ISO 13485 - Separate Microbiology Audits

#1
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!
 
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Philip B

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#3
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

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#4
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.
 

sandra2014

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#5
Hello, I have 2 questions
1-can anyone tell me if there any medical device standard that requires supplier auditing?
2-If a company is already registered to ISO 13485:2016, will this suffice a supplier auditing requirement from a client?

I would appreciate any assistance from Elsmar Cove members.
Thank You!
 

chris1price

Trusted Information Resource
#6
Take a look at ISO13485 7.4.1, it does not say you have to perform supplier audits; just "establish criteria for the evaluation and selection of suppliers" and among other criteria, that that it shall be risk based. That said, the more critical the supplier, the greater the likelihood that you should audit them. A supplier having ISO13485 is a good start, but shouldn't be the only criteria for making this decision.
 

Ralba

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#7
Hello, I have 2 questions
1-can anyone tell me if there any medical device standard that requires supplier auditing?
2-If a company is already registered to ISO 13485:2016, will this suffice a supplier auditing requirement from a client?
Hello Sandra,

We are ISO13485 certified, and we do not audit our suppliers. It has never come up for us in any of our audits.

You do, however, need to meet 7.4.1 like Chris stated above. This is a method you could use to evaluate that supplier, and it pretty common for extremely critical suppliers that need to be highly reliable. We evaluate using their ISO cert as well, but we also annually evaluate their metrics. That is, supplier Non-conformities and Supplier OTD. We require a thoroughly inspected sample before accepting them on the AVL if they are performing custom work of any kind.

Not saying you need to do all of this, just giving an idea of the controls that were necessary to evaluate them in our setting (CM in PCB assemblies).
 
Last edited:

sandra2014

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#8
Hello Sandra,

We are ISO13485 certified, and we do not audit our suppliers. It has never come up for us in any of our audits.

You do, however, need to meet 7.4.1 like Chris stated above. This is a method you could use to evaluate that supplier, and it pretty common for extremely critical suppliers that need to be highly reliable. We evaluate using their ISO cert as well, but we also annually evaluate their metrics. That is, supplier Non-conformities and Supplier OTD. We require a thoroughly inspected sample before accepting them on the AVL if they are performing custom work of any kind.

Not saying you need to do all of this, just giving an idea of the controls that were necessary to evaluate them in our setting (CM in PCB assemblies).
Thank You for your information, this helps! I appreciate it!
 

sandra2014

Involved In Discussions
#9
Take a look at ISO13485 7.4.1, it does not say you have to perform supplier audits; just "establish criteria for the evaluation and selection of suppliers" and among other criteria, that that it shall be risk based. That said, the more critical the supplier, the greater the likelihood that you should audit them. A supplier having ISO13485 is a good start, but shouldn't be the only criteria for making this decision.
Hello,
Yes , this is good advice, I believe some of our clients designated us as a critical supplier, hence annual audits are necessary from our clients. Thank You for clarifying this!
 
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