ISO 9001 / Procedure vs processes
Hi! I am looking at the documentation toolkit and there are many usel procure documents. But let say, procedure for design & development. The design & development could be based on one main process or many processes with dependencies to each other. But these processes don´t have to be documented - right? (I will document the processes anyway!) . The procedure in your list seems to be at the top. The procedure document contains process flows, planning, requirement settings, controls and so on. Is the procedure manadatory and the processes up to the organization to document? Just want to have a clarification on that...
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Procedures are not mandatory documents in ISO 9001:2015 anymore. But even though you don´t need to write any procedure, they can be very useful for the organization, since procedures can help you to conduct processes in a sistematically way and therefore, you will be able to compare results correctly.
Regarding the procedure for design and development you can adapt to your own situation, as you mention it can have dependencies with other processes or be based on one main process.
Here you can find the mandatory documents and records that you need to create in order to comply with ISO 9001:2015 requirements - List of mandatory documents required by ISO 9001:2015: https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/
The following material will provide you more information about procedures and mandatory documents:
- 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/
- How to structure quality management system documentation: https://advisera.com/9001academy/knowledgebase/how-to-structure-quality-management-system-documentation/
- 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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Feb 14, 2020