FDIS ISO 9001:2000 vs. ISO 9001:1994

12 questions to ask before buying a QMS
Elsmar Forum Sponsor
G

Graeme

#2
#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
#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
#4
An ISO 9001:2000 gap analysis checklist is now available at the pdf files area.

------------------
 
Marc

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
#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
#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
 
You must log in or register to reply here.
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
G National Structural Steel Specification 7th Edition - Do I now have to be audited against ISO 3843-3 as well as ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
L How to understand the clause 6 Planning of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
B ISO 8536-4 Contamination Index ISO 13485:2016 - Medical Device Quality Management Systems 0
S Practical Implementation of ISO 14971 ISO 14971 - Medical Device Risk Management 6
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
J Recommendations for online ISO 19011 training? Training - Internal, External, Online and Distance Learning 6
D ISO 13485 8.2.1 and 8.2.2 - Customer Feedback and Customer Complaints ISO 13485:2016 - Medical Device Quality Management Systems 5
S Requirements to obtain ISO 50001 Certification ISO 14001:2015 Specific Discussions 2
A ISO 11135:2014, B.1.4, BI resistance x product bioburden ISO 13485:2016 - Medical Device Quality Management Systems 6
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
J Sister-company providing parts is only ISO 9001 registered IATF 16949 - Automotive Quality Systems Standard 7
M Getting started in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 21
G Copy of withdrawn ISO 9001:1994 Quality Management Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P ISO 80369 and endoscope port/lumen Other ISO and International Standards and European Regulations 4
C ISO 639-1 Languages Other Medical Device Related Standards 0
B ISO 11607-2 "Critical Parameter" vs. "Process Parameter" Other Medical Device Related Standards 3
S ECG Cable Banana to Snap or Tab electrode Adapters -- ISO 10993 Requirement Other Medical Device Related Standards 0
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
P ISO Class 8 particle count (annual certification vs monitoring) ISO 13485:2016 - Medical Device Quality Management Systems 4
T ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
G Logistic organization and controls - IATF/ISO 9001 audit Nonconformance and Corrective Action 2
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
A ISO 17021-1:2015 toolkit General Auditing Discussions 2
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 14971 PFMEA Manufacturing Risk ISO 14971 - Medical Device Risk Management 2
J Scope of ISO 9001 clause 10.2 in the product life cycle ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C SOP Template needed for ISO 13485 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 9
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
T ISO 9001 8.5.2. - Identification and traceability to Identify Outputs - Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Outsourced process in ISO 45001 Occupational Health & Safety Management Standards 2
K Overall residual risk according to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 5
M Gap analysis on ISO 14971:2019 with previous revision ISO 14971 - Medical Device Risk Management 3
T ISO 9001:2015 - Small Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T ISO 17025:2017 requirement 5.7.b. about maintenance the integrity of the management system ISO 17025 related Discussions 1

Similar threads

Top Bottom