Is it an onsite audit mandatory as part of ISO 13485 certification?

[Mangafanga]

I am a single person company, my home is basically my office and my product is a SaMD. Will the certification bodies require an onsite visit before they issue certificates? Or they can audit virtually using Zoom/Teams etc.?

 

[shimonv]

Hi Mangafanga,
The audit has to take place at the official business address. During COVID they relaxed that requirement a bit; they had no choice because of health and safety reasons.

 

[Sidney Vianna]

ISO 17021-1, which is mandatory for accredited management system certification, stipulates the requirements for on-site audits. On the other hand, realizing the importance of the digital auditsphere, there are developments to facilitate virtual/remote audits.

 

[Quality-Nation]

I am a single person company, my home is basically my office and my product is a SaMD. Will the certification bodies require an onsite visit before they issue certificates? Or they can audit virtually using Zoom/Teams etc.?

If you are committed to being certified, have you selected a CB to perform the audit? If not, ask that question when you are gathering information on which to base you decision. Not all CBs offer the same degree of flexibility. Not everyone who directly answers here has any real knowledge of what the answer actually is, as they only experienced one CB etc.

 

[Sidney Vianna]

If you are committed to being certified, have you selected a CB to perform the audit? If not, ask that question when you are gathering information on which to base you decision. Not all CBs offer the same degree of flexibility. Not everyone who directly answers here has any real knowledge of what the answer actually is, as they only experienced one CB etc.

As I said, an on-site audit is a requirement of 17021-1; read below.

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Any CB doing otherwise would be violating the requirement. Maybe the OP should go that other website where they have a guy that knows it all and can answer any questions in a very assertive manner.

 

[Quality-Nation]

I am a single person company, my home is basically my office and my product is a SaMD. Will the certification bodies require an onsite visit before they issue certificates? Or they can audit virtually using Zoom/Teams etc.?

You might wish to review this document, since your scope would appear to be suitable. https://iaf.nu/iaf_system/uploads/documents/IAF_MD4_Issue_2_Version_4_14062023.pdf

 

[Jen Kirley]

4.1.2 applies. It is not enough to wish for a remote audit though. Registrars are required by accreditation rules to adhere to 17021 as Sidney pointed out.

 

[Sidney Vianna]

4.1.2 applies. It is not enough to wish for a remote audit though. Registrars are required by accreditation rules to adhere to 17021 as Sidney pointed out.

Anyone who thinks an IAF mandatory document would supersede a standard that is listed as a NORMATIVE REFERENCE in that very mandatory document does not fully comprehend the hierarchy of requirements.

 

[Jen Kirley]

True. It is important for less experienced readers of MD-4 to note that 4.1.2 applies only when the remote audit is allowed by accreditation rules. In the case of a Stage 2 registration audit, remote auditing is not allowed as Sidney pointed out. If it is allowed for one or more of the audits in the following registration cycle, then it must be agreed upon (as per the text of 4.2.1) and the rest of MD-4 applies.

 

[Randy]

Simple answer..................YES!