Seeking ISO 13485 Registrar Recommendations

KimGr

Involved In Discussions
#1
We have made the decision to transition from IATF 16949 to ISO 13485. We have been with our current registrar for a long time but they are no longer supporting 13485. I'm looking for recommendations to narrow down my search. We consider audits value added and are not afraid of improvement. If there are still companies out there that are "selling" certificates, we'd like to avoid that. The challenge as always is.....the execs would also like me to watch costs.
 

JoshuaFroud

Involved In Discussions
#2
Hi KimGr

Where are you based? As your geographical location will probably be quite important when selecting a new notified body. As if you are in Australia, a UK based firm is probably not your best choice even if they are excellent, (Though you may make some auditors rather happy if you do).
 
#3
Take a look at those which are also Notified Bodies or have an affiliation. Ask about their client retention. Look at their accreditation status to see if they have been suspended. The cost isn't likely to vary much for the audit. If travel is a worry, the CB should be able to work on if someone is in the area to combine with other 13485 clients for example. Check resumes. Interview prospective auditors.
 

KimGr

Involved In Discussions
#4
Hi KimGr

Where are you based? As your geographical location will probably be quite important when selecting a new notified body. As if you are in Australia, a UK based firm is probably not your best choice even if they are excellent, (Though you may make some auditors rather happy if you do).
Sorry! I meant to post that. I am in the USA in CT. Most of my current auditors are from anywhere in the US & Canada due to IATF auditor availability.
 

JoshuaFroud

Involved In Discussions
#5
That is all good. Unfortunately, I am unable to help you much as I am based out of the UK and have no experience with Notified Bodies/Auditing Organisations in the US.

AndyN has made some excellent points, without further recommendations being provided they are an excellent way to start.
 

Ajit Basrur

Staff member
Admin
#8
Underwriters Laboratories (UL), has merged with DQS, a global registrar in independent third party management system certification services headquartered in Frankfurt, Germany.
 

somashekar

Staff member
Super Moderator
#9
Underwriters Laboratories (UL), has merged with DQS, a global registrar in independent third party management system certification services headquartered in Frankfurt, Germany.
Yes, for all the management system certifications, however for the ISO 13485:2016, they (UL) are still our CB.
This is the scenario in India. I am not sure if UL are operating as CB for ISO 13485 in USA.
 

Cathie

Starting to get Involved
#10
Thank you for this post. If anyone has any experience with ANY of the Auditing Organizations taking on new clients, please let me know. I have been looking for months.
 

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