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  • IAF MD 9, ISO 13485 and ISO 9001

    Is the 13485 will get a MD9 jointed with the 9001 or do they remain 2 separate entities (for example companies wanting to have both 9001 & 13485) in relation to term of audit duration? With the new standard 13485:2016, it's trying to be more inclusive and englobe the product from design to production, selling and post market. Do distributors of medical device have to comply to the new standard (if previously 9001)? Or is it just a nice to have and can keep distributing under a 9001?
  • Risks SOP, Medical Device File and auditing ISO 13485

    I'm currently trying to implement ISO 13485:2012 for the first time and we're planning to have the assessment in few months – I'm also implementing the new ISO 9001:2015 edition so working with both the new and old clauses.
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