Is Version Change needed for ammending ISO 9001:2000 to 2008

J

jaykashkap - 2009

#1
Some of our QMS documents contain reference to ISO standard 9001:2000, now we are going in for certification against 9001:2008, when the reference is changed in a QMS document, without making any other significant change is it necessary to change the document version?
 
Last edited by a moderator:
Elsmar Forum Sponsor

harry

Trusted Information Resource
#2
Re: Version change for ISO 9001:2008

There is a discussion going on about this subject. You can do without reference to ISO 9001 at all. If you prefer, keep it at ISO 9001 without the year so that you will not have this hassle in future.

See: ISO 9001:2000 to ISO 9001:2008 Transition - Changing documentation

If you start afresh, you can start from version 'zero' but this is subjected to how you control your documents and what is written in your procedures.

By the way, welcome to the Cove.
 
Last edited:
Thread starter Similar threads Forum Replies Date
alonFAI Mechanical Drawing Version Change Document Control Systems, Procedures, Forms and Templates 8
V Do we need to enclose Draft version of Proposed Changes in Change Control US Food and Drug Administration (FDA) 8
S Do I need to change my SOPs? Transitioning to ISO 9001:2000 from the 1994 version ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R Declaration of Conformity for updated SaMD version EU Medical Device Regulations 2
S Registation different version of Medical Devices & Germany competend authority EU Medical Device Regulations 3
S PDF version of IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C VDA 6.2 version 2020 - coversheet VDA Standards - Germany's Automotive Standards 0
MaHoDie Where to show the Software version IEC 62304 - Medical Device Software Life Cycle Processes 2
D Does the DoC require a technical documentation version? ISO 13485:2016 - Medical Device Quality Management Systems 1
R Use of historical version of ISO standards CE Marking (Conformité Européene) / CB Scheme 3
Zafortner EU Manufacturing Incident Report (MIR) version 7.3 ISO 13485:2016 - Medical Device Quality Management Systems 9
C How to place software version for SaMD product in HIBC secondary data structure (UDI-PI)? Other US Medical Device Regulations 4
S 21 CFR part 11 version differences Qualification and Validation (including 21 CFR Part 11) 1
S What EMC 60601-1-2 version to use with 60601-2-47 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
H Using/Selling power banks with your product as a "mobile version" CE Marking (Conformité Européene) / CB Scheme 3
J UDI-DI how should we interpret Device version or model to determine if a new UDI-DI is needed? EU Medical Device Regulations 0
K IEC 60601-1:2005/AMD2:2020, Why this standard version is 3.0? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B Struggling with using the 5.6 version Ford Capacity Analysis Report APQP and PPAP 5
SANTHSH API Spec.Q1 Standards Version in Purchasing Information Oil and Gas Industry Standards and Regulations 1
Q Version/Revision Control of CAD files Document Control Systems, Procedures, Forms and Templates 2
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
N Which EN ISO 17664 version compliance to EU MDR? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
M When is EN 62133-1 (new version i.e. IEC 62133:2017) mandatory in EU Other ISO and International Standards and European Regulations 3
I Reissuing documents due to missing version / issue numbers Document Control Systems, Procedures, Forms and Templates 3
M Can someone share a scrubbed version of Clinical Evaluation Plan (CEP) EU Medical Device Regulations 8
F Management of Software version while NB reviews Technical file CE Marking (Conformité Européene) / CB Scheme 9
M Harmonised RED Standard ETSI EN 440 - Which Version? Other ISO and International Standards and European Regulations 0
M Informational EU – Manufacturer incident report (MIR) for serious incident- template 2020 (Directives and new regulations) version 7.2 and related documents Medical Device and FDA Regulations and Standards News 2
M Informational EU – MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.22 (05-2019) Medical Device and FDA Regulations and Standards News 2
dgrainger Informational Updated Borderlines manual - Version 1.22 (05-2019) EU Medical Device Regulations 0
A Usable version of MDR in Word format CE Marking (Conformité Européene) / CB Scheme 0
dgrainger MHRA guidance on Virtual manufacturing - version 2 EU Medical Device Regulations 1
M Scrubbed version of a labeling procedure that is MDR compliant wanted EU Medical Device Regulations 3
B QRQC vs JIDOKA - I read somewhere that QRQC is like a French version of JIDOKA Problem Solving, Root Cause Fault and Failure Analysis 2
C Has an amended version of IEC 60601-1-6 TRF been released for use in conjunction with IEC62366-1:2015? Human Factors and Ergonomics in Engineering 0
Sidney Vianna Accessing the Xenforo version of Elsmar via a smartphone Elsmar Xenforo Forum Software Instructions and Help 8
A AS9100 Rev:D in Spanish - where can I find a Spanish version? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
D I heard that there is no new version of ISO 18001 OHSAS after 2017 version Occupational Health & Safety Management Standards 3
M Which Version of 60601-1 to Purchase (IEC, EN, ANSI...)? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M How to get an electronic version of IATF 16949:2016 which is Searchable IATF 16949 - Automotive Quality Systems Standard 8
E CER (Clinical Evaluation Report) MEDDEV Version 4 Template wanted CE Marking (Conformité Européene) / CB Scheme 5
B Where can I find an English version of Japan's PMD Act? Other ISO and International Standards and European Regulations 2
S Pre-release version of the upcoming AIAG FMEA Revision 5 FMEA and Control Plans 1
I ISO 22001 and ISO 22003 French version Food Safety - ISO 22000, HACCP (21 CFR 120) 2
D Referencing Standards in Procedures - Current version or actual? Document Control Systems, Procedures, Forms and Templates 6
K UDI "Version or Model" for Stand-Alone Medical Device Software US Food and Drug Administration (FDA) 6
R IEC 60601-1 4th Edition - Is a "Red-line" version available? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
R Current version of EN62304/A1 IEC 62304 - Medical Device Software Life Cycle Processes 5
Y Which version of ISO 13485 would be considered for MDSAP certificate? Canada Medical Device Regulations 8
G Insights into the 2016 Version of TS16949 (IATF 16949) IATF 16949 - Automotive Quality Systems Standard 74

Similar threads

Top Bottom