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High Level Structure
Iatf Transition series
By
Suryanshi NaxSys Holding
Guru Speak……..
Quality is not a act but is habits….
1 Correlation Matrix
CONTENTS
Iatf 16949- 2016
Vs
Ts 16949-2009
The Iatf 16949 -2016 is not
standalone management system but
it is supplement of iso 9001-2015.
If we see for view of internal auditor
for itaf It is primary require ment to
have knowledge of iso 9001 ,with
product requirements ,5 core tool &
Csr
Difference between is followed in......
Major Change. A small recap
Adoption of HLL
Explict requirements For risk based Thinking To support application Of process
approach
More dependency on Risk based Thinking & process approach
Requirement of context of organisations
Greater emphasis on limiting boundaries &Scope With consideration of
organisations context
Empasis of active role of top management for role out & implementation of
QMS
Service is added as product & service and replace product
Quality objective include who what when
Operational planning risk consider in Risk analysis
Clause ISO 9001:2015 + Additional IATF 16949:2016 Clauses New/Modified/
Carryover
ISO/TS 16949:2009 Clauses
4.1 ISO 9001:2015
4.1 Understanding the organization and its context
NEW -
4.2 ISO 9001:2015
4.2 Understanding the needs and expectations of interested parties
NEW -
4.3 ISO 9001:2015
4.3 Determining the scope of the quality management system
Modified
4.2.2 Quality manual
4.3.1 Additional
4.3.1 Determining the scope of the quality management system --- supplemental
Modified
1.1 General
1.2 Application
4.3.2 Additional
4.3.2 Customer-specific requirements
NEW -
4.4 ISO 9001:2015
4.4 Quality management system
4.4.1 No Tittle
Modified
4.1 General requirements
4.4.1.1 Additional
4.4.1.1 Conformance of products and processes
NEW
4.1.1 General requirements - Supplemental
4.4.1.2 Additional
4.4.1.2 Product safety
4.4.2 No Tittle
NEW
6.4.1 Personnel safety to achieve conformity to product requirements
5.1, 5.1.1 ISO 9001:2015
5.1 Leadership and commitment
5.1.1 General Modified
5.1 Management Commitment
5.4.2 Quality management system planning
5.1.1.1 Additional 5.1.1.1 Corporate responsibility NEW -
5.1.1.2 Additional
5.1.1.2 Process effectiveness and efficiency
Modified
5.1.1 Process efficiency
5.1.1.3 Additional
5.1.1.3 Process owners
NEW -
5.1.2 ISO 9001:2015
5.1.2 Customer Focus
Modified
5.2 Customer focus
5.2 ISO 9001:2015
5.2 Policy
5.2.1 Developing the quality policy
5.2.2 Communicating the quality policy
Modified
5.3 Quality policy
5.3 ISO 9001:2015
5.3 Organizational roles, responsibilities and authorities
Modified
5.5.1 Responsibility and authority
5.5.2 Management representative
5.3.1 Additional
5.3.1 Organizational roles, responsibilities, and authorities – supplemental
Modified
5.5.2.1 Customer representative
5.3.2 Additional
5.3.2 Responsibility and authority for product requirements and corrective actions
Modified
5.5.1.1 Responsibility for quality
6.1 ISO 9001:2015
6.1 Actions to address risks and opportunities
6.1.1 No Tittle
6.1.2 No Tittle
NEW
5.4.2 Quality management system planning
6.1.2.1 Additional
6.1.2.1 Risk analysis
Modified 7.2.2.2 Organization manufacturing feasibility
6.1.2.2 Additional
6.1.2.2 Preventive action
Modified
8.5.3 Preventive action
6.1.2.3 Additional
6.1.2.3 Contingency plans
Modified
6.3.2 Contingency plans
6.2 ISO 9001:2015
6.2 Quality objectives and planning to achieve them
6.2.1 No Tittle
6.2.2 No Tittle
Modified
5.4 Planning
5.4.1 Quality objectives
6.2.2.1 Additional
6.2.2.1 Quality objectives and planning to achieve them – supplemental
Modified
5.4.1.1 Quality objectives -- Supplemental
6.3 ISO 9001:2015
6.3 Planning of changes
Modified
5.4.2 Quality management system planning
7.1 ISO 9001:2015
7.1 Resources
7.1.1 General
7.1.2 People
Carryover
6.1 Provision of resources
6.2.1 General
7.1.3 ISO 9001:2015
7.1.3 Infrastructure
Carryover
6.3 Infrastructure
7.1.3.1 Additional
7.1.3.1 Plant, Facility, and equipment planning
Modified
6.3.1 Plant, facility and equipment planning
7.1.4 ISO 9001:2015
7.1.4 Environment for the operation of processes
Modified
6.4 Work environment
7.1.4.1 Additional
7.1.4.1 Environment for the operation of processes-
supplemental Carryover
6.4.2 Cleanliness of premises
7.1.5
7.1.5.1
ISO 9001:2015
7.1.5 Monitoring and measuring resources
7.1.5.1 General Carryover
7.6 Control of monitoring and measuring equipment
7.1.5.1.1 Additional
7.1.5.1.1 Measurement System Analysis
Modified
7.6.1 Measurement system analysis
7.1.5.2 ISO 9001:2015
7.1.5.2 Measurement traceability
Modified
7.6 Control of monitoring and measuring equipment
7.1.5.2 Additional
7.1.5.2 Measurement traceability
Modified 7.6.1 Measurement system analysis
7.1.5.2.1 Additional
7.1.5.2.1 Calibration/Verification Records
Modified
7.6.2 Calibration/verification records
7.1.5.3.1 Additional
7.1.5.3 Laboratory requirements
7.1.5.3.1 Internal laboratory Carryover
7.6.3 Laboratory requirements
7.6.3.1 Internal Laboratory
7.1.5.3.2 Additional
7.1.5.3.2 External laboratory
Modified
7.6.3.2 External laboratory
7.1.6 ISO 9001:2015
7.1.6 Organizational knowledge
NEW -
7.2 ISO 9001:2015
7.2 Competence
Modified
6.2 Human resources
6.2.1 General
6.2.2 Competence, training and awareness
7.2.1 Additional
7.2.1 Competence --- supplemental
Modified
6.2.2.2 Training
7.2.2 Additional
7.2.2 Competence --- on the job training
Modified
6.2.2.3 Training on the job
7.2.3 Additional
7.2.3 Internal auditor competency
Modified 8.2.2.5 Internal auditor qualification
7.2.4 Additional
7.2.4 Second-party auditor competency
NEW -
7.3 ISO 9001:2015
7.3 Awareness
Modified 6.2.2 Competence, training and awareness
7.3.1 Awareness – Supplemental
6.2.2.3 Training on the job
6.2.2.4 Employee motivation and empowerment
8.1.1 Additional
8.1.1 Operational planning and control — supplemental
Modified 7.1.1 Planning of product realization -- Supplemental
8.1.2 Additional
8.1.2 Confidentiality
Carryover 7.1.3 Confidentiality
8.2
8.2.1
ISO 9001:2015
8.2 Requirements for products and services
8.2.1 Customer communication Modified
7.2 Customer-related processes
7.2.3 Customer communication
8.2.1.1 Additional
8.2.1.1 Customer communication — supplemental
Modified
7.2.3.1 Customer communication -- Supplemental
8.2.2 ISO 9001:2015
8.2.2 Determining the requirements for products and services
.
Carryover
7.2.1 Determination of requirements related to the product
8.2.2.1 Additional
8.2.2.1 Determining the requirements related to products and
services - supplemental Modified 7.2.1 Determination of requirements related to the product (Notes 2 and 3)
8.2.3
8.2.3.1
ISO 9001:2015
8.2.3 Review of requirements related to products and services
8.2.3.1 No Tittle
Modified
7.2.2 Review of requirements related to the product
8.2.3.1.1 Additional
8.2.3.1.1 Review of the requirements for products and services —
supplemental Modified
7.2.2.1 Review of requirements related to the product -- Supplemental
8.2.3.1.2 Additional
8.2.3.1.2 Customer-designated special characteristics
Carryover
7.2.1.1 Customer-designated special characteristics
8.2.3.1.3 Additional
8.2.3.1.3 Organization manufacturing feasibility
Modified
7.2.2.2 Organization manufacturing feasibility
8.2.3.2 ISO 9001:2015 8.2.3.2 No Tittle Modified
7.2.2.2 Organization manufacturing feasibility
8.2.4 ISO 9001:2015
8.2.4 Changes to requirements for products and services
Modified
7.2.2 Review of requirements related to the product
8.3, 8.3.1 ISO 9001:2015
8.3 Design and development of products and services
8.3.1 General Modified
7.3 Design and development
7.3.1 Design and development planning
8.3.1.1 Additional
8.3.1.1 Design and development of products and services –
supplemental Modified 7.3 Design and development (Note)
8.3.2 ISO 9001:2015
8.3.2 Design and development planning
Modified
7.3 Design and development
7.3.1 Design and development planning
8.3.2.1 Additional
8.3.2.1 Design and development planning --- supplemental
Modified
7.3.1.1 Multidisciplinary approach
8.3.2.2 Additional
8.3.2.2 Product design skills
Carryover
6.2.2.1 Product design skills
8.3.2.3 Additional
8.3.2.3 Development of products with embedded software
NEW -
8.4.1.1 Additional
8.4.1.1 General - supplemental
Modified 7.4.1 Purchasing process (Note 1)
8.4.1.2 Additional
8.4.1.2 Supplier selection process
NEW -
8.4.1.3 Additional
8.4.1.3 Customer-directed sources (also known as
“Directed–Buy”) Modified
7.4.1.3 Customer-approved sources
8.4.2 ISO 9001:2015
8.4.2 Type and extent of control
Modified
7.4.3 Verification of purchased product
8.4.2.1 Additional
8.4.2.1 Type and extent of control – supplemental
Modified
7.4.3.1 Incoming product conformity to requirements
8.4.2.2 Additional
8.4.2.2 Statutory and regulatory requirements
Modified
7.4.1.1 Statutory and regulatory conformity
8.4.2.3 Additional
8.4.2.3 Supplier quality management system requirements
Modified
7.4.1.2 Supplier quality management system development
8.4.2.3.1 Additional
8.4.2.3.1 Automotive product-related software or
automotive products with embedded software NEW -
8.4.2.4 Additional
8.4.2.4 Supplier monitoring
Modified
7.4.3.2 Supplier monitoring
8.4.2.4.1 Additional
8.4.2.4.1 Second-party audits
NEW -
8.4.2.5 Additional
8.4.2.5 Supplier development
Modified
7.4.3.1 Incoming product conformity to requirements
8.4.3 ISO 9001:2015
8.4.3 Information for external providers
Modified
7.4.2 Purchasing information
8.4.3.1 Additional 8.4.3.1 Information for external providers - supplemental Modified -
8.5 ISO 9001:2015
8.5 Production and service provision
8.5.1 Control of production and service provision Modified
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.2 Validation of processes for production and service provision
8.5.1.1 Additional 8.5.1.1 Control plan Modified
7.5.1.1 Control plan
8.5.1.2 Additional
8.5.1.2 Standardized work – operator instructions and visual
standards Modified
7.5.1.2 Work instructions
8.5.1.3 Additional
8.5.1.3 Verification of job set-ups
Modified
7.5.1.3 Verification of job set-ups
8.5.1.4 Additional
8.5.1.4 Verification after shutdown
NEW -
8.5.1.5 Additional
8.5.1.5 Total productive maintenance
Modified
7.5.1.4 Preventive and predictive maintenance
8.5.1.6 Additional
8.5.1.6 Management of production tooling and manufacturing,
test, inspection tooling and equipment Modified
7.5.1.5 Management of production tooling
8.5.1.7 Additional
8.5.1.7 Production scheduling
Modified
7.5.1.6 Production scheduling
8.5.2 ISO 9001:2015
8.5.2 Identification and traceability
Carryover
7.5.3 Identification and traceability
8.5.2.1 Additional
8.5.2.1 Identification and traceability — supplemental
Modified -
8.5.3 ISO 9001:2015
8.5.3 Property belonging to customers or external providers
Carryover
7.5.4 Customer property
8.5.4 ISO 9001:2015
8.5.4 Preservation
Carryover
7.5.5 Preservation of product
8.5.4.1 Additional
8.5.4.1 Preservation - supplemental
Modified
7.5.5.1 Storage and inventory
8.5.5 ISO 9001:2015
8.5.5 Post-delivery activities
Modified
7.2.1 Determination of requirements related to the product
7.5.1 Control of production and service provision
8.5.5.1 Additional
8.5.5.1 Feedback of information from service
Modified
7.5.1.7 Feedback of information from service
8.5.5.2 Additional
8.5.5.2 Service agreement with customer
Modified
7.5.1.8 Service agreement with customer
8.5.6 ISO 9001:2015
8.5.6 Control of changes
Modified -
8.5.6.1 Additional
8.5.6.1 Control of changes - supplemental
Modified
7.1.4 Change control
8.5.6.1.1 Additional
8.5.6.1.1 Temporary change of process controls
NEW -
8.6 ISO 9001:2015
8.6 Release of products and services
Carryover
8.2.4 Monitoring and measurement of product
8.6.1 Additional
8.6.1 Release of products and services — supplemental
NEW -
8.6.2 Additional
8.6.2 Layout inspection and functional testing
Modified
8.2.4.1 Layout inspection and functional testing
8.6.3 Additional
8.6.3 Appearance items
Modified
8.2.4.2 Appearance items
8.6.4 Additional
8.6.4 Verification and acceptance of conformity of externally
provided products and services Modified
7.4.3.1 Incoming product conformity to requirements
8.6.5 Additional
8.6.5 Statutory and regulatory conformity
Modified
7.4.1.1 Statutory and regulatory conformity
8.6.6 Additional
8.6.6 Acceptance criteria
Carryover
7.1.2 Acceptance criteria
8.7.1 ISO 9001:2015
8.7 Control of nonconforming outputs
8.7.1 No Tittle
Modified
8.3 Control of nonconforming product
8.7.1.1 Additional
8.7.1.1 Customer authorization for concession
Modified
8.3.4 Customer waiver
8.7.1.2 Additional
8.7.1.2 Control of nonconforming product – customer-specified
process Modified -
8.7.1.3 Additional
8.7.1.3 Control of suspect product
Modified
8.3.1 Control of nonconforming product --Supplemental
8.7.1.4 Additional
8.7.1.4 Control of reworked product
Modified
8.3.2 Control of reworked product
8.7.1.5 Additional
8.7.1.5 Control of repaired product
Modified 8.3.3 Customer information
8.7.1.6 Additional
8.7.1.6 Customer notification
Modified
8.3.3 Customer information
8.7.1.7 Additional
8.7.1.7 Nonconforming product disposition
NEW 8.3.1 Control of nonconforming product — Supplemental
8.7.2 ISO 9001:2015 8.7.2 No Tittle Modified
8.3.1 Control of nonconforming product — Supplemental
9.1.1 ISO 9001:2015
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General Modified
8.2.3 Monitoring and measurement of processes
8.2.4 Monitoring and measurement of product
9.1.1.1 Additional
9.1.1.1 Monitoring and measurement of manufacturing processes
Modified
8.2.3.1 Monitoring and measurement of manufacturing processes
9.1.1.2 Additional
9.1.1.2 Identification of statistical tools
Modified
8.1.1 Identification of statistical tools
9.1.1.3 Additional
9.1.1.3 Application of statistical concepts
Modified
8.1.2 Knowledge of basis statistical concepts
9.1.2 ISO 9001:2015
9.1.2 Customer satisfaction
Modified
8.2.1 Customer satisfaction
9.1.2.1 Additional
9.1.2.1 Customer satisfaction – supplemental
Modified
8.2.1.1 Customer satisfaction --Supplemental
9.1.3 ISO 9001:2015
9.1.3 Analysis and evaluation
Modified
8.4 Analysis of data
9.1.3.1 Additional
9.1.3.1 Prioritization
Modified
8.4.1 Analysis and use of data
9.2 ISO 9001:2015
9.2 Internal Audit
9.2.1 No Tittle
9.2.2 No Tittle
Modified
8.2.2 Internal audit
9.2.2.1 Additional
9.2.2.1 Internal audit programme
Modified 8.2.2.4 Internal audit plans
9.2.2.2 Additional
9.2.2.2 Quality management system audit
Modified
8.2.2.1 Quality management system audit
9.2.2.3 Additional
9.2.2.3 Manufacturing process audit
Modified
8.2.2.2 Manufacturing process audit
9.2.2.4 Additional
9.2.2.4 Product audit
Modified
8.2.2.3 Product audit
9.3 9.3.1 ISO 9001:2015
9.3 Management review
9.3.1 General Modified
5.6 Management review
5.6.1 General
9.3.1.1 Additional
9.3.1.1 Management review - supplemental
Modified
5.6.1.1 Quality management system performance
9.3.2 ISO 9001:2015
9.3.2 Management review Inputs
Modified
5.6.2 Review input
9.3.2.1 Additional
9.3.2.1 Management review inputs – supplemental
Modified 5.6.2.1 Review input -- Supplemental
9.3.3 ISO 9001:2015
9.3.3 Management review outputs
Modified
5.6.3 Review output
9.3.3.1 Additional
9.3.3.1 Management review outputs – supplemental
NEW 5.6.3 Review output
10.1 ISO 9001:2015
10 Improvement
10.1 General Modified
8.5.1 Continual improvement
10.2 ISO 9001:2015
10.2 Nonconformity and corrective action
10.2.1 No Tittle
10.2.2 No Tittle
Modified
8.5.2 Corrective action
10.2.3 Additional
10.2.3 Problem solving
Modified
8.5.2.1 Problem solving
10.2.4 Additional
10.2.4 Error-proofing
Modified
8.5.2.2 Error-proofing
10.2.5 Additional
10.2.5 Warranty management systems
NEW -
10.2.6 Additional
10.2.6 Customer complaints and field failure test analysis
Modified
8.5.2.4 Rejected product test/analysis
10.3 ISO 9001:2015
10.3 Continual improvement
Modified
8.5.1 Continual improvement
10.3.1 Additional
10.3.1 Continual improvement - supplemental
Modified
8.5.1.1 Continual improvement of the organization
8.5.1.2 Manufacturing process improvement
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CHAPTER 1
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Correlation between Ts16949-Iatf 16949

  • 1. High Level Structure Iatf Transition series By Suryanshi NaxSys Holding
  • 2. Guru Speak…….. Quality is not a act but is habits….
  • 3.
  • 5. Iatf 16949- 2016 Vs Ts 16949-2009 The Iatf 16949 -2016 is not standalone management system but it is supplement of iso 9001-2015. If we see for view of internal auditor for itaf It is primary require ment to have knowledge of iso 9001 ,with product requirements ,5 core tool & Csr Difference between is followed in......
  • 6. Major Change. A small recap Adoption of HLL Explict requirements For risk based Thinking To support application Of process approach More dependency on Risk based Thinking & process approach Requirement of context of organisations Greater emphasis on limiting boundaries &Scope With consideration of organisations context Empasis of active role of top management for role out & implementation of QMS Service is added as product & service and replace product Quality objective include who what when Operational planning risk consider in Risk analysis
  • 7. Clause ISO 9001:2015 + Additional IATF 16949:2016 Clauses New/Modified/ Carryover ISO/TS 16949:2009 Clauses 4.1 ISO 9001:2015 4.1 Understanding the organization and its context NEW - 4.2 ISO 9001:2015 4.2 Understanding the needs and expectations of interested parties NEW - 4.3 ISO 9001:2015 4.3 Determining the scope of the quality management system Modified 4.2.2 Quality manual 4.3.1 Additional 4.3.1 Determining the scope of the quality management system --- supplemental Modified 1.1 General 1.2 Application 4.3.2 Additional 4.3.2 Customer-specific requirements NEW - 4.4 ISO 9001:2015 4.4 Quality management system 4.4.1 No Tittle Modified 4.1 General requirements 4.4.1.1 Additional 4.4.1.1 Conformance of products and processes NEW 4.1.1 General requirements - Supplemental 4.4.1.2 Additional 4.4.1.2 Product safety 4.4.2 No Tittle NEW 6.4.1 Personnel safety to achieve conformity to product requirements 5.1, 5.1.1 ISO 9001:2015 5.1 Leadership and commitment 5.1.1 General Modified 5.1 Management Commitment 5.4.2 Quality management system planning 5.1.1.1 Additional 5.1.1.1 Corporate responsibility NEW - 5.1.1.2 Additional 5.1.1.2 Process effectiveness and efficiency Modified 5.1.1 Process efficiency 5.1.1.3 Additional 5.1.1.3 Process owners NEW - 5.1.2 ISO 9001:2015 5.1.2 Customer Focus Modified 5.2 Customer focus 5.2 ISO 9001:2015 5.2 Policy 5.2.1 Developing the quality policy 5.2.2 Communicating the quality policy Modified 5.3 Quality policy
  • 8. 5.3 ISO 9001:2015 5.3 Organizational roles, responsibilities and authorities Modified 5.5.1 Responsibility and authority 5.5.2 Management representative 5.3.1 Additional 5.3.1 Organizational roles, responsibilities, and authorities – supplemental Modified 5.5.2.1 Customer representative 5.3.2 Additional 5.3.2 Responsibility and authority for product requirements and corrective actions Modified 5.5.1.1 Responsibility for quality 6.1 ISO 9001:2015 6.1 Actions to address risks and opportunities 6.1.1 No Tittle 6.1.2 No Tittle NEW 5.4.2 Quality management system planning 6.1.2.1 Additional 6.1.2.1 Risk analysis Modified 7.2.2.2 Organization manufacturing feasibility 6.1.2.2 Additional 6.1.2.2 Preventive action Modified 8.5.3 Preventive action 6.1.2.3 Additional 6.1.2.3 Contingency plans Modified 6.3.2 Contingency plans 6.2 ISO 9001:2015 6.2 Quality objectives and planning to achieve them 6.2.1 No Tittle 6.2.2 No Tittle Modified 5.4 Planning 5.4.1 Quality objectives 6.2.2.1 Additional 6.2.2.1 Quality objectives and planning to achieve them – supplemental Modified 5.4.1.1 Quality objectives -- Supplemental 6.3 ISO 9001:2015 6.3 Planning of changes Modified 5.4.2 Quality management system planning 7.1 ISO 9001:2015 7.1 Resources 7.1.1 General 7.1.2 People Carryover 6.1 Provision of resources 6.2.1 General 7.1.3 ISO 9001:2015 7.1.3 Infrastructure Carryover 6.3 Infrastructure 7.1.3.1 Additional 7.1.3.1 Plant, Facility, and equipment planning Modified 6.3.1 Plant, facility and equipment planning 7.1.4 ISO 9001:2015 7.1.4 Environment for the operation of processes Modified 6.4 Work environment
  • 9. 7.1.4.1 Additional 7.1.4.1 Environment for the operation of processes- supplemental Carryover 6.4.2 Cleanliness of premises 7.1.5 7.1.5.1 ISO 9001:2015 7.1.5 Monitoring and measuring resources 7.1.5.1 General Carryover 7.6 Control of monitoring and measuring equipment 7.1.5.1.1 Additional 7.1.5.1.1 Measurement System Analysis Modified 7.6.1 Measurement system analysis 7.1.5.2 ISO 9001:2015 7.1.5.2 Measurement traceability Modified 7.6 Control of monitoring and measuring equipment 7.1.5.2 Additional 7.1.5.2 Measurement traceability Modified 7.6.1 Measurement system analysis 7.1.5.2.1 Additional 7.1.5.2.1 Calibration/Verification Records Modified 7.6.2 Calibration/verification records 7.1.5.3.1 Additional 7.1.5.3 Laboratory requirements 7.1.5.3.1 Internal laboratory Carryover 7.6.3 Laboratory requirements 7.6.3.1 Internal Laboratory 7.1.5.3.2 Additional 7.1.5.3.2 External laboratory Modified 7.6.3.2 External laboratory 7.1.6 ISO 9001:2015 7.1.6 Organizational knowledge NEW - 7.2 ISO 9001:2015 7.2 Competence Modified 6.2 Human resources 6.2.1 General 6.2.2 Competence, training and awareness 7.2.1 Additional 7.2.1 Competence --- supplemental Modified 6.2.2.2 Training 7.2.2 Additional 7.2.2 Competence --- on the job training Modified 6.2.2.3 Training on the job 7.2.3 Additional 7.2.3 Internal auditor competency Modified 8.2.2.5 Internal auditor qualification 7.2.4 Additional 7.2.4 Second-party auditor competency NEW - 7.3 ISO 9001:2015 7.3 Awareness Modified 6.2.2 Competence, training and awareness 7.3.1 Awareness – Supplemental 6.2.2.3 Training on the job 6.2.2.4 Employee motivation and empowerment
  • 10. 8.1.1 Additional 8.1.1 Operational planning and control — supplemental Modified 7.1.1 Planning of product realization -- Supplemental 8.1.2 Additional 8.1.2 Confidentiality Carryover 7.1.3 Confidentiality 8.2 8.2.1 ISO 9001:2015 8.2 Requirements for products and services 8.2.1 Customer communication Modified 7.2 Customer-related processes 7.2.3 Customer communication 8.2.1.1 Additional 8.2.1.1 Customer communication — supplemental Modified 7.2.3.1 Customer communication -- Supplemental 8.2.2 ISO 9001:2015 8.2.2 Determining the requirements for products and services . Carryover 7.2.1 Determination of requirements related to the product 8.2.2.1 Additional 8.2.2.1 Determining the requirements related to products and services - supplemental Modified 7.2.1 Determination of requirements related to the product (Notes 2 and 3) 8.2.3 8.2.3.1 ISO 9001:2015 8.2.3 Review of requirements related to products and services 8.2.3.1 No Tittle Modified 7.2.2 Review of requirements related to the product 8.2.3.1.1 Additional 8.2.3.1.1 Review of the requirements for products and services — supplemental Modified 7.2.2.1 Review of requirements related to the product -- Supplemental 8.2.3.1.2 Additional 8.2.3.1.2 Customer-designated special characteristics Carryover 7.2.1.1 Customer-designated special characteristics 8.2.3.1.3 Additional 8.2.3.1.3 Organization manufacturing feasibility Modified 7.2.2.2 Organization manufacturing feasibility 8.2.3.2 ISO 9001:2015 8.2.3.2 No Tittle Modified 7.2.2.2 Organization manufacturing feasibility 8.2.4 ISO 9001:2015 8.2.4 Changes to requirements for products and services Modified 7.2.2 Review of requirements related to the product 8.3, 8.3.1 ISO 9001:2015 8.3 Design and development of products and services 8.3.1 General Modified 7.3 Design and development 7.3.1 Design and development planning 8.3.1.1 Additional 8.3.1.1 Design and development of products and services – supplemental Modified 7.3 Design and development (Note) 8.3.2 ISO 9001:2015 8.3.2 Design and development planning Modified 7.3 Design and development 7.3.1 Design and development planning 8.3.2.1 Additional 8.3.2.1 Design and development planning --- supplemental Modified 7.3.1.1 Multidisciplinary approach 8.3.2.2 Additional 8.3.2.2 Product design skills Carryover 6.2.2.1 Product design skills 8.3.2.3 Additional 8.3.2.3 Development of products with embedded software NEW -
  • 11. 8.4.1.1 Additional 8.4.1.1 General - supplemental Modified 7.4.1 Purchasing process (Note 1) 8.4.1.2 Additional 8.4.1.2 Supplier selection process NEW - 8.4.1.3 Additional 8.4.1.3 Customer-directed sources (also known as “Directed–Buy”) Modified 7.4.1.3 Customer-approved sources 8.4.2 ISO 9001:2015 8.4.2 Type and extent of control Modified 7.4.3 Verification of purchased product 8.4.2.1 Additional 8.4.2.1 Type and extent of control – supplemental Modified 7.4.3.1 Incoming product conformity to requirements 8.4.2.2 Additional 8.4.2.2 Statutory and regulatory requirements Modified 7.4.1.1 Statutory and regulatory conformity 8.4.2.3 Additional 8.4.2.3 Supplier quality management system requirements Modified 7.4.1.2 Supplier quality management system development 8.4.2.3.1 Additional 8.4.2.3.1 Automotive product-related software or automotive products with embedded software NEW - 8.4.2.4 Additional 8.4.2.4 Supplier monitoring Modified 7.4.3.2 Supplier monitoring 8.4.2.4.1 Additional 8.4.2.4.1 Second-party audits NEW - 8.4.2.5 Additional 8.4.2.5 Supplier development Modified 7.4.3.1 Incoming product conformity to requirements 8.4.3 ISO 9001:2015 8.4.3 Information for external providers Modified 7.4.2 Purchasing information 8.4.3.1 Additional 8.4.3.1 Information for external providers - supplemental Modified - 8.5 ISO 9001:2015 8.5 Production and service provision 8.5.1 Control of production and service provision Modified 7.5 Production and service provision 7.5.1 Control of production and service provision 7.5.2 Validation of processes for production and service provision 8.5.1.1 Additional 8.5.1.1 Control plan Modified 7.5.1.1 Control plan
  • 12. 8.5.1.2 Additional 8.5.1.2 Standardized work – operator instructions and visual standards Modified 7.5.1.2 Work instructions 8.5.1.3 Additional 8.5.1.3 Verification of job set-ups Modified 7.5.1.3 Verification of job set-ups 8.5.1.4 Additional 8.5.1.4 Verification after shutdown NEW - 8.5.1.5 Additional 8.5.1.5 Total productive maintenance Modified 7.5.1.4 Preventive and predictive maintenance 8.5.1.6 Additional 8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and equipment Modified 7.5.1.5 Management of production tooling 8.5.1.7 Additional 8.5.1.7 Production scheduling Modified 7.5.1.6 Production scheduling 8.5.2 ISO 9001:2015 8.5.2 Identification and traceability Carryover 7.5.3 Identification and traceability 8.5.2.1 Additional 8.5.2.1 Identification and traceability — supplemental Modified - 8.5.3 ISO 9001:2015 8.5.3 Property belonging to customers or external providers Carryover 7.5.4 Customer property 8.5.4 ISO 9001:2015 8.5.4 Preservation Carryover 7.5.5 Preservation of product 8.5.4.1 Additional 8.5.4.1 Preservation - supplemental Modified 7.5.5.1 Storage and inventory 8.5.5 ISO 9001:2015 8.5.5 Post-delivery activities Modified 7.2.1 Determination of requirements related to the product 7.5.1 Control of production and service provision 8.5.5.1 Additional 8.5.5.1 Feedback of information from service Modified 7.5.1.7 Feedback of information from service 8.5.5.2 Additional 8.5.5.2 Service agreement with customer Modified 7.5.1.8 Service agreement with customer 8.5.6 ISO 9001:2015 8.5.6 Control of changes Modified - 8.5.6.1 Additional 8.5.6.1 Control of changes - supplemental Modified 7.1.4 Change control
  • 13. 8.5.6.1.1 Additional 8.5.6.1.1 Temporary change of process controls NEW - 8.6 ISO 9001:2015 8.6 Release of products and services Carryover 8.2.4 Monitoring and measurement of product 8.6.1 Additional 8.6.1 Release of products and services — supplemental NEW - 8.6.2 Additional 8.6.2 Layout inspection and functional testing Modified 8.2.4.1 Layout inspection and functional testing 8.6.3 Additional 8.6.3 Appearance items Modified 8.2.4.2 Appearance items 8.6.4 Additional 8.6.4 Verification and acceptance of conformity of externally provided products and services Modified 7.4.3.1 Incoming product conformity to requirements 8.6.5 Additional 8.6.5 Statutory and regulatory conformity Modified 7.4.1.1 Statutory and regulatory conformity 8.6.6 Additional 8.6.6 Acceptance criteria Carryover 7.1.2 Acceptance criteria 8.7.1 ISO 9001:2015 8.7 Control of nonconforming outputs 8.7.1 No Tittle Modified 8.3 Control of nonconforming product 8.7.1.1 Additional 8.7.1.1 Customer authorization for concession Modified 8.3.4 Customer waiver 8.7.1.2 Additional 8.7.1.2 Control of nonconforming product – customer-specified process Modified - 8.7.1.3 Additional 8.7.1.3 Control of suspect product Modified 8.3.1 Control of nonconforming product --Supplemental 8.7.1.4 Additional 8.7.1.4 Control of reworked product Modified 8.3.2 Control of reworked product 8.7.1.5 Additional 8.7.1.5 Control of repaired product Modified 8.3.3 Customer information 8.7.1.6 Additional 8.7.1.6 Customer notification Modified 8.3.3 Customer information 8.7.1.7 Additional 8.7.1.7 Nonconforming product disposition NEW 8.3.1 Control of nonconforming product — Supplemental 8.7.2 ISO 9001:2015 8.7.2 No Tittle Modified 8.3.1 Control of nonconforming product — Supplemental
  • 14. 9.1.1 ISO 9001:2015 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General Modified 8.2.3 Monitoring and measurement of processes 8.2.4 Monitoring and measurement of product 9.1.1.1 Additional 9.1.1.1 Monitoring and measurement of manufacturing processes Modified 8.2.3.1 Monitoring and measurement of manufacturing processes 9.1.1.2 Additional 9.1.1.2 Identification of statistical tools Modified 8.1.1 Identification of statistical tools 9.1.1.3 Additional 9.1.1.3 Application of statistical concepts Modified 8.1.2 Knowledge of basis statistical concepts 9.1.2 ISO 9001:2015 9.1.2 Customer satisfaction Modified 8.2.1 Customer satisfaction 9.1.2.1 Additional 9.1.2.1 Customer satisfaction – supplemental Modified 8.2.1.1 Customer satisfaction --Supplemental 9.1.3 ISO 9001:2015 9.1.3 Analysis and evaluation Modified 8.4 Analysis of data 9.1.3.1 Additional 9.1.3.1 Prioritization Modified 8.4.1 Analysis and use of data 9.2 ISO 9001:2015 9.2 Internal Audit 9.2.1 No Tittle 9.2.2 No Tittle Modified 8.2.2 Internal audit 9.2.2.1 Additional 9.2.2.1 Internal audit programme Modified 8.2.2.4 Internal audit plans 9.2.2.2 Additional 9.2.2.2 Quality management system audit Modified 8.2.2.1 Quality management system audit 9.2.2.3 Additional 9.2.2.3 Manufacturing process audit Modified 8.2.2.2 Manufacturing process audit 9.2.2.4 Additional 9.2.2.4 Product audit Modified 8.2.2.3 Product audit 9.3 9.3.1 ISO 9001:2015 9.3 Management review 9.3.1 General Modified 5.6 Management review 5.6.1 General 9.3.1.1 Additional 9.3.1.1 Management review - supplemental Modified 5.6.1.1 Quality management system performance 9.3.2 ISO 9001:2015 9.3.2 Management review Inputs Modified 5.6.2 Review input 9.3.2.1 Additional 9.3.2.1 Management review inputs – supplemental Modified 5.6.2.1 Review input -- Supplemental 9.3.3 ISO 9001:2015 9.3.3 Management review outputs Modified 5.6.3 Review output 9.3.3.1 Additional 9.3.3.1 Management review outputs – supplemental NEW 5.6.3 Review output
  • 15. 10.1 ISO 9001:2015 10 Improvement 10.1 General Modified 8.5.1 Continual improvement 10.2 ISO 9001:2015 10.2 Nonconformity and corrective action 10.2.1 No Tittle 10.2.2 No Tittle Modified 8.5.2 Corrective action 10.2.3 Additional 10.2.3 Problem solving Modified 8.5.2.1 Problem solving 10.2.4 Additional 10.2.4 Error-proofing Modified 8.5.2.2 Error-proofing 10.2.5 Additional 10.2.5 Warranty management systems NEW - 10.2.6 Additional 10.2.6 Customer complaints and field failure test analysis Modified 8.5.2.4 Rejected product test/analysis 10.3 ISO 9001:2015 10.3 Continual improvement Modified 8.5.1 Continual improvement 10.3.1 Additional 10.3.1 Continual improvement - supplemental Modified 8.5.1.1 Continual improvement of the organization 8.5.1.2 Manufacturing process improvement
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