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Implementation ISO 13485 on making medical materials for medical laboratories

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Guest user Created:   Aug 25, 2021 Last commented:   Aug 30, 2021

Implementation ISO 13485 on making medical materials for medical laboratories

Can we use ISO13485 in the materials industry for medical laboratories?

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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 Aug 30, 2021

You can use it because ISO 13485 standard covers all necessary elements regarding the production; it guides you on how to best organize production, how to ensure that you know at all times what stage your product is at, how to ensure traceability (both raw-repro material and finished product) and the required purity. Regardless of the fact that ISO 13485 covers medical devices, this approach is acceptable for the production of any product.

However, please be aware that ISO 13485:2016 is standard for preparing quality management systems explicitly for manufacturers of medical devices. In section 3. Terms and definitions, in point 3.11 is described what a medical device is. A product may be a medical device if it has one or more of the following roles: diagnosis, prevention, monitoring, treatment, or alleviation of disease. Therefore, if your materials meet this definition (and the rest of what is written in point 3.11) then the materials for ISO 13485 are applicable. 

If you need more information what is ISO 13485:2016, please see following articles:

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Aug 25, 2021

Aug 30, 2021