ISO 9001 documents and processes for implementation
1.Quality manual is compulsory for 9001:2015?
2. One organization contains different processes, so they required process separate process documentation or in one it is included?
3. Does documents required clause no. mentioned in their header or footer? or only mentioning in process documentation is enough
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ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
1.Quality manual is compulsory for 9001:2015?
Answer.
No, it is not mandatory to have a quality manual, according to ISO 9001:2015. Please check this article - List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/ - where you can see the mandatory documents and records according to ISO 9001:2015.
2.one organization contains different processes, so they required process separate process documentation or in one it is included?
Answer:
According to my understanding of your question. ISO 9001:2015, clause 4.4.2, invites each organization to determine which documents and records are needed, besides those mandatory. So, it is up to each organization to determine if it is needed to document its processes and how to do it. Any solution is allowed as long as it is useful, as long as it is clear and followed consistently.
3. Does documents required clause no. mentioned in their header or footer? or only mentioning in process documentation is enough"
Answer:
No, ISO 9001:2015, clause 7.5.2 a), invites each organization to determine a document identification methodology. In no part of clause 7.5 is mentioned the need to include related ISO 9001:2015 clauses. Having said that, I must add that I like to include that information in the procedures, to allow people to make connections between what they do daily and the standard.
You can find more information about documentation below:
- How to structure quality management system documentation - https://advisera.com/9001academy/knowledgebase/how-to-structure-quality-management-system-documentation/
- New approach to document and record control in ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/
- Some tips to make Document Control more useful for your QMS - https://advisera.com/9001academy/blog/2014/05/20/tips-make-document-control-useful-qms/
- Free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
- Book - Managing ISO Documentation: A Plain English Guide - https://advisera.com/books/managing-iso-documentation-plain-english-guide/
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Jan 25, 2021