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
 
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
M Customer Property - ISO 13485:2016 Clause 7.5.10 ISO 13485:2016 - Medical Device Quality Management Systems 9
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
D Lead time to schedule an ISO 13485 audit Auditing Quality and Environmental Management Systems 2
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 1
H QMS ISO 13485:2016 - ISO14971 IEC60304 etc ISO 13485:2016 - Medical Device Quality Management Systems 2
J Definition Outsourced process - Clear definition - 13485 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 5
S IS0 13485 process flows ISO 13485:2016 - Medical Device Quality Management Systems 2
B Operational Procedures for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 7
D ISO 14971 applicability in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
C Quality Manager as part of Management - 13485 ISO 13485:2016 - Medical Device Quality Management Systems 9
E ISO 13485 in Clinical Trial conduct: Applicable or No ISO 13485:2016 - Medical Device Quality Management Systems 2
G ISO 13485 Certification - Can we get the ISO 13485 certification prior to shipment of the device? ISO 13485:2016 - Medical Device Quality Management Systems 6
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
0 To which part of 13485 does this refer? ISO 13485:2016 - Medical Device Quality Management Systems 3
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
T ISO 13485 - Assembly instructions written vs. online ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5

Similar threads

Top Bottom