ISO 9001:2015 ISO 14001:2015 ISO 45001:2018

Introduction Introduction Introduction

0.1 General 0.1 Background
0.2 Quality management principles 0.2 Aim of an environmental management system
0.3 Process approach 0.3 Success factors
0.3.1 General 0.4 Plan-D0-Check-Act model
0.3.2 Plan-Do-Check-Act cycle 0.5 Contents of this international standard
0.3.3 Risk-based thinking
0.4 Relationship with other management standards
1 Scope 1 Scope 1 Scope

2 Normative references 2 Normative references 2 Normative references

3 Terms and definitions 3 Terms and definitions 3 Terms and definitions.

4 Context of the organization 4 Context of the organization 4 Context of the organization.

4.1 Understanding the organization and its context 4.1 Understanding the organization and its context 4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties 4.2 Understanding the needs and expectations of interested parties 4.2 Understanding the needs and expectations of workers and other interested parties
4.3 Determining the scope of the quality management system 4.3 Determining the scope of the environmental management system 4.3 Determining the scope of the OH&S management system.

4.4 Quality management system and its processes 4.4 Environmental management system 4.4 OH&S management system
4.4.1 .. Establish, implement, maintain and continually improve ..

4.4.2 .. Maintain documented information ..

5 Leadership 5 Leadership 5 Leadership and worker participation
5.1 Leadership and commitment 5.1 Leadership and commitment 5.1 Leadership and commitment
5.1.1 General

5.1.2 Customer focus

5.2 Policy 5.2 Environmental policy 5.2 OH&S policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.3 Organizational roles, responsibilities and authorities 5.3 Organizational roles, responsibilities and authorities 5.3 Organizational roles, responsibilities and authorities

5.4 Consultation and participation of workers

6 Planning 6 Planning 6 Planning

6.1 Actions to address risks and opportunities 6.1 Actions to address risks and opportunities 6.1 Actions to address risks and opportunities
6.1.1 .. Consider issues of 4.1 and requirements of 4.2 .. 6.1.1 General 6.1.1 General
6.1.2 .. Actions to address risks and opportunities 6.1.2 Environmental aspects 6.1.2 Hazard identification and assessment of risks and opportunities

6.1.3 Compliance obligations 6.1.3 Determination of legal requirements and other requirements
6.1.4 Planning action 6.1.4 Planning action
6.2 Quality objectives and planning to achieve them 6.2 Environmental objectives and planning to achieve them 6.2 OH&S objectives and planning to achieve them
6.2.1 .. Quality objectives at relevant functions .. 6.2.1 Environmental objectives 6.2.1 OH&S objectives
6.2.2 .. Determine what, who, when, how .. 6.2.2 Planning actions to achieve environmental objectives 6.2.2 Planning to achieve OH&S objectives.

6.3 Planning of changes

7 Support 7 Support 7 Support
7.1 Resources 7.1 Resources 7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure

7.1.4 Environment for the operation of processes

7.1.5 Monitoring and measuring resources * 9.1.1 Operational control - Monitoring, measuring equipment
7.1.5.1 General

7.1.5.2 Measurement traceability

7.1.6 Organizational knowledge

7.2 Competence 7.2 Competence 7.2 Competence

7.3 Awareness 7.3 Awareness 7.3 Awareness

7.4 Communication 7.4 Communication 7.4 Communication

7.4.1 General 7.4.1 General
7.4.2 Internal communication 7.4.2 Internal communication
7.4.3 External communication 7.4.3 External communication
7.5 Documented information 7.5 Documented information 7.5 Documented information
7.5.1 General 7.5.1 General 7.5.1 General

7.5.2 Creating and updating 7.5.2 Creating and updating 7.5.2 Creating and updating
7.5.3 Control of documented information 7.5.3 Control of documented information 7.5.3 Control of documented information

7.5.3.1 .. Documented information controlled ..

7.5.3.2 .. Activities for control of information ..
 ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
8 Operation 8 Operation 8 Operation
8.1 Operational planning and control 8.1 Operational planning and control 8.1 Operational planning and control
8.1.1 General
8.1.2 Eliminating hazards and reducing OH&S risks
8.1.3 Management of change
8.1.4 Procurement

8.2 Requirements for products and services 8.2 Emergency preparedness and response 8.2 Emergency preparedness and response
8.2.1 Customer communication

8.2.2 Determining the requirements for products and services

8.2.3 Review of the requirements for products and services

8.2.3.1 .. Ensure ability to meet requirements ..

8.2.3.2 .. Retain documented information ..

8.2.4 Changes to requirements for products and services
8.3 Design and development of products and services *8.1 Operational control - Design and development
8.3.1 General

8.3.2 Design and development planning

8.3.3 Design and development inputs

8.3.4 Design and development controls

8.3.5 Design and development outputs

8.3.6 Design and development changes

8.4 Control of externally provided processes, products and services *8.1 Operational control- External providers
8.4.1 General

8.4.2 Type and extent of control

8.4.3 Information for external providers

8.5 Production and service provision

8.5.1 Control of production and service provision *8.1 Operational control-Provision of production and service

8.5.2 Identification and traceability

8.5.3 Property belonging to customers or external providers

8.5.4 Preservation

8.5.5 Post-delivery activities *8.1 Operational control - Delivery and post delivery

8.5.6 Control of changes

8.6 Release of products and services

8.7 Control of nonconforming outputs

9 Performance evaluation 9 Performance evaluation 9 Performance evaluation

9.1 Monitoring measurement, analysis and evaluation 9.1 Monitoring measurement, analysis and evaluation 9.1 Monitoring, measurement, analysis and performance evaluation
9.1.1 General 9.1.1 General 9.1.1 General

9.1.2 Customer satisfaction

 ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
9.1.3 Analysis and evaluation 9.1.2 Evaluation of compliance 9.1.2 Evaluation of compliance

9.2 Internal audit 9.2 Internal audit 9.2 Internal audit

9.2.1 .. Conduct internal audits at planned intervals .. 9.2.1 General 9.2.1 General
9.2.2 .. Plan, establish, implement and maintain audit program .. 9.2.2 Internal audit program 9.2.2 Internal audit programme

9.3 Management review 9.3 Management review 9.3 Management review

9.3.1 General

9.3.2 Management review inputs

9.3.3 Management review outputs

10 Improvement 10 Improvement 10 Improvement

10.1 General 10.1 General 10.1 General

10.2 Nonconformity and corrective action 10.2 Nonconformity and corrective action 10.2 Incident, nonconformity and corrective action

10.2.1 .. When a nonconformity occurs ..

10.2.2 .. Retain documented information ..

10.3 Continual improvement 10.3 Continual improvement 10.3 Continual improvement

 ISO 9001:2015 ISO 14001:2015 ISO 13485:2015 ISO 16949:2016 OHSAS 18001:2007 ISO 45001:2018 AS9100D AS9110C AS9120B
Introduction Introduction Introduction Introduction Introduction Introduction Introduction Introduction Introduction
0.1 General 0.1 Background 0.1 General 0.1 General 0.1 General 0.1 General
0.2 Quality management principles 0.2 Aim of an environmental management system 0.2 Quality management principles 0.2 Quality management principles 0.2 Quality management principles 0.2 Quality management principles
0.3 Process approach 0.3 Success factors 0.3 Process approach 0.3 Process approach 0.3 Process approach 0.3 Process approach
0.3.1 General 0.4 Plan-D0-Check-Act model 0.3.1 General 0.3.1 General 0.3.1 General 0.3.1 General
0.3.2 Plan-Do-Check-Act cycle 0.5 Contents of this international standard 0.3.2 Plan-Do-Check-Act cycle 0.3.2 Plan-Do-Check-Act cycle 0.3.2 Plan-Do-Check-Act cycle 0.3.2 Plan-Do-Check-Act cycle
0.3.3 Risk-based thinking 0.3.3 Risk-based thinking 0.3.3 Risk-based thinking 0.3.3 Risk-based thinking 0.3.3 Risk-based thinking
0.4 Relationship with other management standards 0.4 Relationship with other management standards 0.4 Relationship with other management standards 0.4 Relationship with other management standards 0.4 Relationship with other management standards
1 Scope 1 Scope 1 Scope 1 Scope 1 Scope 1 Scope 1 Scope 1 Scope 1 Scope
1.1 Automotive Supplemental to ISO 9001:2015
2 Normative references 2 Normative references 2 Normative references 2 Normative references 2 Reference publications 2 Normative references 2 Normative references 2 Normative references 2 Normative references
2.1 Normative and informative references
3 Terms and definitions 3 Terms and definitions 3 Terms and definitions 3 Terms and definitions 3 Terms and definitions 3 Terms and definitions. 3 Terms and definitions 3 Terms and definitions 3 Terms and definitions
3.1 Terms and definitions for the automotive industry
4 Context of the organization 4 Context of the organization 4 Quality Management System 4 Context of the organization 4 OH&S management system requirements 4 Context of the organization. 4 Context of the organization 4 Context of the organization 4 Context of the organization
4.1 Understanding the organization and its context 4.1 Understanding the organization and its context 4.1 General requirements 4.1 Understanding the organization and its context 4.1 General requirements 4.1 Understanding the organization and its context 4.1 Understanding the organization and its context 4.1 Understanding the organization and its context 4.1 Understanding the organization and its context
42 Understanding the needs and expectations of interested parties 42 Understanding the needs and expectations of interested parties 42 Understanding the needs and expectations of interested parties 42 Understanding the needs and expectations of workers and other interested parties 42 Understanding the needs and expectations of interested parties 42 Understanding the needs and expectations of interested parties 42 Understanding the needs and expectations of interested parties
43 Determining the scope of the quality management system 43 Determining the scope of the environmental management system 43 Determining the scope of the quality management system 43 Determining the scope of the OH&S management system. 43 Determining the scope of the quality management system 43 Determining the scope of the quality management system 43 Determining the scope of the quality management system
431 Determining the scope of the quality management system — supplemental
432 Customer-specific requirements
4.4 Quality management system and its processes 4.4 Environmental management system 4.4 Quality management system and its processes 4.4 OH&S management system 4.4 Quality management system and its processes 4.4 Quality management system and its processes 4.4 Quality management system and its processes
4.4.1 .. Establish, implement, maintain and continually improve .. 4.4.1 'See ISO 9001:2015 requirements'
4.4.1.1 Conformance of products and processes
4.4.1.2 Product safety
4.4.2 .. Maintain documented information .. 4.4.2 'See ISO 9001:2015 requirements'
5 Leadership 5 Leadership 5 Management Responsibility 5 Leadership 5 Leadership and worker participation 5 Leadership 5 Leadership 5 Leadership
5.1 Leadership and commitment 5.1 Leadership and commitment 5.1 Management commitment 5.1 Leadership and commitment 5.1 Leadership and commitment 5.1 Leadership and commitment 5.1 Leadership and commitment 5.1 Leadership and commitment
5.1.1 General 5.1.1 General 5.1.1 General 5.1.1 General 5.1.1 General
5.1.1.1 Corporate responsibility
5.1.1.2 Process effectiveness and efficiency
5.1.1.3 Process owners
5.1.2 Customer focus 5.2 Customer focus 5.1.2 Customer focus 5.1.2 Customer focus 5.1.2 Customer focus 5.1.2 Customer focus
5.2 Policy 5.2 Environmental policy 5.3 Quality policy 5.2 Policy 4.2 OH&S policy 5.2 OH&S policy 5.2 Policy 5.2 Policy 5.2 Policy
5.2.1 Establishing the quality policy 5.2.1 Establishing the quality policy 5.2.1 Establishing the quality policy 5.2.1 Establishing the quality policy 5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy 5.2.2 Communicating the quality policy 5.2.2 Communicating the quality policy 5.2.2 Communicating the quality policy 5.2.2 Communicating the quality policy
53 Organizational roles responsibilities and authorities 53 Organizational roles responsibilities and authorities 55 Responsibility authority and communication 53 Organizational roles responsibilities and authorities 441 Resources roles responsibility and authority 53 Organizational roles, responsibilities and authorities 53 Organizational roles responsibilities and authorities 53 Organizational roles responsibilities and authorities 53 Organizational roles responsibilities and authorities
551 Responsibility and authority 531 Organizational roles responsibilities and authorities — supplemental 531 Accountable Manager
552 Management representative 532 Responsibility and authority for product requirements and corrective actions 532 Quality Manager
54 Consultation and participation of workers 533 Other Appointed Manager(s)
6 Planning 6 Planning 5.4 Planning 6 Planning 4.3 Planning 6 Planning 6 Planning 6 Planning 6 Planning
5.4.2 Quality management system planning
6.1 Actions to address risks and opportunities 6.1 Actions to address risks and opportunities 6.1 Actions to address risks and opportunities 4.3.1 Hazard Identification, Risk Assessment & Determining controls. 6.1 Actions to address risks and opportunities 6.1 Actions to address risks and opportunities 6.1 Actions to address risks and opportunities 6.1 Actions to address risks and opportunities
6.1.1 .. Consider issues of 4.1 and requirements of 4.2 .. 6.1.1 General 6.1.1 'See ISO 9001:2015 requirements' 6.1.1 General
6.1.2 .. Actions to address risks and opportunities 6.1.2 Environmental aspects 6.1.2 'See ISO 9001:2015 requirements' 6.1.2 Hazard identification and assessment of risks and opportunities
6.1.2.1 Risk analysis
6.1.2.2 Preventive action
6.1.2.3 Contingency plans
6.1.3 Compliance obligations 4.3.2 Legal and other requirements 6.1.3 Determination of legal requirements and other requirements
6.1.4 Planning action 6.1.4 Planning action
6.2 Quality objectives and planning to achieve them 6.2 Environmental objectives and planning to achieve them 5.4.1 Quality objectives 6.2 Quality objectives and planning to achieve them 4.3.3 Objectives, targets and programs 6.2 OH&S objectives and planning to achieve them 6.2 Quality objectives and planning to achieve them 6.2 Quality objectives and planning to achieve them 6.2 Quality objectives and planning to achieve them
6.2.1 .. Quality objectives at relevant functions .. 6.2.1 Environmental objectives 6.2.1 'See ISO 9001:2015 requirements' 6.2.1 OH&S objectives
6.2.2 .. Determine what, who, when, how .. 6.2.2 Planning actions to achieve environmental objectives 6.2.2 'See ISO 9001:2015 requirements' 6.2.2 Planning to achieve OH&S objectives.
6.2.2.1 Quality objectives and planning to achieve them — supplemental
6.3 Planning of changes 6.3 Planning of changes 6.3 Planning of changes 6.3 Planning of changes 6.3 Planning of changes
7 Support 7 Support 6 Resource Management 7 Support 4.4 Implementation and operation 7 Support 7 Support 7 Support 7 Support
7.1 Resources 7.1 Resources 6.1 Provision of resources 7.1 Resources 4.4.1 Resources, roles, responsibility, accountability and authority 7.1 Resources 7.1 Resources 7.1 Resources 7.1 Resources
7.1.1 General 7.1.1 General 7.1.1 General 7.1.1 General 7.1.1 General
7.1.2 People 6.2 Human Resources 7.1.2 People 7.1.2 People 7.1.2 People 7.1.2 People
7.1.3 Infrastructure 6.3 Infrastructure 7.1.3 Infrastructure 7.1.3 Infrastructure 7.1.3 Infrastructure 7.1.3 Infrastructure
7.1.3.1 Plant, facility, and equipment planning
7.1.4 Environment for the operation of processes 6.4.1 Work environment 7.1.4 Environment for the operation of processes 7.1.4 Environment for the operation of processes 7.1.4 Environment for the operation of processes 7.1.4 Environment for the operation of processes
6.4 Work environment and contamination control 7.1.4.1 Environment for the operation of processes — supplemental
6.4.2 Contamination control
715 Monitoring and measuring resources * 9 1 1 Operational control - Monitoring measuring equipment 76 Control of monitoring and measuring equipment 715 Monitoring and measuring resources *4 5 1 Operational control - Monitoring measuring equipment 715 Monitoring and measuring resources 715 Monitoring and measuring resources 715 Monitoring and measuring resources
7151 General 7151 General
71511 Measurement systems analysis
7152 Measurement traceability 7152 Measurement traceability
71521 Calibration/verification records
7153 Laboratory requirements
71531 Internal laboratory
71532 External laboratory
716 Organizational knowledge 716 Organizational knowledge 716 Organizational knowledge 716 Organizational knowledge 716 Organizational knowledge
72 Competence 72 Competence 62 Human Resources 72 Competence 442 Competence training and awareness 72 Competence 72 Competence 72 Competence 72 Competence
721 Competence supplemental
722 Competence — on-the-job training
723 Internal auditor competency
724 Second party auditor competency
73 Awareness 73 Awareness 62 Human Resources 73 Awareness 442 Competence training and awareness 73 Awareness 73 Awareness 73 Awareness 73 Awareness
731 Awareness — supplemental
732 Employee motivation and empowerment
74 Communication 74 Communication 553 Internal communication 74 Communication 4 4 3 Communication participation and consultation 74 Communication 74 Communication 74 Communication 74 Communication
741 General 4 4 3 1 Communication 741 General
742 Internal communication 4 4 3 2 Participation and consultation 742 Internal communication
743 External communication 743 External communication
75 Documented information 75 Documented information 42 Documentation requirements 75 Documented information 444 Documentation 75 Documented information 75 Documented information 75 Documented information 75 Documented information
751 General 751 General 421 General 751 General 751 General 751 General 751 General 751 General
7511 Quality management system documentation
752 Creating and updating 752 Creating and updating 752 Creating and updating 752 Creating and updating 752 Creating and updating 752 Creating and updating 752 Creating and updating
753 Control of documented information 753 Control of documented information 424 Control of documents 753 Control of documented information 445 Control of documents 753 Control of documented information 753 Control of documented information 753 Control of documented information 753 Control of documented information
425 Control of records
422 Quality manual
423 Medical device file
7531 Documented information controlled 7531 'See ISO 9001:2015 requirements' 454 Control of records
7532 Activities for control of information 7532 'See ISO 9001:2015 requirements'
75321 Record retention
75322 Engineering specifications
8 Operation 8 Operation 7 Product Realization 8 Operation 44 Implementation and operation 8 Operation 8 Operation 8 Operation 8 Operation
81 Operational planning and control 81 Operational planning and control 71 Planning of product realization 81 Operational planning and control 446 Operational control 81 Operational planning and control 81 Operational planning and control 81 Operational planning and control 81 Operational planning and control
811 Operational planning and control — supplemental 811 General 811 Operational Risk Management 811 Operational Risk Management 811 (Not Used)
812 Confidentiality 812 Eliminating hazards and reducing OH&S risks 812 Configuration Management 812 Configuration Management 812 Configuration Management
813 Management of change 813 Product Safety 813 Product Safety 813 (Not Used)
814 Procurement 814 Prevention of Counterfeit Parts 814 Prevention of Counterfeit Parts 814 Prevention of Counterfeit Parts
815 Prevention of Suspected Unapproved Parts 815 Prevention of Suspected Unapproved Parts
816 Installation of Approved Parts
82 Requirements for products and services 82 Emergency preparedness and response 72 Customer-related processes 82 Requirements for products and services 447 Emergency preparedness and response 82 Emergency preparedness and response 82 Requirements for products and services 82 Requirements for products and services 82 Requirements for products and services
821 Customer communication 723 Communication 821 Customer communication 821 Customer communication 821 Customer communication 821 Customer communication
721 Determination of requirements related to product 8211 Customer communication supplemental
822 Determining the requirements for products and services 722 Review of requirements related to product 822 Determining the requirements for products and services 822 Determining the requirements for products and services 822 Determining the requirements for products and services 822 Determining the requirements for products and services
8221 Determining the requirements for products and services — supplemental
823 Review of the requirements for products and services 823 Review of the requirements for products and services 823 Review of the requirements for products and services 823 Review of the requirements for products and services 823 Review of the requirements for products and services
8231 Ensure ability to meet requirements 8231 'See ISO 9001:2015 requirements'
82311 Review of the requirements for products and services — supplemental
82312 Customer designated special characteristics
82313 Organization manufacturing feasibility
8232 Retain documented information 8232 'See ISO 9001:2015 requirements'
824 Changes to requirements for products and services 824 Changes to requirements for products and services 824 Changes to requirements for products and services 824 Changes to requirements for products and services 824 Changes to requirements for products and services
83 Design and development of products and services *8 1 Operational control - Design and development 73 Design and development 83 Design and development of products and services *4 4 6 Operational control - Design and devevelopment 83 Design and development of products and services 83 Design and development of products and services 83 Design and development of products and services
831 General 731 General 831 General 831 General 831 General 831 General
8311 Design and development of products and services supplemental
832 Design and development planning 732 Design and development planning 832 Design and development planning 832 Design and development planning 832 Design and development planning 832 Design and development planning
8321 Design and development planning — supplemental
8322 Product design skills
8323 Development of products with embedded software
833 Design and development inputs 733 Design and development inputs 833 Design and development inputs 833 Design and development inputs 833 Design and development inputs 833 Design and development inputs
8331 Product design input
8332 Manufacturing process design input
8333 Special characteristics
834 Design and development controls 735 Design and development review 834 Design and development controls 834 Design and development controls 834 Design and development controls 834 Design and development controls
736 Design of development verification
8341 Monitoring
737 Design of development validation 8342 Design and development validation
8343 Prototype programme
8344 Product approval process
835 Design and development outputs 734 Design and development outputs 835 Design and development outputs 835 Design and development outputs 835 Design and development outputs 835 Design and development outputs
738 Design and development transfer
8351 Design and development outputs — supplemental
8352 Manufacturing process design output
836 Design and development changes 7 3 9 Control of design and development changes 836 Design and development changes 836 Design and development changes 836 Design and development changes 836 Design and development changes
7 3 10 Design and development files 8361 Design and development changes — supplemental
84 Control of externally provided processes products and services *8 1 Operational control External providers 74 Purchasing 84 Control of externally provided processes products and services *4 4 6 Operational control External providers 84 Control of externally provided processes products and services 84 Control of externally provided processes products and services 84 Control of externally provided processes products and services
841 General 7 4 1 Purchasing process 841 General 841 General 841 General 841 General
8411 General — supplemental
8412 Supplier selection process
8413 Customer-directed sources {also known as "Directed-Buy")
842 Type and extent of control 743 Verification of purchased product 842 Type and extent of control 842 Type and extent of control 842 Type and extent of control 842 Type and extent of control
8421 Type and extent of control supplemental
8422 Statutory and regulatory requirements
8423 Supplier quality management system development
84231 Automotive product related software or automotive products with embedded software
8424 Supplier monitoring
84241 Second-party audits
8425 Supplier development
843 Information for external providers 742 Purchasing information 843 Information for external providers 843 Information for external providers 843 Information for external providers 843 Information for external providers
8431 Information for external providers — supplemental
85 Production and service provision 75 Production and service provision 85 Production and service provision 85 Production and service provision 85 Production and service provision 85 Production and service provision
851 Control of production and service provision *8 1 Operational control-Provision of production and service 751 Control of production and service provision 851 Control of production and service provision 446 Operational control - Provision of production and service 851 Control of production and service provision 851 Control of production and service provision 851 Control of production and service provision
752 Cleanliness of product 8511 Control Plan
753 Installation activities 8512 Standardised work operator instructions and visual standards
754 Servicing activities 8513 Verification of job set-ups
755 Particular requirements for sterile medical devices 8514 Verification after shutdown
756 Validation of processes for production and service provision 8515 Total productive maintenance
757 Particular requirements for validation of processes for sterilization and 8516 Management of production tooling and manufacturing test inspection tooling and equipment
8517 Production scheduling
852 Identification and traceability 7 5 8 Identification 852 Identification and traceability 852 Identification and traceability 852 Identification and traceability 852 Identification and traceability
7 5 9 Traceability 8521 Identification and traceability — supplemental
853 Property belonging to customers or external providers 7 5 10 Customer property 853 Property belonging to customers or external providers 853 Property belonging to customers or external providers 853 Property belonging to customers or external providers 853 Property belonging to customers or external providers
854 Preservation 7 5 11 Preservation of product 854 Preservation 854 Preservation 854 Preservation 854 Preservation
8541 Preservation — supplemental
855 Post-delivery activities *8 1 Operational control - Delivery and post delivery 855 Post-delivery activities *4 4 6 Operational control - Delivery and post delivery 855 Post-delivery activities 855 Post-delivery activities 855 Post-delivery activities
8551 Feedback of information from service
8552 Service agreement with customer
856 Control of changes 856 Control of changes 856 Control of changes 856 Control of changes 856 Control of changes
8561 Control of changes supplemental
85611 Temporary change of process controls
86 Release of products and services 86 Release of products and services 86 Release of products and services 86 Release of products and services 86 Release of products and services
861 Release of products and services supplemental
862 Layout inspection and functional testing
863 Appearance items
864 Verification and acceptance of conformity of externally provided products and services
865 Statutory and regulatory conformity
866 Acceptance criteria
87 Control of nonconforming outputs 83 Control of nonconforming product 87 Control of nonconforming outputs 87 Control of nonconforming outputs 87 Control of nonconforming outputs 87 Control of nonconforming outputs
871 'See ISO 9001:2015 requirements'
8711 Customer authorization for concession
8712 Control of nonconforming product customer specified process
8713 Control of suspect product
8714 Control of reworked product
8715 Control of repaired product
8716 Customer notification
8717 Nonconforming product disposition
872 'See ISO 9001:2015 requirements'
9 Performance evaluation 9 Performance evaluation 8 Measurement Analysis and Improvement 9 Performance evaluation 45 Checking 9 Performance evaluation 9 Performance evaluation 9 Performance evaluation 9 Performance evaluation
91 Monitoring measurement analysis and evaluation 91 Monitoring measurement analysis and evaluation 82 Monitoring and measurement 91 Monitoring measurement analysis and evaluation 451 Performance measuring and monitoring 91 Monitoring, measurement, analysis and performance evaluation 91 Monitoring measurement analysis and evaluation 91 Monitoring measurement analysis and evaluation 91 Monitoring measurement analysis and evaluation
911 General 911 General 81 General 911 General 911 General 911 General 911 General 911 General
9111 Monitoring and measurement of manufacturing processes
9112 Identification of statistical tools
9113 Application of statistical concepts
912 Customer satisfaction 821 Feedback 912 Customer satisfaction 912 Customer satisfaction 912 Customer satisfaction 912 Customer satisfaction
822 Complaint handling
823 Reporting to regulatory authorities
825 Monitoring and measurement of processes
826 Monitoring and measurement of product
9121 Customer satisfaction supplemental
913 Analysis and evaluation 912 Evaluation of compliance 84 Analysis of data 913 Analysis and evaluation 452 Evaluation of compliance 912 Evaluation of compliance 913 Analysis and evaluation 913 Analysis and evaluation 913 Analysis and evaluation
9131 Prioritization
92 Internal audit 92 Internal audit 824 Internal audit 92 Internal audit 455 Internal audit 92 Internal audit 92 Internal audit 92 Internal audit 92 Internal audit
921 Conduct internal audits at planned intervals 921 General 921 'See ISO 9001:2015 requirements' 921 General
922 Plan establish implement and maintain audit program 922 Internal audit program 922 'See ISO 9001:2015 requirements' 922 Internal audit programme
9221 Internal audit programme
9222 Quality management system audit
9223 Manufacturing process audit
9224 Product audit
93 Management review 93 Management review 56 Management review 93 Management review 46 Management review 93 Management review 93 Management review 93 Management review 93 Management review
931 General 561 General 931 General 931 General 931 General 931 General
9311 Management review supplemental
932 Management review inputs 562 Review input 932 Management review inputs 932 Management review inputs 932 Management review inputs 932 Management review inputs
9321 Management review inputs — supplemental
933 Management review outputs 563 Review output 933 Management review outputs 933 Management review outputs 933 Management review outputs 933 Management review outputs
9331 Management review outputs — supplemental
10 Improvement 10 Improvement 85 Improvement 10 Improvement 10 Improvement 10 Improvement 10 Improvement 10 Improvement
851 General
852 Corrective action
853 Preventive action
10 1 General 10 1 General 10 1 General 10 1 General 10 1 General 10 1 General 10 1 General
10 2 Nonconformity and corrective action 10 2 Nonconformity and corrective action 83 Control of nonconforming product 10 2 Nonconformity and corrective action 453 Incident investigation nonconformity corrective and preventive action 10 2 Incident, nonconformity and corrective action 10 2 Nonconformity and corrective action 10 2 Nonconformity and corrective action 10 2 Nonconformity and corrective action
831 General
832 Actions in response to nonconforming product detected before delivery
833 Actions in response to nonconforming product detected after delivery
834 Rework
10 2 1 When a nonconformity occurs 10 2 1 'See ISO 9001:2015 requirements' 4 5 3 1 Incident investigation
10 2 2 Retain documented information 10 2 2 'See ISO 9001:2015 requirements' 4 5 3 2 Nonconformity corrective and preventive action
10 2 3 Problem solving
10 2 4 Error proofing
10 2 5 Warranty management systems
10 2 6 Customer complaints and field failure test analysis
10 3 Continual improvement 10 3 Continual improvement 85 Improvement 10 3 Continual improvement 10 3 Continual improvement 10 3 Continual improvement 10 3 Continual improvement 10 3 Continual improvement
10 3 1 Continual improvement — supplemental
11 Notes 11 Notes 11 Notes
11 1 Revision Indicator 11 1 Revision Indicator 11 1 Revision Indicator