I am preparing documentation from 7.3.3 to 7.3.10 under ISO 13485:2016.
7.3.3 - Should I document all the sub-topics from 7.3.3? meaning, all together in one document? I am confused about how to start and where to start. I have supporting files such as PRD, SDRS, VOC. should I make a document that refers to all these files? including risk management? or I should have a separate document for each and every specification? Share me a sample document if you have any.
7.3.4 - Records such as schematic, PCB, BOM, Mechanical designs come under this clause? Should I form a document that refers to all the files that I mentioned previously? also share me a template if you have any.
All I am confused about is that should I form a document that refers to all the records I have? and should I have a procedure for each and every sub-clauses of 7.3?
7.3.3 - Should I document all the sub-topics from 7.3.3? meaning, all together in one document? I am confused about how to start and where to start. I have supporting files such as PRD, SDRS, VOC. should I make a document that refers to all these files? including risk management? or I should have a separate document for each and every specification? Share me a sample document if you have any.
7.3.4 - Records such as schematic, PCB, BOM, Mechanical designs come under this clause? Should I form a document that refers to all the files that I mentioned previously? also share me a template if you have any.
All I am confused about is that should I form a document that refers to all the records I have? and should I have a procedure for each and every sub-clauses of 7.3?