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Auditing documentation requirements for ISO 9001 and ISO 13485

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Guest user Created:   Oct 15, 2017 Last commented:   Oct 15, 2017

Auditing documentation requirements for ISO 9001 and ISO 13485

Please advice me in may concern. We are in process of re-certification audit for ISO 9001:2015 and ISO 13485:2016 but there is a difference clause in Documentation for ISO 9001:2015 it in clause 7.5 Documented information but in ISO 13485 its 4.2 Documentation requirement. What clause shall we use for internal audit? Clause 7.5 of 9001:2015 or Clause 4.2 of ISO 13485:2016.
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Strahinja Stojanovic Oct 15, 2017

Answer:

If your Quality Management System is compliant with both ISO 9001 and ISO 13485, during the internal audit you need to check compliance with both standards. When it comes to common requirements or requirements related to the same elements of the system, you need to audit against requirements of both standards. Whichever standard has stricter requirements, those requirements should be applied and auditing should be done against those requirements.

Another option is to conduct separate audits for ISO 9001 and ISo 13485 but this would just mean that you will double the work.

For more information, see: How to create a checklist for an ISO 13485 internal audit fo r your QMS https://advisera.com/13485academy/knowledgebase/how-to-create-a-checklist-for-an-iso-13485-internal-audit-for-your-qms/
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Oct 14, 2017

Oct 14, 2017