Questions about ISO 13485 implementation
My company (a contract manufacturer) will, in the near future, be manufacturing and distributing (and exporting) medical devices alongside products not classified as medical devices. We were advised to implement the Good Manufacturing Practice (GMP) and the Good Distribution Practice For Medical Devices (GDPMD). I would be very grateful if you could advise me on the following matters:
1) Is it a requirement for the medical device outsourcing company to have implemented ISO 13485 before my company implements GMP?
2) If the outsourcing company (who owns the product label or brand name) fails in being ISO 13485 compliant, should my company then implement ISO 13485 instead of GMP?
3) In doing my research for my company, I noticed that GMP and GDPMD have certain similar mandatory document requirement – e.g. the Quality Manual, SOP on Document Control, SOP on Pest Control, SOPs on Internal Audit and Management Review. Instead of having duplicate documents, could such documents be adapted to accommodate both GMP and GDPMD? For instance, drafting one Quality Manual that caters for both GMP and GDPMD?
4) Should the scope of the GMP include the other products (not technically defined as medical devices) manufactured and distributed by my company, or could it be limited to the medical products only?
Thanking you in anticipation of your kind response to my above questions.
Note: It is by chance that I came across Advisera’s publications in the web, and I found them to be very insightful. Keep up the good work.
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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
1) Is it a requirement for the medical device outsourcing company to have implemented ISO 13485 before my company implements GMP?
According to the MDR 2017/745, any entity that is involved in the life cycle of medical devices (manufacturer, outsourced production company, distributor, importer, authorized representative), needs to have a quality management system. ISO 13485:2016 is a standard that is specific for Manufacturers of medical devices (Medical devices — Quality management systems — Requirements for regulatory purposes).
Besides that, on the web pages of the European Commission are stated which standards are applicable for all types of medical devices: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
On that list, which has around 300 standards, only ISO 13485:2015 is the standard for the quality management system.
From this point of view, ISO 13485 is more important than GMP and GDP.
2) If the outsourcing company (who owns the product label or brand name) fails in being ISO 13485 compliant, should my company then implement ISO 13485 instead of GMP?
The company that owns a product label or brand name can not fail in being ISO 13485 compliant because it won't be in compliance with MDR requirements. Yes, from the medical device point of view, ISO 13485 is more suitable.
3) In doing my research for my company, I noticed that GMP and GDPMD have certain similar mandatory document requirements – e.g. the Quality Manual, SOP on Document Control, SOP on Pest Control, SOPs on Internal Audit and Management Review. Instead of having duplicate documents, could such documents be adapted to accommodate both GMP and GDPMD? For instance, drafting one Quality Manual that caters for both GMP and GDPMD?
You do not need to duplicate documents, you can adapt them to accommodate both GMP and GDP.
4) Should the scope of the GMP include the other products (not technically defined as medical devices) manufactured and distributed by my company, or could it be limited to the medical products only?
GMP can be applicable to different kinds of products, therefore, it does not need to be limited to medical device products only.
If you need more information regarding ISO 13485, please see the following articles:
- What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
- How to get ISO 13485 certified? https://advisera.com/13485academy/iso-13485-certification/
- Checklist of ISO 13485 implementation and certification steps https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
You can even see how our ISO 13485:2016 Documentation toolkit looks like on the following link: https://advisera.com/13485academy/iso-13485-documentation-toolkit/
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Aug 20, 2020