"Licensed" copy of ISO 9001 Standard During Audit - Has an Auditor Asked for Proof?

Antonio Vieira

Involved - Posts
Trusted Information Resource
#21
I perform registration quality audits for one of largest registrar organizations in the world. Frankly I never loose any time in asking this “important” thing to the audited organizations.
By reading what some colleagues are doing elsewhere, I’m just assuming they have lots of time left during their audits...
:notme:
 
Elsmar Forum Sponsor
#22
Systems are audited to criteria (hopefully you know that:rolleyes: ). If they meet the criteria, fine, if not, oh well. Where is it dictated that the criteria "MUST" be used to establish the system?
Well, yes, Randy, of course. Spoken like a true auditor! :rolleyes:

However, your 'story' is biased towards auditing!:notme:

Requirements such as ISO 9001 et al, are not uniquely 'audit criteria'. They are implementation requirements. If you go back through the mists of time, way past the date you were trained to audit :cool: , back to the days before registrars were visited as a plague on industry:mg: .......you will find that most qms requirements were a contractual specification used as the basis of agreement between a customer and a supplier. Indeed, it was the proliferation of such customer/supplier requirements which made way for ISO 9000 to be so universally acceptable - but it took the third party auditors to (ab)use it as simply audit criteria.:lmao:

Since the use of the specification should be as the basis for the implementation and not uniquely for audit (see the 'scope' and 'applicability' statements) it would important for someone in the organization to posses a copy.:yes:

After all, you wouldn't want to buy a house which had been designed by an architect who didn't have a copy of the building regs, would you? - even if the building inspector had the latest version -it's too late to find out once the house is built.........:yes:

Andy
 
B

Baldrick

#23
The original post was asking "Must you be able to show an auditor that you own a copy of ISO9001". Several posts so far have correctly pointed out the answer to this as "absolutely not".

Other posts have touched on the subject of copyright issues - do copies of the standard have to be original, purchased copies?

I have to say that under UK (and I suspect other countries') copyright law, you are definitely NOT permitted to buy one copy, then photocopy it as many times as you like. It doesn't matter if you have an original copy somewhere.

There are some relaxations of this - e.g. you can make temporary copies for training purposes, but these have to be withdrawn and destroyed. You can also lend the document within your organisation, but as soon as you make a copy you are breaking the law. This applies to electronic downloads as well as hard copy versions.

Our BSI auditor occasionally asks to see that all of our copies are originals (we purchased 10 copies for our internal auditors), and I have put a sticker on each identifying it to an Excel database that logs who has it, etc.

I'm also reasonably sure that if he were to see an illegal copy, he is obliged to report it. Especially since he works for the company that stand to lose $$$ through illegal copying of standards. I'm certain that our guy would raise it.

Randy and others are right to say it is not a big issue, but I did hear several years ago about a major computer manufacturer who were fined a large amount when an auditor discovered ONE photocopy of ISO9001. The fine was based not on how many illegal copies were actually found, but how many copies a company of that size would be expected to have, given that copyright was shown to have been infringed.

These stories are few and far between, which suggests no-one cares that much - but SOMEONE will get caught next.
 
T

tyker

#24
Our BSI auditor occasionally asks to see that all of our copies are originals (we purchased 10 copies for our internal auditors), and I have put a sticker on each identifying it to an Excel database that logs who has it, etc.

I'm also reasonably sure that if he were to see an illegal copy, he is obliged to report it. Especially since he works for the company that stand to lose $$$ through illegal copying of standards. I'm certain that our guy would raise it.

.
I'm an ex-BSI auditor and, on many occasions, pointed out to companies the error of their ways in photocopying standards but I never reported it back to BSI Standards. That's a separate part of BSI and I would have regarded such communication as a breach of confideentiality. I did raise NCs for the use of uncontrolled documents.
 
B

Baldrick

#25
:topic:

Thanks for your insight Tyker - I think you've raised an interesting point here. You see something that you know to be illegal (in this case, a minor issue), but you also have a confidentiality clause in place with the "perpetrator". How do these trade off against each other?

Let's forget the copyright debate - if you see something REALLY illegal during an audit, aren't you obliged to report it by law? Can you "hide" behind a confidentiality clause?

And what would happen if you reported such an illegal activity? Could the perpetrator still sue you for breach of confidentiality, even if the activity that was reported was clearly illegal? :confused:

Anyone?
 

Randy

Super Moderator
#26
English guys I'm an auditor too (and we have something in common) and one of the least important things I worry about is their copy of the standard, if fact I have never asked because I consider it a bogus, bs question. In the total sum of things who really gives a qrap anyway? There are many more important issues during an audit than looking at a standard.
 
G

Gert Sorensen

#27
English guys I'm an auditor too (and we have something in common) and one of the least important things I worry about is their copy of the standard, if fact I have never asked because I consider it a bogus, bs question. In the total sum of things who really gives a qrap anyway? There are many more important issues during an audit than looking at a standard.
Sure sounds like more than fun to be audited by you. I'd like to try it sometime....
 

gpainter

Quite Involved in Discussions
#29
The desk audit usually covers the addressing of "shalls", usually after that it is "are you following your requirements that should meet or in some cases exceed the standard?".I do not think that I would worry about if they had a purchased or copied standard as long as it was current. How many of us have copies? As long as you are not selling them? Maybe we can do a poll on this in another thread?
 

Ajit Basrur

Staff member
Admin
#30
Well said gpainter. In fact this question popped up to me when I was reading the thread on "free" standards.

This thread highlighted different perspectives to a single question and was very interesting to read.
 
Thread starter Similar threads Forum Replies Date
A What ISO 9001:2015 clause could be used to write nonconformance for not updating licensed driver list? General Auditing Discussions 8
Q What is the difference between normal and licensed internal auditor? VDA Standards - Germany's Automotive Standards 9
Jane's What steps do you take to terminate a product which was licensed for sale in Canada Canada Medical Device Regulations 14
S Why Drugs and generics are Approved while Biologics are Licensed ? US Food and Drug Administration (FDA) 1
K Advertising as MDEL (Medical Device Establishment Licensed) Canada Medical Device Regulations 6
Y How can a Marketing Authorization Holder (MAH) be Licensed? Japan Medical Device Regulations 5
Q Health Canada - Licensed Devices now considered Drugs? Canada Medical Device Regulations 2
S Licensed Quality Engineer - Which states actually license "Quality Engineers"? Quality Manager and Management Related Issues 22
Wes Bucey FAA licensed pilots submit false medical reports Federal Aviation Administration (FAA) Standards and Requirements 4
J Argentina Asked for FSC Hard-Copy Edition Only Other Medical Device Regulations World-Wide 0
G Copy of withdrawn ISO 9001:1994 Quality Management Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A EC declaration of conformity - In the event clients ask for a copy CE Marking (Conformité Européene) / CB Scheme 12
J Where I can get a copy of either the 3rd or 4th edition of UL544? Other Medical Device Regulations World-Wide 7
A MDRS Standards Harmonisation - copy of ISO 15223-1 EU Medical Device Regulations 3
K Does anyone have a copy of a GM 5 Phase Problem solving form Problem Solving, Root Cause Fault and Failure Analysis 1
W Is it required to stamp obsolete hard copy DHR's "obsolete"? ISO 13485:2016 - Medical Device Quality Management Systems 6
V IATF 16949 - Buy PDF copy IATF 16949 - Automotive Quality Systems Standard 11
R Please help me with attached copy of AS 9100D internal audit check sheet AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A Alternative to keeping hard copy records that is 21 CFR part 11 compliant Document Control Systems, Procedures, Forms and Templates 0
S Looking for English Copy of MHLW 169 regulation Japan Medical Device Regulations 5
D Need a copy of IATF 16949 IATF 16949 - Automotive Quality Systems Standard 2
M I am looking for a copy of the ISO 16232 standard Other ISO and International Standards and European Regulations 2
C PDF Copy of IATF 16949:2016 IATF 16949 - Automotive Quality Systems Standard 1
A Where to find a Draft Copy of IATF 16949:2016? IATF 16949 - Automotive Quality Systems Standard 23
M Where to buy ISO 3951-1 and ISO 3951-2 standard copy Other ISO and International Standards and European Regulations 1
N Can anyone provide me a copy of uncertainty in excel file? Excel .xls Spreadsheet Templates and Tools 4
J Legal source to purchase a copy of the 9001:2015 Draft ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
F How to copy a Minitab graph template Using Minitab Software 3
Wes Bucey Code of Federal Regulations Electronic Copy Searchable Database Quality Manager and Management Related Issues 1
G Could I destroy my DHR hard copy after 2 years after pdf'ing them ? ISO 13485:2016 - Medical Device Quality Management Systems 4
A Minitab - Using the INSERT command to copy-paste text from and to a worksheet Using Minitab Software 6
A Copy-Paste in Minitab using Session Commands Using Minitab Software 5
H Layered Process Audit Hard Copy Records Retention Records and Data - Quality, Legal and Other Evidence 6
I Electronic vs. Paper Copy Document Approval Process Document Control Systems, Procedures, Forms and Templates 9
R Para 4.2.2 b) Referenced Documents - Adequate referencing? Copy and Paste? ISO 13485:2016 - Medical Device Quality Management Systems 5
M Can Copy of ISO 9001 be shared by affiliated companies? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
G Document Control-AS9100 - Marking of Documents as Master Copy of Controlled Copy AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Proud Liberal Table of Capability Indices - Copy from Minitab to Excel Using Minitab Software 3
P ISO 9001:2008 - I'm missing page 3 in my copy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Should I submit the entire copy of my software in a 510(k) submission?? US Food and Drug Administration (FDA) 7
shimonv Requirement for a Printed Copy of the User Manual with a Medical Device US Food and Drug Administration (FDA) 3
R Declaration of Conformity Paper Copy Shipped with Product? CE Marking (Conformité Européene) / CB Scheme 1
Mikishots Trying to locate a LEGIBLE MIL-STD-105E copy Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
C Hard Copy Documents not in Fireproof Cabinets - Document Storage Questions... ISO 13485:2016 - Medical Device Quality Management Systems 3
M Looking for a copy or template of a In House Calibration Report for a Dial Indicator General Measurement Device and Calibration Topics 1
R Control of Documents - Drawing (soft copy) for further work by other Consultants Document Control Systems, Procedures, Forms and Templates 1
S Contribute to research and have the chance to win an iPAD 2 or a copy of Minitab 16 Coffee Break and Water Cooler Discussions 1
V Disabling Copy Paste option in MS Word After Work and Weekend Discussion Topics 30
I MDNR (Medical Devices National Registry) and Hard Copy Other Medical Device Regulations World-Wide 3
S Document Control - Does the Intranet Copy need to be Stamped "CONTROL COPY". ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9

Similar threads

Top Bottom