ISO/TS 16949 Introduction Guide

To an Introduction to

ISO/TS/16949

©Robere & Associates (Thailand) Ltd. 2002 1

Agenda
• Company approach
• The Specification
• Administrative issues


How to Create, Implement and
Maintain an ISO/TS16949 System that
adds “value” to your company..

©Robere & Associates (Thailand) Ltd. 2002
3

Management vs Assurance
• QS9000 with it’s foundation in ISO9001:1994 is
a Quality Assurance Customer requirement.
• ISO/TS 16949 with it’s foundation in
ISO9001:2000 is a Quality Management System
• This difference identifies the focus of our
activities.


Steps to transition..QS – TS
- The Seven “R’s” -
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

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


Reformat the structure and the
approach
• Existing document
structure will work QUALITY SYSTEM DOCUMENTATION
PROGRESSION

• Identify new International Standards ISO 9001/ISO9002

Sector Requirements
Defines
international quality
system requirements

International
automotive quality

references
ISO/TS 16949 system requirements

Part and Process Approval
Procedures
Customer-supporting
reference manuals on:
Level 1  (see bibliography)
RS Defines
IE Quality Approach & Advanced

• ISO/TS 16949 more
Quality Planning
PL
Responsibility

S UP
Manual
Level 2
 Control Plan
L Defines Who
UA
Procedures What, When Tools and techniques
ID
DIV Level 3

prescriptive than
Job Instructions Answers
IN How

Level 4
Prompts recording of
Other Documentation information such as forms,
tags, labels

ISO9001:2000


QUALITY SYSTEM DOCUMENTATION
PROGRESSION
Defines
International Standards ISO 9001/ISO9002 international quality
system requirements
 International
Sector Requirements automotive quality
ISO/TS 16949 system requirements

Part and Process Approval
Procedures Customer-supporting
reference manuals on:
Level 1  (see bibliography)

ERS Defines
Approach & Advanced
P LI Quality Responsibility Quality Planning

SU
P Manual
Level 2
 Control Plan

U AL Procedures Defines Who
What, When Tools and techniques
V ID
DI
Level 3
Job Instructions Answers
IN How

Level 4
Prompts recording of
Other Documentation
information such as forms,
tags, labels


QUALITY MANAGEMENT SYSTEM
CONTINUAL IMPROVEMENT
R S C
e Management a
C q
responsibility t
u
s
u u
i
s
i
r 5 s t
o
e f
t m Resource Measurement, a m
o e management 6 8 analysis
improvement
c e
n t r
m t o
s
e n
r
Input Product Output
(and/or service) 7
Realization Product/
Service

Quality Management Process Model

Regulate the implementation
activities
• Establish the QMR
and the team
• Establish the plan
• Follow the plan
• Management must
“lead” the activities
through example


Renew your skills for the new
•
system
Ensure that all staff responsible
for the system are trained in:
– Customer focused activities
Eight Quality Management Principles
– Leadership 1. Customer-Focused Organization.
Customer-
– How to involve their staff in the day 2. Leadership.
3. Involvement of People.
to day activities 4. Process Approach.

– The philosophy of a process and 5. System Approach to Management.
6. Continual Improvement.
system approach to management 7. Factual approach to decision making.
8. Mutually beneficial supplier relationships.
– Continuous improvement tools
– The methods of a factual approach to
decision making
– The steps to develop supplier
relationships


Eight Quality Management Principles
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.

Renew your skills for the
additional requirements
• All clauses of ISO9001:2000
• Many requirements were
carried over from the 1st edition
• Helps to strengthen the
automotive QMS
Requirements


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.


Report on the Audit activities

• Audits are for
improvement and for
the prevention of
non-conformances.
• Use the internal
audits for continuous
improvements


Redo the process
• Even though you’ve been
certified, constantly
review existing process
for improvement.
• Document your
activities..they become
part of your overall
quality improvement
program


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

THE GLOBAL QUALITY SYSTEM
SPECIFICATION FOR THE
AUTOMOTIVE INDUSTRY


Evolution of ISO/TS16949
International Automotive Task Force (IATF)
•France (EAQF-94)
Peugeot / Citroen, Renault Automobiles
•Germany (VDA 6.1)
BMW, AUDI, Bosch, GME/Opel, Mercedes Benz, Volkswagen
•Italy (AVSQ)
Fiat, Magneti Marelli
•USA (QS-9000)
Daimler Chrysler, Ford, General Motors, VW of America


Evolution of ISO/TS16949
Trade Associations supporting the IATF
•ANFIA, Italy
•AIAG, USA
•CCFA, France
•FIEV, France
•SMMT Ltd., UK
•VDA, Germany


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”.


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.

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

Quality Related Requirements

Part More
Specific
Commodity
Division
Company
ISO/TS /TS16949 Sector
Fundamental More
ISO/TS 9001:2000 Generic


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


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


Foreword to the ISO/TS/16949
•Based on ISO9000 - ISO 9001:2000 Text is Boxed

•Sector specific requirements are outside the boxes
•“Shall” is a mandatory requirement
•“Notes” are for guidance in understanding
•“Should” in a note is for guidance purposes only
•The term “such as” is used only for guidance

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


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.

Foundation & Familiarization

ISO/TS 16949
Conformance and
Guidance Standards


Foundation & Familiarization
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.


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”

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.


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


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.


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”.


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


4.1 General Requirements
• Shall
– Establish
– Document
– Implement
– Maintain
– Continually improve the Quality
Management System (QMS)


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


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
a. Quality records required by ISO/TS 9001:2000


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


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
a. Documented procedures or reference to
these
b. Description of sequence & interaction of
processes included in the QMS.


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


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


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; ISO
I SO
/ TS
169
49
/ TS
– Identification 900
1

– Legibility ISO
ISO
/ TS
900
4
/ TS
– Storage 100
11

– 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

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 it’s affect on your
management approach.

46

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
a. Establishing the quality policy
b. Ensuring quality objectives are established
c. Conducting management reviews
d. Ensuring the availability of resources


5.1.1 Process efficiency
• Top management shall monitor the
product realization processes and the
support processes to assure their
effectiveness and efficiency


5.2 Customer Focus
• Top management shall ensure
– Customer requirements are determined,
then
– Fulfilled, thereby,
– enhancing customer satisfaction


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


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


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
a. The integrity of the QMS is maintained
when changes to the QMS are planned
and implemented

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


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.


5.5.3 Internal
Communication
• Top management shall;
– Ensure appropriate communication
processes are established
– Ensure communication takes place
regarding the effectiveness of the QMS


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

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


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


TEAM EXERCISE: 15
Minutes

59

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


Human Resources:
6.2.1 General
• Personnel performing work affecting
quality shall be competent on the
basis of;
– Appropriate education
– Training
– Skills
– Experience


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


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.


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.


•
6.3 Infrastructure
The organisation shall:
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


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

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.


TEAM EXERCISE: 15
Minutes

68

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


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


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


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

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*
a. Requirements not stated by the customer but
necessary for specified use or known intended use
b. Statutory and regulatory requirements related to the
product
c. Any additional requirements determined by the
organisation

* Post-delivery includes any after sales servicing


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.


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…..


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


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.


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

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).


Design and Development:
7.3.1 Design & Development
planning
• The organisationthe product.and control the design and
development of
shall plan

• During design and development staged determine;
The
this stage the organisation shall

 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.


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


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.


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

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 customer’s special characteristic symbol.


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


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.

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

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

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.


Verification
• 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

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.


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


Requirements
• 7.3.6.3 Product approval process:
– The organization shall conform to a product
and process approval procedure recognized by
the customer.


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


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.


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


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


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.


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

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


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


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.


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


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.


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

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

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

Continued next slide


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


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

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.

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.

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


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
a. Be adjusted or re-adjusted as necessary
b. Be identified to enable calibration status to be determined
c. Be safeguarded from adjustments that would invalidate the
measurement result
d. Be protected from damage and deterioration during
handling, maintenance and storage

Continued next slide…

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


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


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.

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


– 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


TEAM EXERCISE: 15
Minutes

119

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.


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


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


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

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

Continued next slide…


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.

• Continued next slide…


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.


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)

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


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


• 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


8.2.4 Monitoring &
measurement of product
• The organisation shallproduct to verify that product
characteristics of the
monitor and measure the

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.


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


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



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



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


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


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

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


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.


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


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.

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


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.


• 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
customer’s manufacturing plants
– The organization shall minimize the cycle time for this
activity
– The organization shall perform analysis and initiate
corrective action to prevent recurrence.


ISO/TS 16949 Introduction Guide

ISO/TS 16949 Introduction Guide

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