First ISO13485 accreditation audit: What are things that can go wrong?

[Phoenixber]

Dear All,

I have been reading post in this forum for a while but never posted a question. However today I do have one. What are major NC's that will prevent our small IVD manufacturing company in South Africa from getting the 13485:2003 accreditation during the initial accreditation audit. I do remeber from the 9001:2000 accreditation process that if there are only minor NC's the acceditation is still granted and the NC's are followed up in the next survailance audit. How is this handeled in 13485:2003.

Thank in advance for your help.

 

[Randy]

Re: First accreditation audit: What are things that can go wrong?

1st, thanks for participating and welcome

OK back to the subject. I can't speak for the other registration bodies, but I can tell you what our basic policy is. The existance of any Major NC will prevent a recommendation for registration. We normally require the submission of a CA and a special visit to verify effectiveness. Upon the verification then recomendation for registration will be made.

The follow up and clearance actions will be delineated in your contract and may vary from body to body. That's it in a nutshell.

 

[Roland Cooke]

Here are some things that could result in a Major Non-Conformity being identified, which would prevent certification being awarded until closed out, or at least reduced to a Minor.

• Products have been placed on the market or may have been placed on the market, which would cause undue risk to the patient or user.
• Products have been placed on the market or may have been placed on the market which do not meet the Essential Requirements or do not meet regulatory requirements including labelling and marking
• Any unjustifiable exclusion from a regulatory requirement
• Products have been placed on the market or may have been placed on the market which, do not comply with the manufacturer's specifications due to defective elements in the quality system.
• There is an absence and/or failure to address or implement one or more applicable element of the regulatory requirements for quality systems.
• There are an excessive number of minor non conformities against an element of the regulatory requirement for quality systems indicating an adverse trend or lack of control
• There is a failure to implement appropriate corrective and preventative actions when an investigation of post market data indicates a pattern of product defects.
• There is unsatisfactory or delayed corrective action of non conformities from previous audits or a pattern of non conformities with respect to the same element of the regulatory requirements for quality systems.
• The auditor requires verification of the corrective action prior to the next visit.


Pretty standard stuff, of course. The product, the system, the implementation of the system, meeting regulatory requirements.

 

[Achemd]

Off topic, I know. I grew up in South Africa and have been in the USAfor 16 years now. Anyway I just wanted to say hi and welcome to the world of ISO 13485.
Laurel

 

[Gert Sorensen]

If you are switching certifications from 9001 to 13485 then the interpretation by Notified Bodies in DK is that you can not have any outstanding NC's, i.e any NC's found during the initial assessment of your system will have to be amended before the certificate is issued.

With that being said, if you have done a GAP analysis of your system (preferably with the cooperation of your NB) and ammended and adjusted the system where needed, then the transition should be fairly simple.

Most NB's that I have come across fail to adress the issue of being "process oriented" when it comes to specifically 13485 , that's nice when you're transitioning but it does not bring a lot value to the system and the subsequent audits. If the system is meant to add to your quality and the understanding of quality then I would strongly advise you to bring the process into focus.