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Are ISO 22716 and ISO 13845 comparable as certification scheme?

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Guest user Created:   May 04, 2021 Last commented:   May 05, 2021

Are ISO 22716 and ISO 13845 comparable as certification scheme?

I'm quality assurance and regulatory manager for a biotech company in Italy. We are going to do the ISO 9001, 14001 and 22716 standards the next june. I was wondering if 22716 and 13845 are comparable as certification scheme which are the difference between the two scheme?

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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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Kristina Zvonar Brkić May 05, 2021

ISO 22716:2007 is a standard that covers Good Manufacturing Practices for cosmetic products, while ISO 13485:2016 is a standard that covers requirements for developing quality management for the manufacturers of medical devices. The main principle regarding the production itself is rather similar - both standards require traceability of raw materials, confirmation of the correctness of the entire production process, traceability in the production itself, to maintain the required purity of the product and production (depending on product type), etc. 

Furthermore, the similarity is that both standards require an internal audit, that deviations and nonconformities are managed, and that documentation is managed appropriately. However, in ISO 22716 there is no requirements management review. 

Given this review, it can be said that these two standards are comparable. 

A lot of information about ISO 13485 you can find on the following links:

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May 04, 2021

May 05, 2021

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