Our Registration has Lapsed - Comments?

A

Andrews

#1
#1
Recertification

Our QS9000 certificate is valid only upto July 2003. Due to unvaoidable reasons we have planned our recert for 2nd week of September 2003 ONLY. My question is will this time lapse affect recert audit.

FYI, we are not going in for TS16949 at this stage.

Advise requested.
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
D

db

#2
#2
I'm not sure about how it fits with your registrar, however the important question is how does it fit with your customers? Technically, you are currently not registered! Because QS registration is usually customer mandated, you must notify your customer about the lapse. I would worry less about how the lapse would affect your recertification audit, and more about how your customers will (are?) reacting.
 
P

p_tww

#3
#3
Andrews said:
Our QS9000 certificate is valid only upto July 2003. Due to unvaoidable reasons we have planned our recert for 2nd week of September 2003 ONLY. My question is will this time lapse affect recert audit.

FYI, we are not going in for TS16949 at this stage.

Advise requested.
Click to expand...
Obviously, your certificate had been out of expiry. you could not get any audit expense benefits for 3 years re-certification. and if you still want QS9000 or any other automotive certificates, you should start a new audit cycle(from initial to surveillance to re-cert).
Consult with your registrar's comments.
Inform your customers what contingency plan needed.
hope help.
 
S

SteelWoman

#4
#4
I BELIEVE (could be wrong, wouldn't be a first occurrence) that the "grace period" on this type situation is registrar mandated. What's your registrar saying?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
B Help AS9100 registration in jeopardy (CRB has been "SUSPENDED") Registrars and Notified Bodies 22
P Qualified Registration Bodies (CMDCAS) one has been suspended ISO 13485:2016 - Medical Device Quality Management Systems 4
N Evidence: Has 9001 Registration Increased ROI (Return On Investment)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
S Iraq Medical Device registration Other Medical Device Regulations World-Wide 0
G ITAR Registration for Metrology Laboratory? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
A 510(k) registration and listing US Food and Drug Administration (FDA) 1
A GMDN Registration Basic preliminary Information EU Medical Device Regulations 0
C FDA Establishment registration - Buying some medical devices from another manufacturer Medical Device and FDA Regulations and Standards News 5
F UDI Registration - Who is responsible for Registration of the Device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
P Establishment Registration and Device listing - Wording of 807.20 (a) (6) Medical Device and FDA Regulations and Standards News 3
J Medical Device Registration in the UAE MoH Other Medical Device Regulations World-Wide 2
O Cancellation of Registration from ARTG - Sponsor Unresponsive Other Medical Device Regulations World-Wide 0
M Mexico Medical Device Registration Requirements Other Medical Device Regulations World-Wide 1
JoCam False information provided for Medical Device Registration - What are the implications? Other Medical Device Related Standards 3
M CE Mark and 510(k) -Global registration requirements for every country Other Medical Device Regulations World-Wide 3
T Reaction Plan To Drive suppliers to IATF 16949 registration IATF 16949 - Automotive Quality Systems Standard 4
N Post registration variation to medical device Other Medical Device Regulations World-Wide 1
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
MDD_QNA Medical Device registration Argentina Other Medical Device Regulations World-Wide 0
A In which EU countries would it be okay to use sample labels for registration? EU Medical Device Regulations 0
D EUDAMED Single Registration Number (SRN) - How to get it? EU Medical Device Regulations 8
M Informational ANVISA – CONSULTA PÚBLICA No 730, DE 14 DE OUTUBRO DE 2019 – Registro de dispositivos médicos (Public consultation – registration of medical devices) Medical Device and FDA Regulations and Standards News 0
F FDA-registration and inspection cost 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J FDA Establishment Registration Foreign Manufacturer RUO only 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Change in BRH (Brazilian Registration Holder) Technical Manager Other Medical Device Regulations World-Wide 2
C FDA Registration Requirements for Multiple Sites 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
M Setting deadlines (ex. 45 days) for Document Registration & Review Cycle Document Control Systems, Procedures, Forms and Templates 3
S Private Label Requirements, Manufacturer's Registration & Initial Importers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
F 2017/745 Article 31 Single Registration Number Medical Device and FDA Regulations and Standards News 5
S FDA Registration food facility - We operate under CGMP guidelines US Food and Drug Administration (FDA) 0
C Can a manufacturer (in South of Korea) have multiple Brazil Registration Holder (BRH) for same brend name? Other Medical Device Regulations World-Wide 1
S Which department manages Establishment Registration, Device Listing and GUDID? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
V Determining FDA 820 (registration) vs ISO 13485 - Supplier gives us the kit ISO 13485:2016 - Medical Device Quality Management Systems 1
M Courses / Workshops on Registration of Medical Devices WW Other Medical Device and Orthopedic Related Topics 2
L Payment for Establishment Registration and Device Listing US Food and Drug Administration (FDA) 0
M Informational MDCG 2019-5 Registration of legacy devices in EUDAMED Medical Device and FDA Regulations and Standards News 11
M Informational MDCG 2019-4 Timelines for registration of device data elements in EUDAMED Medical Device and FDA Regulations and Standards News 0
S Latest (2019) requirements for MD registration in Kazakhstan (Eurasia region)? Registrars and Notified Bodies 0
R List of countries that require only CE Mark certificate for product registration Other ISO and International Standards and European Regulations 2
S Product registration platforms - A service called Licensale by Arazy Group Medical Information Technology, Medical Software and Health Informatics 0
R Medical device registration in Iran Other Medical Device Regulations World-Wide 0
G Device Registration Ammendments - Modifications to Medical Devices Other Medical Device Regulations World-Wide 4
S Hourly Registration training for operators Manufacturing and Related Processes 1
M IVD Registration - Use of Prospective Study Data Other Medical Device Regulations World-Wide 1
J Medical Device Registration in Argentina - Client asks us to provide “European FSC” Other Medical Device Regulations World-Wide 3
supadrai Just found out the hard way that only one registration per manufacturer is allowed in Yemen, regardless of OEM or private label arrangement. Other Medical Device Regulations World-Wide 0
S Should an Initial Importer separately do Establishment Registration? US Food and Drug Administration (FDA) 1
M RFID (Radio Frequency Identification) Registration in Europe and in MENA countries EU Medical Device Regulations 1
A Philippines Medical Device Registration Transfer Other Medical Device Regulations World-Wide 1

Similar threads

Top Bottom