Getting started in ISO 13485

[Manto]

I agree that with no support I am doomed for failure.
But I have support from Management now (after I stood my ground)
Question
13485 states in section 8.2.3 Reporting to Regulatory.
What are the requirements for reporting? Its been a decade or two but the only time I remember was due to a recall.
What is the procedure and is there an excemption ?

 

[levatorsuperioris]

No... almost every country you sell finished devices in has it's own reporting requirements, what is considered a report able event, how to report and who is responsible for reporting, and timelines when the report is due.

 

[Manto]

Hello Everyone
I am still having issues with what goes where. I am writing a SOP for New Product inspection. Does this go under clause 7.1?
Wish I had a road map of what documents and reports I need and what clause they are attached to.
I think I may need to find a consultant as I am getting overwhelmed. thoughts?

 

[yodon]

Wish I had a road map of what documents and reports I need and what clause they are attached to.

You have a copy of the standard, don't you? That's the roadmap. Each element in the standard indicates if documented information is required, if records are to be kept, etc.

I think I may need to find a consultant

It's not a bad idea to get a little expert time. Maybe get enough to set the foundation and provide guidance for the path forward.

 

[John Broomfield]

Do not write procedures around the standard to impose on your colleagues.

Instead, respect the system already used by your colleagues to understand and fulfill requirements.

When you have done this you’ll be able to make more sense of the standard and your colleagues are more likely to welcome any changes they need to make.

And, if you want, you’ll be able to describe in a pamphlet what your organization does to assure product quality in terms understood by your colleagues.

Write nothing for your auditors except, perhaps, a one page matrix as an appendix of each clause in the standard showing which of the documented parts of your management system contribute to conformity.

You’ll probably find many parts that contribute to conformity to clause 7.1.

 

[Tagin]

Hello Everyone
I am still having issues with what goes where. I am writing a SOP for New Product inspection. Does this go under clause 7.1?
Wish I had a road map of what documents and reports I need and what clause they are attached to.
I think I may need to find a consultant as I am getting overwhelmed. thoughts?

This was the mistake I made when I first created our QMS. Rather than document by business processes, I tried to document by clause. It was both painful and ineffective, as few in the company could make heads or tails of what applied to them, and the resulting segmenting in documentation were not natural process segmentations.

Instead, document your business processes, and then ask of each business process: does clauses 4 apply here? how is it covered?...does clause 5 apply here? how is it covered?..., etc. Something like that.

So, while documenting your Design process, you would ask if 7.1 applies, and if so, tie this SOP into the Design process in a way that makes business flow sense, while complying with the ISO clause.

A cross-reference as @John Broomfield mentioned will provide you some assistance and assurance as well as being helpful for the auditor.

 

[Manto]

Thank you
This is a bigger job than I thought. 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. There are several brands under one roof and no one is just tied to this one brand. I am trying to get a handle on how the company works but because there are so many brands no one really knows what is going on. suggestions?

 

[Ninja]

This company does not have ...{snip}... any documentation.

That cannot possibly be true. Back up, take a deep breath, and look again with new eyes.

You buy stuff, there are PO's and packing lists and checks sent...those are documentation...you've got enough going on without overlooking things that are already sitting waiting for you to use...

...and just think of the level of job security you'll have when you pull this off!

 

[Manto]

Thanks for the Pep talk you make an excellent point I will take your advise and run with it
thanks again feeling a little bit better

 

[Tagin]

Thank you
This is a bigger job than I thought. 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. There are several brands under one roof and no one is just tied to this one brand. I am trying to get a handle on how the company works but because there are so many brands no one really knows what is going on. suggestions?

If they have no documentation (i.e., process documentation), then you need to start with documenting those business processes, before even glancing at the standard. You cannot apply the standard to something which is not yet defined.

I would do the process docs at first as flow charts with notes added, since you are going to eventually document them more fully once you apply the standard. Flow charts are quicker to create and also easier when you are trying to collaborate with others to get these tribal processes on paper.