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List of Mandatory Documented Information

The document lists 25 clauses that require documented information or records to be maintained by the quality management system. These include documenting the scope of the quality management system, processes, quality policy, objectives, monitoring resources, competence, operational planning and control, requirements for products and services, design and development planning, inputs, controls, outputs, changes, externally provided processes, production and service provision, identification and traceability, property belonging to customers, changes, release of products and services, nonconforming outputs, monitoring, measurement and evaluation, internal audit program and results, management review results, and corrective actions results.

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73 views2 pages

List of Mandatory Documented Information

The document lists 25 clauses that require documented information or records to be maintained by the quality management system. These include documenting the scope of the quality management system, processes, quality policy, objectives, monitoring resources, competence, operational planning and control, requirements for products and services, design and development planning, inputs, controls, outputs, changes, externally provided processes, production and service provision, identification and traceability, property belonging to customers, changes, release of products and services, nonconforming outputs, monitoring, measurement and evaluation, internal audit program and results, management review results, and corrective actions results.

Uploaded by

ge120120
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
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List of Mandatory Documented Information

No. Clause Clause No.


1. Scope of the QMS 4.3
2. QMS and its processes 4.4.2
3. Quality policy 5.2.2
4. Quality objectives 6.2.1
5. Monitoring and measuring resources (Records) 7.1.5.1
6. Competence (Record) 7.2
7. Operational planning and control, (Document & record) 8.1 (e)
8. Review of the requirements for products and services (Records) 8.2.3.2
9. Design and development planning (Record) 8.3.2
10. Design and development inputs (Record) 8.3.3
11. Design and development controls (Record) 8.3.4 f
12. Design and development outputs (Record) 8.3.5
13. Design and development changes (Record) 8.3.6
14. Control of externally provided processes, products and services (Record) 8.4.1
15. Control of production and service provision (Document/Record) 8.5.1
16. Identification and Traceability (Record) 8.5.2
17. Property belonging to customers or external providers (Record) 8.5.3
18. Control of changes (Record) 8.5.6
19. Release of products and services (Record) 8.6
20. Control of nonconforming outputs (Record) 8.7.2
21. Monitoring, measurement analysis and evaluation (Record) 9.1.1
22. Internal audit program (Document/Record) 9.2.2
23. Results of internal audits (Record) 9.2.2
24. Results of the management review (Record) 9.3.3
25. Results of corrective actions (Record) 10.2.2

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