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 TS 16949 1st edition TS 16949 2nd edition Comments 4.1.1.2 Objectives 5.4.1.1 – Quality Objectives – Supplemental Changed to “Top management shall define quality objectives and measurements in the business plan to deploy the quality policy. 4.1.1.3 Customer Satisfaction 8.2.1.1 – Customer satisfaction – Supplemental 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.

Comparison between 1st and 2nd edition TS 16949 1st edition TS 16949 2nd edition Comments 4.1.1.4 Continuous Improvement 5.3.1 Quality Policy – Supplemental 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 4.1.1.4 – Remaining requirements 8.5.5.1 – Organizational continuous improvement Wordings changed “Shall define a process for continual improvement” Note 1 and Note 2 deleted 4.1.2.1.2 – Customer representative 5.5.2.1 – Customer representative Minor wording changes 4.1.2.1.3 - Quality responsibility 5.5.1.1 – Quality Responsibility 4.1.2.2.2 – Shift resources

Comparison between 1st and 2nd edition TS 16949 1st edition TS 16949 2nd edition Comments 4.1.2.4 – Organizational interfaces 7.3.1.1 – Multi – Disciplinary approach 7.2.3.1 – Customer communication supplemental 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,…) “ 4.1.3.2 Management review – Supplemental 4.2.8 – Quality system performance (Above elements are moved to 5.6.1.1) 5.6.1.1 – Quality management system performance 5.6.2.1- Management review – supplemental Minor wording changes. Added “Analysis of field failures and their impact on quality, safety or the environment shall be input to management review”

Comparison between 1st and 2nd edition TS 16949 1st edition TS 16949 2nd edition Comments 4.1.4 – Business Plan Removed 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 4.1.5 – Analysis and use of Company level data 8.4.1 – Analysis and use of company level data 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) 4.1.6 – Employee motivation, empowerment and satisfaction 6.2.2.4 – Employee motivation, empowerment and satisfaction Removed “Employee satisfaction process” Note deleted. This should be 6.2.2.4. There is an error in the standard in the numbering 4.1.7.1 Product Safety 6.4.1 Safety Removed “Potential risks to Customers, users and the environment”. Only “Risk to employees” is there 4.1.7.2 – Regulations 7.2.1 – Determination of requirements relating to product Added as Note-2

Comparison between 1st and 2nd edition 4.2 Quality Systems TS 16949 1st edition TS 16949 2nd edition Comments 4.2.2.2 – Quality System documentation 4.2.1 – General Note added: At the moment in Parking lot 4.2.3.2 – Quality Plan requirements 7.1.1 – Quality Plan requirements Word “appropriate” is removed 4.2.4.1 – Product Realization – General 7.1 – Product realization 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 4.2.4.2 - Measurements 7.3.4.1 – Monitoring “These measurements shall include quality risks, costs, lead-times, critical paths” moved to Notes. 4.2.4.3 – Review cycle Removed the requirement. Note still there

Comparison between 1st and 2nd edition 4.2 Quality Systems TS 16949 1st edition TS 16949 2nd edition Comments 4.2.4.4 – Multidisciplinary approach 7.3.1.1 – Multi disciplinary approach No Change 4.2.4.5 Tools and techniques 8.2.3.1 – Monitoring and measurement of processes – Supplemental Last para “The supplier shall perform process studies…… as well as acceptance criteria” is moved to this element 7.3.3.1 – Product design outputs 7.3.3.2 – Process design outputs 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 4.2.4.6 – Computer aided design 6.2.2.1 – Product design skills 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

Comparison between 1st and 2nd edition 4.2 Quality Systems TS 16949 1st edition TS 16949 2nd edition Comments 4.2.4.7 – Special characteristics 7.3.2.4 – Special characteristics “appropriate methods” removed Note –2 removed 4.2.4.8 – Feasibility reviews 7.2.2.1 – Manufacturing feasibility “including risk analysis” added 4.2.4.9.1 – Management of Process design – General Removed Removed – Documentation requirements removed 4.2.4.9.2 – Process design inputs 7.3.2.2 – Manufacturing process design input “applicable regulations” removed 4.2.4.9.3 – Process design output 7.3.3.2 – Manufacturing process design output “manufacturing process flow chart/layout” added “Control plan” added

Comparison between 1st and 2nd edition 4.2 Quality Systems TS 16949 1st edition TS 16949 2nd edition Comments 4.2.4.9.4 – Process verification 7.3.5 – Design and Development verification 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” 4.2.4.10 – Control Plan 7.5.1.2 – Control Plan “prototype control plan when required by customer” removed 4.2.4.11 – Product Approval Process 7.3.6.3 – Product Approval Process First two requirements including two notes are moved to 7.3.6.3 4.2.4.11 – Product Approval process 7.3.7.1 – Control of Design and development changes – supplemental Requirements relating to change moved to 7.3.7.1 Note added as : See 7.1.2 7.1.2 – Change Control New requirement added incorporating Change requirements

Comparison between 1st and 2nd edition 4.2 Quality Systems TS 16949 1st edition TS 16949 2nd edition Comments 4.2.5 – Plant, facility and equipment planning 6.3.1 – Plant, facility and equipment planning “Plant layouts shall minimize material travel” changed to “Plant layouts shall optimize material travel” In Methods shall be developed, added “implemented” Note removed 4.2.6 – Tooling management 7.5.1.6 – Tooling management Minor wording changes Note added : “This requirement also applies to tooling availability for vehicle spare parts” 4.2.7 – Process Improvement 8.5.1.2 – Manufacturing Process Improvement Minor wording changes. 2 notes deleted and two new notes added 4.2.8 – Quality System performance 5.6.1.1 – Quality Management System performance This requirement incorporated along with 4.1.3.2 – Management review supplemental

Comparison between 1st and 2nd edition 4.3 Contract review TS 16949 1st edition TS 16949 2nd edition Comments 4.3.2.2 – Review – Supplemental Removed This requirement is removed

Comparison between 1st and 2nd edition 4.4 Design Control TS 16949 1st edition TS 16949 2nd edition Comments 4.4 Design Control – Important 7.3 – Design and Development 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 4.4.2.2 Required skills 6.2.2.1 – Product design skills Just says that Suppliers resources should be qualified to achieve design requirements and skilled tools and techniques. List of skills has been removed 4.4.2.3 Research and Development 7.3.2.3 Innovation 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

Comparison between 1st and 2nd edition 4.4 Design Control TS 16949 1st edition TS 16949 2nd edition Comments 4.4.4.2 Reliability Objectives 7.3.2.1 – Product design inputs The existing requirement added as one of the inputs to Product design 4.4.4.3 – Use of information 4.4.5.2 – Design Optimization 7.3.3.1 – Product design outputs Minor wording changes. Product outputs and the Optimization processes clearly seperated out 4.4.8.2 – Design Validation – Supplemental 7.3.6.1 – Design and development validation – supplemental 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 4.4.8.3 – Prototype Programme 7.3.6.2 – Prototype program No Change

Comparison between 1st and 2nd edition 4.4 Design Control TS 16949 1st edition TS 16949 2nd edition Comments 4.4.9.2 – Evaluation of design change 7.3.7.1 – Control of design and development changes - Supplemental 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

Comparison between 1st and 2nd edition 4.5 Document and data control TS 16949 1st edition TS 16949 2nd edition Comments 4.5.2.1 Note Removed Note is Removed 4.5.2.2 Engineering specifications 4.2.3.1 – Engineering Specifications Word “procedure removed” and “process” added 2 notes currently present removed

Comparison between 1st and 2nd edition 4.6 Purchasing TS 16949 1st edition TS 16949 2nd edition Comments 4.6.1.1 Note Note removed and added two notes under 7.4.1 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” 4.6.1.2 – Customer approved subcontractors 7.4.1.4 Customer approved sources “including tool and gaging suppliers” added 4.6.1.3 – Regulatory compliance 7.4.1.2 – Regulatory compliance “applicable to country of manufacture and sale” removed

Comparison between 1st and 2nd edition 4.6 Purchasing TS 16949 1st edition TS 16949 2nd edition Comments 4.6.2.2 – Subcontractor development 7.4.1.3 – Supplier Quality management system development 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 4.6.2.3 – Scheduling subcontractors 8.2.4.3 – Supplier Monitoring “Shall require 100% on time delivery and providing planning information and purchase commitments” removed. Only Delivery performance tracking and premium freight tracking retained

Comparison between 1st and 2nd edition 4.7 Control of customer supplied product TS 16949 1st edition TS 16949 2nd edition Comments 4.7.2 – Customer owned tooling 7.5.4.1 – Customer owned tooling “manufacturing,test,inspection tooling and equipment” added.

Comparison between 1st and 2nd edition 4.8 Product identification and traceability TS 16949 1st edition TS 16949 2nd edition Comments 4.8 7.5.3 – Product Identification and traceability No change

Comparison between 1st and 2nd edition 4.9 Process Control TS 16949 1st edition TS 16949 2nd edition Comments 4.9.1.2 Cleanliness of Premises 6.4.2 – Cleanliness of premises Minor wording changes 4.9.1.3 – Contingency plans 6.3.2 – Contingency plans “to satisfy the customer specified requirements” added Natural disaster and force major removed 4.9.1.4 – Designation of special characteristics 7.2.1.1 – Customer designated special characteristics 4.9.1.5 – Preventive maintenance 7.5.1.5 – Preventive and predictive maintenance “Predictive methods to maximize the effectiveness and efficiency of equipments” added

Comparison between 1st and 2nd edition 4.9 Process Control TS 16949 1st edition TS 16949 2nd edition Comments 4.9.2 – Job instructions 7.5.1.3 – Work instructions “Job instructions” changed to “Work instruction” “without disruption of job” removed “Job instructions shall include or reference ….” removed Note 1 and Note 2 removed 4.9.3 Maintaining process control 8.2.3.1 –Monitoring and measurement of processes – Supplemental Word “exceed” removed Minor wording changes 4.9.4 Verification of job-setups 7.5.1.4 – Verification of Job setups Word “Setup is” missing. This is an error. “significant time period between runs” removed 4.9.5 Appearance items 8.2.4.5 – Appearance items It is 8.2.4.4, should be 8.2.4.5. Minor wording changes

Comparison between 1st and 2nd edition 4.10 Inspection and Testing TS 16949 1st edition TS 16949 2nd edition Comments 4.10.1.1 Note Note removed Existing note removed. New note pertaining to selection of measurement types added. In parking lot 4.10.1.2 Acceptance criteria 8.2.4.1 – Acceptance criteria Changed to “Acceptance criteria shall be defined by the customer and documented by the organization”. This is not clear 4.10.2.4 – Incoming product quality 8.2.4.2 – Incoming Product quality “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 1st edition. This is required only as a corrective action

Comparison between 1st and 2nd edition 4.10 Inspection and Testing TS 16949 1st edition TS 16949 2nd edition Comments 4.10.4.2 – Layout inspection and functional testing 8.2.4.3 – Layout inspection and functional testing No change 4.10.6 Laboratory requirements 7.6.4 – Laboratory requirements 7.6.4.1 – Internal Labs 7.6.4.2 – External Labs Compliance with ISO/IEC 17025 removed. Now it is not mandatory. Earlier requirements in QS9000:1998 written as mandatory in 2nd 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

Comparison between 1st and 2nd edition 4.11 Control of inspection, measuring and test equipment TS 16949 1st edition TS 16949 2nd edition Comments 4.11.1.2 – Measurement System Analysis 7.6.1 – Measurement System analysis 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 4.11.3 – Records 7.6.2 – Calibration records “an assessment of the impact of the out-of specification condition” added

Comparison between 1st and 2nd edition 4.12 Inspection and Test status TS 16949 1st edition TS 16949 2nd edition Comments 4.12 – Inspection and Test status 7.5.3 – Product identification and traceability No change. Merged with Product identification and traceability

Comparison between 1st and 2nd edition 4.13 Control of nonconforming product TS 16949 1st edition TS 16949 2nd edition Comments 4.13.1.2 Suspect material or product 8.3 – Control of nonconforming product “Visual identification for any nonconforming product….” removed Added “Important: Nonconforming includes material of unknown or suspect status” 4.13.1.3 – Corrective action plan 8.3.1 – Customer information “Customer information in case of nonconforming product shipped” is moved to this element Requirement relating to quantify,analyze and initiating actions removed 4.13.3 – Control of reworked product 8.3.2 – Control of reworked product Minor wording change 4.13.4 – Engineering approved authorization 8.3.3 – Customer authorization Change – “Shall obtain customer authorization prior to changing product/process” Minor wording changes

Comparison between 1st and 2nd edition 4.14 Corrective and Preventive action TS 16949 1st edition TS 16949 2nd edition Comments 4.14.1.2 Problem solving 8.5.2.1 – Problem Solving “Shall have a process for problem solving leading to root cause identification and elimination” (Wording change) 4.14.1.3 Mistake proofing 8.5.2.2 – Mistake proofing 8.5.3.1 – Mistake proofing in preventive action No Change 4.14.2.2 – Corrective action impact 8.5.2.3 – Corrective action impact No change 4.14.2.3 – Returned product test/analysis 8.5.2.4 – Returned product test/analysis “Rejected” should be “Returned”. This is an error in the standard.

Comparison between 1st and 2nd edition 4.15 Handling, Storage, packaging,preservation and delivery TS 16949 1st edition TS 16949 2nd edition Comments 4.15.3.2 – Inventory 7.5.5.1 – Storage and inventory No Change 4.15.4.2 Customer packaging standards Removed 4.15.4.3 – Labelling 4.15.6.2 – Performance monitoring of supplier delivery 8.2.1.1 –Customer satisfaction – Supplemental “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

Comparison between 1st and 2nd edition 4.15 Handling, Storage, packaging,preservation and delivery TS 16949 1st edition TS 16949 2nd edition Comments 4.15.6.3 – Production scheduling 7.5.1.7 – Production scheduling Minor wording changes 4.15.6.4 – Electronic communication Removed 4.15.6.5 – Shipment notification system

Comparison between 1st and 2nd edition 4.16 Control of Quality Records TS 16949 1st edition TS 16949 2nd edition Comments 4.16.2 Record retention 4.2.4.1 – Record retention No change

Comparison between 1st and 2nd edition 4.17 – Internal quality audits TS 16949 1st edition TS 16949 2nd edition Comments 4.17.2.1 – Internal quality audits – supplemental – General 8.2.2.1 – Internal audit plans Note pertaining to adherence to ISO10011-1 removed , since now meeting ISO10011-1 is mandatory 4.17.2.2 – System audit “Audits shall cover all activities and shifts” moved to 8.2.2.1 8.2.2.2 – Quality management system audit Remaining requirements of 4.17.2.2 are moved here. No change 4.17.2.3 – Process audit 8.2.2.3 – Manufacturing Process audit Removed the word “Product realization”. Now the focus is only on manufacturing process. 4.17.2.4 – Product audit 8.2.2.4 – Product audit No change 4.17.3 – Auditor qualification 8.2.2.2 – Internal auditor qualification “Shall comply with ISO10011-2 requirements unless specified by customer”. This is a big change.

Comparison between 1st and 2nd edition 4.18 – Training TS 16949 1st edition TS 16949 2nd edition Comments 4.18.1 – Training 6.2.2.2 – Training Even though this is ISO9000:1994 requirement, this is not a requirement in ISO9001:2000. In the 2nd edition, this along with the 2 notes which were present in ISO9000:1994 have been added in this element without any change 4.18.2 Training effectiveness 6.2.2.c Effectiveness requirements is added now as part of ISO9001:2000 6.2.2.c “Special attention shall be given on customer specific requirements” is moved to 6.2.2.2 Note is removed 4.18.3 – Training on the job 6.2.2.3 – Training on the job This should be actually 6.2.2.3. This is an error in the standard in numbering. No change

Comparison between 1st and 2nd edition 4.19 - Servicing TS 16949 1st edition TS 16949 2nd edition Comments 4.19.1 Servicing – Note Note removed 4.19.2 Feedback of information from service 7.5.1.8 – Feedback of information from service No change 4.19.3 – Servicing agreement with customer 7.5.1.9 – Servicing agreement with customer Earlier it was “Special purpose tools” now it is “Special purpose tools or measuring equipments”

Comparison between 1st and 2nd edition 4.20 – Statistical techniques TS 16949 1st edition TS 16949 2nd edition Comments 4.20.3 – Identification of statistical tools 8.1.1 – Identification of Statistical tools No change 4.20.4 – Knowledge of basic statistical concepts 8.1.2 – Knowledge of basic statistical concepts Word “where appropriate” removed

Comparison between 1st and 2nd edition New requirements TS 16949 1st edition TS 16949 2nd edition Comments - 6.5 Sourcing “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.”