Getting started in ISO 13485

[James]

This company does not have an ERP system, work orders or any documentation..... I have no traceability as components are bought under another brand and for the most part no help in getting this project completed. I keep reviewing the standard but still get stuck and overwhelmed.

As suggested before, it may be best to put the standard down for now and just focus on understanding how the company works; what it does; why it does what it does; why it does it the way that it does it.. Apply some Socratic questioning to really understand how things work.

If I were you I would create a high level process map (flow chart) to help understand overall process flow (this also helps in communicating changes when you need to make them later down the line). Ask lots of questions and make notes. It seems that you might have to recommend some changes to how things are done, but dont fall into the trap of making changes based on what the standard's clauses bluntly require... you are the 'go between', interpreting how the standard applies in your organisation's context, based on how it works now...

I'd be happy to give some basic advice conversationally via zoom if it helps

All the best

James

 

[Manto]

As suggested before, it may be best to put the standard down for now and just focus on understanding how the company works; what it does; why it does what it does; why it does it the way that it does it.. Apply some Socratic questioning to really understand how things work.

If I were you I would create a high level process map (flow chart) to help understand overall process flow (this also helps in communicating changes when you need to make them later down the line). Ask lots of questions and make notes. It seems that you might have to recommend some changes to how things are done, but dont fall into the trap of making changes based on what the standard's clauses bluntly require... you are the 'go between', interpreting how the standard applies in your organisation's context, based on how it works now...

I'd be happy to give some basic advice conversationally via zoom if it helps

All the best

James

thanks James I in the process of creating that right now. I will contact you if I get stuck. Thanks in advance for your help