SBS - The best value in QMS software

Is not having a controlled copy of ISO 9001 standard a NonConformance?

Is not having a current copy of ISO9001:2000 a Nonconformance?

  • Yes

    Votes: 5 21.7%
  • No

    Votes: 18 78.3%

  • Total voters
    23
  • Poll closed .

Patricia Ravanello

Quite Involved in Discussions
Re: Not having an original copy of ISO 9001 standard, Is it a NonConformance?

My point was simply that a "copy" as long as it is the latest revision is OK. How you obtain it may raise other questions:notme: but if I can show revision control on my "copy" I would argue only that it is not a finding.

End of my story and I am off to catch those bigger fish I want to fry...

Thanks to all
Agreed...auditors don't have to bother themselves with the legality of the "copy" provided. They're not copyright police.

Patricia
 
Elsmar Forum Sponsor

Paul Simpson

Trusted Information Resource
Re: Not having an original copy of ISO 9001 standard, Is it a NonConformance?

Please excuse me reordering your points. I wanted to answer the main question first.
I'm just curious...why so adamant and/or defensive about not having a copy (not just Tyker...anyone???)
The original poll was for covers to decide if a nonconformity exists merely because a current copy of ISO is not held. Some said yes, others like me said no because I don't believe there is a contravention of the standard requirements. So we are not necessarily defending people who don't have copies of the standard but saying you can't raise an NC just because they don't have one. As an auditor you have to identify a failing and the cause could be that the MR doesn't understand the requirements well enough because they don't have a copy of the standard.

|Why wouldn't you have a copy? What did you use when you designed and documented your system?
As has been said earlier many on the cove know the requirements well enough to design an effective system.

People like me even prefer you document a management system (that BTW must already exist for an organization to operate) without using the standard but based on the principles of systems thinking; process approach; involvement of people; anlaysis of data etc., etc. (Familiar?). At the end if you have used good practices then the system will automatically meet all of ISO 9001.

If you want to check yourself you might get some value from your own copy of ISO 9001. ;)
|Did your management team never ask..."Show me where it says that we have to do that?...."
I would hope that people who have given me a job (to implement a management system) would trust me enough to describe what they do in a way that meets the standard. IMHO the only time I hear "Where does it say that?" is if the system is poor and is tying a department up in paperwork for no good reason.
|When you conducted internal training to introduce the standard and the system, did you never pull out the book?
OK, agreed it is fine as a presentation prompt.
| Do all of your internal auditors have the sub-clauses and their contents committed to memory?
No need - they look at the system documentation. Audits should be carried out against the documented system (that should meet the requirements of ISO 9001 if it has been designed correctly - see 1st point above).
|Not having a copy of the standard is like saying you don't need your "Bill of Materials' after you've designed and created a new product...
I don't quite agree with the analogy. A BOM is a very specific listing of parts. ISO is a broad management system standard. But - to use your analogy - I wouldn't expect someone on the shop floor to need access to the BOM. Their work instructions (verbal or written) should tell them what parts to use for their work activity.
 

Patricia Ravanello

Quite Involved in Discussions
Re: Not having an original copy of ISO 9001 standard, Is it a NonConformance?

The fact is that a Nonconformance was issued because he didn't have a "Controlled Copy" not that he didn't have a copy.
.
Hi Coury,
I realize that the original issue was the lack of a "controlled copy", but it evolved into a question of whether you need to have any copy at all, and many contributors seem to feel that "no copy" is required, be it controlled, uncontrolled, original, electronic, photocopied or otherwise.

A verification of the "inputs" to Internal Audit would no doubt uncover the need for some form of the standard to be available (regardless of it's legal implications). Failure to produce the "input" document might raise concerns at an audit...or even a non-conformance, but as so frequently stated in this thread, most auditors have bigger fish to fry.

I think I've exhausted my perspective on this subject. I'm outta' here :magic:

Thanks,
Patricia
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
Re: Not having an original copy of ISO 9001 standard, Is it a NonConformance?

Hi Coury,
I realize that the original issue was the lack of a "controlled copy", but it evolved into a question of whether you need to have any copy at all, and many contributors seem to feel that "no copy" is required, be it controlled, uncontrolled, original, electronic, photocopied or otherwise.

A verification of the "inputs" to Internal Audit would no doubt uncover the need for some form of the standard to be available (regardless of it's legal implications). Failure to produce the "input" document might raise concerns at an audit...or even a non-conformance, but as so frequently stated in this thread, most auditors have bigger fish to fry.

I think I've exhausted my perspective on this subject. I'm outta' here :magic:

Thanks,
Patricia
I really hate to see that you feel that you have exhausted your perspective. I don't think you have.

The OP hasn't been back in awhile to provide the results.

I agree with you whole heartily that you need a copy of the Standard, and I think most people do.
 
Re: Not having an original copy of ISO 9001 standard, Is it a NonConformance?

Good Grief! Time to change CB's? ;););):notme:
Automotive Certification Scheme for ISO/TS 16949:2002 Rules for achieving IATF recognition Section 3.3 said:
At least one auditor of the initial audit team should participate in all audits of the three year audit cycle. For each subsequent audit cycle, different auditors should be used.
Emphasis mine, NB those are should and not shall. If my CB sends another hack in here they may lose a customer by taking a hard line on this section. During closing meetings, my executive staff would actually thank our initial auditor for his findings.

Make that three more now. :tg:
I make it six at this point but who's counting.:rolleyes:

Unless the auditor can prove that you are not using a current version of the ISO standard, it doesn't matter if the one you have is a copyright infringement, written in crayon or displayed in lasers on your ceiling. This is not a finding. If you sent a PSW last week and are still using PPAP 3rd Edition and you don't have a customer request on file that you stay with 3rd Edition, now that's a finding.
 

Stijloor

Staff member
Super Moderator
Re: Not having an original copy of ISO 9001 standard, Is it a NonConformance?

Friends,

Time for an update (in case you missed it!) ;)
On September 5, 2008 at 9:09 P.M.

According the Top Ten Cove statistics, this thread ranked:
  • #2 in "Most viewed" 2,632 :applause:
  • #1 in "Most replied to" 104 :applause:

All this was triggered by a question related to a document that cost 102 Swiss Francs....

Where else can get so much response and participation for that kind of money than on The Cover Forums? :lol:

Keep responding folks....:agree1:

Stijloor.
 

BradM

Staff member
Admin
Re: Not having an original copy of ISO 9001 standard, Is it a NonConformance?

Friends,

Time for an update (in case you missed it!) ;)
On September 5, 2008 at 9:09 P.M.

According the Top Ten Cove statistics, this thread ranked:
  • #2 in "Most viewed" 2,632 :applause:
  • #1 in "Most replied to" 104 :applause:

All this was triggered by a question related to a document that cost 102 Swiss Francs....

Where else can get so much response and participation for that kind of money than on The Cover Forums? :lol:

Keep responding folks....:agree1:

Stijloor.
Stijloor, thank you for making mention of this.

Friends, old and new.... please don't be afraid to ask a question. What may seem like a basic question... may not be. Some of my most respected (and knowledgeable) friends in the quality field have responded and carried on a most spirited discussion on this. In the end.. I'm not sure if there is a slam-dunk answer to this. But please, anyone reading this, let this show two things. 1) I think that most auditors are good people and truly care about the job they are doing. Keep that in mind. 2) Auditors are human, and some decisions may be based on experience, training, and sheer gut feeling. In the end, the audit report is yours, to do with the information as you see fit. But in the words of the great one "Seek first to understand, then to be understood". Your auditor may have some basis behind their reporting, and you can benefit by trying to see their side of the issue.
 

Stijloor

Staff member
Super Moderator
Re: Not having an original copy of ISO 9001 standard, Is it a NonConformance?

But in the words of the great one "Seek first to understand, then to be understood". Your auditor may have some basis behind their reporting, and you can benefit by trying to see their side of the issue.
:topic: It's #5 of the "Seven Habits of Highly Effective People." by Stephen R. Covey; a great read for everyone seeking improvement in their own lives.

Stijloor.
 
Last edited:

Stijloor

Staff member
Super Moderator
Re: Not having an original copy of ISO 9001 standard, Is it a NonConformance?

External Auditor issued a NC for not having the original standards of ISO9001:2000 with us. We have only uncontrolled copy of the standard.

My question is :

which clause address this requirement?
I am curious. Has your question been answered? ;)

Stijloor.
 

eternal_atlas

Involved In Discussions
Re: Not having an original copy of ISO 9001 standard, Is it a NonConformance?

I am curious. Has your question been answered? ;)

Stijloor.
This is the answer, I got from this thread sofar..I agree with this as an auditor..

There is no requirement in ISO 9001:2000 stating that you must have a controlled copy of ISO 9001:2000. Thus the absence of such a document does not constitute a nonconformity. By Stijloor

I don't think it's a valid or value adding nonconformity for a CB to raise…….. By Tyker

My contention is that so long as the system as a whole is compliant, an auditor shouldn't be concerned with whether there's a copy of the standard in evidence or not.. By Jim Wynne
 
Thread starter Similar threads Forum Replies Date
J Ever heard of having a Controlled SOP template? Document Control Systems, Procedures, Forms and Templates 12
J Having to say about controlled documents on forms,WI,and procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
NDesouza No Quality Professional vs Having a Quality Professional Benchmarking 24
A EU MDR Annex I section 11.3 - Medical Devices labelled as having a specific microbial state EU Medical Device Regulations 7
O Inspecting paint and having workable standards in the supply chain Supplier Quality Assurance and other Supplier Issues 1
P Received a minor for not having good measureables/goals. Need help with KPIs. IATF 16949 - Automotive Quality Systems Standard 52
N GDP - Having to provide a reason when writing N/A? ISO 13485:2016 - Medical Device Quality Management Systems 1
O How do reduce the risk of suppliers having similar problems? Supplier Quality Assurance and other Supplier Issues 4
D Having got ISO 13485:2016 are you dropping ISO 9001? ISO 13485:2016 - Medical Device Quality Management Systems 8
Q Partial non applicability of ISO 9001 Cl. 7.1.5 (not having services)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Not having an internal audit during the year ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
T Having Fun While Learning ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S Having a hard time closing CAR/ PAR Nonconformance and Corrective Action 13
M Justification for Not Having a Validation Plan for a Critical Process ISO 13485:2016 - Medical Device Quality Management Systems 4
I Not having "effectiveness" in the Quality Policy ISO 13485:2016 - Medical Device Quality Management Systems 8
U Root Cause for a Form not having all info (traceability standard and the gage number) Problem Solving, Root Cause Fault and Failure Analysis 14
M How to compare 2 independent samples having 3 factors 3 levels Statistical Analysis Tools, Techniques and SPC 5
W Thoughts on having Safety Shower in ISO Class 7 Cleanroom ISO 13485:2016 - Medical Device Quality Management Systems 5
T Customer Escape of a part having features reversed 180 degrees Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
ScottK Is anyone else having problems uploading Proprietary Names into the DRLM? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
K Calibration Standards - Master weight having more tolerance than our gram scale General Measurement Device and Calibration Topics 3
D Having trouble with corrective action on external audit nonconformance Nonconformance and Corrective Action 8
S Minor NC for Not Having Management Review When Scheduled Management Review Meetings and related Processes 12
B Example of Production Process Change having Significant Consequences AS9100C 7.5.1.2 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
C Can a Company get away with not having Employees Trained to the Processes they use? Training - Internal, External, Online and Distance Learning 2
J DOE Analysis Experiment, 5 factors, 4 factors having 3 levels, and 1 factor having 5 Using Minitab Software 38
B Having trouble writing a directive (procedure) that points to the right place ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
J What is the advantage of having an NCA 3800 Quality Certificate Various Other Specifications, Standards, and related Requirements 3
N Benefits of having an EDMS in a Construction Company Various Other Specifications, Standards, and related Requirements 5
S CE Label having the indication for the applied part EU Medical Device Regulations 7
Marc Florida Professor Arrested for Having a "Suspicious" Bagel on a Plane Travel - Hotels, Motels, Planes and Trains 14
F Reliability of a System - Estimation of R(t) having constant failure rate "Lambda" Reliability Analysis - Predictions, Testing and Standards 2
D What is the basis for having 1 or 6 Quality Manuals? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
V Having quality in your resume in today's economy. Imported Legacy Blogs 3
C What is the Purpose of or Requirement for having a Gage Glossary? IATF 16949 - Automotive Quality Systems Standard 2
I Not having Training Records for Documentation Changes - ISO 13485 Clause 4.2.3 Document Control Systems, Procedures, Forms and Templates 22
C Objective Evidence of Internal Auditors having Audit Clause 4.1. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
S Feasibility of having one Quality Manual that documents 2 businesses? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Ajit Basrur Anyone having procedure on "Handling Regulatory Audits" ? US Food and Drug Administration (FDA) 2
somashekar Optical epoxy for LED having good thermal shock resistance. Manufacturing and Related Processes 2
Q 510k for Exempt Class I Medical Device - Industry Advantage to having a 510k Approval 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
L Having faith in your Layered Process Auditors - Pencil whipping audits Process Audits and Layered Process Audits 8
P Having only influential control for some Legal needs. Miscellaneous Environmental Standards and EMS Related Discussions 2
S What are the consequences of having an expired ISO 9001:2000 Certificate ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
J Advantage of having 2 marks - RvA and ANAB, for example Registrars and Notified Bodies 5
L Objectives: Measurable or having a tangible value? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R Evaluate Customer Satisfaction without having to send questionnaires Supplier Quality Assurance and other Supplier Issues 2
Ajit Basrur Anyone having ppt file on Advisory Notices ? ISO 13485:2016 - Medical Device Quality Management Systems 2
Ajit Basrur Can you recommend websites having GMP posters? Training - Internal, External, Online and Distance Learning 6
MarilynJ6354 Observed Audit Behavior - Internal auditors having lunch with the auditees Internal Auditing 32

Similar threads

Top Bottom