Implications of failing an Anvisa Audit for ISO 13485 Certification

[kys123]

Hello everyone,

I'd like to know more about the potential implications of nonconformances found during a third-party audit by Anvisa (the Brazilian regulatory agency as you may or not know), for a European manufacturer that is ISO 13485 certified and was looking to export their products to Brazil.

While I do not have the specific details about the nonconformances found, I am curious about how failing an international audit might impact the manufacturer's ISO 13485 certification.

Are there any potential consequences that could arise from the nonconformances (depending on how serious they were), and if so, what would they be?

 

[yodon]

I was hoping someone would jump on this but since nobody has yet and it's aging a bit, let me toss out what I *think* (I don't know for sure). Check your agreement with your CB.

I was thinking that agreements with certification bodies require notification of findings from other audits. I may well be wrong.

I would not look at it as an audit "failure" (I presume they didn't require you to pull your device from the market?) but, as you later not, identification of nonconformities. I presume you're going to take action to resolve them and that will only strengthen your system / product. I would be forthcoming with the CB and show them the steps taken. It just shows you're properly operating your QMS.

I wouldn't volunteer it in an audit but, as noted above, I think it may be required to be reported to them.

 

[Sidney Vianna]

While I do not have the specific details about the nonconformances found,

That is a critical piece of information. Maybe the nonconformances were specific against Brazilian regulations only.

Regulatory noncompliance is no reason for yanking anyone’s management system certification, as long as the organization reacts appropriately to correct the situation, what could even be departure from a market with an unreasonable regulatory exposure and/or corrupt inspectors from a regulatory body.

 

[kys123]

I was hoping someone would jump on this but since nobody has yet and it's aging a bit, let me toss out what I *think* (I don't know for sure). Check your agreement with your CB.

I was thinking that agreements with certification bodies require notification of findings from other audits. I may well be wrong.

I would not look at it as an audit "failure" (I presume they didn't require you to pull your device from the market?) but, as you later not, identification of nonconformities. I presume you're going to take action to resolve them and that will only strengthen your system / product. I would be forthcoming with the CB and show them the steps taken. It just shows you're properly operating your QMS.

I wouldn't volunteer it in an audit but, as noted above, I think it may be required to be reported to them.

Hello yodon, thanks for jumping on in the discussion.

Sorry for not making it very clear, I am currently employed at a consulting company in Brazil who was interested in the manufacturer's products.
The stakeholders are looking at it as a "failure" because they failed to meet the Anvisa GMP standard, which to be fair is very similar to ISO 13485 (it does have some specific points as Sidney pointed out), and will probably not even have a chance of receiving the brazilian GMP certificate, having wasted quite some time and a hefty fee.

The word around is that they had quite a few major nonconformances, which is why I was curious about their certification due to IMDRF rules/CBs/etc., however, I do not know what exactly happened but I might find out soon and share if possible.

 

[kys123]

I was hoping someone would jump on this but since nobody has yet and it's aging a bit, let me toss out what I *think* (I don't know for sure). Check your agreement with your CB.

I was thinking that agreements with certification bodies require notification of findings from other audits. I may well be wrong.

I would not look at it as an audit "failure" (I presume they didn't require you to pull your device from the market?) but, as you later not, identification of nonconformities. I presume you're going to take action to resolve them and that will only strengthen your system / product. I would be forthcoming with the CB and show them the steps taken. It just shows you're properly operating your QMS.

I wouldn't volunteer it in an audit but, as noted above, I think it may be required to be reported to them.

That is a critical piece of information. Maybe the nonconformances were specific against Brazilian regulations only.

Regulatory noncompliance is no reason for yanking anyone’s management system certification, as long as the organization reacts appropriately to correct the situation, what could even be departure from a market with an unreasonable regulatory exposure and/or corrupt inspectors from a regulatory body.

Hey guys, hope you are doing well. I finally got some more information regarding what happened:

The audit uncovered almost 30 nonconformities, with around 5 of them being considered major.

While I did not get to read the entire report yet, the two most concerning nonconformities were that the company was (is?) manufacturing injectable products without effective measures for water quality control (their water system was not validated and only being monitored at a single tank) and microbiological control (only tested in the sterilization tank, no control whatsoever over the equipment used for filling syringes).
What can you do...