Renewal of Certificate: How Many Mandays?

E

Eugène

#1
#1
In the third quarter of this year our certificate is three years old, so we need a now one. It isn't clear to me what the procedure will be for the renewal. Will we get a new initial audit with all the required mandays or will we go on with surveillance audits as we do already for some years? To me QS9000 isn't clear about this. Can anyone help me? Thanks in advance!
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
Casana

Casana

Blueberry Nut
#2
#2
Your registrar would be the best one to give you guidance on this… especially with the new ISO 9K2K standard being out.
My expectation based on previous experience with ISO 9K is that you’ll have to go through the whole registration process, as you did when you were first registered (same amount of man-days etc), then they’ll repeat their current surveillance process & frequency. Given how AIAG has not spoken regarding ISO 9K2K I susupect that your registrar may register you to the current QS standard (which only has the ISO 1994 version) with the caveat that they’ll upgrade you to the ISO 9K2K whenever AIAG decides what they want to do.
Please let us know what your registrar’s final decision is… my current company is QS registered and we’re waiting with baited breath to see what AIAG will decree on this topic…
 
D

D.Scott

#5
#5
Marc, are you sure this is up to date? I seem to remember the renewal audit requirements were recently changed and the requirement is now the same for renewal as it is for initial. I have no idea where I saw that but for some reason it is ringing a bell.

Dave
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A How many mandays needed for QS certificate renewal? QS-9000 - American Automotive Manufacturers Standard 3
S Renewal of "Accreditation Certificate of Foreign Medical Device Manufacturer" Japan Medical Device Regulations 3
D License annual renewal - What changes to report to HC? Canada Medical Device Regulations 1
J License renewal process in Iran Other Medical Device Regulations World-Wide 0
V Regulations renewal IATF 16949 - Automotive Quality Systems Standard 1
J IVD registration renewal in China China Medical Device Regulations 6
S Medical Device License Renewal (MDL) Period - Health Canada Canada Medical Device Regulations 6
S ISO 9001 Certification Renewal until 2017 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K Saudi Arabia - Renewal of Registration Other Medical Device Regulations World-Wide 1
T Health Canada - Device Changes to include in License Renewal Canada Medical Device Regulations 3
sagai Renewal of Canada Manufacturer Licence if there is no Sales (Only Support) Canada Medical Device Regulations 5
sagai Renewal of US Manufacturer Licence if there are no Sales (Only Support Activities) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q Renewal Audit comment and question General Auditing Discussions 8
I Registration Renewal of Drug Establishment US Food and Drug Administration (FDA) 3
K Does Australia require any annual registration or license renewal for Medical Devices Other Medical Device Regulations World-Wide 1
Stijloor ASQ Membership Renewal Request Comes Early - Will you renew?? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 35
M Implementation period for standards - CE renewal submission - Class II medical device EU Medical Device Regulations 3
B 3 year renewal audit this September, and I am worried already ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
H Document Revision Service? Auditor wants a service for document revision/renewal ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
P We passed our ISO9001 and ISO/TS16949:2002 renewal December 2005 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
O How can fraud be avoided while getting an ISO certificate? ISO 17025 related Discussions 0
blackholequasar A Registration Certificate... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
B Validating calibration certificate as per API Q1 General Measurement Device and Calibration Topics 9
O Issue with free sales certificate for implants from China China Medical Device Regulations 0
C ARTG certificate Other Medical Device Regulations World-Wide 0
I Certificate of Conformity to NFL 00-015 How Do We Comply? Document Control Systems, Procedures, Forms and Templates 0
L A certificate of conformance used to support a calibration General Measurement Device and Calibration Topics 6
M Lapse in AS9100 Certificate AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S Requirements for Certificate of Destruction for Surgical Instruments Medical Device and FDA Regulations and Standards News 2
D Can an ISO 9001 Certificate have Remote Locations? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Certificate of Conformance for Country of Origin - Made in the USA claim Contract Review Process 16
Ed Panek Is anyone familiar with Article 60 Certificate of Free Sale EU Medical Device Regulations 6
Y MDR Transition - make "Available on the market" after CE certificate expiration EU Medical Device Regulations 3
M Storing Calibration Certificate Document Control Systems, Procedures, Forms and Templates 7
B Site removal from MDSAP multi-site Certificate ISO 13485:2016 - Medical Device Quality Management Systems 4
N Class I accessories covered by EC certificate EU Medical Device Regulations 0
D Distribution Center mandatory addition to Certificate? IATF 16949 - Automotive Quality Systems Standard 3
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
S Certification Body Changeover - Transfer of Certificate Registrars and Notified Bodies 9
J How to keep MDD certificate valid when legal manufacturer has liquidity problem EU Medical Device Regulations 0
D ISO 17021 Certificate Registrars and Notified Bodies 1
B Free Sales Certificate for Non Medical Devices Other Medical Device Related Standards 2
Louddogsbark When your 13485:2016 certificate has been pulled ISO 13485:2016 - Medical Device Quality Management Systems 2
lanley liao The validity of API Spec Q1 certificate Oil and Gas Industry Standards and Regulations 2
B Countries with no need for FSC (Free sales certificate) Other Medical Device Regulations World-Wide 0
M Calibration Certificate Result issued by an accredited external laboratory General Measurement Device and Calibration Topics 9
U Certificate of Free Sale Other US Medical Device Regulations 6
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
D ISO 9001 certificate issued by QMS International for 10 years - legit? Registrars and Notified Bodies 17
E Adding models to an approved Russian Registration Certificate Other Medical Device Regulations World-Wide 1

Similar threads

Top Bottom