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Robert Soares
I am new to the ISO 13485 Standard, by recently joining a company that upgraded in September to the 2003 standard. My background is mainly in automotive (TS 16949) which requires each clause (and subclause) of the standard be covered within the internal audit cycle (typically 1 year). For instance, I would need to show evidence that subclause "7.5.3.3 Status Identification" was covered during my internal audit cycle. Is this a requirement in ISO 13485, that all clauses and subclauses be covered over the audit cycle, and that there is documented evidence to support it?
Any help is appreciated.
Bob Soares
Any help is appreciated.
Bob Soares