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 with a Mask on...
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
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 3
M Transferring ISO 17025 from one company to another ISO 17025 related Discussions 1
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
B ISO 17025:2017 risk management Risk Management Principles and Generic Guidelines 0
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO 2768-mk print call out Other ISO and International Standards and European Regulations 11
T ISO 17024, clauses 4.3.8. and 5.1.1. Other ISO and International Standards and European Regulations 4
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
John C. Abnet ISO 26262 ISO 26262 - Road vehicles – Functional safety 3
Marc ISO 26262- Road vehicles – Functional safety ISO 26262 - Road vehicles – Functional safety 0
John C. Abnet ISO 26262 IATF 16949 - Automotive Quality Systems Standard 0
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 0
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
K PDCA cycle and ISO processes alternative model Quality Management System (QMS) Manuals 14
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
D Which ISO Standard to purchase? ISO 13485:2016 - Medical Device Quality Management Systems 7
V ISO 10360-5: 2020 Gap analysis and Action plan Excel .xls Spreadsheet Templates and Tools 1
Q ISO 9001 - Reseller Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
C ISO 45001 6.1.2.1 Hazard Identification Occupational Health & Safety Management Standards 1
T The difference between ISO 14644-3:2005 and ISO 14644:2019 Other Medical Device Related Standards 2
S Any ISO standards around Artificial Intelligence and Machine Learning? Medical Information Technology, Medical Software and Health Informatics 4
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
N ISO 9001 - Training business with fewer than 5 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
J Opportunity in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom