ISO 13485 reassessment audit and passed with no NCs and 2 OFIs

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GStough

Staff member
Super Moderator
#3
Re: ISO 13485 reassessment

Indeed, Doug!! That's quite an accomplishment (from my limited experience :lol:) and definitely something to be proud of.... :applause:
 

DannyK

Trusted Information Resource
#6
Re: ISO 13485 reassessment

Congratulations on a job well done.

Ensure that everyone at your organization understands that certification is just the beginning.

It takes a lot of effort to maintain the quality management system and keep everyone motivated to work with it.
 
R

Roland Cooke

#7
Re: ISO 13485 reassessment

Congratulations Doug.

Can you give us a bit more information about the audit:
Was there a noticeable change in emphasis (focus on hot topics etc) from previous major ISO audits?
What was the audit team like (in terms of knowledge, coverage, and interaction with you)?
What were your areas of weakness, how are you addressing them?
 

Doug Tropf

Quite Involved in Discussions
#8
Re: ISO 13485 reassessment

Congratulations Doug.

Can you give us a bit more information about the audit:
Was there a noticeable change in emphasis (focus on hot topics etc) from previous major ISO audits?
What was the audit team like (in terms of knowledge, coverage, and interaction with you)?
What were your areas of weakness, how are you addressing them?
Thanks to all for the kind words.

We had a one person auditor team and this was the third time he has audited us. He is a microbiologist and seems very knowledgeable and fair - doesn't play "gotcha" and comes across as being geniunely interested in helping our organization.

There was a hightened emphasis on risk management and a "suggestion" that, rather than mainly relying on the number of complaints to assess customer satisfaction, we utilize other measurment tools such as customer satisfaction surveys.

Our two OFIs were related to not using a large enough sample size for the employee training portion of our internal audit and for failing to adequately document the reason for extending the due date on a CAPA.

I believe we could improve our CAPA efforts in general, particularly in the area of root cause analysis. We are also looking at software to improve the document control process.
 
D

DeviceMaker

#9
Congrats Doug. We are looking to start down the road of 13485 certification. I am alos looking at software to handle document managment. So far i have looked at ISOExpress, Quality Collaboration By Design, and possibly Grand Avenue. All have pros and cons. What are you looking at for software? Thanks.

Mike
 
R

Roland Cooke

#10
That's good to hear.

Risk management is definitely under the spotlight, even though it is far from a new issue. I'm gradually seeing compliance and improvement across the industry, with a few companies implementing excellent systems (that are actually functional rather than just being "pretty'! :D).


Customer feedback/customer satisfaction is still fairly weak around the place, with - as you indicated - a bit too much tunnel-vision on complaint management.


I'm seeing a gradual increase in electronic QMS, but the major integrated systems are generally still too costly for the small/medium businesses that form the bulk of the medical device industry. The odd module (e.g. document management) is seen fairly often.

Some of the integrated systems are jaw-droppingly good though, and likely to be the way forward for an increasing proportion of companies in the future. So I think I'd like to see a bit more long-term planning in this area, especially from companies that intending to grow significantly over the next few years.
 
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