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

R

ron_f

#1
#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
 
QMS for Life Sciences
Elsmar Forum Sponsor
somashekar

somashekar

Staff member
Super Moderator
#3
#3
ron_f said:
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
Click to expand...
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.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
V Determining FDA 820 (registration) vs ISO 13485 - Supplier gives us the kit ISO 13485:2016 - Medical Device Quality Management Systems 1
R ISO 13485:2016 Registration - NC on full cycle of internal audits ISO 13485:2016 - Medical Device Quality Management Systems 7
K Including ISO 13485 Audit JPAL Registration Japan Medical Device Regulations 3
A Scope of ISO 13485 Registration and Component Makers ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 9001 vs. ISO 13485 Registration - Approximately 1/3 of our customers are medical ISO 13485:2016 - Medical Device Quality Management Systems 4
R How much "harder" is an ISO 13485 Registration Audit compared to ISO 9001 ISO 13485:2016 - Medical Device Quality Management Systems 6
M ISO 13485 Multiple Site Registration - Corporate HQ is listed as a subsidiary ISO 13485:2016 - Medical Device Quality Management Systems 4
K ISO 13485 Registration Certificate Life-Time (Validity Period) ISO 13485:2016 - Medical Device Quality Management Systems 21
W Celebrating Registration - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 9
E Does European Manufacturer with ISO 13485 need QSR820 for FDA registration? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
P Cost to obtain ISO 13485 Certification/Registration from Start-up ISO 13485:2016 - Medical Device Quality Management Systems 18
D Continuing Assessment Audit - Recommended for continued registration 13485:2003 ISO 13485:2016 - Medical Device Quality Management Systems 4
S Average Cost of ISO 13485 Registration in US ISO 13485:2016 - Medical Device Quality Management Systems 10
H ISO 13485 registration for non medical devices Registrars and Notified Bodies 4
Le Chiffre Impact of CE Marking on ISO 13485 Registration ISO 13485:2016 - Medical Device Quality Management Systems 3
L MDD confomity assessment - ISO 13485 registration counts for nothing??? EU Medical Device Regulations 7
D ISO 13485:2003 Registration Audit - Management Review of major regulatory standards Management Review Meetings and related Processes 5
C ISO 13485 - why keep 9001 registration ISO 13485:2016 - Medical Device Quality Management Systems 15
S Starting ISO 13485:2003 Registration - Introduce Myself ISO 13485:2016 - Medical Device Quality Management Systems 11
C Production and Post Production feedback - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 4
T ISO 13485 - 5.5.1 Responsibility and authority - Small Company Independence ISO 13485:2016 - Medical Device Quality Management Systems 13
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
O ISO 13485 vs. GMP - Comparison matrix wanted EU Medical Device Regulations 0
O ISO 13485 - Is management review required before stage 1? ISO 13485:2016 - Medical Device Quality Management Systems 6
O In addition to the standard, what other ISO 13485 sources do people recommend? ISO 13485:2016 - Medical Device Quality Management Systems 5
Watchcat ISO 13485 for IVD (In-vitro Diagnostic Device) Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 9
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 11
H ISO 13485:2016 Gap Analysis by NB ISO 13485:2016 - Medical Device Quality Management Systems 7
F ISO 13485 - EU countries that could request another audit ISO 13485:2016 - Medical Device Quality Management Systems 2
O Adding ISO 13485 to an AS9100 QMS ISO 13485:2016 - Medical Device Quality Management Systems 10
JoCam Increase to bi-annual ISO 13485 audits ISO 13485:2016 - Medical Device Quality Management Systems 2
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 15
A ISO 13485 - Clause 8.3.3 appropriate actions in response to nonconforming product ISO 13485:2016 - Medical Device Quality Management Systems 2
N Address of Legal Manufacturing Site in ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 13485 for general purpose disinfectants? ISO 13485:2016 - Medical Device Quality Management Systems 9
L How to deal with an ISO 13485 Supplier Audit nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 17
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485 extended Site (Two companies) ISO 13485:2016 - Medical Device Quality Management Systems 2
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 8
C ISO 13485 Requirement in Australia/NZ for class 1? ISO 13485:2016 - Medical Device Quality Management Systems 1
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 7
K Restricted Scope of ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485:2016, Clause 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 4
J ISO 14971 applied to ISO 13485? Low risk class 1 devices ISO 13485:2016 - Medical Device Quality Management Systems 3
T Document control ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
D Sample Calibration SOP for ISO 13485 General Measurement Device and Calibration Topics 4
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
Q Is that any difficulty to do software DFMEA and PFMEA in ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 5
Similar threads
Top Bottom