ISO/TS 16949 : 2009

AUTOMOTIVE STANDARD
 Objectives of the Presentation
 Understanding goals and purpose of ISO/TS
16949 : 2009.
 Understanding process approach of ISO 9001 :
2000 and additional requirements of ISO/TS 16949
: 2009.
 Documentation and actions required for
implementation.
 Forward
 What is the difference between normal ISO
standards and ISO/TS standards ?
 Prepared by -
 International Automotive Task Force (IATF).
 Japan Automobile Manufacturers Association
Inc. (JAMA).
 Supported by ISO/TC 176.
 Publication of ISO/TS 16949 : 2009 (Second
Edition) shall -
 Replace ISO/TS 16949 : 1999 (First Edition).
 Base document is ISO 9001 : 2000.
 Harmonised Standard
ISO/TS 16949 : 2009
JAMA

VDA 6.1 ISO/TC

(Germany) ISO/TS 176
16949 :
AVSQ (Italy) 2002

EAFQ
(France)

QS 9000 (Big Automotive Supply

3 + others) chain and OEMs
(vehicle manufacturers)
 Introduction
0.3 Relationship with ISO 9004 and
IATF Guidance
 ISO 9001 and ISO 9004 consistent pair of QMS
Standards.
 Can be used independently.
 IATF Guidance published to provide assistance in
application of ISO/TS.
 ISO 9004 and IATF Guidance are not for
Certification Purpose.
 Introduction
0.4 Compatibility with other
management systems
 Intended to be compatible with other
internationally recognised Management System
Standards.
 Aligned with ISO 14001, to enhance compatibility
of two standards.
 Does not cover requirements of Environmental or
QHS of Financial Management or Risk
Management.
 Standard allows organisation to integrate QMS
with other related Management Systems.
 Introduction
 Goals of technical specification
 Development of fundamental quality systems that
provide for -
 Continuous improvement.
 Emphasizing defect prevention, and
 The reduction of variation and waste in the
supply chain.
 This TS and customer specified requirements
defines fundamental QMS for those subscribing
to this document.
 To avoid multiple certification and provide
common approach.
 1. Scope
 Requirements in Standard are generic and
applicable to all organisations.
 EXCLUSSIONS PERMISSIBLE.
 Exclusions are limited to Product Realisation
Processes (Clause 7) and such exclusions do not

 Affect the organisation’s ability or responsibility

to provide product that fulfills customer and
applicable regulatory requirements.
 For 7.3, exclusion is limited to “Product Design
and Development” and not related to
“Manufacturing Process Design”.
 2. Normative Reference
 ISO 9000 : 2000
 Quality Management System - Fundamentals and
Vocabulary.
3. Terms and Conditions
Organisation Company implementing QMS
Supplier Providing product and/or service
to organisation
Customer Customer End User
Product Result of a Process.
(Means Service Also)
Site Location at which value added
manufacturing process
occurs.
Process Approach Audit Application
for ISO/TS 16949
Critical Elements of the Process Audit
 Process owner exists.
 Process is defined.
 Process is documented, as appropriate.
 Linkage of process established.
 Process monitored, analysed and improved.
 Records maintained.
Process Approach Audit Application
for ISO/TS 16949
Key Questions of the Process Approach
 Are customer requirements understood and
fulfilled ?
 Is the Process Value Added ?
 What are the results of Process Performance and
Effectiveness ?
 What is the evidence of Continual Improvement ?
 Listing and Analysis of Customer Oriented Processes
(for an organisation that supplies an Automotive OEM)

Input Output Title of Indicator of

(Initial (Final process
State) State)
Perform- Satisfac-
ance tion
1. Enquiry Quotation Tendering Target 95% Not more
& sam- or on time than 5%
ples Contract clarifica-
Review tions
2 Cus- Produc- PPC 100% on Number
tomer tion plan time of times
schedule delivery line stop-
page in a
year
 Customer Oriented Process (COP)

 Market analysis / Customer requirements.

 Bid/ Tender.
 Order/ Contract.
 Product and Process Design.
 Product and Process Verification/ Validation.
 Product Production.
 Delivery.
 Payment.
 Warranty/ Service.
 Post Sales/Customer Feedback.
 Support Processes

 Training and Development.

 Information System.
 Maintenance.
 Purchasing.
 Supplier Management.
 Logistics.
 Facilities.
 Quality.
 Management Processes

 Business Planning.
 Business Development.
 4.Quality Management System
4.1 General Requirements
 Establish document, implement and maintain a QMS and continually improve its effectiveness
 Implement QMS by -

 Identifying processes needed for the QMS throughout the

organisation.
 Determining sequence and interaction between these
processes.
 Determining criteria and methods required to ensure that
both operation and control of these processes are effective.
 Ensuring the availability of resources and information
necessary for operation and monitoring of processes.
 4.Quality Management System
4.1 General Requirements (Contd.)
 Implement QMS by (Contd.)
 Monitoring, measuring and analysing these processes, and
 Implementing actions necessary to achieve planned results
and continual improvement of these processes.
 Identify and control outsource processes

 4.1.1 Ensuring control over outsource

processes and does not absolve responsibility
of conformity to customer requirements.
 4.Quality M anagement System
4.2 Documentation Requirements
 4.2.1 General : QMS documentation to include
 Documented Statement of Quality Policy and Quality
Objectives.
 A Quality Manual.
 Documented procedures required in this standard.

 Documents needed by organisation to ensure effective

planning, operation and control of its processes.
 Quality records required by this standard (see 4.2.4)
 4.Quality Management System
4.2 Documentation Requirements (Contd.)
 4.2.2 Quality Manual
 Establish a procedure defining the controls
 The scope of QMS, including details of, and justification for
any exclusions referred at 1.2
 Documented procedures established for QMS or their
reference.
 A description of the interaction between the processes of
QMS.

NOTE : The above applies to all requirements of TS

 4.Quality Management System
4.2 Documentation Requirements (Contd.)
 4.2.3 Control of Documents
 Establish a procedure defining the controls
4.2.3.1 Engineering Standards/ Specifications
and Changes
Establish a process to assure timely review (max. two weeks),
Distribution and Implementation as per customer schedule.
 Maintain a record of the date each change is implemented
in production.
 Implementation to include updated documents.

NOTE 1 : Update record of customer production part approval

when the specifications change (e.g., FMEA/control Plan etc.)
 4.Quality Management System
4.2 Documentation Requirements (Contd.)
 4.2.4 Control of Quality Records
 Establish a procedure defining control of records.
Controls to include :
 Identification, Storage.
 Protection, Retrieval.
 Retention Time and Disposition including (Disposal)
Note : Records include customer specified records.
4.2.4.1 Records Retention
 The control of records shall satisfy regulatory
and customer specific requirements.
 5.Management Responsibility
 5.1 - MANAGEMENT COMMITMENT
 Top management to demonstrate commitment to QMS and
continually improving its effectiveness by

 Communicating to organisation the importance of meeting

customer and statutory / regulatory requirements.
 Establishing Quality Policy and Quality Objectives.
 Conducting Management Reviews, and
 Ensuring the availability of necessary resources.
 5.1.1 Process Efficiency

• Review product realisation and support

processes for effectiveness and efficiency.
 5.Management Responsibility
 5.2 CUSTOMER FOCUS
 Aim to enhance customer satisfaction.

 5.3 QUALITY POLICY

 Appropriate to purpose of the organisation.
 Commitment to comply with requirements and continually
improve the effectiveness of QMS.
 Provides a frame work for establishing and reviewing
Quality Objectives.
 Communicated and understood.
 Reviewed for continuing suitability.
 5.Management Responsibility
 5.4 PLANNING
 5.4.1 Quality Objectives
 Shall be for meeting the requirements of products.
 Established at relevant functions and levels.
 Shall be measurable and consistent with Quality Policy.

5.4.1.1 Quality Objectives - Supplemental

 Quality objectives shall be included in Business Plan and
used to deploy Quality Policy.

Note : Objectives should address customer

expectations and be achievable in defined time
frame.
 5.Management Responsibility
 5.4.2 QUALITY MANAGEMENT SYSTEM
PLANNING

 Top management to ensure that -

 The planning of QMS is carried out to meet requirements

given in 4.1 and quality objectives.
 The integrity of QMS is maintained when changes to
quality management systems are planned and
implemented.
 5.Management Responsibility
 5.5 RESPONSIBILITY, AUTHORITY
AND COMMUNICATION
 5.5.1 Responsibility and Authority
 Top management to ensure that -
 Responsibilities and authorities and their interrelations are
defined and communicated within the organisation.
5.5.1.1 Responsibility for Quality
 Management personnel responsible and authroised for
corrective action to be promptly informed of any non
conforming product/ process.
 Such (management) personnel to have authority to stop
production.
 Production operation across shifts to have or delegated a
Shift Quality in charge.
 5.Management Responsibility
 5.5.2 Management Representative

 Appoint member of the Management as

Management Representative (MR). He is
responsible for -
 Promotion of awareness of customer requirements
throughout the organisation..

5.5.2.1 Customer Representative

 Designate person(s) to represent customer to address
quality related requirements.
 He/ She represents customers needs in internal functions.
 5.Management Responsibility
 5.5.3 Internal Communication
 Top management to ensure that communication
processes are established between various levels
and functions and takes place regarding
effectiveness of QMS.

 5.6 MANAGEMENT REVIEW

 Management review to include all elements of QMS and its
performance trends, quality objectives and cost of poor
quality.
 Management review result to provide evidence of
achievement of quality policy objectives, business plan
objectives and customer satisfaction.
 5.Management Responsibility
 5.6 MANAGEMENT REVIEW (Contd.)
Review Input

 Shall include information on Audit Results : Customer

feedback ; Process performance and product conformity ;
Status of preventive and corrective actions ; Follow up
actions of previous management reviews ; Planned changes
that could effect QMS and Recommendations for
improvement.
 Input to include analysis of actual and potential field failures
and their impact on Quality, Safety or Environment.
 5.Management Responsibility
 5.6 MANAGEMENT REVIEW (Contd.)

 5.6.3 Review output

 To include any decisions and actions taken related to

improvement of the effectiveness of QMS and its processes ;

improvement of product related to customer requirements

and resource needs.

Management Responsibility

Business
Plan

Policy

Objectives

Planning

Employee understanding/involvement
 6. Resource Management
 6.1 Provision of Resources

 Determine and provide resources needed :

 To implement, maintain and continually improve

effectiveness of QMS and
 To enhance customer satisfaction by meeting customer
requirement.
 6. Resource Management
 6.2 Human Resources
 6.2.1 General :

 Personnel whose work affect product quality to be

COMPETENT on the basis of appropriate education, skills
and experience.
 6. Resource Management
 6.2 Human Resources (Contd..)
 6.2.2 Competence, Awareness and Training:
 The organisation to -
Determine necessary competence for personnel
performing work affecting product quality.
Provide training or take any other actions to satisfy these
needs.
Evaluate effectiveness of the actions taken
ensure that its personnel are aware of
relevance and importance of their activities.
How they contribute to the achievement of the quality
objectives.
Maintain records of education, training, skills and
experience.
 6. Resource Management
6.2.2.1 Product Design Skills:

 Product Design Responsible personnel be competent to

Achieve design requirements, and

Have skills in applicable tools and techniques as
identified by organisation.
 6. Resource Management
6.2.2.2 Training
 Establish “Documented Procedure” for

Identifying training needs and achieving competence.

Personnel with specified assigned tasks be qualified, as
required.
Attention be given for citifying customer specific
requirements.

Note 1 : Applies to all employees at all levels.

Note 2 : Customer specific requirements, for

example, digitized mathematically based data..
 6. Resource Management
6.2.2.3 Training on the job

 On job training to personnel including contract or agency

personnel for new or modified jobs and personnel be

aware of consequences to the customer of the non

conformity to quality requirements and the potential

consequences of departure from specified procedures.

 6. Resource Management
6.2.2.4 Employee Motivation and Empowerment
 For “Employee Motivation”, have a “Process” to
Motivate employees to achieve objectives.
Make continual improvements.
Create an environment to promote innovation.
Promote quality and technological awareness.

 For “Employee Empowerment”, have a “Process” to

measure the extent to
Which personnel are aware of their relevance and
importance of their activities.
How they contribute to the achievement of the quality
objectives.
 6. Resource Management
 6.3 Infrastructure
 Determine, provide and maintain infrastructure
needed to achieve the conformity to product
requirement.
 Infrastructure includes, as applicable -

• Buildings, workspace and associated utilities.

• Process equipment (both hardware and software)
• supporting services (such as transport or communication)
 6. Resource Management
 6.3.1 Plant, Facility and Equipment Planning

 Use multi disciplinary approach in developing plans for

plant, facilities and equipment.
 Plant layout to optimize Material Travel and Handling ;
Optimize value added use of floor space ; facilitate
synchronous material flow.
 Develop methods to evaluate and monitor the
effectiveness of existing operations and implement them.

Note : Focus on Lean Manufacturing Systems and

link to effectiveness of the QMS.
 6. Resource Management
 6.3.2 Contingency Plans
 Prepare Contingency Plans to satisfy customer
requirements during emergency conditions, such as
 Contingency.
 Utility Interruption.
 Labour shortages.
 Key Equipment failure.
 Field returns.

 6.4 Work Environment

 Determine and manage work environment needed to
achieve the conformity to product requirements.
 6. Resource Management
 6.4.1 Personnel safety to achieve product quality
 Address product safety and means for minimising
potential risks to employees, especially during
 Design and development process.
 Manufacturing process activities.

 6.4.2 Cleanliness of Premises

 Maintain the premises in state of order ; cleanliness and
repair consistent with requirements of product and
process needs.
 7. Product Realisation
 7.1 Planning of Product Realisation
 Plan and develop product realisation process.
 Product realisation process must be compataible with all
the other process of quality management system e.g.
documentation, resource identification and provision,
human resource development.
 Determine the following as appropriate :
 Product specific quality objective and system
requirements.
 Product specific processes, documents and resources
 Product specific verification, validation, monitoring,
inspection testing and acceptance criteria.
 Records required to demonstrate the compliance of
product and processes to the requirements.
 Use suitable form(s) for documenting/ recording planning
output2.
 7. Product Realisation
 7.1 Planning of Product Realisation
NOTE 1 - A document covering QMS process (including
product realisation processes and resources required can
be referred as Quality Plan.

NOTE 2 - Requirements given in 7.3 may be applied for

development of product realisation processes.

NOTE - Some customers refer to Project Management or

APQP for product realisation. APQP emphasizes for
defect prevention and continual improvement instead of
defect detection and based on multi disciplinary approach.
 7. Product Realisation
 7.1.1 Planning of Product Realisation - Supplemental
 Include customer requirements and references of its
technical specifications in the product realisation as a part
of quality plan.
 7.1.2 Acceptance Criteria
 Define acceptance criteria for each process e.g., process
capability).
 Have approval from customer, if required.
 Use Zero Defect as acceptance level for attribute data
sampling.
 7.1.3 Confidentiality
 Ensure confidentiality by customer contracted product
and project under development and related product
information.
 7. Product Realisation
 7.1.4 Change Control
 Establish a process to control and react to changes
having effect on product realisation including change
done by supplier.
 Define system for assessment, verification and validation
of change to ensure the compliance with customer
requirements. Perform validation before implementation
to the extent possible.
 For proprietary designs, review the effect of change(s) on
fit, form and function (including performance and.or
durability) with customer.
 Ensure the compliance for additional verification/approval
identification requirements when specified by customer.
Note 1 : Any product realisation change affecting
customer requirements requires notification to and
agreement from the customer.
Note 2 : This applies to product and manufacturing
changes.
7.2 Customer Related Processes
 7.2.1 Determination of requirements related to
the product
 Specified by customer including delivery and post delviery
activities (inspection testing and servicing).
 Not specified by customer but are necessary for intended
use.
 Statutory and regulatory related to product.
 Any additional determined by the organisation.
Note 1 : Post delivery activities include any after sales product
servicing provided as part of customer contract or purchase
order.
Note 2 : This requirement include recycling, environmental
impact and characteristics identified as a result of the
organisation’s knowledge of product and manufacturing
processes (7.3.2.3 - Special Characteristics).
Note 3 - Compliance to government regulations include all
applicable safety and environmental regulations applied to
acquisitions, storage, handling, recycling and elimination or
disposal of materials.
7.2 Customer Related Processes
7.2.1.1 Customer Designated Special Characteristics
 Demonstrate conformity to customer requirements for
designation, documentation and control of special
characteristics.
 7.2.2 Review of requirements related to product
 Review the requirements related product before giving
commitment for supply (e.g., submission of tenders,
acceptance of contract/order, acceptance of changes) te
ensure
 Product requirements are completely defined.
 Differing requirements of contract/order are resolved.
 Organsiation have the ability to meet the requirements.
 Maintain the records of review and subsequent action
planned and taken.
 When customer does not provide documented
requirements, confirm the requirements before
acceptance.
7.2 Customer Related Processes
7.2.2.2 Organisation’s Manufacturing Feasibility
 Investigate, confirm and document the manufacturing
feasibility including risk analysis during the contract
review
 7.2.3 Customer Communication
 Determine and implement effective arrangements for
communicating about
 Product information.
 Enquiry, contract/order handling including
amendments.
 Customer feedback and customer complaints.

7.2.3.1 Customer Communication-Supplemental

 Have ability to communicate necessary information/data in
customer prescribed language and format (e.g., CAD,
Electronic Data Exchange)
 7.3 Design and Development
7.3 Design and Development
Note - This requirement includes product and manufacturing
process design and development and focus on error
prevention than detection.
 7.3.1 Design and Development Planning
 Plan and control design and development by determining
 Design and development stages.
 Review, verification and validation of design and
development activities required at different stages.
 Responsibility and authority for design and
development
 Manage interfaces between different groups involved in
design and development activities to ensure
 Effective communication.
 Clear assignment of responsibility
 Update planing output as design and development
activities progress.
 7.3 Design and Development
7.3.1.1 Multi Disciplinary Approach
 Use multi disciplinary approach to prepare for product
realisation including
 Development/ Finalisation and monitoring of special
characteristics.
 Development and review of FMEA including actions to
reduce potential risks.
 Development and review of control plans

Note - A multi disciplinary approach typically

includes the organisation’s design, manufacturing,
engineering, quality, production and other
appropriate personnel.
 7.3 Design and Development
 7.3.2 Design and Development Inputs
 Determine the following inputs related to product and
maintain records
 Functional and performance requirements.
 Applicable statutory and regulatory requirements.
 Information derived from previous similar design
(where required).
 Other requirements necessary for design and
development.
 Review the inputs for adequacy.
 Ensure the requirements are complete, unambiguous and
do not conflict with each other.

Note - Special characteristics are included in these

requirements.
7.3 Design and Development
7.3.2.1 Product Design Input
 Identify. document and review product design input
requirements including
 Customer requirements given in contract such as
 Special characteristics.
 Identification and traceability.
 Packaging.
 Establishing a process to use information gained from
previous design projects, for current and future
projects of similar nature. The information includes
 Competitor analysis.
 Internal inputs.
 Field data.
 Other relevant sources.
 Target for product quality, life, reliability, durability,
maintainability, timing and cost.
7.3 Design and Development
7.3.2.2 Manufacturing Process Design Input

 Identify. document and review the manufacturing process

design input requirements

 Product design and output data.

 Target for productivity, process capability and cost.
 Customer requirement, if any.
 Experience from previous developments.

Note - The manufacturing process design includes

the use of error proofing methods to degree
appropriate to the magnitude of problems and
commensurate with the risk encountered.
7.3 Design and Development
7.3.2.3 Special Characteristics

 Identify special characteristics and

 Include all special characteristics in the control plan.
 Comply with customer specified definitions and
symbols.
 Identify in the process control documents including
Drawings, FMEAs, Control Plans, Operator Instructions.
Use customer prescribed symbols/notation or equivalent
to identify special characteristics.

Note - Special characteristics can include product

characteristics and process parameters.
 7.3 Design and Development
 7.3.3 Design and Development Output
 Define design and development output using units or
measurable which can be verified and validated to meet
design output requirements.
 Ensure design and development output

 Meets the input requirements.

 Provide appropriate information for purchasing,
production and service provision.
 Contain or reference product acceptance criteria.
 Specify the characteristics of product that are
essential for its safe and proper use.
7.3 Design and Development
7.3.3.1 Product Design Output - Supplemental
 Express the product design output in terms that can be
verified and validated against product design input
requirements, include the following in product design
output.

 Design FMEA, reliability results.

 Product special characteristics, specifications.
 Product error proofing, as appropriate.
 Product definitions (drawings, math data).
 Product design reviews results.
 Diagnostics guidelines, where applicable.
7.3 Design and Development
7.3.3.2 Manufacturing Process Design Output
 Express in terms that can be verified and validated against
manufacturing process design input requirements.
Include the following in manufacturing process design
outputs.
 Specifications and drawings.
 Manufacturing process flow chart/ layout.
 Control plans.
 Work instructions.
 Process approval acceptance criteria.
 Data for quality, reliability, maintainability and
measurability.
 Results of error proofing activities, and
 methods of rapid detection and feedback of product/
manufacturing process non conformities.
 7.3 Design and Development
 7.3.4 Design and Development Review
 Plan and perform systematic review of design and
development at different stages.
 To evaluate the ability of the results of design and
development to meet requirements.
 To identify any problem and propose necessary
actions.
 Include representatives from the relevant stages of design
and development in review.
 Prepare and maintain records of review and subsequent
actions.
 7.3 Design and Development
7.3.4.1 Monitoring
 Define and analyse the measurements at different stages
of design and development.
 Report summary results as input to management review.
Note - These measurements include quality risks, costs,
lead times, critical paths and others as appropriate.

 7.3.5 Design and Development Verification

 Plan and perform design and development verification.
 To ensure design and development output meets the
input requirements.
 Maintain the records of verification and subsequent
actions.
 7.3 Design and Development
 7.3.6 Design and Development Validation
 Plan and perform design and development validation to
ensure
 Resulting product is capable of meeting the
requirements for application or intended use where
known.
 Whenever applicable, complete validation before delivery
or implementation of product.
 Prepare and maintain records of validation and
subsequent actions.
Note 1 - The validation process should include an analysis of
field results.
Note 2 - The requirements of verification and validation apply
to both product and manufacturing process.

7.3.6.1 Design and Development Validation-Supp

 Perform design and development validation in line with
customer requirements including programme timing.
7.3 Design and Development
7.3.6.2 Prototype Programme

 Develop a prototype programme and control plan when

required by the customer.
 To the extent possible -

 Use same supplier, tooling, manufacturing processes

for prototype as will be used for regular production.
 Monitor the timely completion and conformance of all
performance testing activities.
 When design services are outsourced.

 Provide technical leadership, and

 Compliance of outsourced processes/ services lies
 with the organisation.
 7.3 Design and Development
 7.3.7 Control of Design and Development Changes

 Identify and maintain records of design and development

changes.
 Review, verify, validate and approve changes before
implementation.
 Evaluate the effects of changes on
 Constituent parts.
 Already delivered product.
 Prepare and maintain records of review of changes and
subsequent actions.
Note - Design and Development changes include all
changes during product programme life.
 7.4 Purchasing
 7.4 Purchasing
7.4.1.1 Regulatory Compliance
 Ensure all purchased products or materials used in
product comply with applicable regulatory requirements.

7.4.1.2 Supplier Quality Management System Development

 The goal shall be supplier conformity with the TS.
Conformity with ISO 9001:2000 is the first step in
achieving this goal.
 Suppliers shall be ISO 9001:2000 certified by a third party
certification body, unless otherwise specified by the
customer.
 Develop Quality Management Systems complying to the
requirements of ISO/TS 16949:2009.
Note - The prioritisation of supplier for development
depends upon suppliers quality performance and
importance of product, material or service supplied.
 7.4 Purchasing
7.4.1.3 Customer Approved Sources
 Purchase products, material or services from approved
sources when specified in the contract.
 Responsibility for ensuring quality of purchased product
bought from customer approved sources lies with the
organisation.
 7.4.2 Purchasing Information
 Describe clearly all the purchasing information/
requirements including
 Requirements for approval of product, procedure,
processes and equipment.
 Requirement for qualification of personnel.
 Quality Management System requirements.
 Ensure adequacy of specified purchase requirements
before communication to the suppliers.
 7.4 Purchasing
 7.4.3 Verification of purchased product
 Establish and implement inspection or other similar
activity to ensure the conformance specified purchasing
requirements.
 When verification is desired at supplier’s premises, shall
state in purchase information.
 The intended verification arrangements.
 Method of product release.
 7.4 Purchasing
7.4.3.1 Incoming Product Quality

 Establish a process to assure the quality of purchased

product.
 Utilise one or more of the following methods -

 Receipt of and evaluating statistical data.

 Receiving inspection and testing.
 Second or third party audits of suppliers site when
coupled with the records of acceptable quality
performance.
 Part evaluation by a designated laboratory.
 Any other method agreed with the customer.
 7.4 Purchasing
7.4.3.2 Supplier Monitoring

 Monitor the performance of supplier using -

 Delivered part quality performance.

 Customer disruption including field failure.
 Delivery schedule performance (including incidents of
premium freight).
 Special status - customer notifications related to
quality or delivery issues.

 Promote suppliers own monitoring of their manufacturing

processes.
7.5 Production and Service Provision
 7.5.1 Control of production and service provision

 Plan and carry out production and service provisions

under controlled conditions which include, as applicable -

 Availability of information that describes product

characteristics.
 Availability of work instructions, as necessary.
 Implementation and use of monitoring and
measurement.
 Implementation of release, delivery and post delivery
activities.
7.5 Production and Service Provision
7.5.1.1 Control Plan

 Develop control plans for products supplied covering -

 System.
 Sub system
 Parts.
 Material (including bulk material)

 Prepare control plan for pre launch and production stages.

Use Design FMEA and Process FMEA as inputs.
7.5 Production and Service Provision
7.5.1.1 Control Plan

 Define the following in the control plan -

 Controls used for manufacturing process control.

 Methods for monitoring of controls exercised over
special characteristics.
 Customer required information, if any.
 Reaction Plan when the process becomes unstable or
statistically non capable.
7.5 Production and Service Provision
7.5.1.1 Control Plan

 Review and update control plan when change occurs

which affect Product, Manufacturing Process,
Measurement, Logistics, Supply sources, FMEA.

Note - Customer approval may be required after

review or update of the control plan.
7.5.1.2 Work Instructions
 Prepare work instructions for all personnel having
responsibility for operation of processes ensuring
accessibility at work station.
 Derived work instructions from sources such as
Quality Plan/ Control Plan, Product Realisation
Processes.
7.5 Production and Service Provision
7.5.1.3 Verification of Job Setups
 Verify whenever setup is performed

For example, initial run of a job, material change

over, job change.

 Ensure availability of work instructions for setup

personnel.
 Use statistical methods of verification where
applicable.

Note - Last off comparisons recommended.

7.5 Production and Service Provision
7.5.1.4 Preventive and Predictive Maintenance
 Identify key process equipment.
 Provide appropriate resources for machine/ equipment
maintenance.
 Develop an effective, planned total maintenance system.
As a minimum, this system to include -
 Planned maintenance activities.
 Packaging and preservation of equipment, tooling and
gauging.
 Availability of replacement parts for key manufacturing
equipment.
 Documenting, evaluating and improving maintenance
objectives.

 Utilise predictive maintenance methods to continually

improve the effectiveness and efficiency of production
equipment.
7.5 Production and Service Provision
7.5.1.5 Management of Production Tooling
 Shall provide resources for -
 Tool and gauge design.
 Fabrication and verification activities.
 Establish and implement a system for production
tooling management including -
 Maintenance and repair facilities and personnel.
 Storage and recovery.
 Set up.
 Tool change programmes for perishable tools.
 Tool design, modification, documentation (including
engineering change level)
 Tool identification, defining the status such as
production, repair or disposal.
 Implement a system to monitor these activities, if any work
is outsourced.
Note - This requirement also applies to availability of tools for
vehicle service parts.
7.5 Production and Service Provision
7.5.1.6 Production Scheduling
 Plan/Schedule production to meet customer requirements
(e.g., Just In Time), Develop information system to access
production information at key stages of the process, plan/
Schedule production to be order drive.

7.5.1.7 Feedback of Information from Service

 Establish and maintain a process for communication of

information on service concerns to Manufacturing,
Engineering and Design activity.

Note - The intent of addition of service concerns to

this element is to ensure that the organisation is
aware of non conformities that occur external to its
organisation.
7.5 Production and Service Provision
7.5.1.8 Servicing Agreement with customer

 Verify the effectiveness of following when agreed

contractually with customer.

 Any organisation service center.

 Any special purpose tool for measurement equipment.
 Training of service personnel.
7.5 Production and Service Provision
 7.5.2 Validation of Processes for Production and
Service Provision

 Validate any process for production and service provision

where resulting output cannot be verified by subsequent
monitoring/ measurement.
 Include any process where deficiencies become apparent
only after the product is in use or service has been
delivered.
 Validate this ability of process to demonstrate
achievement of planned results.
7.5 Production and Service Provision
 7.5.3 Identification and Traceability

 Where appropriate, identify the product by suitable means

throughout product realisation.
 Identify the product status w.r.t. monitoring and
measurement requirements.
 Where traceability is a requirement, control and record the
unique identification of the product

Note - In some sectors, the above is met by

configuration management.
7.5 Production and Service Provision
 7.5.3 Identification and Traceability
Note - Inspection and test status is not indicated by
the location of product in production flow unless
inherently obvious such as material in an
automated production transfer process.
Alternatives are permitted if the status is clearly
identified, documented and achieve the designated
purpose.
7.5.3.1 Identification and Traceability - Supp.
The words “where appropriate” in 7.5.3 above
shall not apply.
7.5 Production and Service Provision
 7.5.4 Customer Property
 Exercise care with customer property while under
organisation control or being used in the organisation.
 Identify, verify, protect and safeguard customer property,
provided for use or incorporation into the project.
 Record and report the details of customer property to the
customer in the event of loss ; Damage and any other
unsuitability for use.
Note – Customer property can include intellectual
property.
Note – Customer owned returnable packaging is
included in this element.
 7.5.4 Customer owned production tooling
 Provide permanent marking on customer owned (tools,
manufacturing, test, inspection tooling and equipment) to
determine ownership.
7.5 Production and Service Provision
 7.5.5 Preservation of product
 Ensure product conformity is preserved during internal
processing ; Delivery to the intended destination.
 This includes identification, handling, packaging, storage,
protection.

7.5.5.1 Storage and Inventory

 Assess the condition of stored material at appropriate
planned intervals to detect deterioration.
 Establish the Inventory Management System to
 Optimise inventory turns over time.
 Assure stock relation (e.g. First In First Out).
 Control obsolete products as non conforming product.
 7.6 Control of Monitoring and
Measuring Devices
 Determine -

 The monitoring and measurements to be undertaken.

 Monitoring and measuring devices needed to provide
evidence of conformity of product to determined
requirements.
 Establish processes to ensure that monitoring and
measurement
 Can be carried out.
 Are carried out.
 In a manner that is consistent with the monitoring and
measurement requirements.
 7.6 Control of Monitoring and
Measuring Devices
 Where necessary to ensure valid results, measuring
equipment be
 Calibrated or verified at specified interval or prior to
use with
 A reference traceable to national/ international
standards.
 Where no such standards exists, basis used for
calibration or verification to be recorded.
 Adjusted or re-adjusted as necessary.
 Identified to enable calibration status to be
determined.
 Safeguarded from adjustments that would invalidate
measurement results.
 Protected from damage and deterioration during
handling, maintenance and storage.
 7.6 Control of Monitoring and
Measuring Devices
 Assess and record the validity of previous measuring
results.
 If equipment is found not conforming to the
requirements.
 Take appropriate actions on equipment and products
affected.
 Maintain records of the results of calibration and
verification.
 Verify the ability of Computer Software to satisfy the
intended application when used for monitoring or
measurement of specified requirements.
 To be undertaken prior to initial use and re-confirmed
as necessary.
Note – See ISO 10012-1 and 10012-2 for guidance..
Note – A number of other identifier traceable to the
device calibration record meets the intent of calibration
status identification..
 7.6 Control of Monitoring and
Measuring Devices
 7.6.1 Measurement System Analysis

 Conduct statistical studies to analyse the variation present

in the results of each type of measuring and test
equipment system.
 Cover all types of measurement system mentioned in
Control Plan.
 Use customer reference manual (MSA Third Edition 2009)

 Other analytical methods and acceptance criteria may

be used if approved by the customer.
 7.6 Control of Monitoring and
Measuring Devices
 7.6.2 Calibration/Verification Records
 Prepare and maintain the following calibration/ verification
records for all gauges, measuring and test equipment
including employee and customer owned gauges.

 Equipment identification including the measurement

standard against which equipment is calibrated.
 Revisions following engineering changes.
 Any out of specification readings as received for
calibration/ verification.
 An assessment of the impact of out of calibration
conditions.
 Statement of conformance to specification/
verification.
 Notification to the customer if suspect product or
material has been shipped.
 7.6 Control of Monitoring and
Measuring Devices
 7.6.3 Laboratory Requirements

7.6.3.1 Internal Laboratory

 Establish a defined scope for internal laboratory.

 Include capability to perform the required inspection, test
or calibration services.
 Include laboratory scope in Quality Management System
documentation.
 Ensure the lab complies with technical requirements
including Adequacy of Laboratory procedure ;
Qualification of Laboratory personnel conducting tests ;
Testing of the commodity(ies) ; Capability to perform
these tests correctly, traceable to the relevant process
standard (e.g., ASTM, EN) ; Review of related quality
records.
 7.6 Control of Monitoring and
Measuring Devices
7.6.3.2 External Laboratory
 Ensure external commercial, independent laboratory have
defined scope which
 Include the capability of lab to perform required
inspection, test or calibration.
 Laboratory must have accreditation to ISO/IEC 17025
or National equivalent.
 Capability to perform these tests correctly, traceable
to the relevant process standard (e.g., ASTM, JIS, DIN,
IS)
Note – When a qualified laboratory is not available for a
given piece of equipment, calibration services may be
performed by the equipment manufacturer. In such
cases, the organisation should ensure that the
requirements listed for internal laboratory have been
met.
 8. Measurement Analysis and
Improvement
 8.1 General
 Plan and implement monitoring, measurement, analysis
and improvement processes needed
 To demonstrate conformity of the product.
 To ensure conformity of the Quality Management
System.
 To continually improve the effectiveness of QMS.

 The above includes determination of applicable methods

including statistical techniques, and the extent of their
use.
 8. Measurement Analysis and
Improvement
8.1.1 Identification of Statistical Tools
 Identify statistical tools for each process during advanced
Quality Planning; Include identified tools in the Control
Plan.
8.1.2 Knowledge of Basic Statistical Concepts
 Understand and utilize basic statistical tools throughout
the organisation such as Variation; Control (Stability);
Process Capability; Over adjustments.
8.2.1 Customer Satisfaction
 One of the measure of the performance of QMS.
 Monitor information relating to customer perception
(satisfaction/dissatisfaction) as to organisation has
fulfilled customer requirements.
 Establish methods for obtaining and using the
information.
 8. Measurement Analysis and
Improvement
8.2.1 Customer Satisfaction - Supplemental
 Monitor customer satisfaction through evaluation of
performance indicators such as
 Quality performance of delivered parts.
 Customer disruptions including field returns.
 Delivery performance (including premium freight paid).
 Customer notifications related to issues of
 Quality
 Delivery

 Monitor manufacturing process performance to

demonstrate compliance to customer requirements related
to
 Product Quality.
 Process Efficiency.
 8. Measurement Analysis and
Improvement
 8.2 Monitoring and Measurement (M&M) (Contd..)
8.2.2 Internal Audit
 Conduct at planned intervals Internal Audit to determine
whether QMS
 Conforms to the planned arrangements (see 7.1)
 Requirements of this standard and QMS established
by the organisation.
 Has been effectively implemented and maintained.
 Plan the audit programme considering

 Status and importance of the processes and area

being audited.
 Results of previous audits.
 8. Measurement Analysis and
Improvement
 8.2 Monitoring and Measurement (M&M) (Contd..)

8.2.2 Internal Audit (Contd…)

 Define audit criteria, scope, frequency and methodology.

 Ensure objectivity and impartiality of audit process during
selection of auditors and conduct of audits.
 Auditor not to audit their own work.
 8. Measurement Analysis and
Improvement
 8.2 Monitoring and Measurement (M&M) (Contd..)
8.2.2 Internal Audit (Contd…)
 Document procedure covering

 Responsibilities and requirements for

 Planning and conducting audits.
 Reporting results and maintaining records.
 Management of audited activity to take corrective actions
without undue delay to eliminate detected non
conformities and their causes.
 Follow up activities to include
 Verification of the actions taken.
 Reporting of verification results (see 8.5.2)
 8. Measurement Analysis and
Improvement
8.2.2.1 QMS Audit
 Audit QMS to verify compliance to this standard and
additional QMS requirements.

8.2.2.2 Manufacturing Process Audit

 Audit each manufacturing process and determine its
effectiveness.

8.2.2.3 Product Audit

 Carry out product audit at defined frequency at
appropriate production stages and delivery.
 Product Audit to include verification of specified
requirements vis.
 Product dimensions, Functionality, Packaging,
Labeling.
 8. Measurement Analysis and
Improvement
8.2.2.4 Internal Audit Plans
 Prepare Annual Audit Plan
 internal audits to include all
 Quality Management related processes.
 Activities.
 Shifts.
 Increase Audit Frequency when
 Internal/ External non conformities.
 Customer complaints occur.
Note - Should use specified checklist for each audit.
 Internal Auditor

 Internal Auditor to be qualified to conduct this TS

audit.
 8. Measurement Analysis and
Improvement
 8.2 Monitoring and Measurement (M&M)

8.2.3 Monitoring and Measurement of Processes

 Apply suitable methods for monitoring and where

applicable for measurement of QMS processes.

 To demonstrate ability of processes to achieve

planned results.

 If planned results are not achieved, correction and

corrective actions to be taken as appropriate for ensuring
conformity of product.
 8. Measurement Analysis and
Improvement
8.2.3.1 Monitoring and Measurement of
Manufacturing Processes
 Carry out process studies on all new processes to verify
process capability.
 Provide additional inputs for process control.

 Document results of process studies with specification for

use in instructions related to
 Production.
 Measurement and Test.
 Maintenance.
 Maintain Cpk and performance as specified in customer
part approval process requirements.
 Ensure implementation of Process Flow Diagram and
Control Plan.
 8. Measurement Analysis and
Improvement
8.2.3.1 Monitoring and Measurement of
Manufacturing Processes (Contd..)
 Adhere to specified
 Measurement techniques.
 Sampling plan.
 Acceptance criteria.
 Reaction plans - when acceptance criteria not met.
 Record significant process events - tool change,machine
repair.
 Initiate reaction plan for unstable or non capable
characteristics.
 Reaction plan to include as appropriate
 Containment of product.
 100% inspection.
 8. Measurement Analysis and
Improvement
8.2.3.1 Monitoring and Measurement of
Manufacturing Processes (Contd..)
 To assure that process become stable and capable,
complete corrective action plan detailing

 Target dates.
 Responsibilities.

 When desired by customer, get corrective action plan

reviewed and approved from customer.
 Maintain record of effective dates of changes.
 8. Measurement Analysis and
Improvement
 8.2 Monitoring and Measurement (M&M)

8.2.4 Monitoring and Measurement of Product

 At appropriate stages of product realisation processes

(see 7.1), monitor and measure product requirements to
verify that same are fulfilled.
 Evidence of conformity with acceptance criteria be
maintained.
 Records to indicate person(s) authorising release of
product.
 Product release and service delivery shall not proceed
until all the planned arrangements (see 7.1) are
satisfactorily completed, unless otherwise approved by a
relevant authority, and where applicable by the customer.
 8. Measurement Analysis and
Improvement
8.2.4 Monitoring and Measurement of Product
Note - While selecting product parameters to monitor
compliance to specified requirements, determine types
of product characteristics leading to determination of
 Types of measurements.
 Suitable means of measurements.
 Capability and skills required.
8.2.4.1 Layout inspection and functional testing
 Applicable to all customer engineering material and
performance standard.
 To be performed on all products at frequent intervals as
defined in control plan.
 Results shall be maintained for customer review.
Note - Layout inspection is a complete measurement of
all part dimensions shown on the design records.
 8. Measurement Analysis and
Improvement
8.2.4.2 Appearance Items
 Parts designated by customers as appearance items,
organisation shall include -

 Appropriate sources including lighting for evaluation.

 Masters for colour, grain, texture, metallic brilliance,
distinctness of image as appropriate.
 Maintenance and control of appearance masters and
evaluation equipment.
 Verification that personnel evaluating are qualified.
 8. Measurement Analysis and
Improvement
 8.3 Control of non conforming product
 Establish documented procedure to identify and control
non conforming product to prevent unintended use or
delivery.
 Controls and related responsibilities and authorities
dealing with non conforming product be defined in
procedure.
 Deal with non conforming product by one or more of the
following -
 Taking actions to eliminate the detected non
conformity.
 Authorising its use, release or acceptance under
concession by relevant authority, and where appliable
by the customer.
 By taking action to preclude its original intended use
or application.
 8. Measurement Analysis and
Improvement
 8.3 Control of non conforming product
 Maintain records of nature of non conformities and
subsequent actions taken, including concessions
obtained.
 As and when non conformity product is corrected,
demonstrate conformity to the requirements by re
verification.
 When non conformity is detected after delivery or use has
started, take actions appropriate to the effects or potential
effects of non conformity.
 8. Measurement Analysis and
Improvement
8.3.1 Control of non conforming products - Supp
 Products with unidentified and suspect status shall be
classified as non conforming.

8.3.2 Control of reworked products

 Instructions for rework and re-inspection shall be
accessible to and utilised by all appropriate personnel.

8.3.3 Customer Information

 If non conforming product is shipped, intimate customer
promptly.
 8. Measurement Analysis and
Improvement
 8.3.4 Customer Waiver
 Prior concession or deviation permit required when
 Product or manufacturing process differs from
currently approved.
 Maintain record of expiration date or quantity authorised.
 Ensure compliance with original or superseding
specification and requirements after expiration.
 Material shall be identified on each shipping container.
 This applies equally to purchased products.
 Organisation shall concur with suppliers requests before
submission to customer.
 8. Measurement Analysis and
Improvement
 8.4 Analysis of data
 Determine, collect and analyse appropriate data to
 Demonstrate suitability and effectiveness of QMS.
 Evaluate to identify areas of continual improvement.`

 Analyse the data to provide information on

 Customer satisfaction.
 Conformance to product requirements and
 characteristics and trends of processes and products
including opportunities for preventive action.
 Suppliers.
 8. Measurement Analysis and
Improvement
8.4.1 Analysis and use of data.
 Trends in quality and operational performance be
compared with progress towards objectives and lead for
actions to support
 Development of priorities for prompt solution to
customer related problems.
 Determination of key customer related trends and co-
relation to
 Support status review.
 Decision making.
 Long term planning.

 Timely reporting of product information arising from

usage.

Note - Data should be compared with those of

competitor’s and/or benchmarks.
 8. Measurement Analysis and
Improvement
 8.5 Improvement.

8.5.1 Continual Improvement

 Continually improve the effectiveness of QMS.
 Facilitate Continual Improvement through use of

 Quality Policy.
 Quality Objectives.
 Audit (Internal and External) results.
 Analysis of data.
 Corrective and Preventive Action and
 management review.
 8. Measurement Analysis and
Improvement
8.5.1.1 Continual Improvement
 Define a process for continual improvement (see
Annexure B of ISO 9004:2000)
8.5.1.2 Manufacturing Process Improvement
 Focus on control and reduction of variation in
 Product characteristics.
 Manufacturing process parameters.

Note 1 - Controlled characteristics are documented in

Control Plan.
Note 2 - Continual improvement is implemented once
manufacturing processes are capable and stable or
product characteristics are predictable and meet
customer requirements.
 8. Measurement Analysis and
Improvement
 8.5 Improvement (Contd…)

8.5.2 Corrective Action

 Take corrective action to eliminate the cause of non
conformities to prevent recurrence.
 Documented procedure to define requirements for

 Reviewing non conformities (including customer

complaints).
 Determining the causes of non conformities.
 Evaluating the need for action to ensure the non
conformities do not recur.
 Determining and implementing action needed.
 Records of the results of actions taken.
 Reviewing corrective action taken.
 8. Measurement Analysis and
Improvement
8.5.2.1 Problem Solving
 Establish defined process for problem solving leading to
root cause identification and elimination.
 Use customer prescribed format when provided.
8.5.2.2 Error Proofing
 Use error proofing method in corrective action process.
8.5.2.3 Corrective Action Impact
 Apply to other similar processes and products the
corrective action and controls.
8.5.2.4 Rejected Product Test/ Analysis
 Shall analyse the rejected parts received.
 Shall minimise the cycle time for this process.
 Shall keep the records of analysis.
 Shall initiate the corrective actions to prevent recurrence.
 8. Measurement Analysis and
Improvement
 8.5 Improvement (Contd…)

8.5.3 Preventive Action

 Determine action to eliminate the causes of potential non
conformities to prevent their recurrence.
 Preventive actions to be appropriate to impact of potential
problems.
 Documented procedure to define requirements for
 Determining potential non conformities and their
causes.
 Evaluating the need for action to prevent occurrence
of non conformities.
 Determining and implementing the actions needed.
 Records of results of action taken.
 Reviewing preventive action taken.