Finding NB

Dear everyone,

My full name is Nguyen Quoc Thang. I come from Viet Nam. My company is medical device manufacturer. We would like to get CE marking for the sterile petri dish.

Because of saving the audit fee, so we are looking for a NB can audit remote for our scope.

Could you please introduce to me some NB can process?

Thank you so much.

nthangcnhh said:

Because of saving the audit fee, so we are looking for a NB can audit remote for our scope.

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Good luck; you will need it.

nthangcnhh said:

Because of saving the audit fee, so we are looking for a NB can audit remote for our scope.

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Welcome to the Cove. If I understand correctly, your organization will need to be audited to verify your manufacturing processes - in particular the sterilization process and subsequent handling/packaging processes. It is therefore highly unlikely you will be able to save on any “fees”. I’m sure someone will be able to advise if there’s a NB which operates in Asia and has a good reputation.

Quality-Nation said:

Welcome to the Cove. If I understand correctly, your organization will need to be audited to verify your manufacturing processes - in particular the sterilization process and subsequent handling/packaging processes. It is therefore highly unlikely you will be able to save on any “fees”. I’m sure someone will be able to advise if there’s a NB which operates in Asia and has a good reputation.

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I'm really appreciate your supporting. Actually, in my country have a NB that is a TUV-SUD. However, they request that we have to auditing ISO 13485 by them and we did not accept. So, we would like to look for another NB.
In the past, we had already contacted with some NB, but they audit onsite and take a bunch of business trip fee. So, we decide to cooperate with the NB can audit online. Could you please share with me another NB in Asia?

Sidney Vianna said:

Good luck; you will need it.

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Thank a lot of admin.

nthangcnhh said:

I'm really appreciate your supporting. Actually, in my country have a NB that is a TUV-SUD. However, they request that we have to auditing ISO 13485 by them and we did not accept. So, we would like to look for another NB.
In the past, we had already contacted with some NB, but they audit onsite and take a bunch of business trip fee. So, we decide to cooperate with the NB can audit online. Could you please share with me another NB in Asia?

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It is very unlikely that you will find a NB that will audit remotely. If you do find one, I would very much question their legitimacy.
If you want to be properly certified, you will need to cough up the money and get a proper audit completed onsite.

Agree - an onsite audit is irreplaceable for this serious product. False negatives or positives due to contamination is not something to mess with. Or as I tell my students and organizations: nothing good ever follows the phrase “in order to save money”.

As others have said - I wouldn’t trust an NB that would agree to a remote audit, nor would I trust an organization that requested such an audit to save money. You are better off understanding this advice and taking this message back to your leadership.

NBs are required to audit ISO 13485 on site by accreditation rules and ISO 17021. They are not given a choice.

Welcome to Cove @nthangcnhh

It is upto an NB's discretion whether or not they would agree for a remote audit. Following are some of the considerations that an NB takes into account when deciding to do an onsite or remote audit:

• The kind of activities that are performed at your company - often due to practical requirements, remote audit is not possible
• The activities that you are outsourcing - sometimes supplier certifications can come handy
• Any other certification that you may be maintaining like an MDSAP, ISO 9001 etc.- NBs can leverage other certifications, in terms of confidence in your processes and operations
• Various critical processes that you are undertaking and the impact of those on product's safety and efficacy - critical processes should be witnesses in person by an NB

It would be wise for you to think through these considerations and evaluate if you should ask the NB for a remote audit. From the first look, it does not seem that an NB would agree for a remote ISO 13485 audit in your case, but you can present and discuss these considerations with your leadership so all stakeholders understand that its not just about an NB not allowing a remote audit, but there is reasoning behind why NBs do an onsite audit.


All the best,
Parul Chansoria
Regulatory and Quality Expert