The first thing I needed to do was to define the scope of the certification. In my case “product realisation” includes design and development but excludes series manufacturing.
If I make prototypes or models they are not stand-alone products, but secondary to the engineering documentation I’m delivering. This means that those clauses in the standard dealing with production issues—and for medical devices there are quite a few—are not applicable.
The product design process takes Design Inputs, undertakes Design Activities in order to deliver Design Outputs. Both inputs and outputs are termed “documents”. These can be in the familiar shape of text documents, drawings, circuit schematics, datasheets; but they can also be example products, material samples, prototypes, or software code. ISO 13485 requires all project documents to be managed, reviewed and approved. It requires us to follow a documented procedure for “Document Control”. For each process I created a flow chart—the one for Document Control is show below.
The standard only asks for “documented procedures”, but does not specify in what form they need to be documented. Flow charts are a good form of documentation. I did also work out procedures in text documents, mainly for the benefit of associates and subcontractors who will also have to use the Panchromos QMS if they work in my project teams.
Next up in this series is the assessment visit I had from CQS.