Key changes ts169492002

How the elements have moved from 1st edition to 2nd edition

Element number Chap-4 Chap-5 Chap-6 Chap-7 Chap-84.1 X (Max) X X X

4.2 X X X X (Max) X

4.3 X

4.4 X X (Max)

4.5 X

4.6 X(Max) X

4.7 X

4.8 X

4.9 X X(Max) X

4.10 X X(Max)

4.11 X

4.12 X

4.13 X

4.14 X

How the elements have moved from 1st edition to 2nd edition

Element number Chap-4 Chap-5 Chap-6 Chap-7 Chap-84.15 X(Max) X

4.16 X

4.17 X

4.18 X

4.19 X

4.20 X

Summary of relocation

(includes overlap)3 2 5 13 10

Summary of relocation

(without overlap – Sum is equal to 20 elements)

2 1 1 11 5

Summary of the movements

• More focus on Product realization – 11 elements have moved on to product realization

• Next focus is on Measurement – 5 elements have moved on to measurement

• Considering the overlaps also the focus is on Product realization and Measurement with Resources coming next

• 7.5.2.1 – Validation of Production processes – Shall apply to all production processes

• Changes have not been done only in 17 areas (See table for details)

• Almost in every requirement, change is made either in wording or in removal of certain requirements.

Comparison between 1st and 2nd edition

TS 16949

1st edition

TS 16949 – 2nd edition

Comments

1. Scope 1.2 Application added No change in Scope. Applicable throughout the automotive supply chain

2. Normative reference ISO9000:2000 added

Removed

ISO8402:1994

ISO/IEC 17025

3. Terms and Definition Key definition added as part of 3.0

Scope, Application , Terms and Definitions


TS 16949

1st edition


Comments

4.1.1.2 Objectives 5.4.1.1 – Quality Objectives – Supplemental

Changed to “Top management shall define quality objectives and measurements in the business plan to deploy the quality policy.

4.1.1.3 Customer Satisfaction

8.2.1.1 – Customer satisfaction – Supplemental

Removed “Documented Process”

Monitored through Performance indicators. Mandatory indicators are Delivered part quality performance, Customer disruptions including field failures, Delivery schedule performance (including premium freight),Special status customer notifications relating to quality or delivery issuesAdded “The organization shall monitor manufacturing processes’ performance to demonstrate compliance with customer requirements for product quality and efficiency of the process.

4.1 – Management Responsibility


TS 16949

1st edition


Comments

4.1.1.4 Continuous Improvement

Removed Continuous improvement in quality, cost … shall be provided in Quality policy removed

4.1.1.4 – Remaining requirements

8.5.1.1 – Continual improvement of the Organization

Wordings changed “Shall define a process for continual improvement”

“See examples in annex B of ISO9004:2000” added

Note 1 and Note 2 deleted

4.1.2.1.2 – Customer representative

5.5.2.1 – Customer representative

Minor wording changes

4.1.2.1.3 - Quality responsibility

5.5.1.1 – Responsibility of Quality


4.1.2.2.2 – Shift resources

5.5.1.1 – Responsibility of Quality



TS 16949

1st edition


Comments

4.1.2.4 – Organizational interfaces

7.3.1.1 – Multi – Disciplinary approach

7.2.3.1 – Customer communication supplemental

“The organization shall have the ability to communicate necessary information including data in a customer specified language and format, (e.g. computer-aided design data, electronic data exchange,…) “

4.1.3.2 Management review – Supplemental

4.2.8 – Quality system performance

(Above elements are moved to 5.6.1.1)

5.6.1.1 – Quality management system performance

5.6.2.1- Review Input - Supplemental

Word “trends” added in Performance

Added “Input to Management review shall include an analysis of actual and potential field-failures and their impact on quality, safety or the environment

Comparison between 1st and 2nd editionTS 16949

1st edition


Comments

4.1.4 – Business Plan Removed Requirements are removed, but Business plan Reference is there in 5.4.1.1 and 5.6.1.1

4.1.5 – Analysis and use of Company level data

8.4.1 – Analysis and use of data Removed” Supplier shall document trends in quality, operational performance and current quality objectives” (Still reviewing Cost of poor quality is mandatory under 5.6.1.1)

4.1.6 – Employee motivation, empowerment and satisfaction

6.2.2.4 – Employee motivation and empowerment

Added “Technological awareness” along with Quality

Added “Process to measure the extent to which the personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of Quality objectives”

In the above word “Satisfaction” removed

Note deleted.

4.1.7.1 Product Safety 6.4.1 Personnel Safety to achieve Product Quality

Removed “Potential risks to Customers, users and the environment”. Only “Risk to employees” is there

4.1.7.2 – Regulations 7.2.1 – Determination of requirements relating to product

Added as Note-2


TS 16949

1st edition


Comments

4.2.2.2 – Quality System documentation

Removed No requirement of Documented Processes except for the 6 ISO9001:2000 processes

4.2.3.2 – Quality Plan requirements

7.1.1 – Planning of Product Realization - Supplemental


“shall be included in the planning of the product realization as a component of Quality plan”

4.2.4.1 – Product Realization – General

7.1 – Product realization

7.1.3 - Confidentiality

Only Note-1 retained. Requirements relating to project management approach and a project team is removed. Minor word changes in Note-1

No change

4.2.4.2 - Measurements 7.3.4.1 – Monitoring “Measurements at specified stages of Design and Development shall be defined, analyzed and reported with summary results as input to Management review”. Lot of wording changes from the current one (More clarity)

Input to Management review is mandatory now

Note added to show what could be measured.

4.2.4.3 – Review cycle Removed Deleted

4.2 Quality Systems


TS 16949

1st edition


Comments

4.2.4.4 – Multidisciplinary approach

7.3.1.1 – Multi disciplinary approach

No Change

4.2.4.5 Tools and techniques 8.2.3.1 – Monitoring and measurement manufacturing Processes

Last para “The supplier shall perform process studies…… as well as acceptance criteria” is moved to this element

4.2.4.5 Tools and techniques 7.3.3.1 – Product design outputs - Supplemental

7.3.3.2 – Manufacturing Process design outputs

7.3.2.2 – Manufacturing Process design input

In this “Use of product mistake proofing is added.

This already contains “Mistake proofing” , this is retained in the same element.

First two paras in 4.2.4.5 is removed

Added in Note (7.3.2.2)

4.2.4.6 – Computer aided design

6.2.2.1 – Product design skills

Entire 4.2.4.6 is removed. Instead the follg is added “The Organization shall ensure that personnel with Product design responsibility are competent to achieve design requirements and are skilled in applicable tools and techniques. Applicable tools and techniques shall be identified by the organization”

4.2 Quality Systems


TS 16949

1st edition


Comments

4.2.4.7 – Special characteristics

7.3.2.3 – Special characteristics

“appropriate methods” removed.

Wording changes – now requirements are very clear

Note –2 removed

4.2.4.8 – Feasibility reviews 7.2.2.2 – Organization Manufacturing feasibility

“including risk analysis” added.

Minor wording changes makes it more clear now

4.2.4.9.1 – Management of Process design – General

Removed

4.2.4.9.2 – Process design inputs

7.3.2.2 – Manufacturing process design input

“applicable regulations” removed

“such as Design FMEA’s” removed

Note added relating to error proofing

4.2.4.9.3 – Process design output

7.3.3.2 – Manufacturing process design output

“manufacturing process flow chart/layout” added

“Control plan” added

Everwhere the work “Mistake proofing” changed to “Error proofing”

4.2 Quality Systems


TS 16949

1st edition


Comments

4.2.4.9.4 – Process verification 7.3.5 – Design and Development verification

This is part of Design and Development verification since now Design and Development includes “Product and Process design” which is added at the beginning of 7.3 under title “Important”

4.2.4.10 – Control Plan 7.5.1.1 – Control Plan “prototype control plan when required by customer” removed

“have a control plan that takes into account the Design and Process FMEA Outputs” – Word changes (Mandatory to link now FMEA and Control Plan)

“Control plan updation based on Logistics, Supply sources and FMEA” added

Wording changes – Now very clear

4.2.4.11 – Product Approval Process

7.3.6.3 – Product Approval Process

Important note added “Product Approval should be subsequent to the verification of Manufacturing process”

Otherwise minor wording changes

4.2.4.11 – Product Approval process

7.1.4 – Change control Minor wording changes

4.2 Quality Systems


TS 16949

1st edition


Comments

4.2.5 – Plant, facility and equipment planning

6.3.1 – Plant, facility and equipment planning

“Plant layouts shall minimize material travel” changed to “Plant layouts shall optimize material travel”

In Methods shall be developed, added “implemented”

Note added saying “These requirements should focus on Lean manufacturing Principles and the link to the effectiveness of QMS”

4.2.6 – Tooling management 7.5.1.5 – Management of Production tooling


Note added : “This requirement also applies to tooling availability for vehicle spare parts”

4.2.7 – Process Improvement 8.5.1.2 – Manufacturing Process Improvement

“Manufacturing process improvement shall continuously focus upon control & reduction of variation in product characteristics and process parameters”

Two new notes added

“Highest priority on SC’s” removed

4.2.8 – Quality System performance

5.6.1.1 – Quality Management System performance

5.1.1 – Process efficiency


This is a new requirement but is a redundant along with the above one

4.2 Quality Systems


TS 16949

1st edition


Comments

4.3.2.2 – Review – Supplemental

Removed This requirement is removed

4.3 Contract review


TS 16949

1st edition


Comments

4.4 Design Control – Important

7.3 – Design and Development

Added “The requirements of 7.3 are applicable to Product and manufacturing design and development and should focus on error prevention rather than detection”. This is a big change

4.4.2.2 Required skills 6.2.2.1 – Product design skills

Just says that Suppliers resources should be qualified to achieve design requirements and skilled tools and techniques.

List of skills has been removed

4.4.2.3 Research and Development

Removed Deleted

4.4 Design Control


TS 16949

1st edition


Comments

4.4.4.2 Reliability Objectives 7.3.2.1 – Product design inputs

The existing requirement added as one of the inputs to Product design

4.4.4.3 – Use of information 7.3.2.1 – Product design inputs

The existing requirement added as one of the inputs to Product design

4.4.5.2 – Design Optimization

7.3.3.1 – Product design outputs - Supplemental

Added the following outputs

“Product definitions including drawings, mathematically based data, Product design review results, Diagnostic guidelines where applicable”

“Optimization requirements” are removed

4.4.8.2 – Design Validation – Supplemental

7.3.6.1 – Design and development validation – supplemental

Word changes . “Design and Development validation shall be performed in accordance with the customer requirements including timing”

“Procedure for corrective and preventive action shall be followed “ removed

4.4.8.3 – Prototype Programme

7.3.6.2 – Prototype program

No Change

4.4 Design Control


TS 16949

1st edition


Comments

4.4.9.2 – Evaluation of design change

7.1.4 – Change control Incorporated as part of Change control

4.4 Design Control


TS 16949

1st edition


Comments

4.5.2.1 Note Removed Note is Removed

4.5.2.2 Engineering specifications

4.2.3.1 – Engineering Specifications

“Timely review should be as soon as possible and shall not exceed two working weeks” added

Note –2 retained

4.5 Document and data control


TS 16949

1st edition


Comments

4.6.1.1 Note Note removed and added two notes under 7.4.1

Note removed pertaining to Definition 3.1 in ISO9001”1994

2 Notes added:

Note-1 “Purchased products above includes all products and services that impact customer requirements such as sub-assembly, sequencing, sorting, rework and calibration services”

Note-2 “where there are mergers, acquisitions and affiliations associated with suppliers, the organization should verify the continuity of suppliers quality system and effectiveness”

4.6.1.2 – Customer approved subcontractors

7.4.1.3 - Customer approved sources

“including tool and gaging suppliers” added

“Contract (like drawings, specifications)” Word change

4.6.1.3 – Regulatory compliance

7.4.1.1 – Regulatory compliance

“applicable to country of manufacture and sale” removed

4.6 Purchasing


TS 16949

1st edition


Comments

4.6.2.2 – Subcontractor development

7.4.1.2 – Supplier Quality management system development

“Conformity with ISO9001:2000 is the first step in achieving this goal” added

Note 2 retained

Note 1 – removed

“Unless otherwise specified by the customer, Suppliers to the Organization shall be third party registered to ISO9001:2000 by an accredited Third party certification body” – Added. This is a big big change

4.6.2.3 – Scheduling subcontractors

7.4.3.2 – Supplier Monitoring

“Suppliers performance shall be monitored through the follg: indicators

Delivered product quality

Customer disruptions including field returns

Delivery schedule performance (includes freight)

Special status customer notifications relating to quality or delivery issues

The organization shall promote supplier monitoring of their manufacturing processes”

4.6 Purchasing


TS 16949

1st edition


Comments

4.7.2 – Customer owned tooling

7.5.4.1 – Customer owned Production tooling

“manufacturing,test,inspection tooling and equipment” added.

4.7 Control of customer supplied product


TS 16949

1st edition


Comments

4.8 7.5.3 – Product Identification and traceability

7.5.3.1 – Identification and Traceability - Supplemental

No change

Note added giving clarity on certain aspects of Inspection and test status

4.8 Product identification and traceability


TS 16949

1st edition


Comments

4.9.1.2 Cleanliness of Premises

6.4.2 – Cleanliness of premises


4.9.1.3 – Contingency plans

6.3.2 – Contingency plans

“to satisfy the customer specified requirements” added

Natural disaster and force majeur removed


“Field returns” added

4.9.1.4 – Designation of special characteristics

7.2.1.1 – Customer designated special characteristics


4.9.1.5 – Preventive maintenance

7.5.1.4 – Preventive and predictive maintenance

“Predictive methods to continually improve the effectiveness and efficiency of Production equipments” added

4.9 Process Control


TS 16949

1st edition


Comments

4.9.2 – Job instructions 7.5.1.2 – Work instructions

“Job instructions” changed to “Work instruction”

“without disruption of job” removed

“Job instructions shall include or reference ….” removed

Note 1 and Note 2 removed

4.9.3 Maintaining process control

8.2.3.1 –Monitoring and measurement of processes – Supplemental

Word “exceed” removed


4.9.4 Verification of job-setups

7.5.1.3 – Verification of Job setups “significant time period between runs”

removed

4.9.5 Appearance items 8.2.4.2 – Appearance items

No Change

4.9 Process Control


TS 16949

1st edition


Comments

4.10.1.1 Note 8.2.4 – Monitoring and Measurement of Product

Existing note removed. New note pertaining to selection of measurement types added. In parking lot

4.10.1.2 Acceptance criteria 7.1.2 – Acceptance Criteria

Changed to “Acceptance criteria shall be defined by the customer and documented by the organization”. Attribute data sampling plan shall have zero defects as acceptance criteria”

4.10.2.4 – Incoming product quality

7.4.3.1 – Incoming Product Quality

No change

4.10 Inspection and Testing


TS 16949

1st edition


Comments

4.10.4.2 – Layout inspection and functional testing

8.2.4.1– Layout and functional testing

Note added explaining what is Layout inspection

4.10.6 Laboratory requirements

7.6.3 – Laboratory requirements

7.6.3.1 – Internal Labs

7.6.3.2 – External Labs

Compliance with ISO/IEC 17025 removed. Now it is not mandatory.

Word changes makes reqmt. clear

Lab “shall be included in the quality system”

Word “External” added in addition to “Commercial/Independent”

Lab Scope of External lab is must now

“Evidence of external lab acceptable to the customer” is required if the external lab is not an accredited lab

1 note added pertaining on how the customer acceptance of lab can be demonstrated.

1 note on what has to be done if the equipment is calibrated by Manufacturer is provided

4.10 Inspection and Testing


TS 16949

1st edition


Comments

4.11.1.2 – Measurement System Analysis

7.6.1 – Measurement System analysis


4.11.3 – Records 7.6.2 – Calibration records

“an assessment of the impact of the out-of specification condition” and “equipment identification including master standard against which the equipment is calibrated” added

4.11 Control of inspection, measuring and test equipment


TS 16949

1st edition


Comments

4.12 – Inspection and Test status

7.5.3 – Product identification and traceability

No change. Merged with Product identification and traceability

4.12 Inspection and Test status


TS 16949

1st edition


Comments

4.13.1.2 Suspect material or product

8.3.1 – Control of nonconforming product - Supplemental

“Product with unidentified or suspect status shall be classified as non-conforming product” – Word changes

4.13.1.3 – Corrective action plan

8.3.3 – Customer information

“Customer shall be informed promptly in the event that non-conforming product is shipped” – word changes

Requirement relating to quantify,analyze and initiating actions removed

4.13.3 – Control of reworked product

8.3.2 – Control of reworked product

“Instructions including re-inspection” added - Minor wording change

4.13.4 – Engineering approved authorization

8.3.4 – Customer waiver

Change – “Shall obtain customer concession or deviation permit prior to changing product/process”


4.13 Control of nonconforming product


TS 16949

1st edition


Comments

4.14.1.2 Problem solving 8.5.2.1 – Problem Solving

“Shall have a process for problem solving leading to root cause identification and elimination” (Wording change)

4.14.1.3 Mistake proofing

8.5.2.2 – Error Proofing No Change – “Mistake” changed to “Error”

4.14.2.2 – Corrective action impact

8.5.2.3 – Corrective action impact


4.14.2.3 – Returned product test/analysis

8.5.2.4 – Rejected product test/analysis

The word “Return” changed to “Rejected”. This means the scope is bigger now, it also includes the customer line rejections, receiving rejections etc..

No change

4.14 Corrective and Preventive action


TS 16949

1st edition

TS 16949 – 2nd edition Comments

4.15.3.2 – Inventory 7.5.5.1 – Storage and inventory

No Change

4.15.4.2 Customer packaging standards

7.1.1 – Planning of Product realization – Supplemental

“Customer requirements and references to its technical specifications shall be included in the planning of Product realization”

4.15.4.3 – Labelling 7.1.1 Same as above

4.15.6.2 – Performance monitoring of supplier delivery

8.2.1.1 –Customer satisfaction – Supplemental

“Delivery schedule performance including premium freight” is one of the indicators to be tracked

“Organization shall monitor process performance to meet the customer quality and efficiency of process” (This is for lead time tracking).

Removed “Lead time requirements”

Removed the first sentence of current 4.15.6.2

4.15 Handling, Storage, packaging,preservation and delivery


TS 16949

1st edition


Comments

4.15.6.3 – Production scheduling

7.5.1.6 – Production scheduling


4.15.6.4 – Electronic communication

7.1.1

4.15.6.5 – Shipment notification system

7.1.1

4.15 Handling, Storage, packaging,preservation and delivery


TS 16949

1st edition


Comments

4.16.2 Record retention 4.2.4.1 – Record retention


4.16 Control of Quality Records


TS 16949

1st edition


Comments

4.17.2.1 – Internal quality audits – supplemental – General

8.2.2.4 – Internal audit plans

No change

4.17.2.2 – System audit 8.2.2.1 – Quality Management system audit

“Audits shall cover all activities and shifts” moved to 8.2.2.4

4.17.2.3 – Process audit 8.2.2.2 – Manufacturing Process audit

Removed the word “Product realization”. Now the focus is only on manufacturing process.

4.17.2.4 – Product audit 8.2.2.3 – Product audit No change

4.17.3 – Auditor qualification

8.2.2.5 – Internal auditor qualification

No change.

4.17 – Internal quality audits


TS 16949

1st edition


Comments

4.18.1 – Training 6.2.2.2 – Training Even though this is ISO9000:1994 requirement, this is not a requirement in ISO9001:2000. In the 2nd edition, this along with the 2 notes which were present in ISO9000:1994 have been added in this element without any change

4.18.2 Training effectiveness

6.2.2.c Effectiveness requirements is added now as part of ISO9001:2000 6.2.2.c

6.2.2.2 – Training “Special attention shall be given on customer specific requirements” is moved to 6.2.2.2

Note is removed

4.18.3 – Training on the job

6.2.2.3 – Training on the job

No change

4.18 – Training


TS 16949

1st edition


Comments

4.19.1 Servicing – Note Note removed

4.19.2 Feedback of information from service

7.5.1.7 – Feedback of information from service

No change

4.19.3 – Servicing agreement with customer

7.5.1.8 – Servicing agreement with customer

Earlier it was “Special purpose tools” now it is “Special purpose tools or measuring equipments”

4.19 - Servicing


TS 16949

1st edition


Comments

4.20.3 – Identification of statistical tools

8.1.1 – Identification of Statistical tools

No change

4.20.4 – Knowledge of basic statistical concepts

8.1.2 – Knowledge of basic statistical concepts

Word “where appropriate” removed

4.20 – Statistical techniques


TS 16949

1st edition


Comments

7.5.2.1 – Validation of Processes and Service provision - Supplemental

Validation of Processes and Service provision is applicable to all processes of Production and Service provision

New requirements

Technology

Key changes ts169492002