ISO 13485 procedure change and reflect to legacy manufacture items

[AstorBannerman]

Hi my company is just starting going through the implementation of the ISO 13485 QMS system. We currently have ISO 9001:2015 and manufacture class I medical devices using MDD self certification route for CE. My question is as follows?
As we manufacture medical class I equipment we feel that we should be using ISO 13485 QMS and issue CE using the self certification under MDR.
We are introducing new products and are changing the way we control part traceability for these new products. The change will be written into a high level procedure instruction. For the established product that are already on the market we are going to maintain the previous method of part traceability, the plan is purely to include this in the same high level procedural instruction, so there will be one explanation for new product and one explanation of already on the market products.

Making the change to the already on the market product would require large man hours changing product documentation drawings etc. and simply would not be realistic.

 

[Tidge]

Setting aside specific questions about navigating potential gaps relative to "13485 compliance" for 'legacy' products, it is probably not a best-in-class solution to have different high-level processes for different products that are in the same life-cycle phase (e.g. "in the market").

For example: whatever process you establish for maintaining 13485 compliance for processing design changes for one product on the market should not look different from that used for another product... otherwise you are essentially trying to maintain TWO different 13485-compliant processes, which will involve more work and risk confusion when trying to comply with the different systems. Baking the two different approaches into a single procedure makes me want to echo: "I always refer to my procedure, because that is where we keep the loopholes."

The Design History File of the legacy products almost certainly doesn't need to be fully remediated, but if there are identified gaps (per a new compliant process) than you ought to develop a plan to address the identified gaps. It is also unlikely that the Device Master Record for a legacy product needs to remediated, but again I recommend having a plan that includes a gap assessment (against the new process) with remediation strategies.

 

[AstorBannerman]

Thanks i thought the solution would not be simple. we will start to loo at the remediation strategy.