Why would a non-medical dev manufacturer want to implement QMS using 13485?
Hi, I’m looking for some guidance with quality manual and quality policy, can you help?
ISO 13485 is for medical device manufacturers- why would a non-medical dev manufacturer want to implement QMS using 13485?
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If you are looking for guidance for Quality Policy and Quality Manual, but you are not a manufacturer of medical devices, then you should look for the ISO 9001. ISO 9001:2015 is a standard that is applicable to all businesses.
Following articles can help you to understand the ISO 9001:2015:
- Quality Management System: What is it? - https://advisera.com/9001academy/knowledgebase/quality-management-system-what-is-it/
- ISO 9001 Requirements and Structure - https://advisera.com/9001academy/knowledgebase/iso-9001-requirements-and-structure/
- Where does quality management / ISO 9001 fit into your organization? - https://advisera.com/9001academy/blog/2017/06/06/where-does-quality-management-iso-9001-fit-into-your-organization/
- Six Key Benefits of ISO 9001 Implementation - https://advisera.com/9001academy/knowledgebase/six-key-benefits-of-iso-9001-implementation/
- How to write a short, concise Quality Manual - https://advisera.com/9001academy/knowledgebase/writing-a-short-quality-manual/
- How to Write a Good Quality Policy - https://advisera.com/9001academy/blog/2014/03/25/write-good-quality-policy/
You can even look at our Quality manual template and Quality Policy template from our ISO 9001:2015 Documentation toolkit:
- ISO 9001 Quality manual https://advisera.com/9001academy/documentation/quality-manual/
- ISO 9001 Quality Policy https://advisera.com/9001academy/documentation/quality-policy/
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Jul 29, 2020