How the ISO/TS 16949 Additions have moved from 1st to 2nd edition X / X Sub-element Element
How the ISO/TS 16949 Additions have moved from 1st to 2nd edition 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
Comparison between 1st and 2nd edition 4.1 – Management Responsibility 8.2.1.1 – Customer satisfaction – Supplemental 5.4.1.1 – Quality Objectives – Supplemental TS 16949  2nd 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
Comparison between 1st and 2nd edition Wordings changed “Shall define a process for continual improvement” Note 1 and Note 2 deleted 8.5.5.1 – Organizational continuous improvement 4.1.1.4 – Remaining requirements Minor wording changes 5.5.1.1 – Quality Responsibility 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 – Quality Responsibility 4.1.2.2.2 – Shift resources 5.3.1 Quality Policy – Supplemental TS 16949  2nd edition 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 Comments  4.1.1.4 Continuous Improvement  TS 16949 1st edition
Comparison between 1st and 2nd edition Minor wording changes. Added “Analysis of field failures and their impact on quality, safety or the environment shall be input to management review” 5.6.1.1 – Quality management system performance 5.6.2.1- Management review – 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  2nd edition 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,…)  “ Comments  4.1.2.4 – Organizational interfaces TS 16949 1st edition
Comparison between 1st and 2nd 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 company level 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 Safety 4.1.7.1 Product Safety Removed “Employee satisfaction process” Note deleted. This should be 6.2.2.4. There is an error in the standard in the numbering 6.2.2.4 – Employee motivation, empowerment and satisfaction 4.1.6 – Employee motivation, empowerment and satisfaction Removed TS 16949  2nd edition 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 Comments  4.1.4 – Business Plan TS 16949 1st edition
Comparison between 1st and 2nd edition 4.2 Quality Systems Word “appropriate” is removed 7.1.1 – Quality Plan requirements 4.2.3.2 – Quality Plan requirements Removed the requirement. Note still there 7.3.4.1 – Monitoring 4.2.4.3 – Review cycle “ These measurements shall include quality risks, costs, lead-times, critical paths” moved to Notes. 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 Significant removal “Confidentiality of customer-contracted products and projects under development and related product information 7.1 – Product realization 4.2.4.1 – Product Realization – General 4.2.1 – General TS 16949  2nd edition Note added: At the moment in Parking lot Comments  4.2.2.2 – Quality System documentation TS 16949 1st edition
Comparison between 1st and 2nd 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 of processes – Supplemental 4.2.4.5 Tools and techniques 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 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 sentences in 4.2.4.5 is removed 7.3.3.1 – Product design outputs 7.3.3.2 – Process design outputs 4.2.4.5 Tools and techniques 7.3.1.1 – Multi disciplinary approach TS 16949  2nd edition No Change Comments  4.2.4.4 – Multidisciplinary approach TS 16949 1st edition
Comparison between 1st and 2nd edition 4.2 Quality Systems “ applicable regulations” removed 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 7.3.3.2 – Manufacturing process design output 4.2.4.9.3 – Process design output “ including risk analysis” added 7.2.2.1 – Manufacturing feasibility 4.2.4.8 – Feasibility reviews Removed – Documentation requirements removed Removed 4.2.4.9.1 – Management of Process design – General 7.3.2.4 – Special characteristics TS 16949  2nd edition “ appropriate methods” removed Note –2 removed Comments  4.2.4.7 – Special characteristics TS 16949 1st edition
Comparison between 1st and 2nd edition 4.2 Quality Systems Requirements relating to change moved to 7.3.7.1 Note added as : See 7.1.2 7.3.7.1 – Control of Design and development changes – supplemental 4.2.4.11 – Product Approval process New requirement added incorporating Change requirements 7.1.2 – Change Control “ prototype control plan when required by customer” removed 7.5.1.2 – Control Plan 4.2.4.10 – Control Plan First two requirements including two notes are moved to 7.3.6.3 7.3.6.3 – Product Approval Process 4.2.4.11 – Product Approval Process 7.3.5 – Design and Development verification TS 16949  2nd 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
Comparison between 1st and 2nd edition 4.2 Quality Systems This requirement incorporated along with 4.1.3.2 – Management review supplemental 5.6.1.1 – Quality Management System performance 4.2.8 – Quality System performance Minor wording changes Note added : “This requirement also applies to tooling availability for vehicle spare parts” 7.5.1.6 – Tooling management 4.2.6 – Tooling management Minor wording changes.  2 notes deleted and two new notes added 8.5.1.2 – Manufacturing Process Improvement 4.2.7 – Process Improvement 6.3.1 – Plant, facility and equipment planning TS 16949  2nd edition “ Plant layouts shall minimize material travel” changed to “Plant layouts shall optimize material travel” In Methods shall be developed, added “implemented” Note removed Comments  4.2.5 – Plant, facility and equipment planning TS 16949 1st edition
Comparison between 1st and 2nd edition 4.3 Contract review Removed TS 16949  2nd edition This requirement is removed Comments  4.3.2.2 – Review – Supplemental TS 16949 1st edition
Comparison between 1st and 2nd 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 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 7.3.2.3 Innovation 4.4.2.3 Research and Development 7.3 – Design and Development TS 16949  2nd 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
Comparison between 1st and 2nd edition 4.4 Design Control Minor wording changes. Product outputs and the Optimization processes clearly seperated out  7.3.3.1 – Product design outputs 4.4.5.2 – Design Optimization 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 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  2nd edition The existing requirement added as one of the inputs to Product design Comments  4.4.4.2 Reliability Objectives TS 16949 1st edition
Comparison between 1st and 2nd edition 4.4 Design Control 7.3.7.1 – Control of design and development changes - Supplemental TS 16949  2nd edition 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 Comments  4.4.9.2 – Evaluation of design change TS 16949 1st edition
Comparison between 1 st  and 2 nd  edition 4.5 Document and data control Word “procedure removed” and “process” added 2 notes currently present removed 4.2.3.1 – Engineering Specifications 4.5.2.2 Engineering specifications Removed TS 16949  2nd edition Note is Removed Comments  4.5.2.1 Note TS 16949 1st edition
Comparison between 1st and 2nd edition 4.6 Purchasing “ applicable to country of manufacture and sale” removed 7.4.1.2 – Regulatory compliance 4.6.1.3 – Regulatory compliance “ including tool and gaging suppliers” added 7.4.1.4 Customer approved sources 4.6.1.2 – Customer approved subcontractors Note removed and added two notes under 7.4.1 TS 16949  2nd 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 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
Comparison between 1st and 2nd edition 4.6 Purchasing “ Shall require 100% on time delivery and providing planning information and purchase commitments” removed. Only Delivery performance tracking and premium freight tracking retained 8.2.4.3 – Supplier Monitoring 4.6.2.3 – Scheduling subcontractors 7.4.1.3 – Supplier Quality management system development TS 16949  2nd edition Added “As a minimum the supplier shall be compliant with ISO9001:2000”. This could be a big change Note 2 relating to prioritization removed Note 1 – Minor changes in wordings Comments  4.6.2.2 – Subcontractor development TS 16949 1st edition
Comparison between 1st and 2nd edition 4.7 Control of customer supplied product 7.5.4.1 – Customer owned tooling TS 16949  2nd edition “ manufacturing,test,inspection tooling and equipment” added. Comments  4.7.2 – Customer owned tooling TS 16949 1st edition
Comparison between 1st and 2nd edition 4.8 Product identification and traceability 7.5.3 – Product Identification and traceability TS 16949  2nd edition No change Comments  4.8 TS 16949 1st edition
Comparison between 1st and 2nd 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 maximize the effectiveness and efficiency of equipments” added 7.5.1.5 – Preventive and predictive maintenance 4.9.1.5 – Preventive maintenance “ to satisfy the customer specified requirements” added  Natural disaster and force major removed Minor wording changes 6.3.2 – Contingency plans 4.9.1.3 – Contingency plans 6.4.2 – Cleanliness of premises TS 16949  2nd edition Minor wording changes Comments  4.9.1.2 Cleanliness of Premises TS 16949 1st edition
Comparison between 1st and 2nd edition 4.9 Process Control Word “Setup is” missing. This is an error.  “ significant time period between runs” removed 7.5.1.4 – Verification of Job setups 4.9.4 Verification of job-setups It is 8.2.4.4, should be 8.2.4.5. Minor wording changes 8.2.4.5 – 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 7.5.1.3 – Work instructions TS 16949  2nd 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
Comparison between 1st and 2nd edition 4.10 Inspection and Testing Changed to “Acceptance criteria shall be defined by the customer and documented by the organization”. This is not clear 8.2.4.1 – Acceptance criteria 4.10.1.2 Acceptance criteria “ 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 1 st  edition. This is required only as a corrective action 8.2.4.2 – Incoming Product quality 4.10.2.4 – Incoming product quality Note removed TS 16949  2nd 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
Comparison between 1st and 2nd edition 4.10 Inspection and Testing Compliance with ISO/IEC 17025 removed. Now it is not mandatory. Earlier requirements in QS9000:1998 written as mandatory in 2 nd  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 7.6.4 – Laboratory requirements 7.6.4.1 – Internal Labs 7.6.4.2 – External Labs 4.10.6 Laboratory requirements 8.2.4.3 – Layout inspection and functional testing TS 16949  2nd edition No change Comments  4.10.4.2 – Layout inspection and functional testing TS 16949 1st edition
Comparison between 1st and 2nd edition 4.11 Control of inspection, measuring and test equipment “ an assessment of the impact of the out-of specification condition” added 7.6.2 – Calibration records 4.11.3 – Records 7.6.1 – Measurement System analysis TS 16949  2nd edition 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 Comments  4.11.1.2 – Measurement System Analysis TS 16949 1st edition
Comparison between 1st and 2nd edition 4.12 Inspection and Test status 7.5.3 – Product identification and traceability TS 16949  2nd edition No change. Merged with Product identification and traceability Comments  4.12 – Inspection and Test status TS 16949 1st edition
Comparison between 1st and 2nd edition 4.13 Control of nonconforming product Minor wording change 8.3.2 – Control of reworked product 4.13.3 – Control of reworked product Change – “Shall obtain customer authorization prior to changing product/process” Minor wording changes 8.3.3 – Customer authorization 4.13.4 – Engineering approved authorization “ Customer information in case of nonconforming product shipped” is moved to this element Requirement relating to quantify,analyze and initiating actions removed 8.3.1 – Customer information 4.13.1.3 – Corrective action plan 8.3 – Control of nonconforming product TS 16949  2nd edition “ Visual identification for any nonconforming product….” removed Added “Important: Nonconforming includes material of unknown or suspect status” Comments  4.13.1.2 Suspect material or product TS 16949 1st edition
Comparison between 1st and 2nd edition 4.14 Corrective and Preventive action No change 8.5.2.3 – Corrective action impact 4.14.2.2 – Corrective action impact “ Rejected” should be “Returned”. This is an error in the standard.  No change 8.5.2.4 – Returned product test/analysis 4.14.2.3 – Returned product test/analysis No Change 8.5.2.2 – Mistake proofing 8.5.3.1 – Mistake proofing in preventive action 4.14.1.3 Mistake proofing 8.5.2.1 – Problem Solving TS 16949  2nd 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
Comparison between 1st and 2nd edition 4.15 Handling, Storage, packaging,preservation and delivery Removed Removed 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 Removed Removed 4.15.4.2 Customer packaging standards 7.5.5.1 – Storage and inventory TS 16949  2nd edition No Change Comments  4.15.3.2 – Inventory TS 16949 1st edition
Comparison between 1st and 2nd edition 4.15 Handling, Storage, packaging,preservation and delivery Removed Removed 4.15.6.5 – Shipment notification system Removed Removed 4.15.6.4 – Electronic communication 7.5.1.7 – Production scheduling TS 16949  2nd edition Minor wording changes Comments  4.15.6.3 – Production scheduling TS 16949 1st edition
Comparison between 1st and 2nd edition 4.16 Control of Quality Records 4.2.4.1 – Record retention TS 16949  2nd edition No change Comments  4.16.2 Record retention TS 16949 1st edition
Comparison between 1st and 2nd edition 4.17 – Internal quality audits Remaining requirements of 4.17.2.2 are moved here. No change 8.2.2.2 – Quality management system audit Removed the word “Product realization”. Now the focus is only on manufacturing process. 8.2.2.3 – Manufacturing Process audit 4.17.2.3 – Process audit No change 8.2.2.4 – Product audit 4.17.2.4 – Product audit “ Shall comply with ISO10011-2 requirements unless specified by customer”. This is a big change.  8.2.2.2 – Internal auditor qualification 4.17.3 – Auditor qualification “ Audits shall cover all activities and shifts” moved to 8.2.2.1  8.2.2.1 – Internal audit plans 4.17.2.2 – System audit 8.2.2.1 – Internal audit plans TS 16949  2nd edition Note pertaining to adherence to ISO10011-1 removed , since now meeting ISO10011-1 is mandatory Comments  4.17.2.1 – Internal quality audits – supplemental – General TS 16949 1st edition
Comparison between 1st and 2nd 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 This should be actually 6.2.2.3. This is an error in the standard in numbering. 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  2nd 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
Comparison between 1st and 2nd edition 4.19 - Servicing Earlier it was “Special purpose tools” now it is “Special purpose tools or measuring equipments” 7.5.1.9 – Servicing agreement with customer 4.19.3 – Servicing agreement with customer No change 7.5.1.8 – Feedback of information from service 4.19.2 Feedback of information from service Note removed TS 16949  2nd edition Comments  4.19.1 Servicing – Note TS 16949 1st edition
Comparison between 1st and 2nd 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  2nd edition No change Comments  4.20.3 – Identification of statistical tools TS 16949 1st edition
Comparison between 1st and 2nd edition New requirements 6.5 Sourcing TS 16949  2nd edition “ 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.”   Comments  - TS 16949 1st edition

Comparis

  • 1.
    How the ISO/TS16949 Additions have moved from 1st to 2nd edition X / X Sub-element Element
  • 2.
    How the ISO/TS16949 Additions have moved from 1st to 2nd edition X / X Sub-element Element
  • 3.
    Summary of ChangesA 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
  • 4.
    Comparison between 1stand 2nd edition 4.1 – Management Responsibility 8.2.1.1 – Customer satisfaction – Supplemental 5.4.1.1 – Quality Objectives – Supplemental TS 16949 2nd 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
  • 5.
    Comparison between 1stand 2nd edition Wordings changed “Shall define a process for continual improvement” Note 1 and Note 2 deleted 8.5.5.1 – Organizational continuous improvement 4.1.1.4 – Remaining requirements Minor wording changes 5.5.1.1 – Quality Responsibility 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 – Quality Responsibility 4.1.2.2.2 – Shift resources 5.3.1 Quality Policy – Supplemental TS 16949 2nd edition 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 Comments 4.1.1.4 Continuous Improvement TS 16949 1st edition
  • 6.
    Comparison between 1stand 2nd edition Minor wording changes. Added “Analysis of field failures and their impact on quality, safety or the environment shall be input to management review” 5.6.1.1 – Quality management system performance 5.6.2.1- Management review – 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 2nd edition 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,…) “ Comments 4.1.2.4 – Organizational interfaces TS 16949 1st edition
  • 7.
    Comparison between 1stand 2nd 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 company level 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 Safety 4.1.7.1 Product Safety Removed “Employee satisfaction process” Note deleted. This should be 6.2.2.4. There is an error in the standard in the numbering 6.2.2.4 – Employee motivation, empowerment and satisfaction 4.1.6 – Employee motivation, empowerment and satisfaction Removed TS 16949 2nd edition 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 Comments 4.1.4 – Business Plan TS 16949 1st edition
  • 8.
    Comparison between 1stand 2nd edition 4.2 Quality Systems Word “appropriate” is removed 7.1.1 – Quality Plan requirements 4.2.3.2 – Quality Plan requirements Removed the requirement. Note still there 7.3.4.1 – Monitoring 4.2.4.3 – Review cycle “ These measurements shall include quality risks, costs, lead-times, critical paths” moved to Notes. 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 Significant removal “Confidentiality of customer-contracted products and projects under development and related product information 7.1 – Product realization 4.2.4.1 – Product Realization – General 4.2.1 – General TS 16949 2nd edition Note added: At the moment in Parking lot Comments 4.2.2.2 – Quality System documentation TS 16949 1st edition
  • 9.
    Comparison between 1stand 2nd 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 of processes – Supplemental 4.2.4.5 Tools and techniques 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 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 sentences in 4.2.4.5 is removed 7.3.3.1 – Product design outputs 7.3.3.2 – Process design outputs 4.2.4.5 Tools and techniques 7.3.1.1 – Multi disciplinary approach TS 16949 2nd edition No Change Comments 4.2.4.4 – Multidisciplinary approach TS 16949 1st edition
  • 10.
    Comparison between 1stand 2nd edition 4.2 Quality Systems “ applicable regulations” removed 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 7.3.3.2 – Manufacturing process design output 4.2.4.9.3 – Process design output “ including risk analysis” added 7.2.2.1 – Manufacturing feasibility 4.2.4.8 – Feasibility reviews Removed – Documentation requirements removed Removed 4.2.4.9.1 – Management of Process design – General 7.3.2.4 – Special characteristics TS 16949 2nd edition “ appropriate methods” removed Note –2 removed Comments 4.2.4.7 – Special characteristics TS 16949 1st edition
  • 11.
    Comparison between 1stand 2nd edition 4.2 Quality Systems Requirements relating to change moved to 7.3.7.1 Note added as : See 7.1.2 7.3.7.1 – Control of Design and development changes – supplemental 4.2.4.11 – Product Approval process New requirement added incorporating Change requirements 7.1.2 – Change Control “ prototype control plan when required by customer” removed 7.5.1.2 – Control Plan 4.2.4.10 – Control Plan First two requirements including two notes are moved to 7.3.6.3 7.3.6.3 – Product Approval Process 4.2.4.11 – Product Approval Process 7.3.5 – Design and Development verification TS 16949 2nd 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
  • 12.
    Comparison between 1stand 2nd edition 4.2 Quality Systems This requirement incorporated along with 4.1.3.2 – Management review supplemental 5.6.1.1 – Quality Management System performance 4.2.8 – Quality System performance Minor wording changes Note added : “This requirement also applies to tooling availability for vehicle spare parts” 7.5.1.6 – Tooling management 4.2.6 – Tooling management Minor wording changes. 2 notes deleted and two new notes added 8.5.1.2 – Manufacturing Process Improvement 4.2.7 – Process Improvement 6.3.1 – Plant, facility and equipment planning TS 16949 2nd edition “ Plant layouts shall minimize material travel” changed to “Plant layouts shall optimize material travel” In Methods shall be developed, added “implemented” Note removed Comments 4.2.5 – Plant, facility and equipment planning TS 16949 1st edition
  • 13.
    Comparison between 1stand 2nd edition 4.3 Contract review Removed TS 16949 2nd edition This requirement is removed Comments 4.3.2.2 – Review – Supplemental TS 16949 1st edition
  • 14.
    Comparison between 1stand 2nd 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 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 7.3.2.3 Innovation 4.4.2.3 Research and Development 7.3 – Design and Development TS 16949 2nd 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
  • 15.
    Comparison between 1stand 2nd edition 4.4 Design Control Minor wording changes. Product outputs and the Optimization processes clearly seperated out 7.3.3.1 – Product design outputs 4.4.5.2 – Design Optimization 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 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 2nd edition The existing requirement added as one of the inputs to Product design Comments 4.4.4.2 Reliability Objectives TS 16949 1st edition
  • 16.
    Comparison between 1stand 2nd edition 4.4 Design Control 7.3.7.1 – Control of design and development changes - Supplemental TS 16949 2nd edition 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 Comments 4.4.9.2 – Evaluation of design change TS 16949 1st edition
  • 17.
    Comparison between 1st and 2 nd edition 4.5 Document and data control Word “procedure removed” and “process” added 2 notes currently present removed 4.2.3.1 – Engineering Specifications 4.5.2.2 Engineering specifications Removed TS 16949 2nd edition Note is Removed Comments 4.5.2.1 Note TS 16949 1st edition
  • 18.
    Comparison between 1stand 2nd edition 4.6 Purchasing “ applicable to country of manufacture and sale” removed 7.4.1.2 – Regulatory compliance 4.6.1.3 – Regulatory compliance “ including tool and gaging suppliers” added 7.4.1.4 Customer approved sources 4.6.1.2 – Customer approved subcontractors Note removed and added two notes under 7.4.1 TS 16949 2nd 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 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
  • 19.
    Comparison between 1stand 2nd edition 4.6 Purchasing “ Shall require 100% on time delivery and providing planning information and purchase commitments” removed. Only Delivery performance tracking and premium freight tracking retained 8.2.4.3 – Supplier Monitoring 4.6.2.3 – Scheduling subcontractors 7.4.1.3 – Supplier Quality management system development TS 16949 2nd edition Added “As a minimum the supplier shall be compliant with ISO9001:2000”. This could be a big change Note 2 relating to prioritization removed Note 1 – Minor changes in wordings Comments 4.6.2.2 – Subcontractor development TS 16949 1st edition
  • 20.
    Comparison between 1stand 2nd edition 4.7 Control of customer supplied product 7.5.4.1 – Customer owned tooling TS 16949 2nd edition “ manufacturing,test,inspection tooling and equipment” added. Comments 4.7.2 – Customer owned tooling TS 16949 1st edition
  • 21.
    Comparison between 1stand 2nd edition 4.8 Product identification and traceability 7.5.3 – Product Identification and traceability TS 16949 2nd edition No change Comments 4.8 TS 16949 1st edition
  • 22.
    Comparison between 1stand 2nd 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 maximize the effectiveness and efficiency of equipments” added 7.5.1.5 – Preventive and predictive maintenance 4.9.1.5 – Preventive maintenance “ to satisfy the customer specified requirements” added Natural disaster and force major removed Minor wording changes 6.3.2 – Contingency plans 4.9.1.3 – Contingency plans 6.4.2 – Cleanliness of premises TS 16949 2nd edition Minor wording changes Comments 4.9.1.2 Cleanliness of Premises TS 16949 1st edition
  • 23.
    Comparison between 1stand 2nd edition 4.9 Process Control Word “Setup is” missing. This is an error. “ significant time period between runs” removed 7.5.1.4 – Verification of Job setups 4.9.4 Verification of job-setups It is 8.2.4.4, should be 8.2.4.5. Minor wording changes 8.2.4.5 – 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 7.5.1.3 – Work instructions TS 16949 2nd 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
  • 24.
    Comparison between 1stand 2nd edition 4.10 Inspection and Testing Changed to “Acceptance criteria shall be defined by the customer and documented by the organization”. This is not clear 8.2.4.1 – Acceptance criteria 4.10.1.2 Acceptance criteria “ 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 1 st edition. This is required only as a corrective action 8.2.4.2 – Incoming Product quality 4.10.2.4 – Incoming product quality Note removed TS 16949 2nd 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
  • 25.
    Comparison between 1stand 2nd edition 4.10 Inspection and Testing Compliance with ISO/IEC 17025 removed. Now it is not mandatory. Earlier requirements in QS9000:1998 written as mandatory in 2 nd 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 7.6.4 – Laboratory requirements 7.6.4.1 – Internal Labs 7.6.4.2 – External Labs 4.10.6 Laboratory requirements 8.2.4.3 – Layout inspection and functional testing TS 16949 2nd edition No change Comments 4.10.4.2 – Layout inspection and functional testing TS 16949 1st edition
  • 26.
    Comparison between 1stand 2nd edition 4.11 Control of inspection, measuring and test equipment “ an assessment of the impact of the out-of specification condition” added 7.6.2 – Calibration records 4.11.3 – Records 7.6.1 – Measurement System analysis TS 16949 2nd edition 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 Comments 4.11.1.2 – Measurement System Analysis TS 16949 1st edition
  • 27.
    Comparison between 1stand 2nd edition 4.12 Inspection and Test status 7.5.3 – Product identification and traceability TS 16949 2nd edition No change. Merged with Product identification and traceability Comments 4.12 – Inspection and Test status TS 16949 1st edition
  • 28.
    Comparison between 1stand 2nd edition 4.13 Control of nonconforming product Minor wording change 8.3.2 – Control of reworked product 4.13.3 – Control of reworked product Change – “Shall obtain customer authorization prior to changing product/process” Minor wording changes 8.3.3 – Customer authorization 4.13.4 – Engineering approved authorization “ Customer information in case of nonconforming product shipped” is moved to this element Requirement relating to quantify,analyze and initiating actions removed 8.3.1 – Customer information 4.13.1.3 – Corrective action plan 8.3 – Control of nonconforming product TS 16949 2nd edition “ Visual identification for any nonconforming product….” removed Added “Important: Nonconforming includes material of unknown or suspect status” Comments 4.13.1.2 Suspect material or product TS 16949 1st edition
  • 29.
    Comparison between 1stand 2nd edition 4.14 Corrective and Preventive action No change 8.5.2.3 – Corrective action impact 4.14.2.2 – Corrective action impact “ Rejected” should be “Returned”. This is an error in the standard. No change 8.5.2.4 – Returned product test/analysis 4.14.2.3 – Returned product test/analysis No Change 8.5.2.2 – Mistake proofing 8.5.3.1 – Mistake proofing in preventive action 4.14.1.3 Mistake proofing 8.5.2.1 – Problem Solving TS 16949 2nd 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
  • 30.
    Comparison between 1stand 2nd edition 4.15 Handling, Storage, packaging,preservation and delivery Removed Removed 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 Removed Removed 4.15.4.2 Customer packaging standards 7.5.5.1 – Storage and inventory TS 16949 2nd edition No Change Comments 4.15.3.2 – Inventory TS 16949 1st edition
  • 31.
    Comparison between 1stand 2nd edition 4.15 Handling, Storage, packaging,preservation and delivery Removed Removed 4.15.6.5 – Shipment notification system Removed Removed 4.15.6.4 – Electronic communication 7.5.1.7 – Production scheduling TS 16949 2nd edition Minor wording changes Comments 4.15.6.3 – Production scheduling TS 16949 1st edition
  • 32.
    Comparison between 1stand 2nd edition 4.16 Control of Quality Records 4.2.4.1 – Record retention TS 16949 2nd edition No change Comments 4.16.2 Record retention TS 16949 1st edition
  • 33.
    Comparison between 1stand 2nd edition 4.17 – Internal quality audits Remaining requirements of 4.17.2.2 are moved here. No change 8.2.2.2 – Quality management system audit Removed the word “Product realization”. Now the focus is only on manufacturing process. 8.2.2.3 – Manufacturing Process audit 4.17.2.3 – Process audit No change 8.2.2.4 – Product audit 4.17.2.4 – Product audit “ Shall comply with ISO10011-2 requirements unless specified by customer”. This is a big change. 8.2.2.2 – Internal auditor qualification 4.17.3 – Auditor qualification “ Audits shall cover all activities and shifts” moved to 8.2.2.1 8.2.2.1 – Internal audit plans 4.17.2.2 – System audit 8.2.2.1 – Internal audit plans TS 16949 2nd edition Note pertaining to adherence to ISO10011-1 removed , since now meeting ISO10011-1 is mandatory Comments 4.17.2.1 – Internal quality audits – supplemental – General TS 16949 1st edition
  • 34.
    Comparison between 1stand 2nd 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 This should be actually 6.2.2.3. This is an error in the standard in numbering. 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 2nd 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
  • 35.
    Comparison between 1stand 2nd edition 4.19 - Servicing Earlier it was “Special purpose tools” now it is “Special purpose tools or measuring equipments” 7.5.1.9 – Servicing agreement with customer 4.19.3 – Servicing agreement with customer No change 7.5.1.8 – Feedback of information from service 4.19.2 Feedback of information from service Note removed TS 16949 2nd edition Comments 4.19.1 Servicing – Note TS 16949 1st edition
  • 36.
    Comparison between 1stand 2nd 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 2nd edition No change Comments 4.20.3 – Identification of statistical tools TS 16949 1st edition
  • 37.
    Comparison between 1stand 2nd edition New requirements 6.5 Sourcing TS 16949 2nd edition “ 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.” Comments - TS 16949 1st edition