IS0 13485 process flows


My head has gone blank, at the moment i am implementing a ISO 13485:2016 QMS into a medium sized medical company. In order to achieve compliance obviously we need to have the required documents and records, Quality manual etc.
The way i am attacking this is through High level procedural instructions, process flow charts and then work instruction. The High level procedural instructions are an overview of the process required by the standard i.e. 7.3-Development process.
The Process flows are than a more detailed view of that procedural instruction showing the individual activities required to be completed in that process with input, output and method of authorization (management).
The work instruction are then how each activity is completed, i.e. screen shots of SAP actions required etc.

Through training and ISO 9001:2015 experience i see this method as a sensible approach. Do you agree ?


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Yes. A top-down approach makes the most sense to me. In addition, at some point, it will help to create a cross-reference document which lists all the 13485 clauses in one column and in the other column lists the corresponding QMS documents, records, etc. that cover the clause requirements.

But its more important to first build the QMS around the way you actually do business and then later fill in the gaps, rather than building a QMS to the standard first and then trying to work backwards and fit it to your business.
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