One of my followers sent me a question on LinkedIn:
"We are planning to combine both ISO 13485:2016 and ISO 9001:2015 as we implement our QMS. What is the best way to maintain the quality manual?
Shall we combine the quality manuals and have one (1) manual?
Or
Shall we maintain two (2) separate manuals?"
My response:
"I do not recommend having both certifications. The ISO 13485 is required by Health Canada and recommended for device companies globally. The ISO 9001 has some unique requirements since 2015 that contradict ISO 13485. For example, ISO 9001 no longer has a requirement for a manual and the clause numbering has changed. Therefore, I don't recommend getting both. If you choose to get both, I would combine them into one QMS, but I would identify the 9001 requirements with a different color and symbol for anyone that is color-blind (e.g. blue/#)."
Below are some links to blog postings about this topic:
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