SBS - The best value in QMS software

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

Popular whitepapers from DISCUS
Elsmar Forum Sponsor
J

JaneB

#22
#22
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

SteveK said:
On a more serious note, the new emphasis in 8.2.4 on “release of product for delivery to the customer”, was a point I nearly got a NC for in an audit. My original take was that release of product was “a quality role”, not so said the auditor, it is the person who releases it for delivery to the customer (in his eyes our production manager). Had he just been reading the 2008 draft?
Click to expand...
I'm not sure what you mean by 'quality role' - can you explain?

I'm with your auditor in that whoever says it's OK to go (even by default) is the person who takes responsibility for it (or not, as the case may be!) In the 2000 version, I would reference 8.2.4, particularly 'Records shall indicate the person(s) authorizing release of product) and 7.1d)
I'm guessing that the new wording is to make the meaning crystal clear.

:topic:
SteveK said:
Obviously (in line with Marc) I was a little forward with my 'forewords' - word blindness can happen!
Click to expand...
Sounds like you and Marc went to similar schools ;)

As for word blindness, oh yes. Mine is 'accommodation' where I am wont to drop an 'm' if not thinking![/QUOTE]
 
WCHorn

WCHorn

Rubber, Too Glamorous?
Trusted Information Resource
#23
#23
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

:2cents:Just buy a copy of ISO 9001:2008. Annex B, table B.1 is a comprehensive list of all the differences between ISO 9001:2000 and ISO 9001:2008.
 
J

JaneB

#24
#24
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

WCHorn said:
:2cents:Just buy a copy of ISO 9001:2008. Annex B, table B.1 is a comprehensive list of all the differences between ISO 9001:2000 and ISO 9001:2008.
Click to expand...
Yup - and it's a very clear one.
 
S

SteveK

#25
#25
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

JaneB said:
I'm not sure what you mean by 'quality role' - can you explain?

I'm with your auditor in that whoever says it's OK to go (even by default) is the person who takes responsibility for it (or not, as the case may be!) In the 2000 version, I would reference 8.2.4, particularly 'Records shall indicate the person(s) authorizing release of product) and 7.1d)
I'm guessing that the new wording is to make the meaning crystal clear.

:topic:

Sounds like you and Marc went to similar schools ;)

As for word blindness, oh yes. Mine is 'accommodation' where I am wont to drop an 'm' if not thinking!
Click to expand...
When I said "quality role", we have a quality inspector(s) who gives the (final) approval that the product meets specification via signing off a "Production and Inspection Process Report" i.e. final testing completed, paper work checked, product packed, labelled, serial number correct etc etc etc. In my view it was (is) this person who says OK to go (within the quality system). The Production Manager (PM) makes sure the product matches the order to release from site - which I guess is a final quality check. As I said , the auditor saw the PM as "he who say OK", whereas I saw the quality inspection checking stage the most important part with respect to clause 8.2.4. Anyway I gave in, and fortunately within the PMs job description there was enough information about his role to satisfy the auditor - and thus no NC. Like many sections of standards in general, it's down to differing interpretations, I suppose that is why you get "guidelines" e.g. the ISO ones indicated in this thread (thanks guys).

Steve
 
xfngrs

xfngrs

Quite Involved in Discussions
#26
#26
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

As for "forward"...I suppose icanhascheezburger.com drives certain people crazy....?:notme:
 
T

TamTom

#27
#27
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

sittelle said:
Hi

What will be for you the impacts of the changes to the 9001-2008 standard.

Sittelle
Click to expand...
Hey,

our auditor say, that he expect that some companies, have to make more Quality Assurance Agreements with theire service suppliers (outsourced processes) cause here the requirement is now more clear. (So far I have no chance to read it, so I just state his opinion)

But that is all. He clearly mentioned, that because our System fits the ISO/TS we need no change.

Regards,

TamTom
 
T

TamTom

#28
#28
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

SteveK said:
As I said , the auditor saw the PM as "he who say OK", whereas I saw the quality inspection checking stage the most important part with respect to clause 8.2.4. Anyway I gave in, and fortunately within the PMs job description there was enough information about his role to satisfy the auditor - and thus no NC. Like many sections of standards in general, it's down to differing interpretations, I suppose that is why you get "guidelines" e.g. the ISO ones indicated in this thread (thanks guys).

Steve
Click to expand...
Does your Management already make plans to end the Final inspection?

Because if you PM makes the release (I can't imagine how he does it), why need a final inspection?

Regards,

TamTom
 
S

SteveK

#29
#29
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

Hi TamTom,

Just to finish off. Because of the change in clause 8.2.4, some people may have to alter something in a “product realization” related procedure regards final release of their product from site. I have now made it crystal clear in my procedure that our Production Manager is the person who is responsible for “authorizing release of product for delivery to the customer”. It is he who finishes off the production paper work (by signing the appropriate production record) and prints off the delivery note, whereas the final “quality release” is signed off by our quality inspector (separate “quality” inspection record). So previously in 9001, it could be argued who authorized “release” – QC, Production, the CEO or by Santa’s Clause (sorry – just being festive!:lmao:) - as I did with my auditor. Within a particular QMS it should now be made unambiguous.

Steve
 
howste

howste

Thaumaturge
Super Moderator
#30
#30
Re: Summary of Changes - ISO 9001:2000 and ISO 9001:2008

Sidney Vianna said:
Look at this IRCA briefing document, duly attached.
Click to expand...
It looks like IRCA is still being a little more aggressive than warranted?
Auditors must be aware that changes will be required to management systems in order to ensure effective audits against the new standard.
Click to expand...
(my emphasis)

If ISO 9001:2000's original intent was already being met in a system, will IRCA auditors write a nonconformity if there are no changes made? :mg: If so, what will they write it against?
 
You must log in or register to reply here.
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

Similar threads

Top Bottom