ISO 13485 implementation
When a company is going for IS 13485 certification, is it mandatory to go for ISO 9001
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No, it is not mandatory for the company to go for the ISO 9001 as well. 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 On that list, which has around 300 standards, only ISO 13485:2015 is the standard for the quality management system.
For more information, please see the following links:
- Similarities and differences between ISO 9001:2015 and ISO 13485:2016 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/
- What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
- Checklist of ISO 13485 implementation and certification steps - https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
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Dec 29, 2020