ISO 13485 Registration Certificate Life-Time (Validity Period)

[korbse]

Hi,

is there some regulation (specifically in the EU) for how long a 13485 certificate is valid? I only found ISO 17021 which states that it (the norm) is valid for certification of all types of management systems and in chapter 9.1.1 talks about re-certification cycles of 3 years.

Thanks for your help.

 

[Stijloor]

Re: Certificate Life-Time of ISO 13485 Registration

Can someone clarify?

Thank you!!

Stijloor.

 

[harry]

Re: Certificate Life-Time of ISO 13485 Registration

A previous discussion thread: Why the general Valid period of QMS certificate is 3 years?

 

[korbse]

Re: Certificate Life-Time of ISO 13485 Registration

A previous discussion thread: [Link removed]

Thanks for the link. However, I asked this question because I've got quotations from different notified bodies with either 3 or 5 years re-certification cycles and wanted to know why the cycles are different.

 

[harry]

Re: Certificate Life-Time of ISO 13485 Registration

................I've got quotations from different notified bodies with either 3 or 5 years re-certification cycles and wanted to know why the cycles are different.

For me, I will be interested in whether these CB's that quoted are properly accreditated. You should find out who their accreditation body is.

 

[Stijloor]

Re: Certificate Life-Time of ISO 13485 Registration

Thanks for the link. However, I asked this question because I've got quotations from different notified bodies with either 3 or 5 years re-certification cycles and wanted to know why the cycles are different.

Are you not confused with 5-year CE Mark cycles? I found a list of fees from BSI (Europe) that listed all these options.

Stijloor.

 

[korbse]

Re: Certificate Life-Time of ISO 13485 Registration

For me, I will be interested in whether these CB's that quoted are properly accreditated. You should find out who their accreditation body is.

They are accreditated by the government (I've got the corresponding law gazette) according to ISO 17021.

 

[Stijloor]

Re: Certificate Life-Time of ISO 13485 Registration

They are accredited by the government (I've got the corresponding law gazette) according to ISO 17021.

Which government?

Stijloor.

 

[Stijloor]

Re: Certificate Life-Time of ISO 13485 Registration

Thanks for the link. However, I asked this question because I've got quotations from different notified bodies with either 3 or 5 years re-certification cycles and wanted to know why the cycles are different.

For clarification: Are you referring to a Registrar (certification Body) or a Notified Body?

Stijloor.

 

[korbse]

Re: Certificate Life-Time of ISO 13485 Registration

Are you not confused with 5-year CE Mark cycles?

No.

Which government?

Austrian and german governments (EU countries).