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Is ISO 13485 required if we manufacture non-medical parts?

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Guest user Created:   Mar 16, 2019 Last commented:   Mar 16, 2019

Is ISO 13485 required if we manufacture non-medical parts?

We are a plastics manufacturer. Most of our products are not for the medical industry, and we do not own those medical products (we do not manufacture medical devices), only manufacture parts for the customer. We are currently certified to ISO9001:2015 and are seeking ISO 13485. Question, do we need to have both certificates? Also, I am presuming that the non-medical parts would not need the additional requirements for medical devices, and through an audit.
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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 Mar 16, 2019

Answer:

ISO 13485 applies to all companies dealing with medical devices. Since in your case, you have clarified that the plastic part is not part of the medical device, ISO 13485 will not be applicable to you. However , you will still need to maintain the specifications and technical details about the part that you are manufacturing for the medical device manufacturer. Since you are currently certified to ISO 9001, it will be quite easy for you to adapt to ISO 13485 which will give you more advantage with your medical device clients in the future.

For more information, please refer to :

-Six key benefits of ISO 13485 implementation
https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/

-How to structure Quality Management System documentation according to ISO 13485
https://advisera.com/13485academy/knowledgebase/how-to-structure-quality-management-system-documentation-according-to-iso-13485/

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

- ISO 9001 vs. ISO 13485
https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/
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Mar 16, 2019

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