Updating a Quality Manual from ISO 9001:2000 to ISO 9001:2008

S

samsung

#21
Re: ISO 9001:2008 and Quality Manual

Fixed that for you. There were no changes in the requirements. If extensive changes are needed in a quality manual because of the 2008 changes, the problem is with the manual.
May the problem lies with the manual and that's what the auditor asked OP to look into.

BTW, there are more than 65 changes. I don't say that every change warrants a change in manual or other documents. The message is just to review the existing documentation/ processes/ procedures and based on the analysis of the 'revised' interpretation/ changes listed in 'Annexure B', if one finds any gaps, those are to be fixed.

"....who knows what"
Here it is:
 
Last edited by a moderator:
Elsmar Forum Sponsor
P

PGTIPS8

#22
Re: ISO 9001:2008 and Quality Manual

HAVING READ THROUGH SOME OF THE REPLIES TO YOUR MANUAL QUESTION. READ THROUGH THE MANUAL AGAINST THE DIFFERENCES FROM 9001 TO 9001:2008 TRANSITION. TO ENSURE ANY DIFFERENCES POSTED BY MOST CERTIFYING BODIES, ARE PICKED UP AND CRYSTAL CLEAR IN THE MANUAL, USE THE USUAL SIDELINING METHOD. ALSO MAKE SURE WHAT YOU SAY IN THE MANUAL ABOUT YOUR PROCESSES AND THE MODIFICATIONS YOU HAVE MADE IN THE MANUAL ALIGN IN THE SUPPORTING DOCUMENTED MANAGEMENT SYSTEM. OF COURSE THEN CONDUCT YOUR OWN iNTERNAL AUDIT TO TEST THE ARRANGEMENTS!:agree:
 
Last edited by a moderator:
#23
Re: ISO 9001:2008 and Quality Manual

If both the versions of 9001 are same, means there are absolutely no changes, then it shouldn't make any difference whether you call it 2000 or 2008; if one writes 2000, it means 2008 or even if one writes 2008, it should mean 2000.

If two objects are exactly alike and fit into the definition of, let's say, 'square', then both are 'squares' without any adjectives.
Samsung - no one has said both revisions are the same! As we know with the English language, words can be different but have the same meaning. Words have been changed and added to the standard, but the meaning hasn't been added to or changed in any substantial manner.

I fear that over analysis of such things will lead to missing the bigger picture, whether it's this or categorization of audit findings, etc. leading to the confusion of those who are new or unsure of how to implement systems.

Implementing ISO 9001 really isn't technically challenging to most organizations, in my experience - and for all the people I've assisted - this type of over analysis and nit picking through the standard is totally unnecessary.
 
P

PGTIPS8

#24
Re: ISO 9001:2008 and Quality Manual

As we know the knit picking often is generated by the CB. Your points are well made and valid:applause:
 

Big Jim

Trusted Information Resource
#25
Re: ISO 9001:2008 and Quality Manual

HAVING READ THROUGH SOME OF THE REPLIES TO YOUR MANUAL QUESTION. READ THROUGH THE MANUAL AGAINST THE DIFFERENCES FROM 9001 TO 9001:2008 TRANSITION. TO ENSURE ANY DIFFERENCES POSTED BY MOST CERTIFYING BODIES, ARE PICKED UP AND CRYSTAL CLEAR IN THE MANUAL, USE THE USUAL SIDELINING METHOD. ALSO MAKE SURE WHAT YOU SAY IN THE MANUAL ABOUT YOUR PROCESSES AND THE MODIFICATIONS YOU HAVE MADE IN THE MANUAL ALIGN IN THE SUPPORTING DOCUMENTED MANAGEMENT SYSTEM. OF COURSE THEN CONDUCT YOUR OWN iNTERNAL AUDIT TO TEST THE ARRANGEMENTS!:agree:
This is the approach that I was taught as well. That an organization should look to see if the old wording may have contributed to misunderstandings on how to apply the standard and to make corrections in their documentation and practice as needed. Usually, little or none is needed.

My understanding is that if you have implemented your quality management system the way the framers envisioned it, no changes would be needed. If there had been a misunderstanding, this was an opportunity to get back on course.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#26
Re: ISO 9001:2008 and Quality Manual

BTW, there are more than 65 changes.
Change denotes something different. Upon reading and understanding the CLARIFICATIONS, most organizations realize that there is NO NEED to revise anything in their manuals, command media, processes and systems.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#27
Re: ISO 9001:2008 and Quality Manual

Bear in mind, folks, the quality manuals do not need to refer to ISO 9001:2008 throughout. Take this opportunity to refer to ISO 9001 in a generic sense. When I develop manuals, the only place I mention the current version of the standard is near the beginning, when I mention it is compliant "to ISO 9001:2008," and will consider revisions in a reasonable timeframe when new versions are released. The rest of the time, if mentioned, it is just "ISO 9001," or "the standard."
A better approach is not to make any reference to the ISO 9001 standard whatsoever. There is no need for that.
 

Helmut Jilling

Auditor / Consultant
#28
Re: ISO 9001:2008 and Quality Manual

A better approach is not to make any reference to the ISO 9001 standard whatsoever. There is no need for that.
Perhaps, but most manuals have some kind of notation that it is based on and meets the requirements of ISO 9001, or TS-16949, or whatever. I think it is a good thing.
 

Jim Wynne

Staff member
Admin
#29
Re: ISO 9001:2008 and Quality Manual

Perhaps, but most manuals have some kind of notation that it is based on and meets the requirements of ISO 9001, or TS-16949, or whatever. I think it is a good thing.
A good thing how? I think a case can be made for it being harmful, as it supports the "ISO says so" way of thinking. At the very least it has the potential to create unnecessary effort, which we see here all the time. An entire compliant QMS can be built that's completely free from references to the standard, and I've always believed that if something can be eliminated without affecting outcomes, it should be eliminated.
 

Helmut Jilling

Auditor / Consultant
#30
Re: ISO 9001:2008 and Quality Manual

A good thing how? I think a case can be made for it being harmful, as it supports the "ISO says so" way of thinking. At the very least it has the potential to create unnecessary effort, which we see here all the time. An entire compliant QMS can be built that's completely free from references to the standard, and I've always believed that if something can be eliminated without affecting outcomes, it should be eliminated.
Oh c'mon. A single notation notation that the QMS is based on and meets the requirements of ISO 9001, or TS-16949, or whatever, is a "harmful" thing?. Especially when a company is spending a lot of time and money getting certified to the standard. And trying to promote it within the company. Seriously, Jim, I think you are letting your anti-ISO certification bias show a bit much on this one.

Can the QMS be done without mentioning it, I suppose. But, I still think it is a good thing. I just recommend to do it simple and don't plaster the specific reference everywhere. Just state it once, and let any other references be more generic.

Some people still like ISO, Jimmie-boy...they even still buy flags... :cool:
 
Thread starter Similar threads Forum Replies Date
F Updating a Quality Manual from ISO 9001 to ISO TS 16949 - Process Mapping IATF 16949 - Automotive Quality Systems Standard 2
V Updating Quality Manual - Adding the word Statutory in front of laws and regulations Quality Management System (QMS) Manuals 3
B Tips on updating our Quality Systems Manual from ISO 9001:1994 to ISO 9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
N Updating the website of the manufacturer EU Medical Device Regulations 1
A Technical File - Updating Applied Standards EU Medical Device Regulations 4
A What ISO 9001:2015 clause could be used to write nonconformance for not updating licensed driver list? General Auditing Discussions 8
N Updating QM to 13485:2016 - We do not make medical devices ISO 13485:2016 - Medical Device Quality Management Systems 1
B Site Move - Question about Updating Product Labels 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
O Updating "opportunities" resulting from Corrective Actions Nonconformance and Corrective Action 2
N Updating class I device IFU with instructions to use class II cleared device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
V Periodic review criteria for reviewing/updating SOPs US Food and Drug Administration (FDA) 1
T Design Changes - Updating the Design and Development File EU Medical Device Regulations 5
L Clinical Evaluation Report Updating Procedure Other Medical Device Related Standards 5
A Changing a Form Template & Updating Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M AS9100D - Updating Scope Exclusions AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 9
E Updating DHF (Design History File) to include Alternative Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
W ISO9001:2015 - Clause 7.5.2 - Requirements for Creating & Updating Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Actions Taken - Updating a FMEA for the addition of a downstream poke yoke FMEA and Control Plans 3
I NCR for Customer not updating their drawings AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 14
P Updating a Medical Device's Intended Use Other US Medical Device Regulations 2
N Updating Job Titles - Does This Mean There Needs to Be a rev change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
shimonv Updating Safety Test Report when changing component supplier IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K Updating Outdated Calibration Procedures Document Control Systems, Procedures, Forms and Templates 2
J Is the SFDA in China in the process of updating their Medical Device Regulations ISO 13485:2016 - Medical Device Quality Management Systems 3
T Design & Development in Updating Machines and Equipment - ISO 9001 Help Design and Development of Products and Processes 4
B Requirement for Updating Medical Device Software (Firmware) in the Field 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
S IPC 620 updating from Class 1 to Class 3 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
C Updating (Revising) Documents with a New Logo Document Control Systems, Procedures, Forms and Templates 3
O Sum of Cpk - Updating Product Tolerances Capability, Accuracy and Stability - Processes, Machines, etc. 6
B Updating from ISO 9001:2000 to ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
R Standard Relevance & Updating - ASME B&PVC Various Other Specifications, Standards, and related Requirements 4
T Updating to ISO 9001:2008 - I need to add section 7.3 Design and Development ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
J Declaration of Conformity - Updating the DofC to MMD 2007/47/EC EU Medical Device Regulations 4
C Updating our Laboratory Calibration / Verification Procedures IATF 16949 - Automotive Quality Systems Standard 5
J ISO/AS Surveillance Audit - Minor for not updating my QA Manual to ISO 9001:2008 Quality Management System (QMS) Manuals 95
M Updating Certificate of Foreign Government (CFG's) Other US Medical Device Regulations 18
ScottK How is this for extremes in updating to the ISO9001:2008 rev ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
I Updating Lead Auditor Certifications to ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A FDA - Registration & Listing Updating + when Purchasing another Company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
K Updating Procedures because they are bland and wordy Document Control Systems, Procedures, Forms and Templates 12
C Updating the IPC1752 info RoHS, REACH, ELV, IMDS and Restricted Substances 3
W Standards Updating Service? Current Revision Level of Standards Other ISO and International Standards and European Regulations 11
J Updating a PFMEA (Process FMEA) after a Process Failure FMEA and Control Plans 3
S Requirements for Updating a Medical Device Technical File EU Medical Device Regulations 11
D Updating Training Procedures when other documents change - Over Kill? Training - Internal, External, Online and Distance Learning 14
C ISO 13485 Gap Analysis Checklist - Updating ISO 13485 from the 1996 standard to 2003 ISO 13485:2016 - Medical Device Quality Management Systems 2
D Updating Flow Diagrams - Internal Critical Characteristic Identified FMEA and Control Plans 4
John Broomfield Informational Terms used in quality management Misc. Quality Assurance and Business Systems Related Topics 5
D Imaging/Image Quality Standards Other Medical Device Related Standards 1
D Quality Team Structure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Similar threads


















































Top Bottom