heartbeatISO 9001:2015 to ISO 9001:2008對照表
(本文參考ISO/TC 176/SC2/N1269 www.iso.org/tc176/sc02/public)

ISO 9001:2015

ISO 9001:2008

1        Scope

1         Scope
1.1      General

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
4.2.2  Quality manual

4.4      Quality management systemand its  processes

4         Quality management system
4.1      General requirements

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
5.5.2  Management representative
5.4.2  Quality management system planning

6         Planning

5.4.2  Quality management system planning

6.1      Actions to address risks and opportunities

5.4.2  Quality management system planning
8.5.3  Preventive action

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
6.2.2  Competence, training and awareness

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
4.2.4  Control of records

7.5.3  Control of documented Information

4.2.3  Control of documents
4.2.4  Control of records

8         Operation

7         Product realization

8.1      Operational planning and control

7.1      Planning of product realization

8.2     Requirements for products and services

7.2      Customer-related processes

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
7.3.5  Design and development verification
7.3.6  Design and development validation

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
7.4.1  Purchasing process

8.4.1  General

7.4.1  Purchasing process

8.4.2  Type and extent of control

7.4.1  Purchasing process
7.4.3  Verification of purchased product

8.4.3  Information for external providers

7.4.2  Purchasing information
7.4.3  Verification of purchased product

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
7.5.2  Validation of processes for 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
8.2.4  Monitoring and measurement of 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
8.2.3  Monitoring and Measurement  Processes

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
8.5.2  Corrective action

10.3   Continual Improvement

8.5.1   Continual improvement
8.5.3   Preventive action

                              
                           


heartbeatISO 9001:2008 to ISO 9001:2015對照表
(本文參考ISO/TC176/SC2/N1269 www.iso.org/tc176/sc02/public)

ISO 9001:2008

ISO 9001:2015

1        Scope

1         Scope

1.1     General

1         Scope

1.2     Application

4.3      Determining the scope of the quality
management system

4        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 processes

4.1     General requirements

4.4     Quality management system and its processes
8.4     Control of externally provided processes, products and services

4.2     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 Processes

4.2.3  Control of documents

7.5.2  Creating and updating
7.5.3  Control of documented Information

4.2.4  Control of records

7.5.2  Creating and updating
7.5.3  Control of documented Information

5         Management responsibility

5        Leadership

5.1      Management commitment

5.1     Leadership and commitment
5.1.1  General

5.2      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 policy

5.4      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 changes

5.5      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     Resources

6.1      Provision of resources

7.1.1  General
7.1.2  People

6.2      Human resources

7.2     Competence  

6.2.1   General

7.2     Competence  

6.2.2  Competence, training and awareness

7.2      Competence  
7.3      Awareness

6.3      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 services

7.2.3  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 planning

7.3.2  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 changes

7.4      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 control

7.4.2  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 services

7.5      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 activities

7.5.2  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 traceability

8      Measurement, analysis and improvement

9         Performance evaluation
9.1      Monitoring, measurement, analysis and evaluation

8.1      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 action

8.4      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 Improvement

8.5.2  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