What changes cause to Cancellation of ISO Certifications?

N

nkultur

#1
Hi All,

The company I work is in the process of changing its name & organisation structure due to sell out of the business to existing management team. A core business of the company will remain the same, therefore, most of the processes. The company is currently holding ISO9000:2000 and 14001:2004 certifications.

The question is that whether the newly formed company needs to be re-certified for both certifications from scratch or not ? Or to ask a generic question, what factors/changes trigger a re-certification activity ? Regarding the issue, is there any ISO document available as a reference ?

I would appreciate for your quick reply/comment(s).

:thanx:

Alex
 
Last edited by a moderator:
Elsmar Forum Sponsor
G

Greg B

#2
nkultur said:
Hi All,

The company I work is in the process of changing its name & organisation structure due to sell out of the business to existing management team. A core business of the company will remain the same, therefore, most of the processes. The company is currently holding ISO9000:2000 and 14001:2004 certifications.

The question is that whether the newly formed company needs to be re-certified for both certifications from scratch or not ? Or to ask a generic question, what factors/changes trigger a re-certification activity ? Is any ISO document available as a reference ?

I would appreciate for your quick reply/comment(s).

:thanx:

Alex
Alex,

Welcome to the cove. It is good to have a fellow Aussie on board. There are not many of us.

Anyway, the simple answer is NO you do not have to start from scratch. The registrar will have to issue new certifcates and will probably do another certification audit (or bring a triennial forward). We have been sold MANY times and have retained the original certfication number.

The best people to ask are you registrar company. SAI Global or Sciqual etc. If you have any urgent questions to be answered PM (personnel message at the top right of the main screen) me during business hours
 
N

nkultur

#3
Greg B said:
Alex,

Welcome to the cove. It is good to have a fellow Aussie on board. There are not many of us.

Anyway, the simple answer is NO you do not have to start from scratch. The registrar will have to issue new certifcates and will probably do another certification audit (or bring a triennial forward). We have been sold MANY times and have retained the original certfication number.

The best people to ask are you registrar company. SAI Global or Sciqual etc. If you have any urgent questions to be answered PM (personnel message at the top right of the main screen) me during business hours
Thanks for your reply Greg. I hope I do not start everything from scratch as you suggested but, if I use the response rate as a criteria to my query, it seems to me the issue is not clear amongst the quality people.

Thanks again

Alex :)
 
Thread starter Similar threads Forum Replies Date
R Changes vs CMO - How can we simplify this process? Supplier Quality Assurance and other Supplier Issues 3
Ed Panek What are the limits on manufacturing changes and substantial changes? EU Medical Device Regulations 6
F Hospital Rebrand & Name changes Document Control Systems, Procedures, Forms and Templates 4
M IEC 62304 Software changes - Minor labeling changes on the GUI IEC 62304 - Medical Device Software Life Cycle Processes 3
Aymaneh ISO 11607-1: 2019 main changes Other Medical Device Related Standards 2
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
E ASTM F2118 - Fatigue testing of bone cement - Changes between the 2003 and the 2014? Other Medical Device Related Standards 1
qualprod Documented actions and changes in the QMS by COVID 19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B ASTM E18-2020 - Rockwell testing standard changes? General Measurement Device and Calibration Topics 2
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
I Dating controlled documents after changes - Revision History Document Control Systems, Procedures, Forms and Templates 13
F Medical Devices - Hong Kong - Post approval changes regulation (China's MOH) Other Medical Device Regulations World-Wide 3
F Medical Devices-South Africa _Post approval changes and Software Other Medical Device Regulations World-Wide 0
K Changes in process dispersion, and location hypotheses tests Using Minitab Software 3
NDesouza When Customers Make Changes to Orders Contract Review Process 24
S Managing specification changes on standard parts purchased through trading companies Document Control Systems, Procedures, Forms and Templates 2
I MSA requirement for 5 Micrometers + CP changes need customer approval? IATF 16949 - Automotive Quality Systems Standard 2
A ISO13485:2016 name and ownership changes questions ISO 13485:2016 - Medical Device Quality Management Systems 3
R What are the changes in 5th Edition of FMEA manual? FMEA and Control Plans 6
S Examples of software changes that required a 510k US Food and Drug Administration (FDA) 2
D 510K and Changes to Verification and Validation US Food and Drug Administration (FDA) 2
V IATF 16949 9.2.2.1 Internal Audit Program - "Process Changes" IATF 16949 - Automotive Quality Systems Standard 11
M What are the changes in supervising according to ISO17025? ISO 17025 related Discussions 7
U Changes to Internal Processes and Risk Evaluation - Mitigations Risk Management Principles and Generic Guidelines 10
M Informational New Zealand – Changes to Medical Device Adverse Event Reporting process Medical Device and FDA Regulations and Standards News 0
R Rationale for changes to ISO Standards Other Medical Device Related Standards 4
M Informational TGA Consultation: Proposed changes to medical device essential principles for safety and performance Medical Device and FDA Regulations and Standards News 0
A Changes to an already certified product (IIb, MDR) EU Medical Device Regulations 1
I Tracking Protoype Changes; 8D or simple document revision? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C What if the foreign manufacturer of a medical device changes the Authorized Representative in Saudi Arabia? Other Medical Device Regulations World-Wide 0
A The latest revision number and changes in automotive core tools IATF 16949 - Automotive Quality Systems Standard 1
M Informational EU – MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI Medical Device and FDA Regulations and Standards News 0
J Ethicon suture box design changes - 2019 Other Medical Device Regulations World-Wide 2
E Changes to medical device submitted through a variation? EU Medical Device Regulations 1
T AS9100 Maintain Approval When Business Ownership Changes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Informational TGA – Several proposed changes to classification to better align with the EU MDR Medical Device and FDA Regulations and Standards News 0
S ISO9001:2015 6.3 - Planning of Changes - OFI from auditor ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
M Medical Device News TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia Medical Device and FDA Regulations and Standards News 0
F Device Standards - Managing Changes to existing standards that apply to our devices Other Medical Device Related Standards 1
S Ballooned Drawings and Engineering Changes Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
supadrai Changes to QMS - Contract Term ISO 13485:2016 - Medical Device Quality Management Systems 4
R ISO 9001:2015 6.2 - Planning Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Significant Organizational Changes - Documented Responsibilities Document Control Systems, Procedures, Forms and Templates 4
M Medical Device News Health Canada - Proposed Changes - List of Recognized Standards for Medical Devices Canada Medical Device Regulations 3
Marc 9 September 2018 - Upcoming User Group Changes Forum News and General Information 1
J Class 1 Medical Device ECR (Engineering Change Request) Changes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Douglas E. Purdy ISO/IEC 17025:2017 3rd Ed. Changes from 2nd Ed. ISO 17025 related Discussions 6
M Notifying Registrar of Significant QMS changes ISO 13485:2016 - Medical Device Quality Management Systems 2
S Medical Device Changes and How to Assess Their Impacts to Essential Requirements EU Medical Device Regulations 2
S Design changes a week after regulatory submission 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1

Similar threads

Top Bottom