ISO 10011 Dead - 19011 Is Released - A summary of differences



Subject: Re: ISO AUDITING /Tomo/Arter
Date: Mon, 26 Jul 1999 11:27:47 -0600
From: ISO Standards Discussion

From: Dennis Arter
Subject: RE: ISO AUDITING /Tomo/Arter

Handoko Tomo writes:
>I want to know about criteria of audit finding in ISO14001 and
>ISO9001/ISO9002? Are findings different from observations? What's
>the code of practice for ISO14001 auditors and ISO9000 auditors?

To answer the question fully, one must consult three reference
ISO 8402:1994 (Vocabulary)
ISO 10011:1990 (Quality auditing)
ISO 14010:1996 (Environmental auditing)

The 8402 vocabulary standard provides limited information. Only the term QUALITY AUDIT OBSERVATION is given. It is defined as a "statement of fact made during a quality audit and substianted by objective evidence." You can see that an OBSERVATION can be good or bad. It is a fact. In my teachings, I suggest that it not be used, as it has been quite abused over the years. Some of this abuse is my doing. In the first edition of my book (1987), I suggested that an OBSERVATION was a precurser to something more serious. Sort of like a mini-finding. I was wrong. I corrected my oversight in the second edition, released in 1994.

The 10011 quality auditing standard repeats the 8402 definition of OBSERVATION, dropping the words "quality audit." No problem there. The quality auditing standard also picks up NONCONFORMITY from 8402, as "the nonfulfillment of specified requirements." This is an interesting historical point. When 8402 was first published, NONCONFORMITY was placed under the inspection concepts. This placement carried over for the second edition in 1994. But when the quality audit standard, 10011, was being written in 1989 and 1990, the British model of third-party registration was sweeping the world. The British auditors had picked up the inspection term NONCONFORMITY and were now using it in an audit application! They even attached major and minor classifications to it. Because of the huge British influence in the 10011 development, it is only natural that the term nonconformity would appear in the new standard. Now, I am not trashing the British or the French or the Japanese or any other nation. I am merely showing that standards are developed by "those that show up." The British show up on these committees.

Later on in the 10011 quality auditing standard, the text says, "After all activities have been audited, the audit team should review all of its observations to determine which are to be reported as nonconformities." The word FINDING never appears in the 10011 quality audit standard, even though auditors have been using it for centuries. This is one of the many reasons why an international effort was started over five years ago to revise the 10011 standard. (More on that revision effort below.)

The 14010 environmental auditing series of standards (14010, 14011, 14012) came out in 1996. The terms NONCONFORMITY and OBSERVATION are not used. Rather, AUDIT FINDINGS is presented as, "results of the evaluation of the collected audit evidence compared against the agreed audit criteria." This is a very useful definition, as it can be used to report good stuff as well as bad stuff. In actual practice, however, FINDINGS are mostly used in a negative manner.

As I reported a couple weeks ago, the ISO committees are combining the quality and environmental auditing standards into one: 19011. The first working draft was recently released for comment. In that working draft, the terms CONCLUSIONS, EVIDENCE, and FINDINGS are all defined. The term NONCONFORMITY is missing; although, it creeps into the text every now and then. In my comments back to the committee, I suggested use of the terms FINDING OF NONCONFORMITY and FINDING OF CONFORMITY be used as a compromise between the quality registration camps and the environmantal camps. Only time and several more meetings of the committee will tell.

In a reply to Handoko Tomo, Larry Hillyer states:
>A Finding is something that is either a Minor or Major finding.
>Either one, it details what the auditor found to be "not what you
>said you were doing, was or was not found". The Observation is
>something the auditor noticed that is of possible importance to
>the system, and take the advice and do what you want with it. It
>may be in your interests to improve your system by treating as a

I believe Larry has been misinformed. Perhaps he is still using the old version of my book. [smile]

What's the moral of the story? Use the international and published definitions whenever you can. If they don't work for you, use definitions of your own. But put these definitions in your audit procedures! And define the words in your audit reports. Insist that your third-party registration auditors do the same, in both their procedures and their reports.

Dennis R. Arter
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ISO 10011 Dead - 19011 Evolves

Subject: RE: Guidelines for auditing quality systems /Ramirez/Arter
From: Dennis Arter

Reinaldo Ramirez wrote earlier:
>Does some person in the list know something about the ISO
>10011:2000 as mentioned in ISO/CD2 9001:2000 Bibliography page 27?

ISO 10011 is a dead document, which means it will not be maintained. The Technical Management Board of ISO directed the quality folks (TC 176) and environmental folks (TC 207) to come up with a common standard for auditing both management systems. That writing project has started. The combined standard will bear the number 19011.

Last month, the TC 176 (quality) folks met in San Francisco, where the various drafts were worked. The output of that effort was a proposed Committee Draft (CD). Before it can be released for comment and ballot, it must also be acceptable by the environmental folks (TC 207). That should happen in a few months. (These two very large committees are working closely, but they are not exactly in "synch.")

>If a copy of the document ISO/TC 176/SC 3/WG 7 N94 Date: 1998-02-
>27 Working Draft: WG 7-WD 3 of ISO 10011.

All of these older draft documents are considerably out of date. They should not be used. That is not to say that the older documents are bad, however. Much of the previous work from the effort to update 10011 has found a new home in 19011. Those of us on the 19011 writing committees do not yet have the CD yet.

Dennis R. Arter

[This message has been edited by Marc Smith (edited 22 December 1999).]

Roger Eastin

Yeah, now that you mention it, I do remember reading that post. I guess, because the reference to it is not in the same vein as my previous post, I forgot about it. (Also, this reference is to ISO19011, not ISO19001 which is the one that I saw at the ISO website.) Still, for the potential impact of this standard, I was surprised that its implementation date was so soon and yet, not much has been said about it. I wonder if it will replace ISO9000 and ISO14000 or will just give companies an option to "do it all at once", if they so decide(leaving ISO9000 and ISO14000 intact)? Does anyone have a copy of the Committee Draft of ISO19001? If so, how does it read? (I think I'm going to see if I can get the draft of this one.)


Fully vaccinated are you?
Staff member
Subject: FYI: USA Standards Group Meeting /Arter
Date: Wed, 1 Dec 1999 16:08:52 -0600
From: ISO Standards Discussion

From: Dennis Arter

Report on US TAG Standards Group Meetings

The US Standards Group on Quality, Environment, Dependability and Statistics (QEDS) met in Crystal City, Virginia, the week of November 15, 1999. While many issues were discussed and work was conducted by all working groups, there were several issues surrounding the Draft International Standard (DIS) of ISO 9000:2000 series that bear reporting.

(The pre-publication editions of the DISs (available for translation) were provided to the members of Task Group (TG) 18 for their use in starting the development of a US position. These copies were retrieved after the meeting.)

The issues of concern to the US Technical Advisory Group (TAG), which formulates the US position on documents developed within ISO Technical Committee (TC) 176, are as follows:

A. Non-conformance

Although the requirements for non-conforming products (clause 4.13 in the 1994 edition) had remained virtually unchanged in the new version through the second committee draft (CD 2), the pre- publication version of the DIS being worked on by the International Organization of Standardization (ISO) now has some changes. These changes were apparently made to make the document easier to use in the service sector. This raises issues with manufacturing oriented people since some of the older requirements have been dropped and there are now no directions for the disposition of non-conforming products.

B. Documented procedures

Throughout the DIS, there has been a significant and intentional reduction in the number of places which have specific requirements for documented procedures within the clauses. Although there is some general discussion in Section 4, some participants indicated that the DIS may go too far in eliminating requirements for procedures.

C. Document vs. Record

There are lingering questions concerning the use of documentation terms. In specific, the definitions of "record" and "document" needs to be clarified. This is not considered a significant concern.

ISO 19011, the integrated standard for internal auditing of quality and environmental management systems, is planned for release as a DIS in the September-October 2000 time frame to correspond with the release of ISO 9001:2000 as an FDIS. This will be one of the four core documents contained in the ISO 9000 family. This is down from dozens of documents to ISO 9000, ISO 9001, ISO 9004 and ISO 19011. There is also one international document that is frequently included with these four documents: ISO 10012 on measuring equipment.

Dennis R. Arter

[This message has been edited by Marc Smith (edited 22 December 1999).]

Richard K

Having had a chance to read the CD1 of 19011, I can say that there appears to be nothing earth-shattering. It seems to be simply a rewrite of 10011-1 to remove references to quality and make it more generic. Then in the training/qualifications section (the old 10011-2) it talks about the training and qualifications necessary to audit to each particular standard.


Luis Santos

Message for Richard or anyone else who may have knowledge on this subject:
Did the ISO/CD1 19011 get released ? If so, can it be obtained somewhere on
the internet?
Or if anyone can send me a copy by e-mail I very aprecciate. ([email protected])

Richard K

Oops. Sorry - I neglected to mention that I don't actually have a copy. I merely had an opportunity to read a copy in the possession of a member of the ISO working group. As far as I know, the CD has not been published yet.



CD1-ISO 19011

This message is posted at

Updated: 11th January, 2000

ISO 19011; A new standard for auditors:

All auditors need to be aware of the development of ISO 19011, the new standard that
combines into one document the auditing guidelines for quality management systems
(ISO 10011) and environmental management systems (ISO 14010, 11 &12). In addition,
the new standard is designed to include guidance for internal auditors.

The effect of this new standard

The certification criteria against which IRCA evaluates all auditors are based on the
internationally recognised auditing guidelines. Any significant change in the auditing
standard will therefore cause a similar change in the certification criteria.

It is very likely that the new standard will include some significant changes. It is equally
likely that the IRCA criteria will be amended to incorporate the changes. These changes
may be reflected both at the initial certification stage and at the three-yearly renewal.
However, the development of the standard is at an early stage (CD 1) and, as is usual
practise, it is likely that there will be further amendments to this draft. It is not therefore
appropriate to detail the changes (from ISO 10011 & ISO 14010, 11 & 12) at this time.

IRCA is monitoring very closely the progress in development and will provide information in
a Q&A format when the nature of the changes becomes clearer, at around the time of
issue of the Draft International Standard (DIS).

Timetable for Development & Issue:

Committee Draft 1 (CD1) released for comment November 1999

CD2 circulated for ballot March 2000

Draft International Standard (DIS) circulated for comment September 2000

Final Draft International Standard (FDIS) circulated for comment March 2001

ISO 19011:2001 issued for use September 2001

Auditors who are interested in knowing more about this new standard or who wish to
contribute to its development are advised to contact their National Standards Body or the
International Organization for Standardisation.

Does somebody have any information regarding this CD1?

Senior Member ASQ (1986)
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