new ts16949

ISO/TS 16949 Table of contents based on ISO9001:2000 changes

1. Scope1.1 General1.2 Applicability

2. Normative References3. Terms and Definitions4. Quality Management System

4.1 General Requirements4.2 Documentation Requirements

4.2.1 General4.2.2 Quality manual4.2.3 Control of Documents

4.2.3.1 Engineering Specifications4.2.4 Control of Records

4.2.4.1 Records Retention


5. Management Responsibility5.1 Management commitment

5.1.1 Process Oriented Organization

5.2 Customer focus5.3 Quality Policy

5.3.1 Quality Policy – Supplemental

5.4 Planning5.4.1 Quality Objectives

5.4.1.1 Quality Objectives – Supplemental

5.4.2 Quality Management Systems Planning

5.5 Responsibility, authority and communication5.5.1 Responsibility and authority

5.5.1.1 Quality Responsibility


5.5.2 Management Representative5.5.2.1 Customer representative

5.5.3 Internal Communication

5.6 Management Review5.6.1 General

5.6.1.1 Quality Management system Performance

5.6.2 Review Input5.6.2.1 Review Input – Supplemental

5.6.3 Review Output

6. Resource Management6.1 Provision of Resources6.2 Human Resources

6.2.1 General


6.2.2 Competence, awareness and training6.2.2.1 Product design skills6.2.2.2 Training6.2.2.3 Training on the Job6.2.2.4 Employee motivation, empowerment and satisfaction

6.3 Infrastructure6.3.1 Plant facility and equipment planning6.3.2 Contingency Plan

6.4 Work environment6.4.1 Safety6.4.2 Cleanliness of premises

6.5 Sourcing


7 Product Realization7.1 Planning of Product realization

7.1.1 Quality Plan requirements7.1.2 Change Control

7.2 Customer Related Processes7.2.1 Determination of requirements related to the product

7.2.1.2 Customer designated Special characteristics7.2.2 Review of requirements related to the product

7.2.2.1 Review – Supplemental7.2.2.2 Manufacturing Feasibility

7.2.3 Customer communication7.2.3.1 Customer communication – Supplement

7.3 Design and Development7.3.1 Design and Development Planning

7.3.1.1 Multidisciplinary approach


7.3.2 Design and Development inputs7.3.2.1 Product Design inputs7.3.2.2 Manufacturing Process design inputs7.3.2.3 Innovation7.3.2.4 Special Characteristics

7.3.3 Design and Development Outputs7.3.3.1 Product Design outputs – Supplemental7.3.3.2 Manufacturing Process design outputs

7.3.4 Design and development review7.3.4.1 Monitoring

7.3.5 Design and Development verification7.3.5.1 Process Verification

7.3.6 Design and Development validation7.3.6.1 Design and Development validation – Supplement7.3.6.2 Prototype Program7.3.6.3 Product Approval Process


7.3.7 Control of Design and Development changes7.3.7.1 Control of Design and Development Changes – Supplemental

7.4 Purchasing7.4.1 Purchasing process

7.4.1.1 Regulatory compliance7.4.1.2 Supplier Quality Management systems development7.4.1.3 Customer approved sources

7.4.2 Purchasing information7.4.3 Verification of purchased product

7.5 Production and Service provision7.5.1 Control of Production and service provision

7.5.1.1 Control Plan7.5.1.2 Work instruction7.5.1.3 Verification of Job setups7.5.1.4 Preventive and predictive maintenance7.5.1.5 Tooling Management


7.5.1.6 Production Scheduling7.5.1.7 Feedback information from Service7.5.1.8 Service agreement with Customer

7.5.2 Validation of processes and service provision7.5.3 Identification and traceability7.5.4 Customer property

7.5.4.1 Customer Owned tooling

7.5.6 Preservation of Product7.5.6.1 Storage and Inventory

7.6 Control of monitoring and measuring devices7.6.1 Measurement System Analysis7.6.2 Calibration records7.6.3 Laboratory requirements

7.6.3.1 Internal Laboratory7.6.3.2 External Laboratory


8 Measurement, Analysis and Improvement8.1 General

8.1.1 Identification of Statistical tools8.1.2 Knowledge of Basic statistical concepts

8.2 Monitoring and measurement8.2.1 Customer Satisfaction

8.2.1.1 Customer satisfaction – Supplemental

8.2.2 Internal audit8.2.2.1 Internal audit plans8.2.2.2 Quality management systems audit8.2.2.3 Manufacturing Process audit8.2.2.4 Product audit8.2.2.5 Internal auditor qualification

8.2.3 Monitoring and measurement of Processes8.2.3.1 Monitoring and measurement of processes - Supplemental


8.2.4 Monitoring and measurement of Product8.2.4.1 Acceptance criteria8.2.4.2 Incoming product quality8.2.4.3 Supplier monitoring8.2.4.4 Layout inspection and Functional testing8.2.4.5 Appearance items

8.3 Control of nonconforming product8.3.1 Customer information8.3.2 Control of reworked product8.3.3 Customer authorization

8.4 Analysis of Data8.4.1 Analysis and use of Company level data


8.5 Improvement8.5.1 Continual improvement

8.5.1.1 Organizational continual improvement8.5.1.2 Manufacturing Process improvement

8.5.2 Corrective action8.5.2.1 Problem solving8.5.2.2 Mistake proofing8.5.2.3 Corrective Action impact8.5.2.4 Returned product test/analysis

8.5.3 Preventive action8.5.3.1 Mistake proofing for preventive action

• ISO/TS16949 standard is compared against the ISO9001:2000 standard

• The addition in the TS16949 standard are listed in the second column• The clauses in the current edition of TS16949 that addresses these

elements are listed in the last column• If there is “-” in the last column, it indicates that it is a new addition in

the ISO/TS16949 standard

A snapshot of the additions

ISO9001:2000 TS16949 (All are additions to ISO9001:2000)

1.1 General Note added regarding Remote location and applications

1.2 Applicability Note added about Design Responsible Organizations

2 Normative Reference No additions

3 Terms and Definitions 3.1 – Highlighted automotive terms and definitions



Current TS16949

4.1 General requirements

Note relating to subcontracting added 4.2.1

4.2 Documentation requirements 4.2.1 General

Note relating to additional documentation requirements added

4.2.2.14.2.2.2

4.2.2 Quality Manual

No additions 4.2.1

4.2.3 Control of Documents

4.2.3.1 Engineering Specifications 4.5.1,4.5.2.1,4.5.2.24.5.3

4.2.4 Control of Records

2 Notes added4.2.4.1 Records Retention

4.16.14.16.2

4. Quality Management System



Current TS16949

5.1 Management commitment 5.1.1 Process Oriented Organization

4.1.1.1

5.2 Customer Focus No additions -

5.3 Quality Policy 5.3.1 Quality Policy – Supplemental

4.1.1.1

5.4 Planning 5.4.1 Quality Objectives

5.4.1.1 Quality Objectives – Supplemental

4.1.1.2

5.4.2 Quality Management Systems Planning

No additions 4.2.3.1

5.5 Responsibility, authority and communication 5.5.1 Responsibility and Authority

5.5.1.1 Quality Responsibility 4.1.2.14.1.2.1.34.1.2.2.2

5. Management Responsibility



Current TS16949

5.5.2 Management Representative 5.5.2.1 Customer Representative 4.1.2.34.1.2.1.2

5.5.3 Internal Communication No addition -

5.6 Management Review 5.6.1 General

5.6.1.1 Quality Management System PerformanceNote added to the above element

4.1.3.14.1.3.24.2.8

5.6.2 Review Input 5.6.2.1 Review input – Supplemental

-

5.6.3 Review Output Note relating to the output added -

5. Management Responsibility



Current TS16949

6.1 Provision of resources No addition 4.1.2.2.1

6.2 Human Resources 6.2.1 General

No addition -

6.2.2 Competence, awareness and training

6.2.2.1 Product design skills6.2.2.2 Training6.2.2.3 Training on the Job6.2.2.4 Employee motivation, empowerment and satisfaction

4.4.2.24.18.1,4.18.24.18.34.1.6

6.3 Infrastructure 6.3.1 Plant, facility and equipment planning6.3.2 Contingency plan

4.2.54.9.14.9.1.3

6. Resource Management



Current TS16949

6.4 Work environment 6.4.1 Safety6.4.2 Cleanliness of premises

4.1.7.14.9.1.2

6.5 Sourcing -

5. Resource Management



Current TS16949

7.1 Planning for Product Realization

Note added relating to APQP Process7.1.1 Quality Plan requirements7.1.2 Change Control

4.2.4.1

4.2.3.2-

7.2 Customer Related Processes 7.2.1 Determination of requirements related to the product

2 notes added7.2.1.1 Customer designated special characteristics

4.4.4.14.9.1.4

7.2.2 Review of requirements related to the product

Note relating to waiver added7.2.2.1 Review – Supplemental7.2.2.2 Manufacturing feasibility

4.3.1,4.3.2.1,4.3.2.2,4.3.3,4.3.4,4.2.4.8

7.2.3 Customer communication 7.2.3.1 Customer communication - Suppliment

4.1.2.4

7. Product Realization



Current TS16949

7.3 Design and Development Note added saying that this is applicable to both product and process design and development

4.4

7.3.1 Design and Development Planning

Note added relating to error prevention

7.3.1.1 Multidisciplinary approach

4.4.2.14.4.34.1.2.44.2.4.9.14.2.4.4

7.3.2 Design and Development inputs

Note added7.3.2.1 Product design inputs7.3.2.2 Manufacturing Process design inputs7.3.2.3 Innovation7.3.2.4 Special Characteristics

4.4.4.14.4.4.2,4.4.4.34.2.4.9.2-4.2.4.7


A snapshot of the additionsISO9001:2000 TS16949 (All are additions

to ISO9001:2000)Current TS16949

7.3.3 Design and Development outputs 7.3.3.1 Product Design outputs –

Supplemental7.3.3.2 Manufacturing Process design output

4.4.5.14.4.5.2

4.2.4.9.3

7.3.4 Design and Development Review

Note added7.3.4.1 Monitoring

4.4.6,4.1.2.44.2.4.34.2.4.2

7.3.5 Design and Development Verification 7.3.5.1 Process Verification

4.4.74.2.4.9.4

7.3.6 Design and Development Validation

Note added7.3.6.1 Design and Development Validation – Supplemental7.3.6.2 Prototype program7.3.6.3 Product Approval Process

4.4.8.14.4.8.2

4.4.8.34.2.4.11




Current TS16949

7.3.7 Control of Design and Development Changes

Note added7.3.7.1 Control of Design and Development Changes - Supplemental

4.4.9.14.4.9.24.2.4.11

7.4 Purchasing 7.4.1 Purchasing Process

2 Notes added

7.4.1.2 Regulatory compliance7.4.1.3 Supplier Quality management systems development7.4.1.4 Customer approved sources

4.6.1.14.6.2.14.6.1.34.6.2.2

4.6.1.2

7.4.2 Purchasing information No addition 4.6.3




7.4.3 Verification of Purchased product

No addition 4.6.4.14.6.4.2

7.5 Production and Service Provision 7.5.1 Control of production and service provision

Note added7.5.1.2 Control Plan7.5.1.3 Work Instructions7.5.1.4 Verification of Job setups7.5.1.5 Preventive and predictive maintenance7.5.1.6 Tooling Management7.5.1.7 Production Scheduling

7.5.1.8 Feedback of information from Service7.5.1.9 Servicing agreement with customer

4.9.1.14.2.4.104.9.24.9.44.9.1.5

4.2.64.15.6.24.15.6.34.19.14.19.24.19.3




7.5.2 Validation of Processes for production and service provision

Note added 4.9.1.1

7.5.3 Identification and traceability

Note added 4.8,4.12

7.5.4 Customer property Note added7.5.4.1 Customer Owned tooling

4.7.14.7.2

7.5.5 Preservation of product 7.5.5.1 Storage and inventory 4.15.1,4.15.24.15.3.14.15.3.24.15.4.14.15.4.24.15.4.34.15.5,4.15.6.1




7.6 Control of monitoring and measuring devices

Note added relating to identification7.6.1 Measurement System Analysis7.6.2 Calibration Records7.6.3 Laboratory requirements 7.6.3.1 Internal Laboratory 7.6.4.1 External Laboratory

4.11.1.14.11.24.11.1.2

4.11.34.10.6--




Current TS16949

8.1 General 8.1.1 Identification of Statistical Tools8.1.2 Knowledge of basic statistical concepts

4.20.14.20.24.20.34.20.4

8.2 Monitoring and measurement

8.2.1 Customer satisfaction

Note added8.2.1.1 Customer satisfaction – Supplemental

4.1.1.34.15.6.2

8.2.2 Internal Audit 8.2.2.1 Internal audit plans8.2.2.2 Quality management system audit8.2.2.3 Manufacturing process audit8.2.2.4 Product audit8.2.2.5 Internal auditor qualification

4.17.1.14.17.2.14.17.2.24.17.2.3

4.17.2.44.17.3

8. Measurement, analysis and Improvement



Current TS16949

8.2.3 Monitoring and measurement of processes

8.2.3.1 Monitoring and measurement of processes – supplemental

4.9.34.2.4.5

8.2.4 Monitoring and measurement of Product

Note added

8.2.4.1 Acceptance criteria8.2.4.2 Incoming Product Quality8.2.4.3 Supplier monitoring8.2.4.4 Layout inspection and functional testing8.2.4.5 Appearance items

4.10.1.14.10.24.10.3,4.10.44.10.54.10.1.24.10.2.44.6.2.34.10.4.2

4.9.5




Current TS16949

8.3 Control of Nonconforming Product

Note added indicate what constitutes nonconforming product8.3.1 Customer information8.3.2 Control of reworked product8.3.3 Customer authorization

4.13.1.14.13.1.24.13.2

4.13.1.34.13.34.13.4

8.4 Analysis of Data 8.4.1 Analysis and use of Company level data

4.1.5

8.5 Improvement 8.5.1 Continual improvement

Note added8.5.1.1 Organization Continual improvement8.5.1.2 Manufacturing Process improvement

4.1.1.4

4.2.7




Current TS16949

8.5.2 Corrective Action

8.5.2.1 Problem Solving8.5.2.2 Mistake Proofing8.5.2.3 Corrective action impact8.5.2.4 Returned product test/analysis

4.14.1.14.14.2.14.14.1.24.14.1.34.14.2.24.14.2.3

8.5.3 Preventive Action 8.5.3.1 Mistake Proofing for Preventive action

4.14.1.1,4.14.1.34.14.3


List of Key Changes• 7.3 – Design and Development is mandatory for both Product and

Manufacturing Process designs and development (earlier it was only for the product)

• Sourcing requirements added in 6.5• Change control requirements are added in 7.1.2• Product and Process innovation requirements are added in 7.3.2.3• There is a distinct dealing of internal and external laboratory• Process for doing continual improvements (like Six sigma) is

mandatory – 8.5.1.1• All new process has to be verified for their capability before

introduction – 8.2.3.1

List of Key Changes• Design optimization is mandatory – 7.3.3.1, though Process

Optimization is not mandatory but implied• Internal auditors qualification against ISO10011-2 is a must

(Mandatory)

new ts16949

Documents

statistical

requirements

service provision7

management

1 management

2 management

3 quality

1 quality