ISO 13485 Registration Certificate Life-Time (Validity Period)

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K

korbse

#13
Re: Certificate Life-Time of ISO 13485 Registration

A Notified Body is involved with product certifications.

A Registrar or Certification Body is involved with certifying Quality Management Systems.
Then they must have both roles since they're listed on the EU internet pages as notified bodies but also offer to do quality management system certifications.
 

Peter Selvey

Staff member
Super Moderator
#14
Re: ISO 13485 Registration Certificate Life-Time (duration of)

The three year cycle is specified in ISO 17021, Clause 9.1. It is applicable to your ISO 13485 certificate, which can be voluntary or regulatory depending on the country (e.g. voluntary for EU, mandatory for Canada, depending on the class of device). As per ISO 17021, renewal of the certificate requires a special re-certification audit.

The five year cycle is specified in the European MDD, and is applicable to MDD certification. Renewal in this case does not require an audit and can be a paperwork exercise. But expect to get charged for the processing (which is reasonable, there is a lot of paperwork for the NB to complete).

The Japanese PAL also uses a five year cycle (from memory, which might be out of date).
 
B

Bruce Seidel

#16
Re: ISO 13485 Registration Certificate Life-Time (duration of)

As mentioned previously, ISO 13485 and CE Marking certificates have different renewal timeframes (3 years and 5 years respectively) for the QMS.

As a notified body, we combine ISO 13485 and CE Mark audits as a way to save clients time and money. In doing so, we renew the CE Mark on an earlier schedule (simultaneously with the ISO 13485 renewal) as a way to keep the certificates in line and again save costs. Note that Technical File Review does not require annual surveillance, so that we do issue that as a five-year certificate.

If you have any further questions regarding costs or process, feel free to contact me directly (though my username link).
 

Stijloor

Staff member
Super Moderator
#17
Re: ISO 13485 Registration Certificate Life-Time (duration of)

As mentioned previously, ISO 13485 and CE Marking certificates have different renewal timeframes (3 years and 5 years respectively) for the QMS.

As a notified body, we combine ISO 13485 and CE Mark audits as a way to save clients time and money. In doing so, we renew the CE Mark on an earlier schedule (simultaneously with the ISO 13485 renewal) as a way to keep the certificates in line and again save costs. Note that Technical File Review does not require annual surveillance, so that we do issue that as a five-year certificate.

If you have any further questions regarding costs or process, feel free to contact me directly (though my username link).
Welcome to The Cove Forums! :bigwave:

How does your company keep consulting/training and certification auditing separated?

Stijloor, Forum Moderator.
 
B

Bruce Seidel

#18
Thanks for the welcome message. I look forward to learning from participants here as well as contributing where I can.

Regarding your question, we don't provide consulting as we see that as a conflict of a Notified Body's role. One can't impartially inspect a QMS that they helped build.

However, we do offer training to help people understand the regulations (CE Mark, CMDCAS, steralization, ISO 13485, internal auditing, etc.) and their application to medical device manufacturers. We also provide "mock" audits which can demonstrate non-conformaties, so the manufacturer understands areas to address.
 

Stijloor

Staff member
Super Moderator
#19
Thanks for the welcome message. I look forward to learning from participants here as well as contributing where I can.

Regarding your question, we don't provide consulting as we see that as a conflict of a Notified Body's role. One can't impartially inspect a QMS that they helped build.

However, we do offer training to help people understand the regulations (CE Mark, CMDCAS, sterilization, ISO 13485, internal auditing, etc.) and their application to medical device manufacturers. We also provide "mock" audits which can demonstrate non-conformities, so the manufacturer understands areas to address.
Does your organization audit and issue certificates of registration to ISO 13485? And if so, who is your accreditation organization?

Stijloor.
 
R

Roland Cooke

#20
Speaking for SGS, our certs are issued thusly:

ISO13485 - accredited by United Kingdom Accreditation Service (UKAS).
The certificates have three year expiry, subject to annual surveillance and triennial recertification. We get an annual office by UKAS, I think they typically waive field audits.


ISO13485 under CMDCAS - accredited by Standards Council of Canada (SCC), in turn regulated by Health Canada (HC). The certificates have three year expiry, subject to annual surveillance and triennial recertification. The audit team must always include a HC/SCC-qualified auditor.
We get an annual office audit (on us) by someone from SCC that has a medical devices background and is co-approved by HC. We also have a field audit (i.e. someone watching us watching you!), usually conducted by the same auditor as above, anywhere in the world.


MDD QMS - we are notified by the United Kingdom Medicines and Healthcare products Regulatory Agency. The certificates have three/five year expiry, subject to annual surveillance and triennial recertification.

MDD Class III devices get their own review - i.e. design dossier audit - and the resulting certificate is good for five years.

The MHRA performs a detailed office audit annually, we've had anywhere from three to nine man-days onsite. Their audit is a combination of assessing our management systems, and also reviewing our clinical decision-making, and they bring an assorted team to accomplish that. They also perform field audits, in the UK and/or overseas, on an approximately annual basis.



This is all off the top of my head, so I'm not guaranteeing it's gospel-accurate! :D
 
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