![]() (本文參考ISO/TC 176/SC2/N1269 www.iso.org/tc176/sc02/public) |
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ISO 9001:2015 |
ISO 9001:2008 |
1 Scope |
1 Scope |
4 Context of the organization |
4 Quality management system |
4.1 Understanding the organization and its context |
4 Quality management system |
4.2 Understanding the needs and expectations of interested parties |
4 Quality management system |
4.3 Determining the scope of the quality management system |
1.2 Application |
4.4 Quality management systemand its processes |
4 Quality management system |
5 Leadership |
5 Management responsibility |
5.1 Leadership and commitment |
5.1 Management commitment |
5.1.1 General |
5.1 Management commitment |
5.1.2 Customer focus |
5.2 Customer focus |
5.2 Policy |
5.3 Quality policy |
5.2.1 Developing the Quality Policy |
5.3 Quality policy |
5.2.2 Communicating the Quality Policy |
5.3 Quality policy |
5.3 Organizational roles, responsibilities and authorities |
5.5.1 Responsibility and authority |
6 Planning |
5.4.2 Quality management system planning |
6.1 Actions to address risks and opportunities |
5.4.2 Quality management system planning |
6.2 Quality objectives and planning to achieve them |
5.4.1 Quality objectives |
6.3 Planning of changes |
5.4.2 Quality management system planning |
7 Support |
6 Resource management |
7.1 Resources |
6 Resource management |
7.1.1 General |
6.1 Provision of resources |
7.1.2 People |
6.1 Provision of resources |
7.1.3 Infrastructure |
6.3 Infrastructure |
7.1.4 Environment for the operation of processes |
6.4 Work environment |
7.1.5 Monitoring and measuring resources |
7.6 Control of monitoring and measuring equipment |
7.1.5.1 General |
7.6 Control of monitoring and measuring equipment |
7.1.5.2 Measurement traceability |
7.6 Control of monitoring and measuring equipment |
7.1.6 Organizational knowledge |
No equivalent clause |
7.2 Competence |
6.2.1 General |
7.3 Awareness |
6.2.2 Competence, training and awareness |
7.4 Communication |
5.5.3 Internal communication |
7.5 Documented information |
4.2 Documentation requirements |
7.5.1 General |
4.2.1 General |
7.5.2 Creating and updating |
4.2.3 Control of documents |
7.5.3 Control of documented Information |
4.2.3 Control of documents |
8 Operation |
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8.1 Operational planning and control |
7.1 Planning of product realization |
8.2 Requirements for products and services |
|
8.2.1 Customer communication |
7.2.3 Customer communication |
8.2.2 Determination of requirements related to products and services |
7.2.1 Determination of requirements related to the product |
8.2.3 Review of requirements related to products and services |
7.2.2 Review of requirements related to the product |
8.2.4 Changes to requirements for products and services |
7.2.2 Review of requirements related to the product |
8.3 Design and development of products and services |
7.3Design and development |
8.3.1 General |
7.3.1 Design and development planning |
8.3.2 Design and development planning |
7.3.1 Design and development planning |
8.3.3 Design and development inputs |
7.3.2 Design and development inputs |
8.3.4 Design and development controls |
7.3.4 Design and development review |
8.3.5 Design and development outputs |
7.3.3 Design and development outputs |
8.3.6 Design and development changes |
7.3.7 Control of design and development changes |
8.4 Control of externally provided processes, products and services |
4.1 | General requirements |
8.4.1 General |
7.4.1 Purchasing process |
8.4.2 Type and extent of control |
7.4.1 Purchasing process |
8.4.3 Information for external providers |
7.4.2 Purchasing information |
8.5 Production and service provision |
7.5 Production and service provision |
8.5.1 Control of production and service provision |
7.5.1 Control of production and service provision |
8.5.2 Identification and traceability |
7.5.3 Identification and traceability |
8.5.3 Property belonging to customers or external providers |
7.5.4 Customer property |
8.5.4 Preservation |
7.5.5 Preservation of product |
8.5.5 Post-delivery activities |
7.5.1 Control of production and service provision |
8.5.6 Control of changes |
7.3.7 Control of Design and Development Changes |
8.6 Release of products and services |
7.4.3 Verification of purchased product |
8.7 Control of nonconforming outputs |
8.3 Control of nonconforming product |
9 Performance evaluation |
8 Measurement, analysis and improvement |
9.1 Monitoring, measurement, analysis and evaluation |
8 Measurement, analysis and improvement |
9.1.1 General |
8.1 General |
9.1.2 Customer satisfaction |
8.2.1 Customer satisfaction |
9.1.3 Analysis and evaluation |
8.4 Analysis of data |
9.2 Internal audit |
8.2.2 Internal audit |
9.3 Management review |
5.6 Management review |
9.3.1 General |
5.6.1 General |
9.3.2 Management review input |
5.6.2 Review input |
9.3.3 Management review output |
5.6.3 Review output |
10 Improvement |
8.5 Improvement |
10.1 General |
8.5.1 Continual improvement |
10.2 Nonconformity and corrective action |
8.3 Control of nonconforming product |
10.3 Continual Improvement |
8.5.1 Continual improvement |
ISO 9001:2008 to ISO 9001:2015對照表
(本文參考ISO/TC176/SC2/N1269 www.iso.org/tc176/sc02/public)
ISO 9001:2008ISO 9001:2015
1 Scope
1 Scope
1.1 General
1 Scope
1.2 Application
4.3 Determining the scope of the quality
management system4 Quality management system
4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.4 Quality management system and its processes4.1 General requirements
4.4 Quality management system and its processes
8.4 Control of externally provided processes, products and services4.2 Documentation requirements
7.5 Documented information
4.2.1 General
7.5.1 General
4.2.2 Quality manual
4.3 Determining the scope of the quality management system
7.5.1 General
4.4 Quality management system and its Processes4.2.3 Control of documents
7.5.2 Creating and updating
7.5.3 Control of documented Information4.2.4 Control of records
7.5.2 Creating and updating
7.5.3 Control of documented Information5 Management responsibility
5 Leadership
5.1 Management commitment
5.1 Leadership and commitment
5.1.1 General5.2 Customer focus
5.1.2 Customer focus
5.3 Quality policy
5.2 Policy
5.2.1 Developing the Quality policy
5.2.2 Communicating the Quality policy5.4 Planning
6 Planning
5.4.1 Quality objectives
6.2 Quality objectives and planning to achieve them
5.4.2 Quality management system planning
5.3 Organizational roles, responsibilities and authorities
6 Planning
6.1 Actions to address risks and opportunities
6.3 Planning of changes5.5 Responsibility, authority and communication
5 Leadership
5.5.1 Responsibility and authority
5.3 Organizational roles, responsibilities and authorities
5.5.2 Management representative
5.3 Organizational roles, responsibilities and authorities
5.5.3 Internal communication
7.4 Communication
5.6 Management review
9.3 Management review
5.6.1 General
9.3.1 General
5.6.2 Review input
9.3.2 Management review input
5.6.3 Review output
9.3.3 Management review output
6 Resource management
7 Support
7.1 Resources6.1 Provision of resources
7.1.1 General
7.1.2 People6.2 Human resources
7.2 Competence
6.2.1 General
7.2 Competence
6.2.2 Competence, training and awareness
7.2 Competence
7.3 Awareness6.3 Infrastructure
7.1.3 Infrastructure
6.4 Work environment
7.1.4 Environment for the operation of processes
7 Product realization
8 Operation
7.1 Planning of product realization
8.1 Operational planning and control
7.2 Customer-related processes
8.2 Requirements for products and services
7.2.1 Determination of requirements related to the product
8.2.2 Determination of requirements related to products and services
7.2.2 Review of requirements related to the product
8.2.3 Review of requirements related to products and services
8.2.4 Changes to requirements for products and services7.2.3 Customer communication
8.2.1 Customer communication
7.3 Design and development
8.3 Design and development of products and services
7.3.1 Design and development planning
8.3.1 General
8.3.2 Design and development planning7.3.2 Design and development inputs
8.3.3 Design and development Inputs
7.3.3 Design and development outputs
8.3.5 Design and development outputs
7.3.4 Design and development review
8.3.4 Design and development controls
7.3.5 Design and development verification
8.3.4 Design and development controls
7.3.6 Design and development validation
8.3.4 Design and development controls
7.3.7 Control of design and development changes
8.3.6 Design and development changes
8.5.6 Control of changes7.4 Purchasing
8.4 Control of externally provided processes, products and services
7.4.1 Purchasing process
8.4 Control of externally provided processes, products and services
8.4.1 General
8.4.2 Type and extent of control7.4.2 Purchasing information
8.4.3 Information for external providers
7.4.3 Verification of purchased product
8.4.2 Type and extent of control
8.4.3 Information for external providers
8.6 Release of products and services7.5 Production and service provision
8.5 Production and service provision
7.5.1 Control of production and service provision
8.5.1 Control of production and service provision
8.5.5 Post-delivery activities7.5.2 Validation of processes for production and service provision
8.5.1 Control of production and service provision
7.5.3 Identification and traceability
8.5.2 Identification and traceability
7.5.4 Customer property
8.5.3 Property belonging to customers or external providers
7.5.5 Preservation of product
8.5.4 Preservation
7.6 Control of monitoring and measuring equipment
7.1.5 Monitoring and measuring resources
7.1.5.1 General
7.1.5.2 Measurement traceability8 Measurement, analysis and improvement
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation8.1 General
9.1.1 General
8.2 Monitoring and measurement
9.1 Monitoring, measurement, analysis and evaluation
8.2.1 Customer satisfaction
9.1.2 Customer satisfaction
8.2.2 Internal audit
9.2 Internal audit
8.2.3 Monitoring and measurement of processes
9.1.1 General
8.2.4 Monitoring and measurement of product
8.6 Release of products and services
8.3 Control of nonconforming product
8.7 Control of nonconforming outputs
10.2 Nonconformity and corrective action8.4 Analysis of data
9.1.3 Analysis and evaluation
8.5 Improvement
10 Improvement
8.5.1 Continual improvement
10.1 General
10.3 Continual Improvement8.5.2 Corrective action
10.2 Nonconformity and corrective action
8.5.3 Preventive action
6.1 Actions to address risks and opportunities (see 6.1.1, 6.1.2)
10.3 Continual Improvement