New 13485 Registration questions - Currently registered to ISO 9001 and TL 9000

R

ron_f

#1
We are currently registered to ISO 9001 and TL 9000 and are considering registration to ISO 13485 including CMDCAS as a medical products manufacturer. We have had initial discussions with our current registrar and have been told that the time required for review and submittal of the audit package and issuing the certificate is considerably longer than for the 2 standards we are currently registered for. Currently it takes less than 6 weeks and we have been told that it can take months. What experience have others had in regards to the time the review, submittal and issuing of certificates takes.

Also has anyone had experience using different registrars for different standards for the same organization/facility. I can see multiple risks in doing this since there is a risk the registrars will disagree on core processes and functions such as management review, internal audit, sales, HR, IT, etc
 

somashekar

Staff member
Super Moderator
#3
We are currently registered to ISO 9001 and TL 9000 and are considering registration to ISO 13485 including CMDCAS as a medical products manufacturer. We have had initial discussions with our current registrar and have been told that the time required for review and submittal of the audit package and issuing the certificate is considerably longer than for the 2 standards we are currently registered for. Currently it takes less than 6 weeks and we have been told that it can take months. What experience have others had in regards to the time the review, submittal and issuing of certificates takes.

Also has anyone had experience using different registrars for different standards for the same organization/facility. I can see multiple risks in doing this since there is a risk the registrars will disagree on core processes and functions such as management review, internal audit, sales, HR, IT, etc
It could take about 8 weeks or more for the issue of certificate from the time the satisfactory resolutions of NC's are accepted by the auditor. From the information I have, I understand that the queue for the final review and approval for certificate grant has been the delay process.
We once were with different registrars for various divisions of our organization, which had common processess, but soon changed into a single source for all our certification and testing and notified body services. This does a lot good for both.
 
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