
The organisation shall monitor and measure the
characteristics of the product to verify that product
requirements are fulfilled.
This shall be carried out at appropriate stages of product
realization in accordance with planned arrangements
Evidence of conformance with the acceptance criteria shall be
maintained. Records shall indicate person(s) authorising
release of product
Product release and service delivery shall not proceed until all
the planned arrangements have been satisfactorily completed,
unless otherwise approved by a relevant authority, and where
applicable by the customer.
132
Requirements
8.2.4.1 Layout inspection and functional
testing: a layout inspection and a functional
verification shall be perform for all products
8.2.4.2 Appearance items: for products that are
appearance items the organization shall provide:
Appropriate resources including lighting
Masters for color, grain, gloss, metallic brilliance,
texture, distinctness of image (as appropriate
Maintenance of appearance masters
Verification that qualified personal are used
133
8.3 Control of Nonconforming
product
The organisation shall ensure that product that does not
conform to product requirements is identified and
controlled to prevent unintended use or delivery.
The controls are related to responsibilities and authorities
for dealing with nonconforming product shall be defined in
a documented procedure
134
product.cont
The organisation shall deal with nonconforming
product by one or more of the following methods;
By taking action to eliminate the detected
nonconformity
By authorising its use, release or acceptance under
concession by a relevant authority and where applicable
by the customer
By taking action to preclude its original intended use or
application

135
product.cont
Records of the nature of nonconformities and any
subsequent actions taken, including concessions obtained,
shall be maintained.
When nonconforming product is corrected, it shall be
subject to re-verification to demonstrate conformity to the
requirements
When nonconforming product is detected after delivery or
use has started, the organisation shall take action
appropriate to the effects, or potential effects, of the
nonconformity

136
Requirements
8.3.1 Control of nonconforming product:
product with unidentified or suspect status
shall be classified as nonconforming
8.3.2 Control of reworked product:
Instruction for rework, including re-
inspection requirements, shall be accessible
to and utilized by the appropriate personnel
137
Requirements
8.3.3 Customer information: customers shall be
informed promptly in the event that
nonconforming product has been shipped.
8.3.4 Customer waiver:
Shall obtain customer concession or deviation prior to
processing the order
Shall maintain a record of the expiration date.
shall adhere to the original spec at expiration
Also applies to purchased product; the organization
shall agree with any requests from suppliers before
submission to customer
138
8.4 Analysis of data
The organisation shall determine, collect and analyse
appropriate data to demonstrate the suitability and
effectiveness of the QMS and to evaluate where continual
improvement of the QMS can be made.
This shall include data generated as a result of monitoring
and measurement and from other relevant sources.
The analysis of data shall provide information relating to;
a. Customer satisfaction
b. Conformance to product requirements
c. Characteristics and trends of processes and products
including opportunities for preventive action
d. suppliers
139
Requirements
8.4.1 analysis and use of data:
Trends in quality and operational performance shall be
compared with progress toward objectives
Development of priorities for prompt solutions to customer-
related problems
Determination of key customer-related trends and correlation
to support status review, decision making and longer term
planning
An information system for the timely reporting of product
information arising from usage.
140
Improvement:
8.5.1 Continual Improvement
The organisation shall continually
improve the effectiveness of the QMS
through the use of the;
Quality Policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive action
Management review
141
Requirements
8.5.1.1 Continual improvement of the
organization: the organization shall define
a process for continual improvement
8.5.1.2 Manufacturing process
improvement: Continual improvement
shall focus on control and reduction of
variation in product characteristics and
manufacturing process parameters.
142
8.5.2 Corrective Action
The organisation shall take action to eliminate the cause
of nonconformities in order to prevent recurrence.
Corrective actions shall be appropriate to the effects of
the nonconformities encountered
A documented procedure shall be established to define
requirements for;
a. Reviewing nonconformities (including customer complaints)
b. Determining the causes of nonconformities
c. Evaluating the need for action to ensure that
nonconformities do not recur
d. Determining and implementing the actions needed
e. Records of results of action taken
f. Reviewing corrective action taken
143
Requirements
8.5.2.1 Problem solving: the organization
shall have a defined process for problem
solving leading to root cause identification
and elimination
8.5.2.2 Error-proofing: the organization
shall use error-proofing methods in their
corrective action process.
144
8.5.2.3 Corrective action impact: the
organization shall apply to other similar processes
and products the corrective action, and controls
implemented, to eliminate the cause of a
nonconformity.
8.5.2.4 Rejected product test/analysis:
the organization shall analyze parts rejected by the
customers manufacturing plants
The organization shall minimize the cycle time for this
activity
The organization shall perform analysis and initiate
corrective action to prevent recurrence.
145
8.5.3 Preventive action
The organisation shall take action to eliminate the cause
of potential nonconformities in order to prevent
occurrence.
Preventive actions shall be appropriate to the effects of
the potential problems
A documented procedure shall be established to define
requirements for;
Determining potential nonconformities and their
nonconformities
Evaluating the need for action to prevent occurrence of
nonconformities
Determining and implementing action needed
Records of results of action taken
Reviewing preventive action taken

146
147
Activities before the audit
Supplier Responsibilities - at starting point
Provide Registrar basic information regarding products

and/or employees
Provide Registrar Operational Performance Trends for the last

twelve months minimum
Scope of Certification
Product Design Responsibility
Sites to be registered
Remote Locations
Quality Systems Certifications obtained
Quality Manual - for each site

148
Activities before the audit
Supplier Responsibilities - at starting
point
Internal Audit and Management Review planning and results from

previous twelve months
List of Qualified Internal Auditors
List of Customers and Customer Specific Requirements
Customer Complaints Management

149
Design Responsibility
There are only two options:
1.
Supplier Responsibility (could be sub-contracted)
2.
Customer Responsibility
For sub contracted design, the auditor must verify that both
supplier and design subcontractors have appropriate capability
to meet element 4.4 requirements in its totality, including
interfaces between suppliers and sub contractors
150
Other activities
Registrar Responsibilities - at starting
point
Analysis of information provide by supplier to determine

a. The appropriate scope of Registration
b. Readiness for on-site audit
Preliminary audit is an optional activity- only one allowed!
Preliminary audit is not to be considered part of registration audit
Time spent for Preliminary audit will not reduce audit days
requirement
In case of insufficient readiness to conduct initial audit, the

process can be stopped by supplier in consultation with registrar
This aspect is to be recorded by registrar in its database

151
Other activities
Registrar Responsibilities - Audit
Planning & Execution
Compliance to specified on-site audit days requirement
Initial Audit to be completed within 3 months of document review
Multiple visits for initial audit not acceptable
At least two auditors on team if the audit exceeds 4 Mandays - at

least one of initial audit team to participate in all visits in the cycle
Communication of Monthly Audit Plan to IATF
ISO/TS/16949 checklist to be used for each site
Scope in Audit Report to list products and customer specific

requirements with revision number
Report to be handed over within 15 days of the audit completion-

Report may also be sought by IATF - contract to provide for this
152
Audit Mandays for certification to
ISO/TS/16949
Audited Entity Initial Audit Surveillance Audits Re-certification Audit
Number of Employees (On Site mandays) (Years 1 & 2) (Year 3)
(On-site mandays (On Site mandays)
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
153
Comments on the Audit Mandays Chart
A manday is considered to be eight working hours exclusive of

travel, breaks etc.
On-site review of corrective actions arising from initial audit are

not included included in the chart
50% reduction in initial audit days admissible for upgrade audits

from current automotive certificates from IATF recognized
certification bodies, provided the scope is unchanged.
100% of audit days to be done in case of a change in scope
Upgrades are applicable only if the registrar is the same
On-site mandays may be reduced by 15% for non design capable

suppliers
Reductions in mandays are possible for Corporate / Multi-site

activities
154
Non Conformity Management
Supplier Responsibility
Perform Root Cause Analysis and take corrective actions within

three months from the end of the site visit
Verify corrective actions and provide a supplementary report
Follow up visit to verify implementation of Corrective Action\

within 90 days of handing over of audit report (if reqd.)
Certification decision taken if all issues are resolved 100%

Registrar Responsibility
155
ISO/TS/16949 Certificate
Some Content Requirements
Scope statement to include all products and services being supplied

to all customers subscribing to this document
Standard Reference, certificate validity and exclusions
Reference to assessment in accordance to Rules for the registration

scheme for ISO/TS/16949 certification bodies - Second Edition
List and scope of every registered site (for multi sites) as well as
remote locations
IATF logo
156
Status of Acceptance of
ISO/TS/16949 by
Automotive OEMs
157
Acceptance of ISO/TS/16949
Daimler Chrysler, Ford & GM
Letters sent out to suppliers recognize ISO/TS/16949

as a sanctioned alternative to QS-9000.
BMW Group
In future, a quality standard in accordance with ISO/TS/16949

will be required in the international purhasing conditions.
However, the supplier is generally free to chose an automotive
quality standard
158
Fiat
In a letter to all suppliers, ISO/TS/16949 was introduced as a

new quality standard. The ISO/TS/16949 is recognized
immediately as an equal quality standard and with effect from
the 1st July 2000 a certification in accordance with
ISO/TS/16949 will be compulsory for all new and expired 3rd
party certificates
Bosch
As soon as the ISO/TS/16949 is uniformly required/

recognized by all car manufacturers, Bosch will press forward
with the realization in its own production plants and require the
application of the ISO/TS16949 from all its suppliers
159
Volkswagen
ISO/TS/16949 is now acceptable for US and Canada based

suppliers as an alternative to VDA 6.1 third-party registration

What about the future?
160
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Robere & Associates (Thailand) Ltd.

Heat Treating, painting, plating, or other finishing services, or

Remote Locations need to be covered too.

Remote Locations cannot obtain standalone certification

The Technical Specification can be applied throughout the

The elements of the ISO/TS/are closely aligned

Most of the elements of ISO/TS/can be traced to

Many of the elements can be traced to all four

Improved product and process quality

Provide additional confidence for global sourcing

Freeing up supplier resources for other quality activities

Common quality system approach in the supply chain for

Reduction of variation and increased efficiency

Reduction in 2nd party system audits

Reduction in multiple 3rd party registrations

Common language to improve understanding of quality

Based on ISO9000 - ISO 9001:2000 Text is Boxed

Shall is a mandatory requirement

Notes are for guidance in understanding

Should in a note is for guidance purposes only

Sector specific requirements are outside the boxes

The term such as is used only for guidance

Provide Registrar basic information regarding products

Provide Registrar Operational Performance Trends for the last

Product Design Responsibility

Quality Systems Certifications obtained

Quality Manual - for each site

Internal Audit and Management Review planning and results from

List of Qualified Internal Auditors

List of Customers and Customer Specific Requirements

Customer Complaints Management

Analysis of information provide by supplier to determine

Preliminary audit is an optional activity- only one allowed!

Preliminary audit is not to be considered part of registration audit

In case of insufficient readiness to conduct initial audit, the

This aspect is to be recorded by registrar in its database

Compliance to specified on-site audit days requirement

Initial Audit to be completed within 3 months of document review

Multiple visits for initial audit not acceptable

At least two auditors on team if the audit exceeds 4 Mandays - at

Communication of Monthly Audit Plan to IATF

ISO/TS/16949 checklist to be used for each site

Scope in Audit Report to list products and customer specific

Report to be handed over within 15 days of the audit completion-

A manday is considered to be eight working hours exclusive of

On-site review of corrective actions arising from initial audit are

50% reduction in initial audit days admissible for upgrade audits

100% of audit days to be done in case of a change in scope

Upgrades are applicable only if the registrar is the same

On-site mandays may be reduced by 15% for non design capable

Reductions in mandays are possible for Corporate / Multi-site

Perform Root Cause Analysis and take corrective actions within

Verify corrective actions and provide a supplementary report

Follow up visit to verify implementation of Corrective Action\

Certification decision taken if all issues are resolved 100%

Scope statement to include all products and services being supplied

Standard Reference, certificate validity and exclusions

Reference to assessment in accordance to Rules for the registration

Letters sent out to suppliers recognize ISO/TS/16949

In future, a quality standard in accordance with ISO/TS/16949

In a letter to all suppliers, ISO/TS/16949 was introduced as a

As soon as the ISO/TS/16949 is uniformly required/

ISO/TS/16949 is now acceptable for US and Canada based