ISO 13485 planning related query
We are ISO 9001:2015 certified and would like to initiate ISO 13485:2016 QMS implementation. We manufacture molecular biology reagents for research use only. My query is if we implement ISO 13485:2016, we would still label the reagents as research use only and supply to research customers with the possibility of selling it to Medical device manufacturers as well? Am i correct in my understanding?
Also, is 13485 product specific or for the processes?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
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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
Yes, your understanding is correct. If you implement ISO 13485:2016 you can still label reagents as research use only. ISO 13485:2016 is applicable to the manufacturing of both medical devices and in-vitro devices.
- For Similarities and differences between ISO 9001:2015 and ISO 13485:2016, please see following article: https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/
- Here is a Checklist of ISO 13485 implementation and certification steps: https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
ISO 13485:2016 is a process-oriented standard. Product-specific regulation for your type of the product is In vitro diagnostic directive (current valid IVDD 98/79/Eec, and new version IVDR 2017/746).
For more details about ISO 13485 please read the following articles:
- ISO 13485 structure and requirements https://advisera.com/13485academy/what-is-iso-13485/ What are the consequences of noncompliance with ISO 13485 for manufacturers of medical devices? https://advisera.com/13485academy/blog/2017/11/02/what-are-the-consequences-of-noncompliance-with-iso-13485-for-manufacturers-of-medical-devices/
- How to use ISO 13485 to comply with In Vitro Diagnostic medical devices (IVD) requirements in UK https://advisera.com/13485academy/blog/2017/10/26/how-to-use-iso-13485-to-comply-with-in-vitro-diagnostic-medical-devices-ivd-requirements-in-uk/
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May 11, 2020