ISO 13485:2016 - Medical Device Quality Management Systems Practical Reasons Behind The ISO 13485/QSR Regulations If you know your standards and suspect that he is only aserting an opinion, tell him! I do and my auditor and I have a great working relationship and I know they are always on their toes because I will challenge them. One thing I find is that auditors are not challenged enough. You auditor is talking through his hat! tell him to get off his high horse and stop telling you how to implement your quality system! (well something like that). Have a look at your own procedures do you say you must have a pre-prepared checklist? if it does - remove it, its too tying. This is acceptable for ISO13485 providing you have trained internal audits. The checklist can be created while preparing for the audit. You do not need to provide a checklist document that says what you will be auditing in an area.Īs along as you can produce 'objective verifiable evidence' that the audit has been completed to a satisfactory standard then you are meeting the clauses of the standard. Your auditor is asking too much with regard to the clauses of the standard.
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