Microbiological Audits Required by CB under ISO 13485 Certification

#1
Is anyone aware of a requirement for additional microbiological audits to be performed by CBs - under ISO 13485 certification?
 
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Roland Cooke

#2
I dunno what you mean by "additional" audits, I don't recall any communications to that end.

Clearly the audit team needs to include appropriate skillsets, and those skillsets don't necessarily need to be applied at the exact same time.

BSI handles (handled?) its microbiology skillset requirement via a separate audit.
 
M

MIREGMGR

#3
My employer's microbiologist audits are per our CE certificate rather than our ISO 13485 certificate.

Per MDD we make only Class I and I-s devices, so our CE certificate only encompasses the sterility aspects of the I-s devices. Our ISO 13485 certificate does not explicitly include conformance with ISO 11135-1, even though we do so conform and that conformance (and our conformance to other standards) is appropriately documented.

We utilize two contract sterilization services. Both of them have ISO 13485 certificates that explicitly state that they are certified in regard to their conformance to ISO 11135-1. My understanding is that each of them is separately audited by "regular" auditors and by microbiological auditors.
 
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Doug Tropf

Quite Involved in Discussions
#4
We utilize two contract sterilization services. Both of them have ISO 11135 certificates that explicitly state that they are certified in regard to their conformance to ISO 11135-1. My understanding is that each of them is separately audited by "regular" auditors and by microbiological auditors.
I work for a US based EO contract sterilizer. Our ISO 13485 cert references compliance with ISO 11135 as part of the scope. We are not required to have separate audits, although our auditor is a microbiologist.
 

Ajit Basrur

Staff member
Admin
#5
Is anyone aware of a requirement for additional microbiological audits to be performed by CBs - under ISO 13485 certification?
The ISO 13485 is more a system audit and hence the specific microbiology audits are not covered.

But if the ISO 13485 audit is happening in a sterilization house, the Microbiology background auditor may accompany as a SME.
 
L

Laura Halper

#6
I have a client who manufactures a sterile, class III device. The Notified Body does two separate audits -- one for ISO 13485 and one microbiological audit.
The micro audits are done on a regularly-scheduled basis, but less frequently than the ISO 13485 surveillance audits.

I don't see why the two audits could not be done at the same time, except for the difficulty in coordinating the schedules of the two individual auditors.
 
#7
The odd thing is that this client is being told they now have to have this audit, and their product isn't sterile...the customer sterilizes it and they manufacture in a "clean" environment.
 
M

MIREGMGR

#8
...their product isn't sterile...the customer sterilizes it and they manufacture in a "clean" environment.
Therefore their manufacturing process controls bioburden, and their customer's sterilization validation depends on that bioburden not exceeding in quantity, or differing in character from, what was characterized for the validation.

So is the audit of them for their own certification, or is it an audit of them as a critical supplier to their customer for the customer's certification?
 
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