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ISO 9001 Clauses

The document outlines the sections and subsections of an organization's quality management system. It includes context of the organization, leadership, planning, support, operation, performance evaluation, and improvement. The document was revised with minor changes to section names and numbering.

Uploaded by

Zaheer Nigam
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© © All Rights Reserved
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0% found this document useful (0 votes)
64 views31 pages

ISO 9001 Clauses

The document outlines the sections and subsections of an organization's quality management system. It includes context of the organization, leadership, planning, support, operation, performance evaluation, and improvement. The document was revised with minor changes to section names and numbering.

Uploaded by

Zaheer Nigam
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

16.10.

2023 – 12 Pm

4. Context of the organization

4.1 Understand the organization &it’s context

4.2 understand needs & expectations of interested parties

4.3 determine the scope of quality management system

4.4 quality management systems &it’s process

5 Leadership

5.1 Leadership & commitment

5.1.1 General

5.1.2 Customer Focus

5.2 Policy

5.2.1 establishing the quality policy

5.2.2 communicating the quality policy

5.3 organizational roles & responsibilities

6 Planning

6.1 Action to address risks & opportunities

6.2 quality objectives & planning to achieve them

6.3 planning of changes

7 Support

7.1 Resources

7.1.1 General

7.1.2 People

7.1.3 Infrastructure
7.1.4 Environment for operation of processes

7.1.5 Monitoring & measuring resources

7.1.6 Organizational knowledge

7.2 Competence

7.3 Awareness

7.4 Communication

7.5 Documented Organization

7.5.1 General

7.5.2 Creating & updating

7.5.3 Control of documented information

8. Operation

8.1 operational planning & control

8.2 Requirements of products & services

8.2.1 Customer Communication

8.2.1 determineRequirements of products & services

8.2.2 review of Requirements of products & services

8.2.3 changes of Requirements of products & services

8.3 Design & development of products & services

8.3.1 General

8.3.1 Design & development planning

8.3.2 Design & development inputs

8.3.3 Design & development controls

8.3.4 Design & development outputs

8.3.5 Design & development changes

8.4 Control of externally provided resources , products & services


8.4.1 General

8.4.2type& extent of control

8.4.3 Information of external provider

8.5 Production & service provision

8.5.1 Control of production and service Provision

8.5.2 Identification & traceability

8.5.3 property belonging to external service providers & customers

8.5.4 Preservation

8.5.5 Post delivery activities

8.5.6 Control of changes

8.6 Release of products & services

8.7 Control of non conforming outputs

9 Performance Evaluation

9.1 Montoring , Measurement , Analysis & Evaluation

9.1.1 Genral

9.1.2 Customer satisfaction

9.1.3 Analysis& Evaluation

9.2 Internal Audit

9.3 Management Review

9.3.1 General

9.3.2 Management review inputs

9.3.3 Management review outputs

10. Improvement

10.1 General

10.2 Non conformity & corrective action


10.3 Continual improvement

16.10.2023 – 9 Pm

4. Context of the organization

4.1 understanding the organization &it’s context

4.2 understand the needs & expectations of the interested parties

4.3 determine the scope of quality management system

4.4 quality management system &it’s processes

5 leadership

5.1 leadership & commitment

5.1.1 general

5.1.2 customer focus

5.2 policy

5.2.1 developing the quality policy

5.2.2 communicating the quality policy

5.3 organizational roles & responsibilities

6. Planning

6.1 action to address risks & opportunities

6.1.2 quality objectives& planning to achieve them

6.1.3 planning of changes

7. support

7.1 resources

7.1.1 General

7.1.2 people
7.1.3 infrastructure

7.1.4 environment for operation of processes

7.1.5 monitoring& measuring processess

7.1.6 organizational knowledge

7.2 competence

7.3 awareness

7.4 communication

7.5 documented information

7.5.1 general

7.5.2 creating& updating

7.5.3 control of documented information

8. Operation

8.1 operational planning & control

8.2 requirement of products & services

8.2.1 customer communication

8.2.2 determine the requirements of products & services

8.2.3 review the requirements of products & services

8.2.4 changesto requirements of products & services

8.3 design & development of products & services

8.3.1 design& development planning

8.3.2 design& development inputs

8.3.3 design& development controls

8.3.4 design& development outputs

8.3.5 design& development changes

8.4 control of externally provided services or products


8.4.1 general

8.4.2 type& extent of control

8.4.3 information of external providers

8.5 production & service provision

8.5.1 control of production & service provision

8.5.2 identification&tracebility

8.5.3 property belongs to external providers & customers

8.5.4 preservation

8.5.5 post delivery activities

8.5.6 control of changes

8.6 release of products & services

8.7 control of non conforming outputs

9 . Performance evaluation

9.1. monitoring , measurement , analysis & evaluation

9.1.1 general

9.1.2 customer satisfaction

9.1.3 analysis& evaluation

9.2 internal audit

9.3 management review

9.3.1 general

9.3.2 management review inputs

9.3.3 management review outputs

10 improvement

10.1 general

10.2 non conformity & corrective action


10.3 continual improvement

17.10.2023 – 11.51 Am

4 Context of the org.

4.1 understand the org &it’s context

4.2 understand the needs & expectations of interested parties

4.3 determine the scope of qms

4.4 qms&it’s processes

5 leadership

5.1 leadership & commitment

5.1.1 general

5.1.2 customer focus

5.2 policy

5.2.1 developing the quality policy

5.2.2 communicating the quality policy

5.3 organizational roles & responsibilities

6. planning

6.1 action to address risks & opportunities

6.2 quality objectives & planning to achieve them

6.3 planning of changes

7. support

7.1 resources

7.1.1 general

7.1.2 people
7.1.3 infrastructure

7.1.4 environment for operation of processes

7.1.5 monitoring& measuring resources

7.1.6 organizational knowledge

7.2 competence

7.3 awareness

7.4 communication

7.5 documented information

7.5.1 general

7.5.2 creating& updating

7.5.3 control of documented information

8. operation

8.1 operational planning & control

8.2 requirement of product & services

8.2.1 customer communication

8.2.2 determine the requirement of product & services

8.2.3 review of requirement of product & services

8.2.4 changestorequirement of product & services

8.3 design & development of products & services

8.3.1general

8.3.2 design& development planning

8.3.2 design& development inputs

8.3.3 design& developmentcontrol

8.3.4 design& development output

8.3.5 design& development changes


8.4 control of externally provided resources , service providers , customers

8.4.1 general

8.4.2 type& extent control

8.4.3 information of external providers

8.5 production & service provision

8.5.1 control of production & service provision

8.5.2identification&tracebility

8.5.3 property belonging to external service providers and customers

8.5.4 preservation

8.5.5 post delivery activities

8.5.6 control of services

8.6 release of products & services

8.7 control of non conforming outputs

9 . Performance evaluation

9.1 monitoring , measurement , analysis & evaluation

9.1.1 general

9.1.2 customer satisfaction

9.1.3 analysis& evaluation

9.2 internal audit

9.3 management review

9.3.1 general

9.3.2 management review inputs

9.3.3 management review outputs

10. improvement

10.1 general
10.2 non conformity & corrective action

10.3 continual improvement

Rev. 1

4. context of org .

4.1 understand the org &it’s context

4.2 understand the needs & expectations of interested parties

4.3 determine the scope of qms

4.4 qms&it’s process

5 leadership

5.1 leadership & commitment

5.1.1 general

5.1.2 customer focus

5.2 policy

5.2.1 establishing the quality policy

5.2.2 communicating the quality policy

5.3 org. roles & responsibilities

6. planning

6.1 action to address risks & opportunities

6.2 qms objectives & planning to achieve them

6.3 planning of changes

7 support

7.1 resources

7.1.1 general

7.1.2 people

71.3 infrastructure
7.1.4 environment for operation of processes

7.1.5 monitoring& measuring resources

7.1.6 organizational knowledge

7.2 competence

7.3 awareness

7.4 communication

7.5 documented information

7.5.1 general

7.5.2 creating& updating

7.5.3 control of documented information

8 operation

8.1 operation planning & control

8.2 requirement of products & services

8.2.1 customer communication

8.2.2 determine the requirement of products & services

8.2.3 review of requirement of products & services

8.2.4 changes to requirement of products & services

8.3 design & development of products & services

8.3.1 general

8.3.2 design& development planning

8.3.3 design& development inputs

8.3.4 design& development controls

8.3.5 design& development outputs

8.3.6 design& development changes

8.4 control of externally provided resources , products & services


8.4.1 general

8.4.2 type& extent control

8.4.3 information of external providers

8.5 production & service provision

8.5.1 control of production & service provision

8.5.2 identification&tracebility

8.5.3 property belong to external service providers , customers

8.5.4 preservation

8.5.5 post delivery activities

8.5.6 control of changes

8.6 release of products & services

8.7 control of non conforming outputs

9. performance evaluation

9.1 monitoring , measurement , analysis & evaluation

9.1.1 general

9.1.2 customer satisfaction

9.1.3 analysis& evaluation

9.2 internal audit

9.3 mrm

9.3.1 general

9.3.2 mrm inputs

9.3.3 mrm outputs

10. improvement

10.1 general

10.2 non conformity & corrective action


10.3 continual improvement

17.10.2023 – 11.48 pm

4. context of the org.

4.1 understand the org. and it’s context

4.2 understand the needs & expectations of the interested parties

4.3 determine the scope of qms

4.4 qms&it’s processes

5 .leadership

5.1 leadership & commitment

5.1.1 general

5.1.2 customer focus

5.2 policy

5.2.1 establishing the quality policy

5.2.2 communicating the quality policy

5.3 org, roles & responsibilities

6. planning

6.1 actions take to address risks & opportunities

6.2 quality objectives & planning to achieve them

6.3 planning of changes

7. support

7.1 resources

7.1.1 general

7.1.2 people

7.1.3 infrastructure
7.1.4 environment for operation of processes

7.1.5 monitoring& measuring resources

7.1.6 organizational knowledge

7.2 competence

7.3 awareness

7.4 communication

7.5 documented information

7.5.1 general

7.5.2 creating& updating

7.5.3 control of documented information

8. opr

8.1 opr. Planning & control

8.2 requirement of products & services

8.2.1 customer communication

8.2.2 determine the requirement of products & services

8.2.3 review of requirement of products & services

8.2.4 changes to requirement of products & services

8.3 design & development of products & services

8.3.1 general

8.3.2 design& development planning

8.3.3 design& development inputs

8.3.4 design& development controls

8.3.5 design& development outputs

8.3.6 design& development changes

8.4 control of externally provided services , products , service providers


8.4.1 general

8.4.2 type& extent control

8.4.3 information of external providers

8.5 production & service provision

8.5.1 control of production & service provision

8.5.2 identification&tracebility

8.5.3 property belongs to external service providers or customers

8.5.4 preservation

8.5.5 post delivery activities

8.5.6 control of changes

8.6 release of products & services

8.7 control of non conforming outputs

9. performance evaluation

9.1 monitoring , measurement , analysis & evaluation

9.1.1 general

9.1.2 customer satisfaction

9.1.3 analysis& evaluation

9.2 internal audit

9.3 mrm

9.3.1 general

9.3.2 mrm inputs

9.3.3 mrm outputs

10 improvement

10.1 general

10.2 non conformity & corrective action


10.3 continual improvement

18.10.2023 – 10.35 Am

4. Context of the org.

4.1 understanding the org. &it’s context

4.2 understanding the needs & expectations of interested parties

4.3 determine the scope of qms

4.4 qms&it’s processes

5. leadership

5.1 leadership & commitment

5.1.1 general

5.1.2 customer focus

5.2 policy

5.2.1 establishing the quality policy

5.2.2 communicating the quality policy

5.3 org. roles & responsibilities& authorities

6. planning

6.1 actions to address risks & opportunities

6.2 quality objectives & planning to achieve them

6.3 planning of changes

7 support

7.1 resources

7.1.1 general

7.1.2 people

7.1.3 infrastructure
7.1.4 environment for operation of processes

7.1.5 monitoring& measuring resources

7.1.6 org. knowledge

7.2 competence

7.3 awareness

7.4 communication

7.5 documented information

7.5.1 general

7.5.2 creating& updating

7.5.3 control of documented information

8. operation

8.1 operational planning & control

8.2 requirement for products & services

8.2.1 customer communication

8.2.2 determine of requirement for products & services

8.2.3 review of requirement for products & services

8.2.4 changes to requirement for products & services

8.3 design & development of products & services

8.3.1 general

8.3.2 design& development planning

8.3.3 design& development inputs

8.3.4 design& development controls

8.3.5 design& development outputs

8.3.6 design& development changes

8.4 control of externally provided services & products


8.4.1 general

8.4.2 type& extent of control

8.4.3 informationfor external providers

8.5 production & service provision

8.5.1 control of production & service provision

8.5.2 identification&tracebility

8.5.3 property belonging to external service providers , customers

8.5.4 preservation

8.5.5 post delivery activities

8.5.6 control of changes

8.6 release of products & services

8.7 control of non conforming outputs

9 performance evaluation

9.1. monitoring , measurement , analysis & evaluation

9.1.1 general

9.1.2 customer satisfaction

9.1.3 analysis& evaluation

9.2 internal audit

9.3 management review

9.3.1 general

9.3.2 mrm inputs

9.3.3 mrm outputs

10 improvement

10.1 general

10.2 non conformity & corrective action


10.3 continual improvment

18.10.2023- 9 pm

4. context of the org.

4.1 understanding the org. & it’s context

4.2 understanding the needs & expectations of interested parties

4.3 determine the scope of qms

4.4 qms & it’s processes

5. leadership

5.1 leadership & commitment

5.1.1 general

5.1.2 customer focus

5.2 policy

5.2.1 establishing the quality policy

5.2.2 communicating the quality policy

5.3 org. roles & responsibilities

6 planning

6.1 action to address risks & opportunities

6.2 quality objectives & planning to achieve them

6.3 planning of changes

7. support

7.1 resources

7.1.1 general

7.1.2 people

7.1.3 infrastructure

7.1.4 environment for operation of processes


7.1.5 monitoring & measuring resources

7.1.6 org. knowledge

7.2 competence

7.3 awareness

7.4 communication

7.5 documented information

7.5.1 general

7.5.2 creating & updating

7.5.3 control of documented information

8 operation

8.1 opr. Planning & control

8.2 requirement of products & services

8.2.1 customer communication

8.2.2 determine requirement of products & services

8.2.3 review of requirement of products & services

8.2.4 changes to requirement of products & services

8.3 design & development of products & services

8.3.1 general

8.3.2 design & development planning

8.3.3 design & development inputs

8.3.4 design & development controls

8.3.5 design & development outputs

8.3.6 design & development changes

8.4 control of externally provided processes , products & services

8.4.1 general
8.4.2 type & extent of control

8.4.3 information for external providers

8.5 production & service provision

8.5.1 control of production & service provision

8.5.2 identification & tracebility

8.5.3 property belonging to external service providers , customers

8.5.4 preservation

8.5.5 post delivery activities

8.5.6 control of changes

8.6 release of products & services

8.7 control of non conforming outputs

9 performance evaluation

9.1 monitoring , measurement , analysis & evaluation

9.1.1 general

9.1.2 customer satisfaction

9.1.3 analysis & evaluation

9.2 internal audit

9.3 mrm

9.3.1 general

9.3.2 mrm inputs

9.3.3 mrm outputs

10. improvement

10.1 general

10.2 non conformity & corrective action

10.3 continual improvement


19.10.2023 – 1.11 Pm

4. context of the org.

4.1 understanding the org. & it’s context

4.2 understanding the needs & expectations of interested parties

4.3 determine the scope of qms

4.4 qms & it’s processes

5 leadership

5.1 leadership & commitment

5.1.1 general

5.1.2 customer focus

5.2 policy

5.2.1 establishing the quality policy

5.2.2 communicating the quality policy

5.3 org. roles & responsibilities & authorities

6. planning

6.1 actions to address risks & opportunities

6.2 qms objectives & planning to achieve them

6.3 planning of changes

7 support

7.1 resources

7.1.1 general

7.1.2 people

7.1.3 infrastructure

7.1.4 environment for operation of processes

7.1.5 monitoring & measuring process


7.1.6 org. knowledge

7.2 competence

7.3 awareness

7.4 communication

7.5 documented information

7.5.1 general

7.5.2 creating & updating

7.5.3 control of documented information

8. opr.

8.1 operational planning & control

8.2 requirement for products & services

8.2.1 customer communication

8.2.2 determine the requirement for products & services

8.2.3 review the requirement for products & services

8.2.4 changes to requirement for products & services

8.3 design & development of products & services

8.3.1 general

8.3.1 design & development planning

8.3.2 design & development inputs

8.3.3 design & development controls

8.3.4 design & development outputs

8.3.5 design & development changes

8.4 control of externally provided products , services & customers

8.4.1 general

8.4.2 type & extent of control


8.4.3 information of external providers

8.5 production & service provision

8.5.1 control of production & service provision

8.5.2 identification & tracebility

8.5.3 property belonging to external service providers , customers

8.5.4 preservation

8.5.5 post delivery activities

8.5.6 control of changes

8.6 release of products & services

8.7 control of non conforming outputs

9. performance evaluation

9.1.1 monitoring , measurement , analysis & evaluation

9.1.1 general

9.1.2 customer satisfaction

9.1.3 analysis & evaluation

9.2 internal audit

9.3 mrm

9.3.1 general

9.3.2 mrm inputs

9.3.3 mrm outputs

10. improvement

10.1 non conformity & corrective action

10.2 continual improvement


19.10.2023 – 10.11 pm

4. context of the org.

4.1 understanding the org. & it’s context

4.2 understanding needs & expectations of interested parties

4.3 determine the scope of qms

4.4 qms & it’s processes

5. leadership

5.1 leadership & commitment

5.1.1 general

5.1.2 customer focus

5.2 policy

5.2.1 establishing the quality policy

5.2.2 communicating the quality policy

5.3 org. roles & responsibilities

6 planning

6.1 actions to address risks & opportunities

6.2 quality objectives & planning to achieve them

6.3 planning of changes

7 support

7.1 resources

7.1.1 general

7.1.2 people

7.1.3 infrastructure

7.1.4 environment for operation of processes

7.1.5 monitoring & measuring resources


7.1.6 org. knowledge

7.2 competence

7.3 awareness

7.4 communication

7.5 documented information

7.5.1 general

7.5.2 creating & updating

7.5.3 control of documented information

8 operation

8.1 operational planning & control

8.2 requirement for products & services

8.2.1 customer communication

8.2.2 determine the requirement for products & services

8.2.3 review the requirement for products & services

8.2.4 changes to requirement for products & services

8.3 design & development of products & services

8.3.1 general

design & development planning

8.3.2 design & development inputs

8.3.3 design & development controls

8.3.4 design & development outputs

8.3.5 design & development changes

8.4 control of externally provided resources , services & products

8.4.1 general

8.4.2 type & extent of control


8.4.3 information of external providers

8.5 production & services provision

8.5.1 control of production & services provision

8.5.2 identification & tracebility

8.5.3 property belonging to external service providers , customers

8.5.4 preservation

8.5.5 post delivery activities

8.5.6 control of changes

8.6 release of products & services

8.7 control of non conforming outputs

9 . performance evaluation

9.1 monitoring , measurement , analysis & evaluation

9.1.1 general

9.1.2 customer satisfaction

9.1.3 analysis & evaluation

9.2 internal audit

9.3 mrm

9.3.1 general

9.3.2 mrm inputs

9.3.3 mrm outputs

10 improvement

10.1 general

10.2 non conformity & corrective action

10.3 continual improvement


20.10.2023 – 8.57 Pm

4. context of the org.

4.1 understanding the org. & it’s context

4.2 understanding the needs & expectations of interested parties

4.3 determine the scope of qms

4.4 qms & it’s processes

5. leadership

5.1 leadership & commitment

5.1.1 general

5.1.2 customer focus

5.2 policy

5.2.1 establishing the quality policy

5.2.2 communicating the quality policy

5.3 org. roles & responsilbilities & authorities

6. planning

6.1 action to address risks & opportunities

6.2 quality objectives & planning to achieve them

6.3 planning to changes

7. support

7.1 resources

7.1.1 general

7.1.2 people

7.1.3 infrastructure

7.1.4 environment for operation of processes

7.1.5 monitoring & measuring resources


7.1.6 org. knowledge

7.2 competence

7.3 awareness

7.4 communication

7.5 documented information

7.5.1 general

7.5.2 creating & updating

7.5.3 control of documented information

8. operation

8.1 operational planning & control

8.2 requirement of products & services

8.2.1 customer communication

8.2.2 determine the requirement of products & services

8.2.3 review the requirement of products & services

8.2.4 changes to requirement of products & services

8.3 design & development of products & services

8.3.1 general

8.3.2 design & development planning

8.3.3 design & development inputs

8.3.4 design & development controls

8.3.5 design & development outputs

8.3.6 design & development changes

8.4 control of externally provided products , services , processes

8.4.1 general

8.4.2 type & extent of control


8.4.3 information of external providers

8.5 production & service provision

8.5.1 control of production & service provision

8.5.2 identification & tracebility

8.5.3 property belonging to external service providers , customers

8.5.4 preservation

8.5.5 post delivery activities

8.5.6 control of changes

8.6 release of products & services

8.7 control of non conforming outputs

9. performance evaluation

9.1 monitoring , measurement , analysis & evaluation

9.1.1 general

9.1.2 customer satisfaction

9.1.3 analysis & evaluation

9.2 internal audit

9.3 mrm

9.3.1 general

9.3.2 mrm inputs

9.3.3 mrm outputs

10. improvement

10.1 general

10.2 non conformity & corrective action

10.3 continual improvement

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