ISO 9001:2015 versus ISO 13485:2016
The document Clause by Clause explanation of ISO 13485:2016 states that ISO 13485:2016 discards some of the requirements of ISO 9001:2015, but the ISO 13485 standard Table B.2 identifies an ISO 13485 clause corresponding to each ISO 90001 clause. What are the ISO 9001 requirements that have been discarded from ISO 13485?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 9001:2015 requirements that have been discarded form ISO 13485:2016 are the context of the organization (4.1 Understanding the organization and its context) and interested parties (4.2 Understanding the needs and expectations of interested parties).
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Apr 24, 2020