Are ISO 22716 and ISO 13845 comparable as certification scheme?
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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:
- What is ISO 13485? https://advisera.com/13485academy/what-is-iso-13485/
- Six key benefits of ISO 13485 implementation https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
- How to get ISO 13485 certified? https://advisera.com/13485academy/iso-13485-certification/
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May 05, 2021