ISO 13485 for outsourced supplier – is it necessary?
Hello, I am a Auditor/Consultant and I have a client that is a outsourced supplier (Specialized Outsourcing Services, integrating the assembly of electronic boards, wiring harness and electronic equipment) who works with several MD companies, but without any finished product and he has no Design and development once all production is done under client specifications. He asked me to determine if ISO 13485 was a good option for his company once his scope is only on production involved in one or more stages of the life-cycle of a medical device and he is already ISO 9001 certified. ISO 13485 is mainly for finished product suppliers so it´s no mandatory for this client, but there can be some interesting point evaluating if it is a good option. I must present an overview /report to support management decision about ISO 13485 certification or not. If they decide to go on certification, do you have a solution for this?
Assign topic to the user
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 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
According to the ISO 13485:2016, requirement 1 Scope, it is stated that this standard is applicable for entities involved in all life-cycle of a medical device. Among others, it is also listed as a supplier or external parties, that provides products or parts of the product. What is most important from the notified body's point of view, is that traceability for the entire production process must be covered. Therefore, it is expected that both manufacturers and outsourced suppliers will have implemented ISO 13485:2016.
Since your company is already ISO 9001 certified, you can buy only documents that are requested by ISO 13485 from our ISO 13485:2015 documentation toolkit: https://advisera.com/13485academy/iso-13485-documentation-toolkit/
At the end of this web page, you can check and purchase individual documents as well.
Also, the following articles can be helpful:
- Checklist of ISO 13485 implementation and certification steps: https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
- Six key benefits of ISO 13485 implementation: https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
Comment as guest or Sign in
Jun 12, 2020