Iso ts iat material

10 July 2014
• Welcomes you to IQA /
• Public Seminar on ISO / TS 16949: 2009

Objective of this Program
10 July 2014
4 To understand Process Approach as perceived by IATF
4 To understand compliance requirements of
ISO/TS16949:2009 as an auditor.
4 Audit preparation using process approach
4 To conduct audit based on process approach.
4 To achieve “Qualified Internal Auditor ” status

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ISO 9001:2008 - Background

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The various committees of TC 176 responded to the feedback from a major
“Customer Survey” involving 1100 companies. these changes were designed
to:
Ensure compatibility to ISO 14000 standards
Base the system architecture on process model
Allow for selective application of requirements (Tailoring)
Address Continual Improvement
Facilitate self evaluation
Use of simple terminology and clear language
Suitable for all sizes of organizations

TC 176 also published a document entitled “Quality Management Principles
and Guidelines on their Application”
(REF. ISOTC176/SC2/N130) in the year 1997.
This document was one of the other inputs used by the responsible ISO
working group to develop a consistent pair of standards
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The family of 20 standards in the ISO 9000 series was reduced to 4 Quality
Management systems during the December 2000 revision:-
ISO 9000: FUNDAMENTALS AND VOCABULARY
ISO 9001: REQUIREMENTS
ISO 9004: GUIDELINES FOR PERFORMANCE IMPROVEMENTS
ISO 19011: GUIDELINES FOR AUDITING MANAGEMENT SYSTEMS
(intended to be applicable to both environmental system and quality
system auditing)
MERGER OF ISO 10011- 1, 2, 3 QMS AND ISO 14010, 11 & 12 OF EMS
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8 Quality Management Principles
The ISO 9001 : 2008 is based on eight Quality Management principles
concerning:
Customer focused organization
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach to decision
Mutually beneficial supplier relationships
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4 Main Clauses
These eight principles manifest themselves through the four main
clauses of :
MANAGEMENT RESPONSIBILITY – defining requirements
RESOURCE MANAGEMENT – determine and establish
necessary
resources
PRODUCT REALIZATION – establish and implement
processes
MEASUREMENT, ANALYSIS AND IMPROVEMENT – of
results
These main clauses are structured around the plan-do-check-act
cycle and contain a number of individual clauses
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Relationship with ISO 9004
ISO 9001 and ISO 9004 have been developed as consistent pair
Both can be used together or independently
They have different scopes but similar structure
ISO 9001: specifies requirements for a QMS for contractual
purposes
ISO 9004: gives guidance on a wider range of objectives of the
QMS to improve performance and self assessment.
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Benefits of ISO 9001:2008 to the Industry
The ISO 9001:2008 standard is a management tool
Applicability to all products
Simple to use
Clear language
Continual Improvement
Understanding the Customers Needs
Compatibility With Other Management Systems
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Salient Changes - ISO 9001:2008
A) Major Changes in Documentation
only six documented procedures (mandatory)
add requirements pertaining to training and competence
emphasis on quality planning and customer focus
clarification on the need of required documentation
B) Audit Pattern
structured audit of top management
more focus on improvements
positive way of looking into deficiencies
audit of processes against the measurable objectives
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10 July 2014
EVOLUTION OFISO/TS16949:2009

TS 16949
Formation of task force in 1995 by the Automotive Manufacturers of
USA, UK, France, Germany and Italy to harmonise Quality System
requirements
ISO/TS 16949:2009 was prepared by IATF (International Automotive
Task Force, Japan Automobile Manufactures Association (JAMA) and
representatives from ISO/TC176, Quality Management And Quality
Assurance, and its subcommittees
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Release of TS 16949 as a standard in the year 1999
ISO/TS 16949:2009 was released subsequently

TS 16949
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ISO/TS 16949 is based on four automotive standards in addition to
ISO 9001: 2008. They are:
VDA 6.1 (Germany)
QS 9000 (USA)
AVSQ’94 (Italy)
EAQF’94 (France)

IATF
The International Automotive Task Force was founded in mid 1990
with a clear vision “ A Single Global Automotive Quality System
Standard & Registration Process”
There are 5 oversight offices of IATF:
- ANFIA (ITALY)
- IAOB (US)
- IATF-FRANCE (FRANCE)
- SMMT (UK)
- VDA-QMC (GERMANY)
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IATF
Following are the major tasks of IATF
Develop & update the IATF certification rules which includes:
– Criteria for CB recognition
– Certification Body Processes
– Certification Auditor Qualification
– Certificate Content Requirements
Each oversight office is also responsible for
– Scheduling witness audits for CB
– Monitoring the CB
– Monitoring CB Auditors
– CB Auditor Qualification & Training
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IATF
Includes:
OEMs BMW, DiamlerChrysler, Fiat, Ford, General Motors, Peugeot,
Volkswagen.
Trade associations
ANFIA – Italy (Associatione Nazionale Fra Industrie Automobilistiche)
AIAG – USA. (Automotive Industry Action Group)
CCFA – France (Comite des Constructeurs Francais d’Automobiles)
FIEV – France ( Federation des Industries des Equipements pour
Vehicules).
SMMT Ltd. – UK (Society of Motor Manufacturers and Traders Ltd.)
VDA – Germany (Verband der Automobilindustrie)
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TS 16949
ISO/TS16949:2009
Quality Systems - Automotive Suppliers – Particular requirements for
the application of ISO9001:2008.
Automotive Certification Scheme for ISO/TS 16949. Rules for
achieving IATF recognition
IATF guidance to ISO/TS16949:2009
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TS 16949
The standard is mainly a combination of QS9000 and VDA 6.1
requirements.
Based on ISO9001:2008 Quality System standards
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Field of applications
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Sites where Customer Specified parts for production and/or
service are manufactured.
Supporting functions, whether on-site or remote (such as design
centers, Corporate Headquarters and distribution centers) form
part of the site audit.
Cars, trucks (light, medium, heavy), Buses, Motorcycles included
Industrial, agricultural, off-highway (mining, Forestry,
Construction etc.) excluded
Support site cannot obtain stand alone certification to this
Technical Specification. Remote location supporting site cannot
be excluded e.g. Design

TS 16949:2009
ISO TS 16949 is not a stand-alone standard.
It is always applicable in conjunction with the Customer Specific
Requirements. (The customer for 2nd tier could be 1st tier)
The customers & their specific requirements (Quality System related)
will be included in the certificate as Annex.
Chrysler Group, Ford & GM company specific ISO TS 16949:09
certification requirements are available through www.iaob.org or
http://www.vda-
qmc.de/de/index.php?catalog=1073&changecat=1056&changelang=
de &lang=en or http://www.iaob.org/oem reg.html
Other OEMs – Contact them or view their website
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Examples of customer specific system requirements
Ford - customer specific requirements for use with ISO/TS 16949
QOS and Q1
Chrysler - customer specific requirements for use with ISO/TS
16949
GM - customer specific requirements for use with ISO/TS 16949
GM/Fiat - customer specific requirements for use with ISO/TS
16949
Global Statement of requirements
Supplier Quality Assurance Manual “SQAM”
Engineering Standard Europe
Opel - customer specific requirements for use with ISO/TS 16949
DC-Mercedes-Benz - Special Terms
BMW - SPQM (Supplied Parts Quality Management)
Contd….
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VW/AUDI/SKODA/SEAT-
Formula Q concrete
Formula Q capability
Formula Q new parts
Formula Q ready to go into mass production (2-day
production)
Renault/Nissan -
ANPQP - (Alliance new Product Quality Procedure)
PSA (Peugeot und Citroen) – AQP
Land Rover - FGTC (Ford Global Terms and Conditions)
Porsche - Quality Guideline for Suppliers
Contd….
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Carozzeria Bertone - regulations of the final customer (e.g DC,
GM, VW)
Karmann GmbH - regulations of the final customer (e.g DC,
GM, VW)
CTS Fahrzeug Dachsysteme - regulations of the final customer
(e.g DC, GM, VW)
Valeo - Valeo 1000 or Valeo 2008 or Valeo 5000
Delphi - GLOBAL SUPPLIER GUIDELINES and SUPPLIER
CONTAINMENT
Bosch - Qualitaetssicherungsvereinbarung QSL 02/98
ZF - 83
Getrag - WN 4404
INA - QN 6.1 und 6.4
Contd….
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Customer Specific Requirements
Customer Specific Requirements listing for some Japanese OEMs
Honda – Honda Supplier Quality Manual –
www.hondasupplyteam.com (password required)
Isuzu – Supplier Quality Manual – www.subaru-
isuzu.com/index2.htm
Mazda – (Contact Customer Directly) –
http://suppliers.mazdausa.com
Hyundai – AOI, ISAR, Revalidation
Nissan – Supplier Quality Manual, Alliance Supplier Guide-
www.supplier.nissan-ix.com (password required)
Toyota – Supplier Quality Assurance Manual –
www.toyotasupplier.com (password required)
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Advantages of TS 16949:2009
The main advantage of acquiring ISO TS 16949:2009 is to do away
with multiplicity of standards (Includes financial benefits too).
Also ISO TS is recognized world-wide as it is an ISO standard.
It is also supported by JAMA.
Infact many OEMs strongly recommend the suppliers to go in for
ISO TS 16949:2009
GM, DaimlerChrysler & Ford has urged their suppliers to upgrade
to ISO TS 16949:09 at the expiration of their current QS 9000
certification
Contd….
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Advantages of TS 16949:2009
Process based audits focused on customer satisfaction
ISO TS has incorporated the improvements learned through QS
9000
Improved & consistent registrar oversight & auditor training
The greatest benefit of ISO TS 16949 is its customer focus
Less paperwork! – although not a requirement, most companies will
look at the upgrade as an opportunity to streamline the quality
system documentation to be consistent with the process approach
(e.g. Flow charts)
There are only 6 (7) mandatory procedures (4.2.3 - Document
Control, 4.2.4 – record control, 8.2.2 – internal audit, 8.3 – control of
nonconforming products, 8.5.2 – corrective action, 8.5.3 –
preventive action, (6.2.2.2 – training))
ISO TS 16949 IS THE STANDARD OF THE FUTURE !
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Terms and Definitions

Quality system vocabulary - Terms & definitions
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Defect: Non - Fulfillment of requirement related to intended or specified
use.
Correction : Action to eliminate a detected non-conformity. E.g. –
Rectification or replacement. Also termed as disposition.
Corrective action : Action taken to eliminate the cause of actual non
conformity.
Note the distinction between correction and corrective action.

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Preventive action: Action taken to eliminate the cause of potential non
conformity
Rework: Action taken on a non-conforming product to restore it to conform
to the requirements
Effectiveness : Extent to which planned activities are realized and planned
results are achieved
Efficiency : Relationship between the result achieved and resources used

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Laboratory - Facility for Inspection, Test or Calibration
May include:
Chemical
Metallurgical
Dimensional
Physical
Electrical
Reliability testing
Others…
Laboratory Scope -
Controlled document
Contains:
• Specific tests, evaluations and calibrations, a lab is
qualified for
• List of Equipment used
• List of methods and standards used

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Manufacturing: Process of making or fabricating
- Production materials
- Production or service parts
- Assemblies
- Heat treating, welding, painting, plating or other finishing services
Site: location at which value added manufacturing processes occur.
Remote location: location that supports sites and at which non-
production process occur.

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Reliability: The probability that an item will continue to function at customer
expectation levels, at a measurement point, under specific environmental &
duty cycle conditions.
Durability: The probability that an item will continue to function at customer
expectation levels, at the useful life without requiring overhaul or rebuild
due to wear-out.
Maintainability: The probability that a failed system can be made operable
in a specified interval or downtime.

Process Approach
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1. Process Approach Introduced
Focus on Business Processes
Establish “ Inputs To” & “Output From”
Generate Directions (Sequence) of Flow
Establish “Interrelation”
Measure Process Capability
For effective target
driven management
Most important

Process Approach
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2. Quality Objectives
S.M.A.R.T
To Implement
Improvement
Initiatives
Strategic
Measurable
Achievable
Relevant
Targeted
KPI

Process Approach
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3. Communication
Internal
With Customer
System Effectiveness
Product Information
Order Management
InfoTech/EDP
processes
in QM scope

Process Approach
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Proactive Approach
for taking Preventive
Action
4. Customer Satisfaction
VOC!!

Terms & definitions
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Process: Set of Interrelated or Interacting Activities which transform Inputs
into Outputs.
Input
Customer
(E.g. Customer
with needs)
PROCESS
Company’s Internal Activities
( PLG, MFG, QA, PUR,
MAINT ,TRG, QC & MGMT )
Product
(E.g. Customer
whose needs have
been met)
Output

Terms & definitions
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What is a process ?
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PROCESS:
Any Activity or Group of Activities that takes an Input, adds Value to it, and
provides an Output to an Internal or External Customer. Processes use an
Organization’s Resources to provide Definitive Results.

What is a process ?
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PROCESS:
Is a chain of value added activities
delivering a product or a service to a customer (internal or external) of the
process
A process has a start and an end defined by two limits
INPUT
Customer who has a need
OUTPUT
Customer who has a need met
And a chain of activities between these two limits
INPUT Step 1 Step 2 Step 3 Step “n” OUTPUT

Types of Processes
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Customer Oriented Process (COP):
Any process that comes in direct contact with the educational product
that is delivered to a Customer, either first level or second level. E.g.
Educational course design, education and assessment process
Key Question
How does an organization develop effective and efficient COPs?
Answer
Support processes

Types of Processes
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Analysis of a COP
O
I
ACTIVITY 1
ACTIVITY 2
ACTIVITY 3
ACTIVITY 4
DEPARTMENT “A”

Types of Processes
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Support Process (SOP):
All Service Processes and Processes that support COPs. E.g.- Internal
and external communication process, operation of library, admission
process
Management Process (MP):
All such processes which establish the quality policy, objectives and
goals, provide necessary and adequate resources and actions to
achieve the same.
Examples
Examples

Typical Processes
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List of typical business processes in a COMPANY:
Market Survey,
Product Launch,
Product & Process Design
Purchasing
Manufacturing
Calibration
Inspection
Dispatch
Plant & Equipment Control
Recruitment & Training ,
Operation Review , Sales Review, Quality Review, Supplier Review
Can
we identify
COP, SOP & MP ?

Process Approach
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Systematic identification and management of the various processes
employed within an organization,
AND PARTICULARLY
The interactions between such processes is referred to as the process
approach to management

Process Approach
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All well-defined and well-managed processes have common characteristics:
A well-defined team with a leader is held accountable for how well the
process performs (the process owner)
Well defined boundaries (the process scope)
Well defined interfaces and responsibilities
Well documented procedures, work instructions and training
Well defined measurement and feedback controls
Customer related measurements and targets
Well known cycle times

Process Approach
• PROCESS APPROACH
• SYSTEMATIC IDENTIFICATION AND MANAGEMENT OF
THE VARIOUS PROCESSES EMPLOYED WITHIN AN
ORGANIZATION,
AND PARTICULARLY
• THE INTERACTIONS BETWEEN SUCH PROCESSES, IS
REFERRED TO, AS THE PROCESS APPROACH TO
MANAGEMENT
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ISO/TS16949 :2009 Element Listing

ISO 9000:2008 concepts
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Action Elements for ISO 9000:2008 is based on
5 key elements
Elements 4 to 8

ISO 9000:2008 concepts
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5 Key Elements can be divided into
System Based :
Elements
4, 5 & 6
Operational
(Product Centered):
Elements 7 & 8

System Based Elements
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ISO 9001:2008
4.1 General Requirements
4.2.1 Documentation
Requirements - General
4.2.2 Quality Manual
4.2.3 Control of Documents
4.2.4 Control of Quality records
ISO /TS 16949:2009
4.1.1 General Requirements
- Supplemental
4.2.3.1 Engineering
Specifications
4.2.4.1 Record of Retention
Clause 4 – Quality Management System

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ISO 9001:2008
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.4.1 Quality Objectives
5.4.2 Quality Management system
Planning
5.5.1 Responsibility and authority
5.5.2 Management representative
5.5.3 Internal Communication
5.6 Management review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
ISO /TS 16949:2009
5.1.1 Process Efficiency
5.4.1.1 Quality Objectives
- Supplemental
5.5.1.1 Responsibility for
quality
5.5.2.1 Customer
Representative
5.6.1.1 Quality Management
system Performance
5.6.2.1 Review input –
Supplemental
Clause 5 – Management Responsibility

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ISO 9001:2008
6.1 Provision of resources
6.2.1 General
6.2.2 Competence, awareness and
training
6.3 Infrastructure
6.4 Work environment
ISO /TS 16949:2009
6.2.2.1 Product design skills
6.2.2.2 Training
6.2.2.3 Training on the job
6.2.2.4 Employee motivation
and empowerment
6.3.1 Plant,facility and
equipment planning
6.3.2 Contingency Plans
6.4.1 Personnel safety to
achieve product
quality
6.4.2 Cleanliness of premises
Clause 6 – Resource Management

Product Based Elements
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ISO 9001:2008
7.3 Design and Development
7.3.1 Design and development
planning
7.3.2 D & D inputs
7.3.3 D & D outputs
7.3.4 D & D review
7.3.5 D & D verification
7.3.6 D & D validation
7.3.7 Control of D & D changes
ISO /TS 16949:2009
7.3.1.1 Multidisciplinary approach
7.3.2.1 Product design input
7.3.2.2 Manufacturing Process
design Input
7.3.2.3 Special Characteristics
7.3.3.1 Product design outputs
- Supplemental
7.3.3.2 Manufacturing process
design output
7.3.4.1 Monitoring
7.3.6.1 D & D validation –
supplemental
7.3.6.2 Prototype programme
7.3.6.3 Product Approval process
Clause 7 – Product Realization

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ISO 9001:2008
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased
product
ISO /TS 16949:2009
7.4.1.1 Regulatory conformity
7.4.1.2 Supplier Quality
Management system
development
7.4.1.3 Customer approved
sources
7.4.3.1 Incoming product quality
7.4.3.2 Supplier monitoring

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ISO 9001:2008
7.5 Product and Service Provision
7.5.1 Control of Production
and service provision
7.5.2 Validation of process for
production and service
provision
7.5.3 Identification and traceability
7.5.4 Customer Property
7.5.5 Preservation of product
ISO /TS 16949:2009
7.5.1.1 Control Plan
7.5.1.2 Work instructions
7.5.1.3 Verification of job set-ups
7.5.1.4 Preventive and predictive
maintenance
7.5.1.5 Management of
production tooling
7.5.1.6 Production scheduling
7.5.1.7 Feedback of information
from service
7.5.1.8 Service agreement with
customer

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ISO /TS 16949:2009
7.5.2.1 Validation of process for
production and service
provision- Supplemental
7.5.3.1 Identification and traceability
- Supplemental
7.5.4.1 Customer owned production
tooling
7.5.5.1 Storage and inventory

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ISO 9001:2008
7.6 Control of Monitoring and
measuring devices
ISO /TS 16949:2009
7.6.1 Measurement system
analysis
7.6.2 Calibration / Verification
records
7.6.3 Laboratory requirements
7.6.3.1 Internal Laboratory
7.6.3.2 External Laboratory

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Clause 8 – Measurement Analysis and Improvement
ISO 9001:2008
8.1 General
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
8.2.2 Internal Audit
8.2.3 Monitoring and
measurement of processes
8.2.4 Monitoring and
measurement of product
ISO /TS 16949:2009
8.1.1 Identification of statistical
tools
8.1.2 Knowledge of basic
statistical concepts
8.2.1.1 Customer satisfaction
- Supplemental
8.2.2.1 QMS audit
8.2.2.2 Manufacturing process
audit
8.2.2.3 Product audit
8.2.2.4 Internal Audit plans
8.2.2.5 Internal auditor
qualification
8.2.3.1 Monitoring & measurement
of processes
8.2.4.1 Layout inspection and
functional testing
8.2.4.2 Appearance items

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Clause 8 – Measurement Analysis and Improvement
ISO 9001:2008
8.3 Control of Non-Conforming
Product.
8.4 Analysis of Data
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective action
8.5.3 Preventive actions
ISO /TS 16949:2009
8.3.1 Control of Non-
Conforming Product.-
Supplemental
8.3.2 Control of reworked
product
8.3.3 Customer Information
8.3.4 Customer Waiver
8.4.1 Analysis of data
8.5.1.1 Continual Improvement of
the organization
8.5.1.2 Manufacturing Process
improvement
8.5.2.1 Problem Solving
8.5.2.2 Error Proofing
8.5.2.3 Corrective action Impact
8.5.2.4 Rejected product test /
analysis

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ISO/TS16949 :2009 Specific Requirements

Colour scheme used in this section
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Colour scheme used in this section of ‘ISO/TS 16949:2009 specific
requirements’–
‘New–’ ISO 9001:2008 summary of changes. (except, clause headings)
Text in brown – ISO TS 16949:2009 requirements which are outside
the boxed requirements in the standard.

1. Scope
The International Standard specifies requirements for a Quality
Management System where an organization
a) needs to demonstrate its ability to consistently provide products
that meet customer and applicable regulatory requirements
b) aims to enhance customer satisfaction through the effective
application of the system, including processes for continual
improvement of the system and the assurance of conformity to
customer and applicable regulatory requirements
Note – In this international standard, the term “product” applies
only to the product intended for, or required by, a customer.
Note : The consideration to meet regulatory requirements
and Continual Improvement
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1.1 General

1. Scope
This technical specification, in conjunction with ISO 9001:2008,
defines the quality management system requirements for the
design & development, production & where relevant,
installation & service of automotive related products.
This technical specification is applicable to sites of the
organization where customer specified parts, for production
&/or service are manufactured.
Supporting functions, whether on-site or remote (such as
design centers, corporate headquarters & distribution centers),
form part of the site audit as they support site, but cannot
obtain stand-alone certification to this Technical Specification.
This technical specification can be applied throughout the
automotive supply chain.
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1.1 General

1. Scope
All requirements of this International Standard are generic and are
intended to be applicable to all organizations, regardless of type, size
and product provided.
Where any requirements of this International standard cannot be
applied due to the nature of an organization and its product, this can
be considered for exclusion.
Where exclusions are made, claims of conformity to this standard are
not acceptable unless these exclusions are limited to the
requirements within Clause 7, and such exclusions do not affect the
organizations ability or responsibility, to provide products that fulfils
the customer and applicable regulatory requirements
Note :Proper justification to be provided for non fulfillment of the
clause mentioned in the TS 16949 Standard
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1.2 Application

1. Scope
The only permitted exclusions for this Technical specification
relate to 7.3 where the organization is not responsible for
product design & development.
Permitted exclusions do not include manufacturing process
design.
Note:
Application to entire supply chain of the automotive industry.
Enlargement to include,
Spare parts manufacturers
Automobile manufacturers
Permissible exclusions are limited to Section 7.3, if the
organization is not responsible for product design. Exclusions do
not cover the design of manufacturing processes.
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1.2 Application

2. Normative References & 3. Terms and Conditions
2 NORMATIVE REFERNCES
The reference standard is ISO 9000
3 TERMS AND DEFINITIONS
The term ‘Supplier’ is replaced by the term ‘Organization’ in
ISO 9000 : 2008
The term ‘Supplier’ shall now be used for the term
‘Subcontractor’ specified in ISO 9000 : 1994
The term ‘Product’ used in the standard also means ‘Service’
Note:
Here terms & definitions for the automotive industry are listed
to round off general terms & definitions in line with ISO
9000:2008
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4.1 General Requirements
The organization shall establish, document, implement and maintain
a quality management system and continually improve its
effectiveness in accordance with the requirements of this
International Standard.
To implement the quality management system, the organization shall;
a) identify the processes needed for the quality management
system & their application throughout the organization;
b) determine the sequence and interaction of these processes;
c) determine criteria and methods required to ensure effective
operation and control of these processes;
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4.1 General Requirements contd.
d) ensure the availability of resources and information necessary to
support the operation and monitoring of these processes
e) monitor, measure and analyze these processes , and
f) implement actions necessary to achieve planned results and
continual improvement of these processes
These processes shall be managed by the organization in
accordance with the requirements of this International Standard.
When an organization chooses to outsource any process that affects
product conformity requirements, the organization shall ensure control
over such processes. Control of such outsourced processes shall be
identified within the Quality Management System.
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4.1 General Requirements contd.
NOTE: Processes needed for Quality Management System
referred to above should include processes for
Management activities, provision of resources, product
realization and measurement.
Note :
Requirements based on ISO 9001:2008 – process model
4.1.1 General requirements – supplemental
Ensuring control over outsourced processes shall not
absolve the organization of the responsibility of conformity
to all customer requirements.
Note – see also 7.4.1 and 7.4.1.3
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What is Continual Improvement?
ISO 9001:2008 addresses the subject of Continual Improvement
as follows:
Improvement refers to the actions taken to enhance the features and
characteristics of products and/or to increase the effectiveness and
efficiency of processes used to produce and deliver them
Such actions include the following:
a) defining , measuring and analyzing the existing situation;
b) establishing the objectives for improvement
c) searching for possible solutions;
d) evaluating theses solutions;
e) implementing the selected solution;
f) measuring , verifying , and analyzing results of implementation;
g) formalizing changes
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What is Continual Improvement?
Continual Improvement Contd…
Results are reviewed, as necessary, to determine further opportunities
for improvement. Audits, customer feedback and review of the quality
management system can also be used to identify opportunities.
Improvement is a continual activity.
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4.2.1 General Documentation Requirements
The quality management system documentation shall include:
a) documented statements of a quality policy and quality objectives
b) a quality manual
c) a documented procedure required by this International Standard
d) documents needed by the organization to ensure the effective
planning, operation and control of its processes
e) quality records required by this International Standard (See 4.2.4)
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NOTE 1: Where the term “documented procedure” appears within this
International Standard, this means that the procedure is to
be established, documented , implemented and maintained.
NOTE 2: The extent of quality management documentation can differ
from one organization to another due to:
a) size and type of organization
b) complexity and interaction of the processes;
c) competence of personnel
NOTE 3: The documentation can be in any form or type of medium
10 July 2014

Comment :
Note :
The specific requirement of “ Documented procedure” not
used for all clauses.
ISO9000:2008 DEFINITION OF “Procedure” states “.. Specified
way to carry out an activity or a process” which may be
documented or not.
Onus on the organization for determination of the need for
documented procedures is one of the methods of defining a
process
10 July 2014

The organization shall establish and maintain a quality manual that
includes
a) the scope of the quality management system, including details of,
and justification for, any exclusion (see1.2) ;
b) the documented procedures established for the quality
management system or reference to them and ;
c) a description of the interaction between the processes of quality
management system.
• Note: Clarity in terms of contents of the manual
10 July 2014

Note:
Scope statement to be specifically added matching the scope
of certification
Description of the processes, their interaction ( e.g.- activity
flow charts )
Any reduction in scope of the standard to be specifically
mentioned along with JUSTIFICATION FOR EXCLUSION
Permissible exclusions are limited to Section 7.3,
if the organization is not responsible for product design.
Exclusions do not cover the design of manufacturing
processes.
10 July 2014

Documents required for the quality management system shall be
controlled.
Records are a special type of document and shall be controlled
according to the requirements given in 4.2.4
A documented procedure shall be established to define the controls
needed
a) to approve documents for adequacy prior to issue;
b) to review; update as necessary and re-approve documents;
c) to ensure that changes & the current revision status of
documents are identified;
d) to ensure that relevant versions of applicable documents are
available at points of use;
• Contd…..
10 July 2014

A documented procedure shall be established to define the controls
needed
e) to ensure that documents remain legible, readily identifiable
f) to ensure that documents of external origin are identified and their
distribution controlled;
g) to prevent the unintended use of obsolete documents and to apply
suitable identification to them if they are retained for any purpose.
10 July 2014

4.2.3.1 Engineering Specifications
The organization shall have a process to assure the timely
review, distribution & implementation of all customer
engineering standards / specifications & changes based on
customer required schedule. Timely review should be as soon as
possible & shall not exceed two working weeks.
The organization shall maintain a record of the date on which
each change is implemented in the production. Implementation
shall include updated documents.
Note: A change in these standards / specifications requires an
updated record of customer production part approval when
these specifications are referenced on the design record or if
they affect documents of production part approval process such
as control plan, FMEAs etc.
10 July 2014

4.2.3.1 Engineering Specifications
Note:
No modification except for “legibility” as such, although—
word “ data” no longer exists due to definition of the
document under ISO9000:2008 as “ information and its
support medium”
Phrase “master list or its equivalent”, has been removed
10 July 2014

4.2.4 Control of Records
Records shall be established and maintained to provide evidence of
conformity to requirements and of the effective operation of the quality
management system. Records shall remain legible, readily identifiable
and retrievable. A documented procedure shall be established to define
the controls needed for the identification, storage, retrieval, protection,
retention time and disposition of records.
Note 1 “disposition” above includes disposal
Note 2 “Records” also includes customer – specified records
10 July 2014

4.2.4.1 Record Retention
The control of records shall satisfy regulatory & customer
requirements.
10 July 2014

5. Management Responsibility
Top management shall provide evidence of its commitment to the
development, implementation and continuous improvement of the
effectiveness of the quality management system by:
a) communicating to the organization the importance of meeting
customer as well as regulatory and statutory requirements.
b) establishing the quality policy
c) ensuring the quality objectives are established
d) conducting management reviews
e) ensuring the availability of resources
10 July 2014
5.1 Management Commitment

5.1.1 Process Efficiency
5.1.1 PROCESS EFFICIENCY
The management shall review the product realization
processes & the support processes to assure their
effectiveness & efficiency. (Previously in TS:1999,
required by means of process audit)
Note:
An organization's awareness of the importance to
meet customer requirements as well as regulatory
and legal requirements.
Ensuring the availability of the resources
10 July 2014

5.2 Customer Focus
Top management shall ensure that customer needs and expectations
are determined and are met with the aim of achieving customer
satisfaction.
(See 7.2.1 and 8.2.1)
Note:
Determination of customer needs and expectations and
conversion into requirements
10 July 2014

5.3 Quality Policy
Top management shall ensure that the quality policy :
a) is appropriate to the purpose of the organization;
b) includes a commitment to meeting requirements and to continual
improvement of effectiveness of the quality management system;
c) provides a frame-work for establishing and reviewing quality
objectives;
d) is communicated and understood at appropriate levels in the
organization;
e) is reviewed for continuing suitability
Note:
Commitment to meeting requirements and continual
improvement.
Act as a framework for determining and reviewing the quality
objectives (see 5.4.1)
The quality policy shall be reviewed for continuing suitability
10 July 2014

Top management shall ensure that quality objectives, including those
needed to meet requirements for product (section 7.1 A), are
established at relevant functions and levels within the organization.The
Quality objectives shall be measurable and consistent with the Quality
Policy.
Note:
Quality objectives shall be established at relevant functions
and levels
Quality objectives shall be measurable and consistent with
the Quality Policy
10 July 2014

•The management shall define quality objectives & measurements
that shall be included in the business plan & used to deploy the
quality policy.
•Note: Quality objectives should address customer expectations &
be achievable within a defined time period.
10 July 2014
5.4.1.1 Quality Objectives – Supplemental

5.4 Planning
Top management shall ensure that:
a) the planning of the Quality Management System is carried out in
order to meet the requirements given in 4.1, as well as the
Quality Objectives, and
b) The integrity of the Quality Management System is maintained
when changes to the Quality Management System are planned
and implemented
Note:This clause refers to Quality Management System Planning
10 July 2014
5.4.1.1 Quality Objectives – Supplemental

5.5 Responsibility, Authority & Communication
Top Management shall ensure that the responsibilities
and authorities are defined and communicated
within the organization.
10 July 2014
5.5.1 Responsibility and Authority

Managers with responsibility & authority for corrective action
shall be promptly informed of products & processes which do not
conform to requirements.
Personnel responsible for product quality shall have the authority
to stop production to correct quality problems. **
Production operations across all the shifts shall be staffed with
personnel in charge of , or delegated responsibility for ensuring
product quality
10 July 2014
5.5.1.1 Responsibility for Quality

Top management shall appoint a member of the management who,
irrespective of other responsibilities, shall have responsibility and
authority that includes:
a) Ensuring that the processes of the quality management system are
established, implemented and maintained;
b) Reporting to the top management on the performance of the quality
management system, and any need for improvement and;
c) Ensuring the promotion of awareness of customer requirements
throughout the organization.
Note: The responsibility of a Management Representative can include
liaison with external parties on matters relating to the Quality
Management System.
Note:
Promoting awareness of customer requirement throughout the
organization.
10 July 2014
5.5.2 Management Representative

Top management shall designate personnel with responsibility &
authority to ensure that customer requirements are addressed.
This includes selection of special characteristics, setting quality
objectives & related trainings, corrective & preventive actions,
product design & development.
10 July 2014
5.5.2.1 Customer Representative

Top Management shall ensure that appropriate communication
processes are established within the organization, and that
communication takes place regarding the effectiveness of the Quality
Management System.
Note:
To ensure communication between the various levels and
functions regarding the processes of the quality
management system and its effectiveness.
10 July 2014
5.5.3 Internal Communication

5.6 Management Review
Top management shall review the quality management system, at
planned intervals to ensure its continuing suitability, adequacy and
effectiveness. This review shall include assessing opportunities for
improvement and the need for changes to the quality management
system, including the quality policy and quality objectives.
Records from management reviews shall be maintained. (4.2.4)
The term effectiveness is defined as extent to which planned activities
are realized and planned results achieved
10 July 2014
5.6.1 General

These reviews shall include all requirements of the quality
management system & its performance trends as an essential
part of continual improvement process.
Part of the management review shall be the monitoring of quality
objectives, & the regular reporting & evaluation of the cost of
poor quality (8.4.1 & 8.5.1)
These results shall be recorded to provide, as a minimum,
evidence of the achievement of
– the quality objectives specified in the business plan
– Customer satisfaction with product supplied
10 July 2014
5.6.1.1 Quality Management System Performance

Inputs to management review shall include information on:
a) results of audits;
b) customer feedback;
c) process performance and product conformance;
d) status of preventive and corrective actions;
e) follow-up actions from earlier management reviews;
f) changes that could affect the quality management system;
g) recommendations for improvement.
10 July 2014
5.6.2 Review Input

Input to management review shall include an analysis of actual &
potential field-failures & their impact on quality, safety &
environment.
Note: Defined precisely the Contents of Review
Includes review of current performance and improvement
opportunities related to:
Follow-up actions from earlier management reviews and,
Changing circumstances that could affect the Quality
Management System
Positive step for reporting on Management Systems
10 July 2014
5.6.2.1 Review input – supplement

The outputs from the management review shall include actions related
to
a) improvement of the quality management system and its
processes;
b) improvement of product related to customer requirements;
c) resource needs.
Note: The output from the review shall include actions
related to:
Improvement of the quality management system and its
processes
Improvement of product related to customer requirements
And resource needs to fulfill the above actions
10 July 2014
5.6.3 Review output

6. Resource Management
The organization shall determine and provide, the resources needed
(ele. 5 is Top mgmt., resource can be by org.)
a) to implement and maintain the quality management system, and
continually improve its effectiveness and,
b) to enhance customer satisfaction by meeting customer
requirements.
10 July 2014
6.1 Provision of Resources

6.2 Human Resources
Personnel performing work affecting product quality shall be competent
on the basis of appropriate education, training, skills and experience.
Note:
More focus on the competency (see 6.2.2)
10 July 2014
6.2.1 General

6.2 Human Resources
The organization shall:
a) determine the necessary competence for personnel performing
work affecting product quality;
b) Provide training or take other actions to satisfy these needs;
c) Evaluate the effectiveness of the action taken;
d) Ensure that its personnel are aware of the relevance and
importance of their activities and how they contribute to the
achievement of the quality objectives;
e) Maintain appropriate records of education, training, skills and
experience ( see 4.2. 4)
10 July 2014
6.2.2 Competence, Awareness and Training

6.2 Human Resources
Note:
Competency needs shall be identified.
Effectiveness of provided training shall be evaluated with
relevance to the organization.
Employees awareness of the relevance and importance of their
activities and their contribution to achieve the quality
objectives shall be ensured.
10 July 2014
6.2.2 Competence, Awareness and Training

6.2 Human Resources
The organization shall ensure that personnel with product
responsibility are competent to achieve design requirements &
are skilled in the applicable tools & techniques.
Applicable tools & techniques shall be identified by the
organization.
10 July 2014
6.2.2.1 Product Design Skills

6.2 Human Resources
The organization shall establish & maintain documented
procedures for identification of training needs & achieving
competence of all personnel performing activities affecting
product quality.
Personnel performing specific assigned tasks shall be qualified,
as required with particular attention to the satisfaction of
customer requirements
Note 1 This applies to all employees having an effect on quality at
all levels of the organization
Note 2 An example of the customer specific requirements is the
application of digitized mathematically based data.
10 July 2014
6.2.2.2 Training

6.2 Human Resources
The organization shall provide on the job training for personnel in
any new or modified job affecting product quality, including
contract or agency personnel. Personnel whose work can affect
quality shall be informed about the consequences to the customer
of nonconformity to quality requirements.
10 July 2014
6.2.2.3 Training on the job

6.2 Human Resources
The organization shall have a process to motivate employees to
achieve quality objectives, to make continual improvements, &
create environment to promote innovation. The process shall
include the promotion of quality & technological awareness
throughout the whole organization.
The organization shall have a process to measure the extent to
which its personnel are aware of the relevance & importance of
their activities & how they contribute to the achievement of
quality objectives (6.2.2.d)
10 July 2014
6.2.2.4 Employee Motivation & Empowerment **

6.3 Infrastructure
The organization shall determine, provide and maintain the
infrastructure needed to achieve the conformity to product
requirements. Infrastructure includes:
a) buildings, workspace and associated facilities;
b) process equipment (both hardware and software); and
c) supporting services (such as transport or communication).
10 July 2014

6.3 Infrastructure
Note:
Formal consideration required to identify, provide the
infrastructure needed to support activities.
Maintenance to cover all such facilities
This shall include:
Workplace and associated facilities
Equipment, hardware and software
Supporting services
10 July 2014

6.3 Infrastructure
The organization shall use a multidisciplinary approach (7.3.1.1)
for developing plant, facility & equipment plans. Plant layout
shall optimize material travel, handling & value added use of floor
space, & shall facilitate synchronous material flow. Methods shall
be developed & implemented to evaluate & monitor the
effectiveness of the existing operations.
Note :These requirements should focus on lean manufacturing
principles & link to the effectiveness of the quality management
system.
10 July 2014
6.3.1 Plant, facility & equipment planning

6.3 Infrastructure
The organization shall prepare contingency plans to satisfy
customer requirements in the event of an emergency such as
utility interruption, labour shortages, key equipment failure &
field returns
10 July 2014
6.3.2 Contingency plans

6.4 Work Environment
The organization shall determine and manage the work environment
needed to achieve conformity to product requirements.
Note:
Identify and manage those human and physical factors of the
work environment needed to achieve conformity of product
and/ or services
Examples of Human factors - Personal protective
equipment( safety), hygiene, ergonomics, interpersonal
relations, welfare etc.
Physical Factors - Lighting, temperature, noise, air
quality, vibration, etc.
10 July 2014

6.4 Work Environment
6.4.1 Personnel safety to achieve product quality
Product safety & means to minimize potential risks to
employees shall be addressed by the organization ,
especially in the design & development process & in the
manufacturing process activities.
The organization shall maintain its premises in a state of
order, cleanliness & repair consistent with the product &
manufacturing process needs.
10 July 2014
6.4.1 Personnel safety to achieve product quality

7. Product Realization
The organization shall plan and develop the processes needed for
Product Realization. Planning of Product Realization shall be
consistent with the requirements of the other processes of the Quality
Management System (See 4.1)
In the planning of Product Realization the organization shall
determine the following, as appropriate:
a) quality objectives and requirements for the product,
b) the need to establish processes, documents and provide
resources specific to the product.
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 meet requirements (See 4.2.4)
10 July 2014
7.1 Planning for Product Realization

The output of this planning shall be in a form suitable for the
organization’s method of operations.
NOTE:
1) A document specifying the processes of the Quality
Management System (including the product realization
processes) and the resources to be applied to a specific product,
project or contact, can be referred to as Quality Plan
2) The organization may also apply the requirements given in 7.3 to
the development of product realization processes.
10 July 2014

Note: Planning of realization processes shall be documented and
includes as appropriate
Quality objectives for the product, project or contract
The need of processes, documentation and resources
Verification and validation activities and criteria for
acceptability
Necessary records
Note – Some customers refer to project management or advanced
product quality planning as a means to achieve product
realization. Advanced product quality planning embodies the
concept of error prevention & continual improvement as
contrasted with error detection, & based on a multidisciplinary
approach.
10 July 2014

Quality Plan
Document specifying which procedures and associated resources
shall be applied by whom and when to a specific product, project,
service.
Quality Plan refers to the product realization process, quality
manual, procedures
10 July 2014

Customer requirements & references to its technical
specifications shall be included in the planning of product
realization as a component of the quality plan.
10 July 2014
7.1.1 Planning of product realization – Supplemental

Acceptance criteria shall be defined by the organization and,
where required, approved by the customer. For attribute data
sampling, the acceptance level shall be zero defects. (8.2.3.1)
10 July 2014
7.1.2 Acceptance criteria

The organization shall ensure the confidentiality of customer
contracted products & projects under development & related
product information.
10 July 2014
7.1.3 Confidentiality

The organization shall have a process to control & react to
changes that impact product realization. The effects of any
change, including those changes caused by any supplier, shall
be assessed, & verification & validation activities shall be
defined, to ensure compliance with the customer requirements.
Changes shall be validated before implementation.
For proprietary designs, impact on form, fit & function (including
performance & / or durability) shall be reviewed with the
customer so that all effects can be properly evaluated.
When required by the customer, additional verification /
identification requirements, such as those required for new
product introduction, shall be met. Contd…..
10 July 2014
7.1.4 Change control

Note 1 - Any product realization change affecting customer
requirements requires notification to, & agreement from, the
customer.
Note 2 - The above requirement applies to product &
manufacturing process changes.
10 July 2014
7.1.4 Change control

7.2 Customer-related Processes
The organization shall determine,
a) requirements specified by the customer, including the
requirements for delivery and post-delivery activities;
b) product requirements not stated by the customer, but necessary
for specified or intended use, where known;
c) statutory and regulatory requirements related to the product,
d) any additional requirements determined by the organization
Note:
Identifying customer requirements stated and implied
(completeness, fitness for purpose, obligations and legal
requirements, availability, delivery, support)
10 July 2014
7.2.1 Determination of requirements related to Product

Note 1 Post delivery activity include any after-sales product
service provided as part of the customer contract or purchase
order.
Note 2 This requirement includes recycling, environment impact
& special product & process characteristics identified by the
organization
Note 3 Compliance to item c) includes all applicable government,
safety & environmental regulations applied to acquisition,
storage, handling, recycling, eliminating or disposal of materials.
10 July 2014
7.2.1 Determination of requirements related to Product

The organization shall demonstrate conformity to customer
requirements for designation, documentation & control of special
characteristics.
Note :
Consideration of cost elements or prices not included.
10 July 2014
7.2.1.1 Customer-designated special characteristics

The organization shall review the requirements related to the
product. This review shall be conducted prior to organizations
commitment to supply a product to the customer (e.g. submission of
tenders, acceptance of contracts or orders, acceptance of changes to
the contracts or orders) and shall ensure that:
a) product requirements are defined;
b) contract or order requirements differing from those previously
expressed are resolved;
c) the organization has the ability to meet the defined requirements.
Records of the results of the review and actions arising from the
review shall be maintained (see 4.2.4).
Where the customer provides no documented statement of requirement, the
customer requirements shall be confirmed by the organization before
acceptance.
10 July 2014
7.2.2 Review of requirements related to the Product

Where product requirements are changed, the organization shall
ensure that relevant documents are amended and relevant personnel
are made aware of the changed requirements.
Note: In some situations, such as internet sales, a formal review
is impractical for each order. Instead the review can cover
relevant product information such as catalogues or advertising
material
Note :
Clearer, Specific requirement for review and amendment of
existing documentation, where product requirements are
changed.
10 July 2014
7.2.2 Review of requirements related to the Product

7.2.2.1 Review of requirements related to the product –
supplemental
Waving the requirement stated in 7.2.2 for a formal review (see
note) require customer authorization.
7.2.2.2 Organization manufacturing feasibility
The organization shall investigate, confirm & document the
manufacturing feasibility of the proposed products in the
contract review process, including risk analysis
10 July 2014
7.2.2.1 Review of requirements related to the product – supplemental
7.2.2.2 Review of requirements related to the Product

The organization shall determine and implement arrangements for
communicating with customers relating to:
a) product information;
b) enquiries, contracts or order handling, including amendments
&;
c) customer feedback, including customer complaints
Note:
Formal arrangements for communication with
customers (actual or potential) during the “sales process”,
relating to product and/or service information.
Example: Operation Instruction Manuals, Data sheets,
Leaflets, Bar charts, Order Status
10 July 2014
7.2.3 Customer Communication

The organization shall have the ability to communicate
necessary information, including data, in a customer-specified
language & format (e.g. computer aided design data, electronic
data exchange)
10 July 2014
7.2.3.1 Customer Communication - supplemental

7.3 Design & Development
Note: The requirements of 7.3 include product & manufacturing
process design & development, & focus on error prevention
rather than detection
10 July 2014

The organization shall plan and control, design and development of the
product.
Design and development planning shall determine:
a) the design and development stages;
b) review, verification and validation activities appropriate to each
design and development stage and;
c) responsibilities and authorities for design and development
The organization shall manage interfaces between different groups
involved in design and development to ensure effective
communication and clear assignment of responsibilities.
Planning output shall be updated, as appropriate, as design and
development progresses.
10 July 2014
7.3.1 Design and Development Planning

Note:
Consideration in planning for the review, verification and
validation activities/ stages also added.
10 July 2014
7.3.1 Design and Development Planning

The organization shall use a multidisciplinary approach to
prepare for product realization, including:
Development/finalization & monitoring of special
characteristics,
Development & review of FMEAs, including actions to
reduce potential risks, and
Development & review of control plans.
Note: A multidisciplinary approach typically included the
organization’s design, manufacturing, engineering, quality,
production & other appropriate personnel.
10 July 2014
7.3.1.1 Multidisciplinary approach

Inputs related to the product requirements shall be determined and
records maintained (See 4.2.4)
These shall include:
a) functional and performance requirements;
b) applicable statutory and regulatory requirements
c) where applicable, information derived from previous similar
designs and;
d) other requirements essential for design and development.
These inputs shall be reviewed for adequacy. The requirements shall
be complete, unambiguous and not in conflict with each other.
Note Special characteristics (see 7.2.1.1) are included in this
requirement.
10 July 2014
7.3.2 Design and development inputs

Note:
Need for Information gathering from previous similar
designs.
The responsibility of gathering data is specified
Example: Product reliability data, performance history,
warranty record, etc.
10 July 2014
7.3.2 Design and development inputs

The organization shall identify, document & review the product
design inputs requirements, including the following:
Customer requirements (contract review) such as special
characteristics (see 7.3.2.3), identification, traceability &
packaging;
Use of information: the organization shall have a process to
deploy information gained from previous design projects,
competitor analysis, supplier feedback, internal input, field
data & other relevant sources, for current & future projects of
a similar nature;
Targets for product quality, life, reliability, durability,
maintainability, timing & cost.
10 July 2014
7.3.2.1 Product design input

The organization shall identify, document & review the
manufacturing process design input requirements, including
Product design output data
Targets for productivity, process capability & cost,
Customers requirements, if any, and
Experience from previous developments.
Note: The manufacturing process design includes the use of
error-proofing methods to a degree appropriate to the magnitude
of the problems & commensurate with the risk encountered.
10 July 2014
7.3.2.2 Manufacturing Process Design Input

At suitable stages, systematic reviews of design and development
shall be performed in accordance with planned arrangements
(see 7.3.1)
a) to evaluate the ability of the results of design development to
meet requirements and;
b) to identify any problems and propose necessary actions.
Participants in such reviews shall include representatives of functions
concerned with the design and development stage(s) being reviewed.
The records of the results of the reviews and necessary actions shall
be maintained (see 4.2.4).
Note: These reviews are normally coordinated with the design
phases & include manufacturing process design &
development.
10 July 2014
7.3.4 Design and Development Review

Note: Further remark about the aim of the review:
Evaluate the ability to fulfill requirements for quality
Identify problems and propose necessary actions
10 July 2014
7.3.4 Design and Development Review

Measurements at appropriate stages of design & development
shall be defined, analyzed & reported with summary results as an
input to management review.
Note: The measurements include quality risks, costs, lead-times,
critical paths & others, as appropriate.
10 July 2014
7.3.4.1 Monitoring (TS:1999 - “Measurements”) **

Verification shall be performed in accordance with planned
arrangements (see 7.3.1) to ensure that the design and development
outputs have met the design and development input requirements.
Records of the results of the verification and any necessary actions
shall be maintained. (See 4.2.4)
Note: Results of verification and subsequent necessary actions to be
recorded
10 July 2014
7.3.5 Design and Development Verification

Design and development validation shall be performed in accordance
with planned arrangements (See 7.3.1) to ensure that the resulting
product is capable of meeting the requirements for the specified
application or intended use, where known.
Wherever practicable, validation shall be completed prior to the
delivery or implementation of the product.
The records of the results of validation and necessary actions
shall be maintained (See 4.2.4)
Note 1 The validation process normally includes an analysis of
field reports for similar products.
Note 2 The requirements of 7.3.5 & 7.3.6 above apply to both
product & manufacturing processes.
10 July 2014
7.3.6 Design and Development Validation

Note :
Wherever applicable, validation shall be defined, planned and
completed prior to the delivery or implementation of the
product and/or service.
Where it is impossible to undertake full validation prior to
delivery or implementation, partial validation of the design or
development outputs shall be undertaken to the maximum
extent practical.
Need to record results of validation and necessary action
specified
10 July 2014
7.3.6 Design and Development Validation

Design & development validation shall be performed in
accordance with customer requirements including programme
timing.
10 July 2014
7.3.6.1Design and Development Validation - Supplemental

When required by the customer, the organization shall have a
prototype programme & control plan. The organization shall use,
whenever possible, the same suppliers, tooling & manufacturing
processes as will be used in production.
All performance-testing activities shall be monitored for timely
completion & conformity to requirements.
While services may be outsourced, the organization shall be
responsible for the outsourced services, including technical
leadership.
10 July 2014
7.3.6.2 Prototype programme

The organization shall confirm to a product & manufacturing
process approval procedure recognized by the customer.
Note Product approval should be subsequent to the verification
of the manufacturing process.
The product & manufacturing process approval procedure shall
also be applied to suppliers.
10 July 2014
7.3.6.3 Product approval process **

Design and development changes shall be identified, and records
maintained. The changes shall be reviewed, verified and validated, as
appropriate, and approved, before implementation.
The review of design and development changes shall include
evaluation of the effect of the changes on constituent parts and
product already delivered.
Records of results of the review of changes and any necessary actions
shall be maintained (see 4.2.4).
Note: Design & development changes include all changes during
the product programme life (see 7.1.4).
10 July 2014
7.3.7 Control of Design and Development Changes

Note: Additionally evaluate the effect of changes on:
Constituent part of the product
Delivered products
The need for carrying out re-effectiveness or re-validation.
Results of reviews of change(s) to be recorded.
10 July 2014
7.3.7 Control of Design and Development Changes

7.4 Purchasing
The organization shall ensure that the purchased product confirms to
specified purchase requirements. The type and extent of control
applied to the supplier and the purchased product shall be dependent
upon the effect of the purchased product on subsequent product
realization or the final product.
The organization shall evaluate and select suppliers based on their
ability to supply product in accordance with the organization's
requirements. Criteria for selection, evaluation and re-evaluation shall
be established. The records of the results of evaluations and any
necessary actions arising from the evaluation shall be maintained (see
4.2.4).
10 July 2014

7.4 Purchasing
Note 1: Purchased products above include all products &
services that affect customer requirements such as sub-
assembly, sequencing, sorting, rework & calibration services.
Note 2: When there are mergers, acquisitions or affiliations
associated with suppliers, the organization should verify the
continuity of the supplier’s quality management system & its
effectiveness.
10 July 2014

7.4 Purchasing
Note :
The type and extent of control these processes shall be
dependent upon the effect on product realization or the final
product
The establishment of selection and evaluation criteria
becomes a specific requirement.
Records of such evaluations to be maintained.
10 July 2014

7.4 Purchasing
All purchased products or materials used in product shall
conform to applicable regulatory requirements.
10 July 2014
7.4.1.1 Regulatory Conformity

7.4 Purchasing
The organization shall perform Supplier Quality Management
System Development with the goal of supplier conformity with
this Technical Specification. Conformity with ISO 9001 : 2008 is
the first step in achieving this goal.
Note: The prioritization of suppliers for development depends
upon, for example, the supplier’s quality performance & the
importance of product supplied.
Unless otherwise specified by the customer, suppliers to the
organization shall be third party registered to ISO 9001:2008 by
an accredited third-party certification body.
10 July 2014
7.4.1.2 Supplier Quality Management System Development

7.4 Purchasing
Where specified by the contract (e.g. customer engineering
drawing, specification) the organization shall purchase products,
materials or services from approved sources.
The use of customer-designated sources, including tool/gauge
suppliers, does not relieve the organization of the responsibility
for ensuring the quality of purchased products.
10 July 2014
7.4.1.3 Customer-approved sources

7.4 Purchasing
Purchasing information shall describe the product to be purchased,
including where appropriate:
a) requirements for approval of
product
procedures
Processes
equipment
b) requirements for qualification of personnel
c) quality management system requirements.
d) The organization shall ensure the adequacy of specified
purchase requirements contained in the purchasing documents
prior to their communication to the supplier.
10 July 2014
7.4.2 Purchasing Information

7.4 Purchasing
Comment : Previous: Element 4.6.3
Note: Simplification of the necessary purchasing information to
ensure adequacy
Requirements for approval or qualification of product and/or
services, procedures, processes, equipment and personnel
Quality management system requirements
10 July 2014
7.4.2 Purchasing Information

7.4 Purchasing
The organization shall establish and implement the inspection or other
activities necessary for ensuring that the purchased product meets
specified purchase requirements.
Where the organization or its customer intends to perform verification
at the supplier’s premises, the organization shall state the intended
verification arrangements and method of product release in the
purchasing information.
10 July 2014
7.4.3 Verification of purchased product

7.4 Purchasing
The organization shall have a process to assure the quality of
purchased product (see 7.4.3) utilizing one or more of the following
methods:
Receipt of, & evaluation of, statistical data by the
organization
Receiving inspection &/or testing such as sampling based on
performance;
Second or third party assessments or audits of supplier sites,
when coupled with records of acceptable delivered product
quality;
Part evaluation by a designated laboratory;
Another method agreed with the customer.
10 July 2014
7.4.3.1 Incoming product quality

7.4 Purchasing
Supplier performance shall be monitored through the following
indicators:
Delivered product quality
Customer disruption including field returns;
Delivery schedule performance (including incidents of
premium freight); (100% on-time removed)
Special status customer notifications related to quality or
delivery issues.
The organization shall promote supplier monitoring of the
performance of their manufacturing processes.
10 July 2014
7.4.3.2 Supplier monitoring

7.5 Production and Service Provisions
The organization shall plan and carry out production and service
provision under controlled conditions. Controlled conditions shall
include, as applicable:
a) the availability of information that describes the characteristics of
the product;
b) the availability of work instructions,as necessary
c) the use of suitable equipment
d) the availability and use of measuring and monitoring devices;
e) the implementation of monitoring & measurement
f) the implementation of release, delivery and post - delivery
activities.
10 July 2014
7.5.1Control of Production and Service Provision

The organization shall
Develop control plans (see annex A) at the system, subsystem,
component &/or material level for the product supplied, including
those for processes producing bulk materials as well as parts, and
Have a control plan for pre-launch & production that takes into
account the design FMEA & manufacturing process FMEA outputs.
The control plan shall
List the controls used for the manufacturing process control,
Includes methods for monitoring of control exercised over special
characteristics (see 7.3.2.3) defined by both the customer & the
organization,
Include the customer-required information, if any.
Initiate the specified reaction plan (see 8.2.3.1) when the process
becomes unstable or not statistically capable.
Contd..
10 July 2014

Control plans shall be reviewed & updated when any changes
occurs affecting the product, manufacturing process,
measurement, logistics, supply sources or FMEA (see 7.1.4)
Note: Customer approval may be required after review or update
of the control plan.
10 July 2014

The organization shall prepare documented work instructions for
all employees having responsibilities for the operation of the
processes that impact product quality. These instructions shall
be accessible for use at the work station.
These instructions shall be derived from sources such as the
quality plan, the control plan & the product realization process
10 July 2014
7.5.1.2 Work instructions

Job set-ups shall be verified whenever performed, such as initial
run of a job, material changeover or job change Work
instructions shall be available for set-up personnel. The
organization shall use statistical methods of verification where
applicable.
Note: Last-off-part comparisons are recommended.
10 July 2014
7.5.1.3 Verification of job set-ups

The organization shall identify key process equipment & provide
resources for machine/equipment maintenance & develop an
effective planned total preventive maintenance system. As a
minimum, this system shall include the following:
Planned maintenance activities;
Packaging & preservation of equipment, tooling & gauging;
Availability of replacement parts for key manufacturing
equipment;
Documenting, evaluating & improving maintenance
objectives.
The organization shall utilize predictive maintenance methods to
continually improve the effectiveness & the efficiency of
production equipment.
10 July 2014
7.5.1.4 Preventive & predictive maintenance

The organization shall provide resources for tool & gauge design,
fabrication & verification activities.
The organization shall establish & implement a system for
production tooling management including:
Maintenance & repair facilities & personnel;
Storage & recovery;
Set-up;
Tool change programme for perishable tools;
Tool design modification documentation, including
engineering change level;
10 July 2014
7.5.1.5 Management of Production Tooling

Tool modification & revision to documentation;
Tool identification, defining the status, such as production,
repair or disposal.
The organization shall 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.
10 July 2014
7.5.1.5 Management of Production Tooling

Production shall be scheduled in order to meet customer
requirements, such as just in time, supported by an information
system that permits access to production information at key
stages of the process & is order driven.
10 July 2014
7.5.1.6 Production scheduling

A process for communication of information on service concerns
to manufacturing, engineering & design activities shall be
established & maintained.
Note: The intent of the addition of “service concerns” to this sub-
clause is to ensure that the organization is aware of
nonconformities that occur external to its organization.
10 July 2014
7.5.1.7 Feedback of information from service

When there is a service agreement with the customer, the
organization shall verify the effectiveness of
Any organization service centres
Any special purpose tools or measurement equipment, &
The training of service personnel.
10 July 2014
7.5.1.8 Service agreement with customer **

7.5.2 Validation of processes for production & service provision
The organization shall validate any processes for production and
service provision where the resulting output cannot be verified by
subsequent measurement or monitoring. 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 the processes to achieve
planned results.
10 July 2014

The organization shall establish arrangements for the processes
including as applicable:
a) defined criteria for review and approval of the processes;
b) approval of equipment and qualification of personnel;
c) use of specific methods and procedures;
d) requirements for records (see 4.2.4);
e) re-validation
10 July 2014

Note :
All manufacturing Processes shall be validated .
Method / arrangements used needs to be defined shall
include, as applicable:
Qualification of processes
Qualification of equipment and/or personnel
Use of specific procedures
Requirements of records
Re-validation
10 July 2014

7.5.2.1 Validation of processes for production & service provision
supplemental
The requirements of 7.5.2 shall apply to all processes for
production & service provision.
10 July 2014
7.5.2.1 Validation of processes for production & service provision

The organization shall identify, where appropriate, the product by
suitable means throughout product realization.
The organization shall identify the status of the product with
respect to measurement and monitoring requirements.
Where tracebility is a requirement, the organization shall control
and record the unique identification of the product (see 4.2.4)
Note: In some industry sectors, configuration management is a
means by which identification and tracebility are maintained
10 July 2014

Note: Inspection & test status is not indicated by the location of
the product in the production flow unless inherently obvious,
such as material in an automated production transfer process.
Alternatives are permitted, if the status is clearly identified,
documented & achieves the designated purpose.
10 July 2014

The words “Where appropriate” in 7.5.3 shall not apply.
10 July 2014
7.5.3.1 Identification and traceability – Supplemental

The organization shall exercise care with customer property while
it is under the organization’s control or being used by the
organization.
The organization shall identify, verify, protect and safeguard
customer property provided for use or incorporation into the
product.
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. (See 4.2.4)
NOTE: Customer Property can include intellectual property
Note: Customer owned returnable packaging is included in this
clause.
All property of the customer, includes information provided in
confidence
10 July 2014
7.5.4 Customer property

Customer owned tools, manufacturing, test, inspection tooling &
equipment shall be permanently marked so that the ownership of
each item is visible, & can be determined.
10 July 2014
7.5.4.1 Customer owned production tooling

The organization shall preserve the conformity of product during
internal processing and delivery to the intended destination. This
preservation shall include identification, handling, packaging,
storage, and protection.
Preservation shall also apply to the constituent parts of a product.
Note: Requirements regarding customer-packaging & labeling
standards not included here. These are included in section
7.3.2.1 Product design input & 7.3.2.2 (customer requirements, if
any) & 7.2.1 a – determination of customer requirements.
10 July 2014
7.5.5 Preservation of Product

In order to detect deterioration, the condition of the product in
stock shall be assessed at appropriate planned intervals.
The organization shall use an inventory management system
to optimize inventory turns over time & assure stock rotation,
such as first – in – first – out.(FIFO) . Obsolete product shall
be controlled in a similar manner to nonconforming product
10 July 2014
7.5.5.1 Storage & inventory

The organization shall determine the monitoring and measurement to
be undertaken and the monitoring and measuring devices needed to
provide evidence of conformity of product to determined requirements.
(See 7.2.1)
The organization shall establish processes to ensure that measuring
and monitoring can be carried out and are carried out in a manner that
is consistent with the monitoring and measuring requirements.
Where necessary to ensure valid results, measuring equipment shall:
a) be calibrated or verified at specified intervals or prior to use, against
measurement standards traceable to international or national
measurement standards; where no such standards exist, the basis
used for calibration or verification shall be recorded
b) be adjusted or re-adjusted as necessary;
c) be identified to enable calibration status to be determined
Contd…
10 July 2014
7.6 Control of measuring and monitoring devices

d) be safe guarded from adjustments that would invalidate the
measurement results
e) be protected from damage and deterioration during handling,
maintenance and storage;
In addition the organization shall assist and record the validity of
the previous measuring results when the equipment is found not to
conform to requirements. The organization shall take appropriate
action on the equipment and any product affected. Records of the
results of calibration and verification shall be maintained. (See
4.2.4)
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.
10 July 2014

Note: See ISO 10012-1 and ISO 10012-2 for guidance.
Note: Knowledge of the measurement uncertainty of the
measuring and monitoring devices and consistency with the
required measurement capability .
More Practical Approach
Note: A number or other identifier traceable to the device
calibration record meets the intent of requirement
10 July 2014

Statistical studies shall be conducted to analyze the variation
present in the results of each type of measuring & test equipment
system. This requirement shall apply to measurement systems
referenced in the control plan. The analytical methods &
acceptance criteria used shall conform to those in customer
reference manuals on measurement system analysis. Other
analytical methods & acceptance criteria may be used if
approved by the customer.
10 July 2014

Statistical studies shall be conducted to analyze the variation
present in the results of each type of measuring & test equipment
system. This requirement shall apply to measurement systems
referenced in the control plan. The analytical methods &
acceptance criteria used shall conform to those in customer
reference manuals on measurement system analysis. Other
analytical methods & acceptance criteria may be used if
approved by the customer.
10 July 2014
7.6.1 Measurement System Analysis

Records of the calibration/verification activity for all gauges,
measuring & test equipment, needed to provide evidence of
conformity of product to determined requirements, including
employee and customer-owned equipment shall include:
Equipment identification, including the measurement
standard against which the equipment is calibrated,
Revisions following engineering changes,
Any out-of-specification reading as received for
calibration/verification.
An assessment of the impact of out-of-specification
condition,
Statements of conformity to specification after
calibration/verification, and
Notification to customer if suspect product or material has
been shipped.
10 July 2014
7.6.2 Calibration / verification records

The organization’s internal laboratory facility shall have a defined
scope that includes its capability to perform the required
inspection, test or calibration services. This laboratory scope
shall be included in the quality management system
documentation. The laboratory shall specify & implement, as a
minimum, technical requirements for:
Adequacy of the laboratory procedures,
Competency of the laboratory personnel, testing of the
product,
Capability to perform these services correctly, traceable to
the relevant process standard (such as ASTM, EN etc.), and
Review of the related records.
Note: Accreditation to ISO/IEC 17025 may be used to
demonstrate supplier in-house laboratory conformity to this
requirement but is not mandatory.
10 July 2014
7.6.3.1 Internal laboratory

External / commercial / independent laboratory facilities used for
inspection, test or calibration services by the organization shall
have a defined laboratory scope that includes the capability to
perform the required inspection, test or calibration, & either
There shall be evidence that the external laboratory is
acceptable to the customer, or
The laboratory shall be accredited to ISO/IEC 17025 or
national equivalent.
10 July 2014
7.6.3.2 External laboratory

Note 1: Such evidence may be demonstrated by customer
assessment, for example, or by customer-approved second party
assessment that the laboratory meets the intent of ISO/IEC 17025
or national equivalent.
Note 2: 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 organization should
ensure that the requirement listed in 7.6.3.1 have been met.
10 July 2014
7.6.3.2 External laboratory

8 Measurement, Analysis and Improve
The organization shall plan and implement the monitoring,
measurement, analysis and improvement processes needed
to demonstrate conformity of the product
to ensure conformity of the quality management system, and
to continually improve the effectiveness of the quality
management system
This shall include determination of applicable methods, including
statistical techniques, and the extent of their use.
Note:
Planning of measurement and monitoring activities needed
to achieve improvements not just limited to products but
also to the processes of the organization and quality
management system itself.
Statistical techniques to be determined for the same.
10 July 2014
8.1General

8 Measurement, Analysis and Improve
8.1.1 Identification of statistical tools
Appropriate statistical tools for each process shall be
determined during advance quality planning & included in the
control plan.
8.1.2 Knowledge of basis statistical concepts
Basic statistical concepts, such as variation, control (stability),
process capability & over-adjustment shall be understood &
utilized throughout the organization.
10 July 2014
8.1.1 Identification of statistical tools
8.1.2 Knowledge of basis statistical concepts

8.2 Measurement and monitoring
As one of the measurements of the performance of the quality
management system the organization shall monitor information
relating to customer perception as to whether the organization has
met customer requirements. The methods for obtaining and using
this information shall be determined.
Note: Consideration should be given to both internal & external
customers.
Comment:
Note:
Monitoring of information on customer satisfaction and/or
dissatisfaction. The methods shall be defined.
Responsibility of determination of methods lies with the
organization.
10 July 2014
8.2.1 Customer satisfaction

Customer satisfaction with the organization shall be monitored
through continual evaluation of performance of the realization
processes. Performance indicators shall be based on objective
data & include, but not limited to
Delivered part quality performance
Customer disruptions including field returns
Delivery schedule performance (including incidences of
premium freight), and
Customer notifications related to quality or delivery issues.
The organization shall monitor the performance of
manufacturing processes to demonstrate compliance with
customer requirements for product quality & efficiency of the
process.
10 July 2014
8.2.1.1 Customer satisfaction – Supplemental

The organization shall conduct internal audits at planned intervals to
determine whether the quality management system :
conforms to the planned arrangements (see 7.1), to the requirement
of this International Standard and to the quality management system
requirements established by the organization; and
is effectively implemented and maintained.
An audit program shall be planned, taking into consideration, the status
and importance of the processes and areas to be audited, as well as the
results of previous audits. The audit criteria, scope, frequency, and
methods shall be defined. Selection of auditors and conduct of audits shall
ensure objectivity and impartiality of the audit process. Auditors shall not
audit their own work.
The responsibilities and requirements for planning and conducting audits,
and for reporting results and maintaining records (see 4.2.4) shall be
defined in a documented procedure.
10 July 2014
8.2.2 Internal audit

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. (See 8.5.2)
NOTE: See ISO 19011 for guidance.
4.17
Note :
More clarity on subject of independence
Verification result shall be reported
10 July 2014
8.2.2 Internal audit contd…..

8.2.2.1 Quality Management System audit
The organization shall audit its quality management system to
verify compliance with this Technical specification & any
additional quality management system requirements.
8.2.2.2 Manufacturing Process Audit
The organization shall audit each manufacturing process to
determine its effectiveness.
10 July 2014
8.2.2.1 Quality management system audit
8.2.2.2 Manufacturing process audit **

8.2.2.3 Product audit
The organization shall audit products at appropriate stages of
production & delivery to verify conformity to all specified
requirements, such as product dimensions, functionality, packaging
& labeling, at a defined frequency
8.2.2.4 Internal audit plans
Internal audit shall cover all quality management related processes,
activities & shifts, and shall be scheduled according to an annul
plan.
When internal/external nonconformities or customer complaints
occur, the audit frequency shall be appropriately increased.
Note: Specific checklists should be used for each audit.
10 July 2014
8.2.2.3 Process Audit
8.2.2.4 Internal audit plans

•The organization shall have internal auditors who are qualified to
audit the requirements of this Technical specification (6.2.2.2)
10 July 2014
8.2.2.5 Internal auditor qualification

8.2.3 Monitoring and measurement of processes
The organization shall apply suitable methods for monitoring and,
where applicable, measurement of the quality management system
processes. These methods shall demonstrate the ability of the
processes to achieve planned results. When planned results are not
achieved, correction and corrective action shall be taken, as
appropriate, to ensure conformity of the product.
Note:
Measurement and monitoring methods to be applied shall
confirm the continuing ability of each process. ( e.g.-
accuracy, timeliness, dependability, reaction time, cycle time,
efficiency etc…-)
10 July 2014

8.2.3.1 Monitoring & measurement of manufacturing processes
same approach, clear & elaborated wordings)
The organization shall perform process studies on all new
manufacturing (including assembly or sequencing) processes to
verify process capability & to provide additional input for process
control. The results of process studies shall be documented with
specifications, where applicable, for means of production,
measurement & test & maintenance instructions. These
documents shall include objectives for manufacturing process
capability, reliability, maintainability & availability, as well as
acceptance criteria.
Contd. ….
10 July 2014

8.2.3 Monitoring and measurement of processes
The organization shall maintain manufacturing process capability
or performance as specified by the customer part approval
process requirements. The organization shall ensure that the
control plan & process flow diagram are implemented, including
adherence to the specified
Measurement techniques
Sampling plans
Acceptance criteria and
Reaction plans when the acceptance criteria are not met
Significant process events, such as tool change or machine
repair, shall be recorded.
•Contd. ….
10 July 2014

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