ISO 13485 - Separate Microbiology Audits

[Heilea]

Hi,

My company is a contract medical device manufacturer and currently searching for a new NB due to various reasons (we have had the same NB for 13 years). The current NB conducts separate microbiology audits and I questioned why that is. When the microbiology audit is performed they are auditing to the applicable 13485 standard and checking that we have our 14644 certification for all cleanrooms.

We manufacture in cleanrooms that are tested and certified by an outside company and do not perform any in-house sterilization. Our company's scope is "Manufacturing, inspection, packaging, and re-packaging of sterile and non-sterile medical devices." I am wondering if there is a requirement that we need to have the separate micro audit due to having "sterile" in the scope.

Thank you for any help!

 

[William55401]

Here's a similar thread from the Cove that may be of interest.
Microbiological Audits Required by CB under ISO 13485 Certification

 

[Philip B]

Yes, if you supply sterile medical devices, it is common to have a separate microbiology audit by your NB (we do). Although you are not sterilising the devices yourself, the audit will assess your controls over the sterilisation process, including selection and approval of sterilisation sub-contractors, sterilisation validation (eg from ISO 11137), bioburden monitoring, dose validation, sterilisation certification and release controls. As these are fairly specialist areas the NB likes to have an assessor trained in microbiology carry out the audit. I personally don't mind hosting microbiology audits, it keeps the scope nice and tight and you pretty much know what to expect.

 

[levatorsuperioris]

Not all NB require this to be separate, there are extensive requirements to audit Sterilization - these people are harder to come by. Some NB have enough of them on staff they perform the audit either offsite or through the regular audit.