ISO 13485:2016/21 CFR 820 requirement question
Is it part of regulations to provide auditors with employee(s) signed job descriptions if asked?
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In the ISO 13485:2016, requirement 6.2 Human resources, it is stated that the organization must ensure that all employees are aware of the relevance and importance of their activities. The auditor will ask for the proof that employees are familiar with this. Usually, the best way to prove that manufacturer has fulfilled this requirement is to show the signed job description. However, if there is another way that manufacture can prove that employee knows exactly their activities and responsibilities covered in the job description, it can also be acceptable.
For more details regarding roles and responsibilities, please see in the following article:
How to define roles and responsibilities within an ISO 13485-based QMS - https://advisera.com/13485academy/blog/2017/11/16/how-to-define-roles-and-responsibilities-within-an-iso-13485-based-qms/
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May 11, 2020