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Product Realization requirements for distribution and manufacturing facility

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Guest user Created:   Nov 30, 2018 Last commented:   Nov 30, 2018

Product Realization requirements for distribution and manufacturing facility

I am currently doing an ISO 13485 system for the first time. I have several years of experience in ISO 9001 and EHS but need help in 13485 please.
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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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Verlene Law Nov 30, 2018

1. The facility is a manufacturing and distribution warehouse. Do I still need to meet clause 7. Product realization requirements as per the standard?

2. Do we need to keep medical device files for all our stored substances or is this for a manufacturer only?

Thanks for your help

Answer:

1. I am currently doing an ISO 13485 system for the first time. I have several years of experience in ISO 9001 and EHS but need help in 13485, please. The facility is a manufacturing and distribution warehouse. Do I still need to meet clause 7. Product realization requirements as per the standard?

Answer: If you are providing services of distribution and manufacturing to external medical device clients, yes you have to meet Clause 7

2. Do we need to keep medical device files for all our stored substances or is this for a manufacturer only?

Answer: Yes, keep a copy of the medical device files.

For further information, you can refer, to :

What is ISO 13485?
https://advisera.com/13485academy/what-is-iso-13485/

Clause-by-clause explanation of ISO 13485:2016
https://info.advisera.com/13485academy/free-download/clause-by-clause-explanation-of-iso-13485

Checklist of ISO 13485 implementation and certification steps
https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
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Nov 30, 2018

Nov 30, 2018