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ISO13485 Sterilisation Validation, Risk Management, Post Market Surveillance

B

bsomerton

#1
Hi,

I was hoping that someone might be able to help me out. I am picking up the pieces of an ISO13485 system and getting it ready for an SGS audit this coming Monday/Tuesday only to find today that there is no procedure avaiable for Risk Management or Post Market Surveillance.

Would anyone be able to offer something to work on bearing in mind I have liitle time to get the thing fully 'up tp speed'.

Anything on Sterilisation Validation would also be very welcome.

Thanks for your help.

Bruce
 
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Coury Ferguson

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#2
Re: Procedures needed !!!

Hi,

I was hoping that someone might be able to help me out. I am picking up the pieces of an ISO13485 system and getting it ready for an SGS audit this coming Monday/Tuesday only to find today that there is no procedure avaiable for Risk Management or Post Market Surveillance.

Would anyone be able to offer something to work on bearing in mind I have liitle time to get the thing fully 'up tp speed'.

Anything on Sterilisation Validation would also be very welcome.

Thanks for your help.

Bruce
See if you can postpone the audit until next month. I don't know if anyone will be able to assist you before Monday. :cfingers:
 
B

bsomerton

#3
Re: Procedures needed !!!

Thanks for your very prompt reply. I wish I could!!! A number of reasons (more political then anything) have determined that Monday is 'the day'.
 
G

Gert Sorensen

#5
I would rather cut off my own arm with a teaspoon than try to make such a "stupid" move. If the procedure is not in place by now there is no point in implementing it just before an audit. Let them find it and take the NC, that will hopefully get peoples attention and make them realize that this is a matter that needs to be adressed. In MHO: finetuning a system just before audit invalidates the audit. Audit should be an objective evaluation of the system, not something you just need to go through to get a certification - you wouldn't cheat on an exam either, would you? :lmao:
 
B

bsomerton

#6
Thanks for your help. Much appreciated.

I take Gert's point however this s a very sensitive situation with job losses in the forefront of the whole thing. There has to be a certain amount of commercial thinking at the same time.
 
W

wrodnigg

#7
There is no requirement for a "documented procedure for risk management" in 13485!

ISO 13485:2003 7.1 requires the establishment of "documented requirements" for risk management activities throughout the product realization and the records of RM activities maintained.

This means, you do not need to have a documented procedure, but you have to address risk management in your design and development procedures as "documented requirements" and you have to maintain you risk management files (for each product).

You also do not need an explicit documented procedure for PMS, but you shall have integrated PMS-activities in yor quality management system (somehow / somewhere, e.g. in the feedback-system (ISO 13485:2003 8.2.1)).

The requirement in the MDD is:
an undertaking by the manufacturer to institute and keepup to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:
but you can include these tasks in any procedure you want (feedback system works pretty fine).

So if you can fulfill these points, there is no need to worry about the audit, if you do not have any records from risk management, you will need more than some days to do your risk management tasks for your products.
 
R

Roland Cooke

#8
I'm auditing Monday/Tuesday. :D :cool:


If it is me, let's chat. :D


If it is not me, feel free to chat anyway - I'll be in the office for a while longer today, and all day tomorrow, give me a ring at the WSM office. (Now how's that for forum service?! :) )


Essentially our assessor should be looking for not just procedures, but evidence of implementation of the same. Lack of either would likely result in a Major CAR.

Whilst you might be able to parachute in some procedures, it will be next to impossible to demonstrate that RM has been adequately implemented throughout product realisation.

But whilst embarrassing, it is not the end of the world, and relatively easy to fix.

The Major could be addressed in several ways, across the business. It may be possible to demonstrate activity via paperwork submission, leading to a downgrade to a Minor (you could even request/negotiate this) - thus avoiding having to wait for a repeat onsite visit.


Good luck!

Roland Cooke
SGS Medical Devices Certification Manager
 
R

Roland Cooke

#9
The same approach could also be applied to implementation of a PMS system.



However the sterilisation validation issue is actually more of a potential show-stopper.

If you can't demonstrate adequate evidence of appropriate sterilisation, you could have a much bigger problem, which will take a minimum time to resolve.

Hopefully your situation is not too grim in regards to this.
 
Last edited by a moderator:
R

Roland Cooke

#10
Just a little disclaimer.

This industry is far too small, even globally, for anonymity to be 100% effective where a forum like this is involved.

This forum is a wonderful resource (I learn plenty every visit). I certainly would not want to deter anyone from posting here.

So this is just to reassure Covers that as far as humanly possible, there will be no special emphasis, either for or against, paid to information posted within the Cove by our customers during subsequent audits (except where safety might be affected).
 
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