Getting started in ISO 13485

[Manto]

Hello everyone here is an update. I have written all the work instructions for making the one and only medical device we carry.
Now I have to write all the SOP. The issue is that I have to do this all on my own. No team and little to no help from management.
Looking to start the SOPs today. Any help will be greatly appreciated. still overwhelmed.

 

[John Broomfield]

Why are you doing the Process Owner’s job?

Did top management assign them and brief them on their duties?

 

[Manto]

I've argue the point about getting everyone involve but it has fallen on deaf ears.
I have been hired to get the certification. It doesn't matter that if won't be effective.
I will just have to set up the SOP and get them to follow it.
Everyone does everything in excel and its keep on their desk tops. IE RMA, Calibration.
Absolutely no procedures from customer service to shipping so I have to do that as well.
and NO ERP system so I will have to develop work orders for traceability.

 

[John Broomfield]

Manto,

Your certification auditor will be looking for evidence of effectiveness.

Effectiveness is a requirement of ISO 13485.

So, my recommendations stand.

Continue to engage your colleagues in developing their system.

Best wishes,

John

 

[Manto]

Throwing this out there
I have started the documentation for the Quality Manual. Is it best for me to just Go to one of the website and pay to have the documents done and edit them as I go or should I write them myself. My issue is the that I over think it and run into writes block. I will have the help from top management but I feel that they will not be helpful as none of them have done this before. As I had said early they do not have any documentation other then drawings. No work instructions not even work orders.

 

[John Broomfield]

Manto,

By analyzing the way the work is planned, resourced, done and verified you’ll never suffer “writer’s block”.

You need your system documents to reflect what actually happens.

You are not advised to prepare a work of fiction, of course. But that is what you’ll probably get from a procedures mill website. And, worse still, such procedures are not “owned” by the folk you will want to use them.

You may also need to work with the process owner to design, develop and validate each new process as part of your management system.

John

 

[lupo_st84]

Agree. It is not only a documentation work, but focus also on the development of culture of quality, which is essential to reach a decent level of compliance for any quality management system.

 

[levatorsuperioris]

If it turns out you are snuffed out for falsity, and its pretty egregious, there is a notified bodies "black list" at the European level - worst case you end up on the list, then you are done -> no notified body will cert you going forward.

 

[James]

Throwing this out there
I have started the documentation for the Quality Manual. Is it best for me to just Go to one of the website and pay to have the documents done and edit them as I go or should I write them myself. My issue is the that I over think it and run into writes block. I will have the help from top management but I feel that they will not be helpful as none of them have done this before. As I had said early they do not have any documentation other then drawings. No work instructions not even work orders.

I think it's best for you to write your own quality manual by mapping 13485 over to your organisation's context, clause by clause, building your system as you work through it by delegating key areas to Procedures. I've been in a similar position to you. Building a system unilaterally will result in a pointless and failing system. I'd have a frank conversation with your boss about that.. you need to see some committment or you, the system and the company will not succeed in this endeavour

Good luck

James

 

[Ed Panek]

I think it's best for you to write your own quality manual by mapping 13485 over to your organisation's context, clause by clause, building your system as you work through it by delegating key areas to Procedures. I've been in a similar position to you. Building a system unilaterally will result in a pointless and failing system. I'd have a frank conversation with your boss about that.. you need to see some committment or you, the system and the company will not succeed in this endeavour

Good luck

James

Agreed.

Of course, one person can write the SOPs for all the process owners but will you sign as the author? If I saw this as an auditor I know I could find a weakness somewhere. Will the employees actually follow your processes? This sounds like a mistake waiting to happen.

Is your resume broad enough to write all the SOPs?