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Hi, I'm having some doubts on ISO 13485, is it necessary to have QMS training once in 6 months, as per the standard?
How to identify the new requirements of ISO 13485:2016 vs 13485:2012
How can ISO 13485 support and improve Staff morale?
Is there a deadline for handling product complaints?
How important is the mould validation documents?
Does 21 CFR 820 requires conformance with ISO 13485?
Qualification procedures need to be developed and implemented for a test or a certain manufacturing procedure. A test, OJT or validation should be included. However, who can be the "first" qualified person? For the validation of the qualification, there needs to be a person to compare. We are in the process of first developing the qualification procedure. Do we need to establish a procedure that specifies the first person to be qualified? Or can anyone or someone who had been doing the job become a first qualified person?
We have an assessment of our QMS to 13485-2003 and need to be in line with 13485-2016 what is the best way to accomplish this?