1. How the elements have moved from 1 st edition to 2 nd edition X 4.11 X 4.12 X 4.14 X 4.13 X X (Max) X X X 4.2 X 4.3 X (Max) X 4.4 X 4.5 X X(Max) 4.6 X 4.7 X 4.8 X X(Max) X 4.9 X(Max) X 4.10 X Chap-6 X (Max) Chap-5 X Chap-7 Chap-4 X Chap-8 4.1 Element number
2. How the elements have moved from 1 st edition to 2 nd edition X 4.16 X 4.17 X 4.18 X 4.19 X 4.20 10 13 5 2 3 Summary of relocation (includes overlap) 5 11 1 1 2 Summary of relocation (without overlap – Sum is equal to 20 elements) Chap-6 Chap-5 X(Max) Chap-7 Chap-4 X Chap-8 4.15 Element number
3.
4. Comparison between 1 st and 2 nd edition Scope, Application , Terms and Definitions Key definition added as part of 3.0 3. Terms and Definition ISO9000:2000 added Removed ISO8402:1994 ISO/IEC 17025 1.2 Application added TS 16949 – 2 nd edition No change in Scope. Applicable throughout the automotive supply chain Comments 2. Normative reference 1. Scope TS 16949 1st edition
5. Comparison between 1 st and 2 nd edition 4.1 – Management Responsibility 8.2.1.1 – Customer satisfaction – Supplemental 5.4.1.1 – Quality Objectives – Supplemental TS 16949 – 2 nd edition 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 issues Added “ The organization shall monitor manufacturing processes’ performance to demonstrate compliance with customer requirements for product quality and efficiency of the process. Changed to “ Top management shall define quality objectives and measurements in the business plan to deploy the quality policy. Comments 4.1.1.3 Customer Satisfaction 4.1.1.2 Objectives TS 16949 1st edition
6. Comparison between 1 st and 2 nd edition Wordings changed “Shall define a process for continual improvement” “ See examples in annex B of ISO9004:2000” added Note 1 and Note 2 deleted 8.5.1.1 – Continual improvement of the Organization 4.1.1.4 – Remaining requirements Minor wording changes 5.5.1.1 – Responsibility of Quality 4.1.2.1.3 - Quality responsibility Minor wording changes 5.5.2.1 – Customer representative 4.1.2.1.2 – Customer representative Minor wording changes 5.5.1.1 – Responsibility of Quality 4.1.2.2.2 – Shift resources Removed TS 16949 – 2 nd edition Continuous improvement in quality, cost … shall be provided in Quality policy removed Comments 4.1.1.4 Continuous Improvement TS 16949 1st edition
7. Comparison between 1 st and 2 nd edition 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 5.6.1.1 – Quality management system performance 5.6.2.1- Review Input - Supplemental 4.1.3.2 Management review – Supplemental 4.2.8 – Quality system performance (Above elements are moved to 5.6.1.1) 7.3.1.1 – Multi – Disciplinary approach 7.2.3.1 – Customer communication supplemental TS 16949 – 2 nd edition “ 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,…) “ Comments 4.1.2.4 – Organizational interfaces TS 16949 1st edition
8. Comparison between 1 st and 2 nd edition 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) 8.4.1 – Analysis and use of data 4.1.5 – Analysis and use of Company level data Added as Note-2 7.2.1 – Determination of requirements relating to product 4.1.7.2 – Regulations Removed “Potential risks to Customers, users and the environment”. Only “Risk to employees” is there 6.4.1 Personnel Safety to achieve Product Quality 4.1.7.1 Product Safety 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. 6.2.2.4 – Employee motivation and empowerment 4.1.6 – Employee motivation, empowerment and satisfaction Removed TS 16949 – 2 nd edition Requirements are removed, but Business plan Reference is there in 5.4.1.1 and 5.6.1.1 Comments 4.1.4 – Business Plan TS 16949 1st edition
9. Comparison between 1 st and 2 nd edition 4.2 Quality Systems Minor wording changes “ shall be included in the planning of the product realization as a component of Quality plan” 7.1.1 – Planning of Product Realization - Supplemental 4.2.3.2 – Quality Plan requirements Deleted Removed 4.2.4.3 – Review cycle “ 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. 7.3.4.1 – Monitoring 4.2.4.2 - Measurements Only Note-1 retained. Requirements relating to project management approach and a project team is removed. Minor word changes in Note-1 No change 7.1 – Product realization 7.1.3 - Confidentiality 4.2.4.1 – Product Realization – General Removed TS 16949 – 2 nd edition No requirement of Documented Processes except for the 6 ISO9001:2000 processes Comments 4.2.2.2 – Quality System documentation TS 16949 1st edition
10. Comparison between 1 st and 2 nd edition 4.2 Quality Systems Last para “The supplier shall perform process studies…… as well as acceptance criteria” is moved to this element 8.2.3.1 – Monitoring and measurement manufacturing Processes 4.2.4.5 Tools and techniques 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” 6.2.2.1 – Product design skills 4.2.4.6 – Computer aided design 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) 7.3.3.1 – Product design outputs - Supplemental 7.3.3.2 – Manufacturing Process design outputs 7.3.2.2 – Manufacturing Process design input 4.2.4.5 Tools and techniques 7.3.1.1 – Multi disciplinary approach TS 16949 – 2 nd edition No Change Comments 4.2.4.4 – Multidisciplinary approach TS 16949 1st edition
11. Comparison between 1 st and 2 nd edition 4.2 Quality Systems “ applicable regulations” removed “ such as Design FMEA’s” removed Note added relating to error proofing 7.3.2.2 – Manufacturing process design input 4.2.4.9.2 – Process design inputs “ manufacturing process flow chart/layout” added “ Control plan” added Everwhere the work “Mistake proofing” changed to “Error proofing” 7.3.3.2 – Manufacturing process design output 4.2.4.9.3 – Process design output “ including risk analysis” added. Minor wording changes makes it more clear now 7.2.2.2 – Organization Manufacturing feasibility 4.2.4.8 – Feasibility reviews Removed 4.2.4.9.1 – Management of Process design – General 7.3.2.3 – Special characteristics TS 16949 – 2 nd edition “ appropriate methods” removed. Wording changes – now requirements are very clear Note –2 removed Comments 4.2.4.7 – Special characteristics TS 16949 1st edition
12. Comparison between 1 st and 2 nd edition 4.2 Quality Systems Minor wording changes 7.1.4 – Change control 4.2.4.11 – Product Approval process “ 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 7.5.1.1 – Control Plan 4.2.4.10 – Control Plan Important note added “Product Approval should be subsequent to the verification of Manufacturing process” Otherwise minor wording changes 7.3.6.3 – Product Approval Process 4.2.4.11 – Product Approval Process 7.3.5 – Design and Development verification TS 16949 – 2 nd edition 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” Comments 4.2.4.9.4 – Process verification TS 16949 1st edition
13. Comparison between 1 st and 2 nd edition 4.2 Quality Systems Minor wording changes This is a new requirement but is a redundant along with the above one 5.6.1.1 – Quality Management System performance 5.1.1 – Process efficiency 4.2.8 – Quality System performance Minor wording changes Note added : “This requirement also applies to tooling availability for vehicle spare parts” 7.5.1.5 – Management of Production tooling 4.2.6 – Tooling management “ 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 8.5.1.2 – Manufacturing Process Improvement 4.2.7 – Process Improvement 6.3.1 – Plant, facility and equipment planning TS 16949 – 2 nd edition “ 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” Comments 4.2.5 – Plant, facility and equipment planning TS 16949 1st edition
14. Comparison between 1 st and 2 nd edition 4.3 Contract review Removed TS 16949 – 2 nd edition This requirement is removed Comments 4.3.2.2 – Review – Supplemental TS 16949 1st edition
15. Comparison between 1 st and 2 nd edition 4.4 Design Control Just says that Suppliers resources should be qualified to achieve design requirements and skilled tools and techniques. List of skills has been removed 6.2.2.1 – Product design skills 4.4.2.2 Required skills Deleted Removed 4.4.2.3 Research and Development 7.3 – Design and Development TS 16949 – 2 nd edition 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 Comments 4.4 Design Control – Important TS 16949 1st edition
16. Comparison between 1 st and 2 nd edition 4.4 Design Control Added the following outputs “ Product definitions including drawings, mathematically based data, Product design review results, Diagnostic guidelines where applicable” “ Optimization requirements” are removed 7.3.3.1 – Product design outputs - Supplemental 4.4.5.2 – Design Optimization 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 7.3.6.1 – Design and development validation – supplemental 4.4.8.2 – Design Validation – Supplemental No Change 7.3.6.2 – Prototype program 4.4.8.3 – Prototype Programme The existing requirement added as one of the inputs to Product design 7.3.2.1 – Product design inputs 4.4.4.3 – Use of information 7.3.2.1 – Product design inputs TS 16949 – 2 nd edition The existing requirement added as one of the inputs to Product design Comments 4.4.4.2 Reliability Objectives TS 16949 1st edition
17. Comparison between 1 st and 2 nd edition 4.4 Design Control 7.1.4 – Change control TS 16949 – 2 nd edition Incorporated as part of Change control Comments 4.4.9.2 – Evaluation of design change TS 16949 1st edition
18. Comparison between 1 st and 2 nd edition 4.5 Document and data control “ Timely review should be as soon as possible and shall not exceed two working weeks” added Note –2 retained 4.2.3.1 – Engineering Specifications 4.5.2.2 Engineering specifications Removed TS 16949 – 2 nd edition Note is Removed Comments 4.5.2.1 Note TS 16949 1st edition
19. Comparison between 1 st and 2 nd edition 4.6 Purchasing “ applicable to country of manufacture and sale” removed 7.4.1.1 – Regulatory compliance 4.6.1.3 – Regulatory compliance “ including tool and gaging suppliers” added “ Contract (like drawings, specifications)” Word change 7.4.1.3 - Customer approved sources 4.6.1.2 – Customer approved subcontractors Note removed and added two notes under 7.4.1 TS 16949 – 2 nd edition 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” Comments 4.6.1.1 Note TS 16949 1st edition
20. Comparison between 1 st and 2 nd edition 4.6 Purchasing “ 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” 7.4.3.2 – Supplier Monitoring 4.6.2.3 – Scheduling subcontractors 7.4.1.2 – Supplier Quality management system development TS 16949 – 2 nd edition “ 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 Comments 4.6.2.2 – Subcontractor development TS 16949 1st edition
21. Comparison between 1 st and 2 nd edition 4.7 Control of customer supplied product 7.5.4.1 – Customer owned Production tooling TS 16949 – 2 nd edition “ manufacturing,test,inspection tooling and equipment” added. Comments 4.7.2 – Customer owned tooling TS 16949 1st edition
22. Comparison between 1 st and 2 nd edition 4.8 Product identification and traceability 7.5.3 – Product Identification and traceability 7.5.3.1 – Identification and Traceability - Supplemental TS 16949 – 2 nd edition No change Note added giving clarity on certain aspects of Inspection and test status Comments 4.8 TS 16949 1st edition
23. Comparison between 1 st and 2 nd edition 4.9 Process Control Minor wording changes 7.2.1.1 – Customer designated special characteristics 4.9.1.4 – Designation of special characteristics “ Predictive methods to continually improve the effectiveness and efficiency of Production equipments” added 7.5.1.4 – Preventive and predictive maintenance 4.9.1.5 – Preventive maintenance “ to satisfy the customer specified requirements” added Natural disaster and force majeur removed Minor wording changes “ Field returns” added 6.3.2 – Contingency plans 4.9.1.3 – Contingency plans 6.4.2 – Cleanliness of premises TS 16949 – 2 nd edition Minor wording changes Comments 4.9.1.2 Cleanliness of Premises TS 16949 1st edition
24. Comparison between 1 st and 2 nd edition 4.9 Process Control “ significant time period between runs” removed 7.5.1.3 – Verification of Job setups 4.9.4 Verification of job-setups No Change 8.2.4.2 – Appearance items 4.9.5 Appearance items Word “exceed” removed Minor wording changes 8.2.3.1 –Monitoring and measurement of processes – Supplemental 4.9.3 Maintaining process control 7.5.1.2 – Work instructions TS 16949 – 2 nd edition “ Job instructions” changed to “Work instruction” “ without disruption of job” removed “ Job instructions shall include or reference ….” removed Note 1 and Note 2 removed Comments 4.9.2 – Job instructions TS 16949 1st edition
25. Comparison between 1 st and 2 nd edition 4.10 Inspection and Testing 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” 7.1.2 – Acceptance Criteria 4.10.1.2 Acceptance criteria No change 7.4.3.1 – Incoming Product Quality 4.10.2.4 – Incoming product quality 8.2.4 – Monitoring and Measurement of Product TS 16949 – 2 nd edition Existing note removed. New note pertaining to selection of measurement types added. In parking lot Comments 4.10.1.1 Note TS 16949 1st edition
26. Comparison between 1 st and 2 nd edition 4.10 Inspection and Testing 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 7.6.3 – Laboratory requirements 7.6.3.1 – Internal Labs 7.6.3.2 – External Labs 4.10.6 Laboratory requirements 8.2.4.1– Layout and functional testing TS 16949 – 2 nd edition Note added explaining what is Layout inspection Comments 4.10.4.2 – Layout inspection and functional testing TS 16949 1st edition
27. Comparison between 1 st and 2 nd edition 4.11 Control of inspection, measuring and test equipment “ an assessment of the impact of the out-of specification condition” and “equipment identification including master standard against which the equipment is calibrated” added 7.6.2 – Calibration records 4.11.3 – Records 7.6.1 – Measurement System analysis TS 16949 – 2 nd edition Minor wording changes Comments 4.11.1.2 – Measurement System Analysis TS 16949 1st edition
28. Comparison between 1 st and 2 nd edition 4.12 Inspection and Test status 7.5.3 – Product identification and traceability TS 16949 – 2 nd edition No change. Merged with Product identification and traceability Comments 4.12 – Inspection and Test status TS 16949 1st edition
29. Comparison between 1 st and 2 nd edition 4.13 Control of nonconforming product “ Instructions including re-inspection” added - Minor wording change 8.3.2 – Control of reworked product 4.13.3 – Control of reworked product Change – “Shall obtain customer concession or deviation permit prior to changing product/process” Minor wording changes 8.3.4 – Customer waiver 4.13.4 – Engineering approved authorization “ 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 8.3.3 – Customer information 4.13.1.3 – Corrective action plan 8.3.1 – Control of nonconforming product - Supplemental TS 16949 – 2 nd edition “ Product with unidentified or suspect status shall be classified as non-conforming product” – Word changes Comments 4.13.1.2 Suspect material or product TS 16949 1st edition
30. Comparison between 1 st and 2 nd edition 4.14 Corrective and Preventive action Minor wording changes 8.5.2.3 – Corrective action impact 4.14.2.2 – Corrective action impact 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 8.5.2.4 – Rejected product test/analysis 4.14.2.3 – Returned product test/analysis No Change – “Mistake” changed to “Error” 8.5.2.2 – Error Proofing 4.14.1.3 Mistake proofing 8.5.2.1 – Problem Solving TS 16949 – 2 nd edition “ Shall have a process for problem solving leading to root cause identification and elimination” (Wording change) Comments 4.14.1.2 Problem solving TS 16949 1st edition
31. Comparison between 1 st and 2 nd edition 4.15 Handling, Storage, packaging,preservation and delivery Same as above 7.1.1 4.15.4.3 – Labelling “ 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 8.2.1.1 –Customer satisfaction – Supplemental 4.15.6.2 – Performance monitoring of supplier delivery “ Customer requirements and references to its technical specifications shall be included in the planning of Product realization” 7.1.1 – Planning of Product realization – Supplemental 4.15.4.2 Customer packaging standards 7.5.5.1 – Storage and inventory TS 16949 – 2 nd edition No Change Comments 4.15.3.2 – Inventory TS 16949 1st edition
32. Comparison between 1 st and 2 nd edition 4.15 Handling, Storage, packaging,preservation and delivery 7.1.1 4.15.6.5 – Shipment notification system 7.1.1 4.15.6.4 – Electronic communication 7.5.1.6 – Production scheduling TS 16949 – 2 nd edition Minor wording changes Comments 4.15.6.3 – Production scheduling TS 16949 1st edition
33. Comparison between 1 st and 2 nd edition 4.16 Control of Quality Records 4.2.4.1 – Record retention TS 16949 – 2 nd edition Minor wording changes Comments 4.16.2 Record retention TS 16949 1st edition
34. Comparison between 1 st and 2 nd edition 4.17 – Internal quality audits Removed the word “Product realization”. Now the focus is only on manufacturing process. 8.2.2.2 – Manufacturing Process audit 4.17.2.3 – Process audit No change 8.2.2.3 – Product audit 4.17.2.4 – Product audit No change. 8.2.2.5 – Internal auditor qualification 4.17.3 – Auditor qualification “ Audits shall cover all activities and shifts” moved to 8.2.2.4 8.2.2.1 – Quality Management system audit 4.17.2.2 – System audit 8.2.2.4 – Internal audit plans TS 16949 – 2 nd edition No change Comments 4.17.2.1 – Internal quality audits – supplemental – General TS 16949 1st edition
35. Comparison between 1 st and 2 nd edition 4.18 – Training “ Special attention shall be given on customer specific requirements” is moved to 6.2.2.2 Note is removed 6.2.2.2 – Training No change 6.2.2.3 – Training on the job 4.18.3 – Training on the job Effectiveness requirements is added now as part of ISO9001:2000 6.2.2.c 6.2.2.c 4.18.2 Training effectiveness 6.2.2.2 – Training TS 16949 – 2 nd edition Even though this is ISO9000:1994 requirement, this is not a requirement in ISO9001:2000. In the 2 nd edition, this along with the 2 notes which were present in ISO9000:1994 have been added in this element without any change Comments 4.18.1 – Training TS 16949 1st edition
36. Comparison between 1 st and 2 nd edition 4.19 - Servicing Earlier it was “Special purpose tools” now it is “Special purpose tools or measuring equipments” 7.5.1.8 – Servicing agreement with customer 4.19.3 – Servicing agreement with customer No change 7.5.1.7 – Feedback of information from service 4.19.2 Feedback of information from service Note removed TS 16949 – 2 nd edition Comments 4.19.1 Servicing – Note TS 16949 1st edition
37. Comparison between 1 st and 2 nd edition 4.20 – Statistical techniques Word “where appropriate” removed 8.1.2 – Knowledge of basic statistical concepts 4.20.4 – Knowledge of basic statistical concepts 8.1.1 – Identification of Statistical tools TS 16949 – 2 nd edition No change Comments 4.20.3 – Identification of statistical tools TS 16949 1st edition
38. Comparison between 1 st and 2 nd edition New requirements 7.5.2.1 – Validation of Processes and Service provision - Supplemental TS 16949 – 2 nd edition Validation of Processes and Service provision is applicable to all processes of Production and Service provision Comments TS 16949 1st edition