Comparis

How the ISO/TS 16949 Additions have moved from 1st to 2nd edition

Element Number 4.0 5.0 6.0 7.0 8.0

Total Additons

Most Additions Applied Within

ElementRemoved Added

4.1 1/6 1/1 1/2 1/2 4/11 5.0 1

4.2 0/1 0/1 1/1 3/13 0/2 4/18 7.0 1 1

4.3 0/1 0/1 7.0 1

4.4 0/1 0/7 0/8 7.0

4.5 0/1 0/2 4.0 1

4.6 0/4 0/1 0/5 7.0 1 note 2 notes

4.7 0/1 0/1 7.0

4.84.9 2/1 0/4 0/2 2/6 7.0

4.10 1/2 0/2 1/4 8.0 1 note

4.11 1/2 1/1 7.0

4.12 1/1 1/1 7.0

4.13 4 2/2 8.0

X/X Sub-element

Element

How the ISO/TS 16949 Additions have moved from 1st to 2nd edition

4.14 0/5 0/4 8.0

4.15 0/2 0/1 0/7 7.0 4 sub-elements

4.16 0/1 0/1 4.0

4.17 0/6 1/4 8.0

4.18 1/2 2 6.0

4.19 0/2 7.0 1 note

4.20 2 2 8.0

Summary of additions

1/2 1/7 5/5 9/36 7/21 25/74 7.0 11* 3

Element Number 4.0 5.0 6.0 7.0 8.0

Total Additons

Most Additions Applied Within

ElementRemoved Added

X/X Sub-element

Element

Summary of Changes

• A majority of additions to First Edition migrate to 7.0 Product Realization, 8.0 Measurement, Analysis and Improvement and 6.0 Resources in Second Edition.

• Just 2 additions from 1st edition to 2nd edition - 6.5 Sourcing, 7.1.2 Change Control

• Changes have not been made in 17 areas• A change is made to the language of almost every

requirement, whether a change to the wording or removal of a term

TS 169491st edition

TS 16949 2nd 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

Comparison between 1st and 2nd edition

TS 169491st edition


Comments

4.1.1.4 Continuous Improvement

5.3.1 Quality Policy – Supplemental

Moved only the first sentence “Continuous improvement in quality, service, cost , technology shall be provided for in the Quality policy” as a separate element 5.3.1

4.1.1.4 – Remaining requirements

8.5.5.1 – Organizational continuous improvement

Wordings changed “Shall define a process for continual improvement”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 – Quality Responsibility


4.1.2.2.2 – Shift resources

5.5.1.1 – Quality Responsibility



TS 169491st edition


Comments

4.1.2.4 – Organizational interfaces

7.3.1.1 – Multi – Disciplinary approach7.2.3.1 – Customer communication supplemental

Removed “The supplier shall have systems in place….. According to customer advance product quality planning and control plan manual.”Retained “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 – Supplemental4.2.8 – Quality system performance (Above elements are moved to 5.6.1.1)

5.6.1.1 – Quality management system performance5.6.2.1- Management review – supplemental

• Minor wording changes.

• Added “Analysis of field failures and their impact on quality, safety or the environment shall be input to management review”


TS 169491st edition


Comments

4.1.4 – Business Plan Removed Reference is there in 5.4.1.1 and 5.6.1.1, but there requirements of 4.1.4 is missing, not even in Parking lot

4.1.5 – Analysis and use of Company level data

8.4.1 – Analysis and use of company level 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, empowerment and satisfaction

• Removed “Employee satisfaction process”• Note deleted.• This should be 6.2.2.4. There is an error in

the standard in the numbering

4.1.7.1 Product Safety 6.4.1 Safety • 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 169491st edition


Comments

4.2.2.2 – Quality System documentation

4.2.1 – General Note added: At the moment in Parking lot

4.2.3.2 – Quality Plan requirements

7.1.1 – Quality Plan requirements

Word “appropriate” is removed

4.2.4.1 – Product Realization – General

7.1 – Product realization

• Only Note-1 retained. Requirements relating to project management approach and a project team is removed

• Significant removal “Confidentiality of customer-contracted products and projects under development and related product information

4.2.4.2 - Measurements 7.3.4.1 – Monitoring • “These measurements shall include quality risks, costs, lead-times, critical paths” moved to Notes.

4.2.4.3 – Review cycle 7.3.4.1 – Monitoring Removed the requirement. Note still there

4.2 Quality Systems


TS 169491st 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 of processes – Supplemental

• 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 outputs7.3.3.2 – Process design outputs

• In this “Use of product mistake proofing is added.

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

• First two sentences in 4.2.4.5 is removed

4.2.4.6 – Computer aided design

6.2.2.1 – Product design skills

• Entire 4.2.4.6 is removed. Instead one sentence “Applicable tools and techniques shall be identified by the organization” is there in 6.2.2.1

4.2 Quality Systems


TS 169491st edition


Comments

4.2.4.7 – Special characteristics

7.3.2.4 – Special characteristics

• “appropriate methods” removed• Note –2 removed

4.2.4.8 – Feasibility reviews

7.2.2.1 – Manufacturing feasibility

• “including risk analysis” added

4.2.4.9.1 – Management of Process design – General

Removed • Removed – Documentation requirements removed

4.2.4.9.2 – Process design inputs

7.3.2.2 – Manufacturing process design input

• “applicable regulations” removed

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

4.2 Quality Systems


TS 169491st 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 7.5.1.2 – Control Plan • “prototype control plan when required by customer” removed

4.2.4.11 – Product Approval Process

7.3.6.3 – Product Approval Process

• First two requirements including two notes are moved to 7.3.6.3

4.2.4.11 – Product Approval process

7.3.7.1 – Control of Design and development changes – supplemental

• Requirements relating to change moved to 7.3.7.1

• Note added as : See 7.1.2

7.1.2 – Change Control • New requirement added incorporating Change requirements

4.2 Quality Systems


TS 169491st 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 removed

4.2.6 – Tooling management

7.5.1.6 – Tooling management

• Minor wording changes• 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

• Minor wording changes. • 2 notes deleted and two new notes

added

4.2.8 – Quality System performance

5.6.1.1 – Quality Management System performance

• This requirement incorporated along with 4.1.3.2 – Management review supplemental

4.2 Quality Systems


TS 169491st edition


Comments

4.3.2.2 – Review – Supplemental

Removed This requirement is removed

4.3 Contract review


TS 169491st 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

7.3.2.3 Innovation • Just says that Organization shall have a process for innovation in product and process

• Removed “access to R&D facilities”• Right now in Parking lot

4.4 Design Control


TS 169491st 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

• Minor wording changes. Product outputs and the Optimization processes clearly seperated out

4.4.8.2 – Design Validation – Supplemental

7.3.6.1 – Design and development validation – supplemental

• At the moment, recording of design failures and corrective actions is put within brackets. Requirements are not written in detail. First sentence pertaining to customer timing is there

4.4.8.3 – Prototype Programme

7.3.6.2 – Prototype program

No Change

4.4 Design Control


TS 169491st edition


Comments

4.4.9.2 – Evaluation of design change

7.3.7.1 – Control of design and development changes - Supplemental

No change. Incorporated as part of 7.3.7.1 In 7.3.7 note added “Design changes include all changes during the life cycle of the product”Note “This includes changes to proprietary designs” removed

4.4 Design Control



TS 169491st edition


Comments

4.5.2.1 Note Removed Note is Removed

4.5.2.2 Engineering specifications

4.2.3.1 – Engineering Specifications

• Word “procedure removed” and “process” added

• 2 notes currently present removed

4.5 Document and data control

TS 169491st 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”19942 Notes added:Note-1 “Purchased products above includes all products and services that impact customer requirements such as 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

7.4.1.4 Customer approved sources

• “including tool and gaging suppliers” added

4.6.1.3 – Regulatory compliance

7.4.1.2 – Regulatory compliance

• “applicable to country of manufacture and sale” removed

4.6 Purchasing


TS 169491st edition


Comments

4.6.2.2 – Subcontractor development

7.4.1.3 – Supplier Quality management system development

Added “As a minimum the supplier shall be compliant with ISO9001:2000”. This could be a big changeNote 2 relating to prioritization removedNote 1 – Minor changes in wordings

4.6.2.3 – Scheduling subcontractors

8.2.4.3 – Supplier Monitoring

• “Shall require 100% on time delivery and providing planning information and purchase commitments” removed. Only Delivery performance tracking and premium freight tracking retained

4.6 Purchasing


TS 169491st edition


Comments

4.7.2 – Customer owned tooling

7.5.4.1 – Customer owned tooling

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

4.7 Control of customer supplied product


TS 169491st edition


Comments

4.8 7.5.3 – Product Identification and traceability

No change

4.8 Product identification and traceability


TS 169491st 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 major removed• Minor wording changes

4.9.1.4 – Designation of special characteristics

7.2.1.1 – Customer designated special characteristics


4.9.1.5 – Preventive maintenance

7.5.1.5 – Preventive and predictive maintenance

• “Predictive methods to maximize the effectiveness and efficiency of equipments” added

4.9 Process Control


TS 169491st edition


Comments

4.9.2 – Job instructions 7.5.1.3 – Work instructions

“Job instructions” changed to “Work instruction”“without disruption of job” removed“Job instructions shall include or reference ….” removedNote 1 and Note 2 removed

4.9.3 Maintaining process control

8.2.3.1 –Monitoring and measurement of processes – Supplemental

• Word “exceed” removed• Minor wording changes

4.9.4 Verification of job-setups

7.5.1.4 – Verification of Job setups

• Word “Setup is” missing. This is an error.

• “significant time period between runs” removed

4.9.5 Appearance items 8.2.4.5 – Appearance items

• It is 8.2.4.4, should be 8.2.4.5. Minor wording changes

4.9 Process Control


TS 169491st edition


Comments

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

4.10.1.2 Acceptance criteria

8.2.4.1 – Acceptance criteria

• Changed to “Acceptance criteria shall be defined by the customer and documented by the organization”. This is not clear

4.10.2.4 – Incoming product quality

8.2.4.2 – Incoming Product quality

• “Shall have a process to assure quality of incoming product”. When the evidence says that quality is not good then, the corrective actions to be initiated using the following methods

• “ Receipt of statistical data……”• This change means that it is not

mandatory to follow the 4 controls listed as per the 1st edition. This is required only as a corrective action

4.10 Inspection and Testing


TS 169491st edition


Comments

4.10.4.2 – Layout inspection and functional testing

8.2.4.3 – Layout inspection and functional testing

No change

4.10.6 Laboratory requirements

7.6.4 – Laboratory requirements7.6.4.1 – Internal Labs7.6.4.2 – External Labs

• Compliance with ISO/IEC 17025 removed. Now it is not mandatory. Earlier requirements in QS9000:1998 written as mandatory in 2nd edition.

• Lab “shall be included in the quality system”

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

• 2 notes added pertaining on how the customer acceptance of lab can be demonstrated.

• This could be a big change

4.10 Inspection and Testing


TS 169491st edition


Comments

4.11.1.2 – Measurement System Analysis

7.6.1 – Measurement System analysis

Note added saying what requirements to be applied for acceptance in the absence of customer reference manuals (ISO10012-1 and ISO10012-2 to be used in such cases)Existing Note deleted

4.11.3 – Records 7.6.2 – Calibration records

• “an assessment of the impact of the out-of specification condition” added

4.11 Control of inspection, measuring and test equipment


TS 169491st 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 169491st edition


Comments

4.13.1.2 Suspect material or product

8.3 – Control of nonconforming product

“Visual identification for any nonconforming product….” removedAdded “Important: Nonconforming includes material of unknown or suspect status”

4.13.1.3 – Corrective action plan

8.3.1 – Customer information

• “Customer information in case of nonconforming product shipped” is moved to this element

• Requirement relating to quantify,analyze and initiating actions removed

4.13.3 – Control of reworked product

8.3.2 – Control of reworked product

• Minor wording change

4.13.4 – Engineering approved authorization

8.3.3 – Customer authorization

• Change – “Shall obtain customer authorization prior to changing product/process”

• Minor wording changes

4.13 Control of nonconforming product


TS 169491st 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 – Mistake proofing8.5.3.1 – Mistake proofing in preventive action

No Change

4.14.2.2 – Corrective action impact

8.5.2.3 – Corrective action impact

No change

4.14.2.3 – Returned product test/analysis

8.5.2.4 – Returned product test/analysis

• “Rejected” should be “Returned”. This is an error in the standard.

• No change

4.14 Corrective and Preventive action


TS 169491st edition


Comments

4.15.3.2 – Inventory 7.5.5.1 – Storage and inventory

No Change

4.15.4.2 Customer packaging standards

Removed Removed

4.15.4.3 – Labelling Removed Removed

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 169491st edition


Comments

4.15.6.3 – Production scheduling

7.5.1.7 – Production scheduling


4.15.6.4 – Electronic communication

Removed Removed

4.15.6.5 – Shipment notification system

Removed Removed

4.15 Handling, Storage, packaging,preservation and delivery


TS 169491st edition


Comments

4.16.2 Record retention 4.2.4.1 – Record retention

No change

4.16 Control of Quality Records


TS 169491st edition


Comments

4.17.2.1 – Internal quality audits – supplemental – General

8.2.2.1 – Internal audit plans

Note pertaining to adherence to ISO10011-1 removed , since now meeting ISO10011-1 is mandatory

4.17.2.2 – System audit 8.2.2.1 – Internal audit plans

• “Audits shall cover all activities and shifts” moved to 8.2.2.1

8.2.2.2 – Quality management system audit

• Remaining requirements of 4.17.2.2 are moved here. No change

4.17.2.3 – Process audit 8.2.2.3 – Manufacturing Process audit

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

4.17.2.4 – Product audit 8.2.2.4 – Product audit • No change

4.17.3 – Auditor qualification

8.2.2.2 – Internal auditor qualification

• “Shall comply with ISO10011-2 requirements unless specified by customer”. This is a big change.

4.17 – Internal quality audits


TS 169491st 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

• This should be actually 6.2.2.3. This is an error in the standard in numbering. No change

4.18 – Training


TS 169491st edition


Comments

4.19.1 Servicing – Note Note removed

4.19.2 Feedback of information from service

7.5.1.8 – Feedback of information from service

No change

4.19.3 – Servicing agreement with customer

7.5.1.9 – Servicing agreement with customer

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

4.19 - Servicing


TS 169491st 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 169491st edition


Comments

- 6.5 Sourcing “The organization shall identify qualified sources of supply needed to realize products. To maintain consistency and stability, sourcing shall include a process to manage supplier communication and improvement.”

New requirements


Comparis

Documents

2nd editionsheet1element

special purpose

product design4

corrective

2nd edition4

parking lot4

01 note2 notes4

quality policy