Process approach to auditing ISO 9001:1994

[Alexander Keith]

hello everyone,

I am an infrequent poster to this forum and today I am looking for expert opinions on the process approach to auditing the 1994 version of ISO 9001.

For the 1994 version of ISO 9001 (94) I am used to auditing element by element. Recently someone mentioned that on Pg 11 and 12 of a reference booklet called "The ISO 9000 Essentials- A Practical Handbook for Implementing the ISO 9000 Standards" it made reference to a conceptual model of grouping the ISO 9001:1994 elements under certain processes. That person then drew the conclusion that the intent of even the old ISO 9001:1994 was process oriented.

I have not been able to locate a copy of this Handbook to get a look at this conceptual model and thus the reason for my posting on your forum today. In your expert opinion, is this conceptual model a true model for a process approach to auditing and is it applicable to a standard such as ISO 9001:1994?

Sincerely,

Alexander Keith

 

[Coury Ferguson]

Re: process approach to auditing ISO 9001 (94)

One question: Why are you looking to audit the 1994 version which is no longer an accepted standard? It is either 2000 or 2008 version, which are the only accepted standards at this point.

 

[AndyN]

Re: process approach to auditing ISO 9001 (94)

I'll humo(u)r you and show you with my 'football' diagram (Shown in this thread Internal Audit Schedule for Multi-site certificate? ) that you can audit a process within an ISO 9001:94 based quality system. Indeed, I developed my football while teaching process audits before the 2000 version.

It should be pretty easy to take each 'bubble' and put the relevant '94 clause number along along side it.

 

[Cari Spears]

Re: process approach to auditing ISO 9001 (94)

Why are you looking to audit the 1994 version ...

That's what I was going to ask.

 

[Sidney Vianna]

Re: process approach to auditing ISO 9001 (94)

In your expert opinion, is this conceptual model a true model for a process approach to auditing and is it applicable to a standard such as ISO 9001:1994?

That is the only sustainable approach, not only to auditing, but, and more importantly, to implement a quality management system.

When I started auditing quality systems in the late 80's, I was cognizant of the fact that, even though standards, such as ISO 9001 were written in distinct clauses/elements/paragraphs, the interfaces existed and, even though, we did not refer to as process-based auditing, the concept of auditing processes was pretty much ingrained. I remember making presentations about ISO 9000 in the early 90's and criticizing the much maligned "say-what-you-do-what-you-say" approach and trying to explain the standard via the PDCA cycle. It was an eye opener for some. But, in my view point, that was the only meaningful way to understand ISO 9001.

Attached you will see a document with the cover page and a separate page from ISO 9004:1987. In the second page, you will see a "quality loop" diagram. I suspect that it was the first attempt to understand QMS as a collection of interconnected processes. If you notice, in paragraph 5.1.1, they talk about activities. I obviously know that ISO 9004:1987 is not the same as ISO 9001:1994 that you are asking about, but I submit that the TC 176 has always intended to explain a QMS as a process based system. Their early attempts missed the mark, "ending up" with the major change in the year 2000.

 

[Alexander Keith]

Re: process approach to auditing ISO 9001 (94)

Well I better explain why I'm focusing on ISO 9001 (94) ...

... there are still organizations which I am responsible to audit with systems based on ISO 9001 (94) and which operate on the "say what you do, do what you say" principle ... ie: procedures for everything. I am a third party auditor, not a Registrar.

Recently there has been talk about using a process approach methodology to audit these organizations but I don't know more than that at this stage. If these organizations had systems based on ISO 9001:2000 that would logical but I have trouble visioning how that can be applied to ISO 9001:1994.

BTW does anyone have a copy of Pg 11 & 12 of the ISO Essentials Handbook by any chance?

Thanks!

Alexander Keith
over & out

 

[Stijloor]

Re: process approach to auditing ISO 9001 (94)

<snip>Recently there has been talk about using a process approach methodology to audit these organizations but I don't know more than that at this stage. If these organizations had systems based on ISO 9001:2000 that would logical but I have trouble visioning how that can be applied to ISO 9001:1994.

The Process Approach can be always be utilized regardless the version/year of the Standard. I have always promoted, taught and audited utlilizing the Process Approach. Processes always existed, that's nothing new at all. Regretfully, folks got too wrapped up in the "clause-by-clause" business because that's what 3rd party auditors tended to focus on. Organizations (although not all) got a little bit wiser now.

Stijloor.

 

[AndyN]

Re: process approach to auditing ISO 9001 (94)

I agree with Jan. That's how I was taught to audit, back in 1986 - to BS 5750, in Internal and Lead Auditor course. Thank heavens for good instructors who knew their stuff!

There's been a corruption along the way to have deviated into clause auditing. I'd pay money to see what instructors taught that - or maybe it was a CB planning process that forced it! When at my previous CB, we only planned audits by process, never clauses.

I guess I got it good from the start.......

 

[Sidney Vianna]

Re: process approach to auditing ISO 9001 (94)

Regretfully, folks got too wrapped up in the "clause-by-clause" business because that's what 3rd party auditors tended to focus on.

If we think about the potential root cause for this, I offer:

• In the early to mid 90's when ISO 9001 certification experienced accelerated growth in North America, many CB's and consultants started developing "assembly line" approaches to audit. Fill in templates. Because processes change from one organization to another, if you had element-based checklists, audit reports, audit plans, etc..., you spend less time pre and post an audit, maximizing profit....
• The Accreditation Bodies demanded that the CB should be able to demonstrate that during the certification, as well as the surveillance audit cycles, all (applicable) requirements of the standard were audited, thus promoting clause-based audits.