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Summary of ISO 9001:2000 and ISO 9001:2008 Changes

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bhartigambhir

#41
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

I am planning to go for certification Audit in the month of January, I had already released Procedure, turtle diagram and manual to concerned department heads. Should I revise all the procedure and manual as new standard ISO:9001:2008 received even in most of the procedure we need not to change anything? Please advice
 
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Jim Wynne

Staff member
Admin
#42
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

I am planning to go for certification Audit in the month of January, I had already released Procedure, turtle diagram and manual to concerned department heads. Should I revise all the procedure and manual as new standard ISO:9001:2008 received even in most of the procedure we need not to change anything? Please advice
It's hard to tell from here what might need to be changed; it depends on how your references are worded. If most of the procedures don't need to be changed, just change the ones that do need changing.
 

Antonio Vieira

Involved - Posts
Trusted Information Resource
#43
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

The only thing I’ve changed in the system that was prepared to ISO 9001:2000, and was certified this week to ISO 9001:2008, was the year of the standard where it was referred in the Quality Manual!

I still can’t understand the reason why people are attending (are they?) to training sessions about the “new” standard…
:lol:
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#44
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

The only thing I’ve changed in the system that was prepared to ISO 9001:2000, and was certified this week to ISO 9001:2008, was the year of the standard where it was referred in the Quality Manual!
But why refer to the year of issuance of the standard? Why refer to a standard at all? There is no need for either.
 

Antonio Vieira

Involved - Posts
Trusted Information Resource
#45
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

But why refer to the year of issuance of the standard? Why refer to a standard at all? There is no need for either.
In this QMS, the standard was refereed on the Quality Manual as a guide line adopted, and also as one of the quality manual’s objective – “to show the conformity of the Quality Management System with the Reference Standard adopted, ISO 9001:2008”.
:)
 
N

neelu

#46
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

If your company is outsourcing and if you have not covered processes under outsourcing, in accordance with requirements applicable to clause 7.4 on purchasing, you may have to modify Manual/Procedures or even come out with some new docs.; so as to conform to the clarifications provided in 2008 standard.
Further if you have excluded any clause of ISO 9001 from scope of your QMS, it is worth having a review in the light of clarity given in clause 1.2 on Application (particularly if you have excluded clause 7.3 on design).
 
S

sevenguo

#47
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

Appreciate a lot if anyone can tell me the differences between DIS and final version? I only attended the introduction training on DIS. There are lots of different versions of the changes in the web. Not sure which is referring to final version standard.
 

Stijloor

Staff member
Super Moderator
#48
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

Appreciate a lot if anyone can tell me the differences between DIS and final version? I only attended the introduction training on DIS. There are lots of different versions of the changes in the web. Not sure which is referring to final version standard.
Hello! Welcome to The Cove Forums! :bigwave: :bigwave:

Obtain/purchase ISO 9001:2008. The most accurate description of the "changes" are provided in Appendix B, Pages 20-25.

Stijloor.
 
E

Eusoof

#50
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

Hello :bigwave:

I just received the information from BM TRADA (MALAYSIA) regarding the ISO 9001:2008. Please refer attachment, please click the Adobe Acrobat icon in below side of letter for the more detailed regarding the summary of ISO 9001:2008. Have nice day.:biglaugh:
 

Attachments

Thread starter Similar threads Forum Replies Date
L ISO 9001:2015 Correlation Matrix & Change Summary ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Internal ISO 9001:2008 Audit Summary Report wanted General Auditing Discussions 4
K Draft ISO 9001:2008 (Feb 08 version) & Summary of Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 60
L Summary of Changes in ISO 9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Marc Summary of Differences and Changes - ISO 9001:1994 and ISO 9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
J Does anyone have a summary of changes made to ISO 11137-2? Other Medical Device Related Standards 3
E Is there a summary of changes from a withdrawn ISO standard to the current version Other ISO and International Standards and European Regulations 5
Q ISO 13485 vs. 21 CFR Part 820 Management Summary wanted 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
J My summary of ISO/TS 16949 Implementation (in Indonesian) IATF 16949 - Automotive Quality Systems Standard 4
J ISO 14971 - Risk Analysis - Seeking guide and / or summary ISO 14971 - Medical Device Risk Management 4
A ISO 9000:2000 Clause 7.3 Design and Development Requirements Summary Design and Development of Products and Processes 23
T ISO 10011 Dead - 19011 Is Released - A summary of differences General Auditing Discussions 18
Marc A summary of ISO Guide 25 and an NVLAB Question General Measurement Device and Calibration Topics 6
Watchcat Summary of De Novo Biocompatibility Information, 2015-2018 Other US Medical Device Regulations 0
Watchcat DE NOVO SUMMARY - IVDs and Radiology Devices, 2015-2018 Other US Medical Device Regulations 2
Watchcat De novo Summary (ODE 2015-2018) Other US Medical Device Regulations 2
M Informational MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019 Medical Device and FDA Regulations and Standards News 0
D Summary of safety and clinical performance in GSPR MDR EU Medical Device Regulations 2
M Informational US FDA – MDR Data Files – Alternative Summary Report Data Since 1999 Available Medical Device and FDA Regulations and Standards News 0
M Informational EU – Hearing on the SCHEER preliminary Guidelines on the presence of Phthalates in certain medical devices (Brussels, 04 April 2019) – Summary records Medical Device and FDA Regulations and Standards News 0
A Minitab 18: How to automate GRR Summary Table save Reliability Analysis - Predictions, Testing and Standards 1
M Informational RIVM – Summary International Expert Meeting on breast implant-associated lymphoma Medical Device and FDA Regulations and Standards News 0
T Executive summary for Traditional 510(k) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
A Summary of safety and clinical performance (SSCP) EU Medical Device Regulations 1
D MDR and Summary Technical Documentation Files EU Medical Device Regulations 18
M MDR Clinical Evaluation & investigation (SUMMARY of changes) EU Medical Device Regulations 2
S 510(k) statement or 510(k) summary ? US Food and Drug Administration (FDA) 2
shimonv Summary of FDA Guidance on “Medical Device Accessories” (Dec 2016) Other US Medical Device Regulations 1
L A "good" non-parametric test summary? Statistical Analysis Tools, Techniques and SPC 0
R 510(k) Executive Summary vs 510(k) Summary - Differences 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Does anyone have experience providing a summary of Pre-IDE discussions in the 510k US Food and Drug Administration (FDA) 1
S Internal Audit Findings Summary Rewrite by an Auditee ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S RAPS Article on STED (Summary Technical Documents) Other Medical Device Regulations World-Wide 1
R What should be the content or elements of an MDR Evaluation Summary? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Are Control Plans "Summary Documents" not meant to replace Work Instructions? IATF 16949 - Automotive Quality Systems Standard 3
K Are you wondering about FDA's UDI rule? Here's a non-exhaustive summary: Other US Medical Device Regulations 12
R Summary / Checklist for ANSI Z80.1 and ANSI Z80.3 Other Medical Device Related Standards 2
C Training Planning - Using Summary Sheet for Documenting Training Activities Training - Internal, External, Online and Distance Learning 3
K Clinical Evaluation Report Article Summary Requirements EU Medical Device Regulations 5
Rameshwar25 Acceptance Criteria for Attribute MSA Study Effectiveness Summary Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
E STED (Summary Technical Document) and CSDT Differences Other Medical Device Regulations World-Wide 6
R CAPA 4-panel or 4-pane for Executive Summary Presentation Nonconformance and Corrective Action 3
S AIAG MSA 4th Edition Summary APQP and PPAP 4
N Audit Summary Report - Need template example and help Internal Auditing 3
Q Adding ISO13485 to existing AS9100 QMS - Summary of the differences ISO 13485:2016 - Medical Device Quality Management Systems 9
C Product Quality Planning Summary and Sign Off Sheet APQP and PPAP 3
B Requirements Summary - Part 21g / Part 21j and Part 145 and DAOS EASA and JAA Aviation Standards and Requirements 4
E Declarations of conformity and summary reports 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S Audit Summary Report - Nonconformance Aging Analysis Nonconformance and Corrective Action 10

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