Comparis

How the ISO/TS 16949 Additions have moved from 1st to 2nd edition X / X Sub-element Element

Summary of Changes ,[object Object],[object Object],[object Object],[object Object]

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 ,[object Object],[object Object],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 ,[object Object],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 ,[object Object],6.4.1 Safety 4.1.7.1 Product Safety ,[object Object],[object Object],[object Object],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 ,[object Object],7.3.4.1 – Monitoring 4.2.4.2 - Measurements ,[object Object],[object Object],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 ,[object Object],8.2.3.1 – Monitoring and measurement of processes – Supplemental 4.2.4.5 Tools and techniques ,[object Object],6.2.2.1 – Product design skills 4.2.4.6 – Computer aided design ,[object Object],[object Object],[object Object],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 ,[object Object],7.3.2.2 – Manufacturing process design input 4.2.4.9.2 – Process design inputs ,[object Object],[object Object],7.3.3.2 – Manufacturing process design output 4.2.4.9.3 – Process design output ,[object Object],7.2.2.1 – Manufacturing feasibility 4.2.4.8 – Feasibility reviews ,[object Object],Removed 4.2.4.9.1 – Management of Process design – General 7.3.2.4 – Special characteristics TS 16949 2nd edition ,[object Object],[object Object],Comments 4.2.4.7 – Special characteristics TS 16949 1st edition

Comparison between 1st and 2nd edition 4.2 Quality Systems ,[object Object],[object Object],7.3.7.1 – Control of Design and development changes – supplemental 4.2.4.11 – Product Approval process ,[object Object],7.1.2 – Change Control ,[object Object],7.5.1.2 – Control Plan 4.2.4.10 – Control Plan ,[object Object],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 ,[object Object],5.6.1.1 – Quality Management System performance 4.2.8 – Quality System performance ,[object Object],[object Object],7.5.1.6 – Tooling management 4.2.6 – Tooling management ,[object Object],[object Object],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 ,[object Object],[object Object],6.2.2.1 – Product design skills 4.4.2.2 Required skills ,[object Object],[object Object],[object Object],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 ,[object Object],7.3.3.1 – Product design outputs 4.4.5.2 – Design Optimization ,[object Object],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 ,[object Object],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 ,[object Object],[object Object],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 ,[object Object],7.4.1.2 – Regulatory compliance 4.6.1.3 – Regulatory compliance ,[object Object],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 ,[object Object],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 ,[object Object],7.5.1.5 – Preventive and predictive maintenance 4.9.1.5 – Preventive maintenance ,[object Object],[object Object],[object Object],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 ,[object Object],[object Object],7.5.1.4 – Verification of Job setups 4.9.4 Verification of job-setups ,[object Object],8.2.4.5 – Appearance items 4.9.5 Appearance items ,[object Object],[object Object],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 ,[object Object],8.2.4.1 – Acceptance criteria 4.10.1.2 Acceptance criteria ,[object Object],[object Object],[object Object],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 ,[object Object],[object Object],[object Object],[object Object],[object Object],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 ,[object Object],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 ,[object Object],8.3.2 – Control of reworked product 4.13.3 – Control of reworked product ,[object Object],[object Object],8.3.3 – Customer authorization 4.13.4 – Engineering approved authorization ,[object Object],[object Object],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 ,[object Object],[object Object],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 ,[object Object],[object Object],[object Object],[object Object],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 ,[object Object],8.2.2.2 – Quality management system audit ,[object Object],8.2.2.3 – Manufacturing Process audit 4.17.2.3 – Process audit ,[object Object],8.2.2.4 – Product audit 4.17.2.4 – Product audit ,[object Object],8.2.2.2 – Internal auditor qualification 4.17.3 – Auditor qualification ,[object Object],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 ,[object Object],[object Object],6.2.2.2 – Training ,[object Object],6.2.2.3 – Training on the job 4.18.3 – Training on the job ,[object Object],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 ,[object Object],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

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to Comparis

Similar to Comparis (20)

More from Omnex Inc.

More from Omnex Inc. (20)

Comparis