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I'm going conduct an internal audit for ISO 13485, MDD and CMDR for ultrasound company.
First, you need to decide for each element, if it is applicable or not for your quality system. If not, you need to justify it. Once it is applicable, if there is a requirement in the standard to have a procedure in place, you should create a procedure. Otherwise it would be a major NC.ht2el;bt1015 said:We just went through a Stage 1 assessment for ISO 13485,... the question came up, that is...
Q: do all the elements in the QMS Manuel have to have a Quality Procedure... such as 5.0 thru 5.5.3 (11) in all. or can you just refer to QOP 5.6 (that one has a QOP)