Registration to the 2015 Version of ISO 9001

C

CHoullion

#1
Question - We plan on going for our registration between September - December of 2015. Obviously we are implementing the system based on the 2008 version, will we be allowed to be registered to that version, then upgrade at the next surveillance audit?
 
Elsmar Forum Sponsor
#3
Question - We plan on going for our registration between September - December of 2015. Obviously we are implementing the system based on the 2008 version, will we be allowed to be registered to that version, then upgrade at the next surveillance audit?
Registrar version of the answer? Yes, because ISO 9001:2015 doesn't exist yet, so we don't know if there's an affect on the audit duration. Only after Dec 31, 2014*** will a new reg to 2008 be unacceptable. You'll also have 3 years to change over...

Added in edit: New registrations to 2008 will be allowed up until March 2017
 
Last edited:

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
Question - We plan on going for our registration between September - December of 2015. Obviously we are implementing the system based on the 2008 version, will we be allowed to be registered to that version, then upgrade at the next surveillance audit?
According to the Draft of the Transition Planning Guidance issued by the IAF which I provided the link in the Hard Cut off date for ISO 9001:2008 certification thread, you will have until February 2017 to attain initial certification to the current edition of the standard.

2.1 Validity of certifications to ISO 9001:2008

ISO 9001:2008 certifications will not be valid after the end of September 2018.
From March 2017 all initial certifications under accreditation shall be to ISO 9001:2015.
No registrar will deviate from the IAF guidance.
 
Last edited:

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
<snip> the Hard Cut off date for ISO 9001:2008 certification, you will have until March 2017 to attain initial certification to the current edition of the standard. <snip>
SO - Even after ISO 9001:2015 is released a company will still be able to register to ISO 9001:2008 until March 2017 - Correct?
 
Thread starter Similar threads Forum Replies Date
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
S ISO 9001:2015 - Scope of Registration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 35
Crusader The calm before the storm... ISO 9001:2015 Registration Audit Coffee Break and Water Cooler Discussions 21
T Cadastro according RDC40/2015 (Brazil) Cadastro Registration Requirements Other Medical Device Regulations World-Wide 1
F 2015 Sudan Medical Device Registration and Labeling Language Requirements Other Medical Device Regulations World-Wide 3
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
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

Similar threads

Top Bottom