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COMPARISON OF REQUIREMENTS

ISO/TS 16949:2002 vs. ISO/TS 16949:1999 & QS-9000
from THE INFORMED OUTLOOK, May 2002
“A Road Map to 21st Century Automotive Quality, Revisited”
by Radley M. Smith
© MRI, Inc., 2002

Requirement

ISO/TS
16949:2002
Reference

ISO/TS
16949:1999
Reference

ISO/TS
16949:2002
Content

0.2
0.3
0.4

None
None
None

None
None
None

New (ISO 9001:2000)
New (ISO 9001:2000)
New (ISO 9001:2000)

RETHINK ENTIRE QMS
No new requirements
No new requirements

QS-9000
Reference

Impact vs. QS-9000

INTRODUCTION
Process Approach
Relationship with ISO 9004*
Compatibility with Other
Management Systems (ISO 14001)
Goal of this Technical Specification
SCOPE
Scope—General
Application (exclusions)

0.5

4.1.1.4

4.2.5

Same (as 1999 edition)

New: Continually improve QMS

1.1
1.2

None
None

None
None

New (ISO 9001:2000)
New (ISO 9001:2000)

No new requirements
No new requirements

NORMATIVE REFERENCE

2

2

None

New (ISO 9001:2000)

No new requirements

TERMS AND DEFINITIONS

3

3; Annex A

Glossary

New (ISO 9001:2000)

No new requirements

QUALITY
MANAGEMENT SYSTEM
General Requirements

4.1

4.2.1

4.2.1

New (ISO 9001:2000)

Documentation Requirements—General
Documentation Requirements
Quality Manual
Control of Documents

4.2.1
4.2.1
4.2.2
4.2.3
4.2.3.1

4.2.2
4.2.1
4.2.1
4.5.1; 4.5.2;
4.5.3
4.5.2.1

Same
Same
New (ISO 9001:2000)
Same

Engineering Specifications

4.2.2
4.2.1
4.2.1, 4.2.2.2
4.5.1; 4.5.2;
4.5.3
4.5.2.2

New: Continually improve QMS; determine
sequence and interaction of QMS processes
No change
No change
New: Describe interaction of process
No change

Control of Records
Records Retention

4.2.4
4.2.4.1

4.16
4.16.2

4.16
4.16.1

Same
Same

MANAGEMENT
RESPONSIBILITY
Management Commitment

5.1

None

None

New (ISO 9001:2000)

Process Efficiency

5.1.1

Customer Focus

5.2

Quality Policy

5.3

Planning—Quality Objectives +
Supplemental
Quality Management System
Planning
Responsibility, Authority and Communication—Responsibility and Authority
Responsibility for Quality
Information to Management
Stopping Production for
Quality Concerns
Shift Resources

5.4.1;
5.4.1.1
5.4.2
5.5.1
5.5.1.1
5.5.1.1
5.5.1.1
5.5.1.1

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New (TS 16949:2002)

New: The period for “timely review” is
defined as not more than two working weeks
No change
No change

New: Management to provide evidence of
commitment to QMS and its continual
improvement
None
5.1.1
New Requirement
New: Management to review
efficiency of product realization process
None
None
New (ISO 9001:2000)
New: Management to pursue enhancement of customer satisfaction
4.1.1.1
4.1.1
Modified in ISO 9001:2000
Modification: Policy to include commitment
to continually improve QMS
4.1.1.1;
4.1.4 (business New (ISO 9001:2000); minor New: Establish quality objectives for relevant
4.1.1.2
plan may include) TS 16949 interpretation
functions and levels; objectives to be measurable
4.2.3.1a;
4.2.3a
Management responsible for Preparation of “quality plans”
4.2.3.2 (expan.)
ensuring QMS planning
not specified
4.1.2.1.1
4.1.2
Simplification of earlier
Documentation requirements removed,
requirement
greater flexibility
4.1.2.1.1
4.1.2.1.1
Same
No change
4.1.2.1.3
4.1.2.5
Same
No change
4.1.2.1.3
Note to 4.1.2.1.a Same
No change
recommends
4.1.2.2.2
None
Same
Modification: May require Quality
(expansion)
personnel on all shifts
1

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9.2.1.1 No change Confidentiality 7.18.18.2.1.11 Requires defined.3 4. 4.5.1.2 4.2 4.6 Deletes 6 factors 6.6.3 None None Registrar Notification None None 4.2.1. 4.2 4.3 None None RESOURCE MANAGEMENT Provision of Resources 6.3.3.2.1 Review Output 5.2.2 4.3.2 6.1 4. summarizes QS-9000 additional requirements No change No change No change www.1 4.5.1.1.1. 4.1 4.2.18.9.3.1 Deletes recommended internal safety awareness Same PRODUCT REALIZATION Planning of Product Realization + Supplemental 7. safety or environment to be input New (ISO 9001:2000) New: Specifies information on sources to be included as outputs Same New: Provide resources for continual improvement of QMS effectiveness New: Personnel to be competent based on education.3 4.8 4.1. 4.2.2.1. training.1 ISO 9001:2000 adopts QS-9000 requirement for training effectiveness Product Design Skills 6.2.1. deletes note on review methods New: Provide OJT for personnel in new/ modified jobs affecting product quality New: Process to motivate quality objective achievement.1.1.1 Less specific than 1999 edition requirements Training 6.1.2.5.1 4. 4.1 Expands on 1999 edition New (with ISO 9001:2000): Quality objectives to be determined for product Acceptance Criteria 7.5.9.4 4.2 None Internal Communication 5. 4.2.1.2.1.1.2.3.4.1 4.5 4.14.18.2. continual improvements and environment for innovation. Facility and Equipment Planning Contingency Plans Work Environment 6.1.2 4.1.3 None 4.4.1 4. note recommends lean manufacturing focus instead of effectiveness metrics No longer excludes natural disasters No change.1.2.b.1 4.2 None “Field returns” added Semantics only Personnel Safety to Achieve Product Quality Cleanliness of Premises 6.4.4 6. with measurement process ISO 9001:2000 adopts QS-9000 additional requirements No change. 7.2.18.10.1.2. 4.3.4.2.1.1.2 None None Review Input—Supplemental 5.1.3. QS-9000 New (ISO 9001:2000) New: Representative to ensure promotion of awareness of customer requirements New Requirement New: Management to designate personnel to insure customer needs are met by QMS New (ISO 9001:2000) New: Management to ensure internal communication processes are created and used to address QMS effectiveness Not Required Requirement that registrar is notified of an OEM “downgrade” of supplier’s status not specified New (ISO 9001:2000) Expanded: Review to include QMS improvement opportunities and need for changes Both editions go beyond New: Review evidence of achievement of business QS-9000 “company level data” plan quality objectives and customer requirement satisfaction.bsiamericas.2.6.© MRI.2 New (ISO 9001:2000) Human Resources—General 6.2.3 Customer Representative 5.18.2.2 4.com/auto .b.2.10.1.3 Employee Motivation and Empowerment 6.2.3 4.1 4.6.4.1 4.18.1 None None New (ISO 9001:2000) Competence. 4. benchmarking and competitive data comparisons not specified New (ISO 9001:2000) New: Specifies information on sources to be included as inputs Derived from QS-9000 New: Analysis of actual and potential field failures and effect on quality.1 4.2 Semantics only Plant.3. Awareness and Training 6.2.2 4.6 None Expansion of 1999 edition Infrastructure 6. list of required skills is deleted—organization must determine what skills are required Limits application to personnel affecting product quality.1 4.4.2 6.2.1 Quality Management System Performance 5.9.1 (partially new) 4. personnel to be aware of the importance of their activities and contributions to meeting quality objectives No change.4 4.6. not documented criteria New (from QS-9000) QS-9000 Reference 2 Impact vs.3 4.18.2.1.10. Inc.1. experience New: Actions besides training may be needed.3.1.18.3 None 4.2..2 4.1 None Same (as 1999 edition) Training on the Job 4.1.1 4.3.1 Management Review 5. skills.6.1.1.2.1.2.2. 4.10.2 4.1.1.6.1. 4.2.2. 4.5 Review Input 5.2.14.1 4. 2002 Requirement ISO/TS 16949:2002 Reference ISO/TS 16949:1999 Reference ISO/TS 16949:2002 Content Management Representative 5.7.

6. 4. 4.6 4.2.2.1 (Partially new) 4.2 Customer-Related Processes—Determination of Requirements Related to Product Customer-Designated Special Characteristics 7.6. Simplified per No change.9. 4.3.7 4.4.2 Expands QS-9000 New: Performance to be monitored by required monitoring indicators beyond delivery performance 4. QS-9000 Expands to require processes to control and react to changes affecting product realization New: Requirements not stated by customer but necessary to be determined No change Review of Requirements Related to the Product + Supplemental 7.2 4.5 Product Design Outputs—Supplemental Manufacturing Process Design Output Design and Development Review 7.6. 4.2.9.2.com New requirement in 1999 edition Same Adds requirement 4.4.1 7.6.4.2.10.9.4.7 Design and Development Inputs Product Design Input 7.1 4.5.6.4.9.1.9.3.1.2 4.3 7.4.2.4.6.8.1 4.1 4.1 4.4.3 4.1 4.3.1 Rewritten 4.4.2.4.9.1.2. deletes specified requirements for 4.2.1.1.2.1.1 4.2.5.2.3.6.1.2.2.2 4.2.4.5 7.8.2.4.2.1 7.1 New: Suppliers must be registered to ISO 9001:2000 unless otherwise specified by the organization’s customer(s) with TS compliance to be pursued 4.9. 4.2 No change 4.4.4.2.2.2.6.4.1 7.4. customer must authorize waiver of formal review with TS 16949 New: Must document feasibility and include risk analysis New: To have process to communicate with customer No change New (minor): Use approach to determine SCs and develop FMEAs as well as control plans New: Lists inputs to be included New: Inputs to be identified.2.4.3.1 4.2 7.1 Regulatory Compliance Supplier Quality Management System Development 7..4.3 7.g.2 4.4.1 Same No change 4. document and review the identified inputs No change New: Appropriate information to purchasing.1.2.2.3 Same No change 4.5.4.2.3.3.4.2. 4.1 None None New requirement Design and Development Verification Design and Development Validation + Supplemental Prototype Programme Product Approval Process 7.3.1 7. 4.3 4.3 4. 4.9.4.2 Less specific than 1999 edition on CAD applicability Deletes list of required skills No change 7.1.3.6.3.7 4.© MRI.4.7 4.10.3.1.2 7.2 New: ISO 9001:2000 note refers to review of Internet situations. 7.2 7.4.1.4 4.6.1 Rewritten Deletes list of items to be included 3 No change Work instructions required only for process operators who impact product quality .4.4.4.4. 4.2 Production and Service Provision— Control of Production and Service Provision Control Plan Work Instructions 7.3.2.2 4.5.2.11 4.4 None Manufacturing Process Design Input Special Characteristics Design and Development Outputs 7. 4.2. 4.1 ISO/TS 16949:2002 Content QS-9000 Reference Expands on 1999 edition (see also 7.2.4.4.2.10.6 4.2.4 Option added by 2002 edition New: Customer may specify alternative methods 4.4.7 4.4.3..6.2 4.3.4 4.1 4.3.2.2 Expands on 1999 edition Organization Manufacturing Feasibility Customer Communication 7.9.4.1 4.4 4.2.1.9.4.1 7.4.3.2 ISO 9001:2000 release for urgent production 4. production and for service provision No change New: Specific outputs to be included Design reviews should include manufacturing process design and development New: Measurements at specified stages to be management review input No change New: To be conducted to customer requirements (e.2 4.2 4.4 4.4.6.4.3.6.4.4.3 4.3.5. documented and reviewed New: Identify.4.4. Inc.2.4.3 None None New (ISO 9001:2000) Customer Communication— Supplemental Design and Development— Design and Development Planning Multidisciplinary Approach 7.3. 4.2 Both editions expand the QS-9000 requirement Adds list of inputs Expands on 1999 edition None 7.1.1.6. program timing) No change New: PPAP to be applied to suppliers No change Adds note in line with IASG Interpretations Same Changed into new requirement 4. 2002 Requirement ISO/TS 16949:2002 Reference ISO/TS 16949:1999 Reference Change Control 7.4.4.3.3 4.2 7. Rewritten 4.6.9 Same QS-9000 recommendation now requirement Same 7.4.6.10.2.3.1 Note adds verification of supplier system if its ownership changes 4.1.3.2 4.6.3.1.2.6.4.8 4.2.2 4.10 4.2 4.3 Adds risk analysis 7.4.10 4.2.1. 4.2.3 4.5.3.4 Control of Design and Development Changes Purchasing—Purchasing Process 7. 4.3. 4.3.6 4.2.6.7 4.2 inquiry@bsiamericas.3.6.1 7.3.1 4.4.3.1.1.9.2.1.2 4.2. 4.9 Same No change 7.9.2.4.3 4.4.3.2.7 4.9.6.2 4.4 4.8 Same Expanded in 1999 edition 4.4.1.4.2.3.3 Incoming Product Quality Supplier Monitoring 7.2 Customer-Approved Sources Purchasing Information Verification of Purchased Product 7.1.2.3.4.3.7) Expands on 1999 edition Generic requirement to meet customer requirements Impact vs.5.1.3.1.4.6.8. note added Monitoring 7.1 4.4.6 Rewritten.3 7.4.4.1.6.3. 7.4.

3.6.6.17.1.4 4. 4.11.2 4.15.3 4.2.2.10.2 Production Scheduling Feedback of Information From Service Servicing Agreement With Customer 7.1.4 4. including status Rewritten Same 1999 edition added new subclause ISO 9001:2000 specifies arrangements to be established.10.3 of ISO 9001:1994 Simplified language in 2002 edition Does not refer to MSA manual in either edition 2002 adds items to be included in records Impact vs.4.7 Expanded MEASUREMENT.5.1 8.10.1 4.1.3 Laboratory Requirements— Internal Laboratory External Laboratory 7. 4.1 Control of Monitoring and Measuring Devices Measurement System Analysis 7.15.3.5.com/auto . 4.3 7.2.3 4.6 7. 2002 ISO/TS 16949:2002 Reference ISO/TS 16949:1999 Reference 7.2.8 4.1.1 4. revisions following engineering changes and assessment of out-of-specification impacts No change New: Lab to be accredited to ISO/IEC 17025 or acceptable via customer-approved 2nd-party audit New (ISO 9001:2000) None 4 New: Organization to plan and implement the processes needed Same No change Added (ISO 9001:2000) New: Concepts to be used as well (as “understood”) throughout the organization Expanded New: Methods and monitor customer (ISO 9001:2000) perception of quality Clarification (ISO 9001:2000) New: Auditor not to audit his/her own work.1.1 4.1 4.10.4 4.4 4.3 4.15.5 4. 4.4 4.2 4. 4.5.2 4.2 4.7. 4.4 Monitoring and Measurement— Customer Satisfaction + Supplemental Internal Audit 8.1.2. 4. otherwise.7.1 7.6 4. Internal Audit Plans 8. Inc.3.2 4.3 4.11.17 Quality Management System Audit Manufacturing Process Audit 8.8 4.1 Same Requirement Verification of Job Set-ups Preventive and Predictive Maintenance Management of Production Tooling 8.1.3.6 4.11. 8.11.10.1.11.2.9 Identification and Traceability + Supplemental Customer Property Customer-Owned Production Tooling Preservation of Product 7.1 4. 4.3 4.4 4.3 Monitoring and Measurement of Processes 8.15.3 None None Monitoring and Measurement of Manufacturing Processes Monitoring and Measurement of Product Layout Inspection and Functional Testing 8.4.15 4.5.17.5.10.5.2.2.5 4.3.2 4.5.1.3 4.2 4.19.1.5.2.2. ANALYSIS AND IMPROVEMENT General 8.3 None Product Audit 8.1.4 7.1 None Validation of Processes for Production and Service Provision + Supplemental 7.2 4.9.11.20.2.1 QS-9000 Reference ISO/TS 16949:2002 Content Same Removes information on predictive maintenance methods 1999 edition added a tool identification requirement.7 4.17 8.2.1.17.5.3.5.1. 4.10.2.15.3.10.5.6.10.2. QS-9000 No change No change New: Tool identification to be covered by tooling management system No change No change New: Effectiveness in servicing customer to be verified if servicing agreement exists New: Validation to apply to all processes.6.2 4.15.2 4.2.4 4.2.6.1 4.2.11.1 4.6.6 4.19.10. expanded 4.9.2.1 Internal Auditor Qualification 8.4.2.2. Rewritten.6 Rewritten 7.3.1.2. 7.5.1.3.2.1.2.1 4.5. not just those that cannot be verified by monitoring and measurement No change Documentation of procedures not required No change No change No change No change No change New: Records to include equipment identification.5.5.2. 7.8 7.9.6 4.5 4.17.2. no change Added to account for New: Audit must verify QMS compliance ISO 9001:2000 with TS 16949:2002 New requirement in New: Audit each manufacturing 1999 edition process for effectiveness 1999 edition expanded New: Audits to include in-process as well as QS-9000 requirement final product audit Expanded (IASG InterpretNew: Audits must cover all shifts and ations and 1999 edition) QMS activities per an annual schedule Modification of 1999 New: Auditors to be qualified to audit edition requirement against TS 16949:2000 New (ISO 9001:2000) New: Monitor and/or measure effectiveness of QMS processes and take corrective action to ensure product conformity Same No change New: Records to indicate who authorized release No change www.7.5 4.3.bsiamericas.1.2.6.© MRI.2 4.2.6 7.4.1 4.2 8.5 4.9.1.3.17.1 8.1 Identification of Statistical Tools Knowledge of Basic Statistical Concepts 8.10.4 4.20.17.1.4 (ISO 9001:2000) 4.17. 4.20.1 7.11.15.9.1 4.4 Calibration/Verification Records 7.10.3 4. 2002 edition expands applicability Same Same Same Covers ISO 9001:1994 Clause 4.19.9.3.2 4.5.2 4.1.2.1 4.15 Repeats 4.20.7 7.17.g.4.1.1.10.9.2 4.1.2 4..2.15 Storage and Inventory 7.

4.2.2.14.13.1 4.1 4.14.2 4. inquiry@bsiamericas. where he served as the co-author of the first edition of QS-9000.13.2 4.1 4. 4. based in Detroit.2 Customer Information 8.9.© MRI.3 4.3 Same Simplified (ISO 9001:2000) Simplified (2002 edition) New (ISO 9001:2000) None None Impact vs. Smith had an extensive career with Ford Motor Company. IATF Guidance to ISO/TS 16949:2002. lists what analysis will relate to New: Trends to support information system to report data from product usage New: QMS effectiveness to be continually improved through various QMS elements New: Process for continual improvement of organization to be defined New: Focus to be on control and reduction of variation.1.5. a training and consulting organization in Saline.3 ISO/TS 16949:2002 Content QS-9000 Reference 4.2.5.2.1 4.1 Rewritten (ISO 9001:2000) Modified (1999 edition) Error-Proofing 8. Prior to joining KPMG.4.3.3 Same Modified (1999 edition) Rewritten for clarity (ISO 9001:2000) 4.1. 4.5.2 Problem Solving 8.20.2.14.1.7 4.13.13.1.1.14. 4. He is also author of The QS-9000 Answer Book.1.1. QS-9000 No change Need to document and segregate nonconformity product not specified Prohibition of rework visibility not specified New: Customer to be alerted if nonconforming product was shipped No change New: Collect and analyze data to verify QMS suitability and effectiveness and evaluate improvement opportunities.2.3 8.13.1: 4.14.14.2.4 4..3 4. currently in its third edition. timing No change New: Customer-prescribed format to be used if one exists Applying methods “to the degree appropriate” not mentioned No change New: Cycle time (of analysis) to be minimized No change *0.2 4.3.1.4 4.5. refers users to a document of the same title developed by the IATF along with ISO/TS 16949:2002 to provide assistance to suppliers on applying the second edition of this TS.2 4. MI.1.1. Radley M.5.14.2 Same New (ISO 9001:2000) Analysis and Use of Data 8. deletes references to improvement in cost.1 8.1 4.2 Modified Corrective Action 8.2 4. He previously served for seven years as Director of the Automotive Division of KPMG Quality Registrar. He is also Associate Director – Quality Systems of Management Resources International.3 4.5.1.5.1.14.14.6 4.5.2 Minor change Corrective Action Impact Rejected Product Test/Analysis Preventive Action 8.4 4. 4. Smith is the Group Leader—Automotive Sector for BSI Management Systems Inc.14.5.2.2.13.2.2.3.4 8.2.2.2.20.5 Expanded (1999 edition) Improvement— Continual Improvement Continual Improvement of the Organization Manufacturing Process Improvement 8.3.1.3. 4. 4.com 5 .1.3 None Customer Waiver Analysis of Data 8. 8.2 8.9.2.14.4.2 None ISO 9001:2000 modification of QS-9000 New (ISO 9001:2000) 8. Mr.5.1 4. Inc.2 4.1.3.13.14.1..2 4.5 4. 2002 Requirement ISO/TS 16949:2002 Reference ISO/TS 16949:1999 Reference Apperance Items Control of Nonconforming Product + Supplemental Control of Reworked Product 8.3.13.1.1.14.1.20.2 4.2 4.20.1. 4.5 8. Inc.4.3 4.4 8.1.14.5.5 4. which is published by Paton Press and is a member of THE OUTLOOK’s Editorial Advisory Board.13. delivery.

bsiamericas.com/auto .Notes: 6 www.

com 7 .Notes: inquiry@bsiamericas.

Notes: 8 www.bsiamericas.com/auto .