FDIS ISO 9001:2000 vs. ISO 9001:1994

Elsmar Forum Sponsor
G

Graeme

#2
The changes from 1994 to 2000 are, in my opinion, too extensive to be presented in a checklist. The new version is radically different in structure, philosophy and content.

"Quality Digest" magazine ( http://www.qualitydigest.com/ ) ran a multi-part series about the new standard starting in March 2000. That series of articles covered each of the major elements individually, but be aware that it was based on an earlier draft. You can also purchase a copy of the FDIS from your national standards organization, and download free transition information from ISO ( http://www.iso.ch/ ).
 
S

sopon

#3
Annex B of ISO/FDIS 90001: 2000 Quality management systems - requirements has define correspondence between ISO/FDIS 9001: 2000 and ISO 9001:1994 and also ,ISO 14002: 1996.
It may help you clarify which part of quality system need to revise.

soponlvm
 
D

David Mullins

#4
An ISO 9001:2000 gap analysis checklist is now available at the pdf files area.

------------------
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
And we thank you for it! The file name is ISO9001_2000_GAP Analysis.doc I believe.

[This message has been edited by Marc Smith (edited 04 January 2001).]
 
C

Carlos Santos

#8
The most recent ISO 9001, the 2000 edition, is causing some hot analysis by all Quality people all over the world. The checklist issue is apparently solved by the help of this wonderful web site, in the PDF Zone, File: Iso9001_2000_gap_analysis.DOC.

Very soon I will try to publish here my checklist. Just let me finish it and translate it to English. In order to make all our participations useful, if any one have any king of additional information, like the standard interpretation, please send it to me and publish it.
Regards,
Carlos Santos – Portugal
 
Thread starter Similar threads Forum Replies Date
D Approval of FDIS ISO 9001:2000 - They've ordered a re-count - Too close to call ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M FDIS ISO 9001:2000 changes to 8.2.1 Customer Satisfaction ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R ISO 45001 (FDIS) Webinar - Jan 24 2018 at 11:00 am ET Occupational Health & Safety Management Standards 1
S FDIS 14001 & 14004 has been issued by the ISO/CS on August 12, 2004 for a vote ISO 14001:2015 Specific Discussions 1
K FDIS of ISO 14001 - Released April 2004? ISO 14001:2015 Specific Discussions 20
Sidney Vianna ISO/FDIS 10002 Quality Management - Customer Satisfaction - Guidelines for Complaints Other ISO and International Standards and European Regulations 7
R ISO/FDIS 19011 (Espa?ol) General Auditing Discussions 0
G FDIS 14001 - Implementation - Gear our EMS towards 14001:2004? ISO 14001:2015 Specific Discussions 10
Marc FDIS 9001:2000 "Trends" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D Changes in FDIS 9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R Risk control measures as per ISO 14971 ISO 14971 - Medical Device Risk Management 3
John C. Abnet ISO 45001:2018 (5.4 - Consultation and participation of workers) Occupational Health & Safety Management Standards 9
Sidney Vianna What ISO Standard (under the TC 176) supports the UN Sustainable Development Goal #10? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 11
S ISO 15223-1:2020 Symbols Other Medical Device Related Standards 1
John C. Abnet ISO 9001 4.4.1 "...shall determine the processes needed..." ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 67
R ISO 10993-18 Medical Device and FDA Regulations and Standards News 1
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
R Applicable ISO standards - packaging and others Medical Device and FDA Regulations and Standards News 4
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 5
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
M ISO 10993-17 - Ancillary Medicinal substance leachables Medical Device and FDA Regulations and Standards News 1
M Medical Devices - Ancillary - ISO 10993-17 Medical Device and FDA Regulations and Standards News 6
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
J New Job Position - Achieving ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
S ISO 9001 Clause 8.2.3 - Review of the requirements for products and services in a Cafe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A ISO 17025 - Methods validation and clients ISO 17025 related Discussions 3
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
D ISO 9001 certificate issued by QMS International for 10 years - legit? Registrars and Notified Bodies 17
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
K Medical Device Repairs and ISO Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
K Software Updates in the Field and ISO scope ISO 13485:2016 - Medical Device Quality Management Systems 2
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
Z Auditor Findings ISO 14001:2015 vs. 45001:2015 ISO 14001:2015 Specific Discussions 5
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO/IEC 17021-1 clause 7.1.2 - Determination of competence criteria Document Control Systems, Procedures, Forms and Templates 2
G ISO 17023 2017-11 - Suggestions for good books ISO 17025 related Discussions 0
B Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 10
M ISO 9001:2015 and AS6081:2012 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Gage calibration frequency, ISO and IATF - What are the requirements Calibration Frequency (Interval) 3
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
C Implementation ISO 9001: 2015 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
L Biological Assessment (ISO 10993-1) Other Medical Device Related Standards 1
M ISO 13485:2016 Complaint Definition Clarity Customer Complaints 2
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34

Similar threads

Top Bottom