The ISO 9001:2008 addendum - What would you like to add or subtract?

[Paul Simpson]

Don't you just love selective quotes!

But that doesn't mean that the purpose makes sense.



Do you mean that we shouldn't want to improve it, or that it's beyond the abilities of mere mortals to make it better?

Look at it in terms of objective evidence. If 7.4.3 weren't there, would you audit any differently?

Either your IQ is on the slide or you're just being argumentative, Jim.

I tried to put comments against your "points" but couldn't do the usual cut and paste for some reason. So I'll just have to risk confusing you further by responding in a list.

1. What is so confusing? I chose not to insult anyone's intelligence by emphasizing the some but clearly should have identified that the scope and coverage of the two clauses is very different.
   
   The bit you left out of your quote was where I went into how 7.4.1 covers a wider scope (at the planning stage) and 7.4.3 is about immediate activities when the goods arrive.
   
   Any clearer?
2. Purpose to my mind means there is sense - otherwise it fulfils no purpose - if you have any examples?
3. Mere mortals - interesting choice of phrase ... As mere mortals we can have as many discussions about the structure and layout as we like both here, in our workplace or around the ISO table.
   
   My point is that in the end it doesn't matter - we just have to work with the end result.
4. In answer to your question - probably yes. Because the inclusion of this clause forces organizations to think about how they verify incoming product meets their needs they tend to have some things in place that they might not have if the requirement was not there (please excuse emphasis, sometimes I have to explain). Without this clause the auditing of 7.4.1 is more open.

 

[Paul Simpson]

Anyone prepared to say what this means? Is it something to do with the QS of the supplier, or some (unspecified) requirement of the organisation's QS, or ...? Should it not be more specific?

It is precisely to do with the suplier's QMS. I echo what Sidney has said. It gives the purchasing organization an opportunity to say exactly what they want as the supplier makes the part / supplies the service for the products/services they are buying. For example they can re-emphasize the need to apply ISO 9001 for the contract, they can ask for certificates of conformance / SPC (depends how much credence you give to these).

Anyone used this element in the real world?

 

[Peter Fraser]

It is precisely to do with the suplier's QMS. I echo what Sidney has said. It gives the purchasing organization an opportunity to say exactly what they want as the supplier makes the part / supplies the service for the products/services they are buying. For example they can re-emphasize the need to apply ISO 9001 for the contract, they can ask for certificates of conformance / SPC (depends how much credence you give to these).

Anyone used this element in the real world?

Paul and Sidney

I agree that all these examples make sense - I am questioning whether the wording of the standard is clear to a new reader (bearing in mind the thread topic...)

 

[Paul Simpson]

Paul and Sidney

I agree that all these examples make sense - I am questioning whether the wording of the standard is clear to a new reader (bearing in mind the thread topic...)

Problem is standard wording isn't designed for the new reader - only old duffers like me. My point (No. 1) was that unless you delve into the meaning of the clause and understand why it is there you can't say that it doesn't belong.

Point No. 2 was that we can argue about wording but in the end it is a matter of opinion. There are plenty of barrack rooms lawyers around who can find their way out of a clear requirement - never mind one that is worded in a friendly fashion.

You only have to look at legalese to see how hard some people try to make wording bulletproof.

Perhaps there is another way - I'm sure the Cove will be the place to discuss!

 

[Sajjad Chaudhry]

Dear folks What would you add or amend in the upcoming ver of ISO 9001:2008?

Besides what has been suggested in response to original question, I have the following two cents to add:
I find the standard still lacking in its direct relevance to non-manufacturing areas. For example, its interpretation and application to a 'distribution' business require an expert in ISO 9000 that every (particularly) small company cannot afford.
ISO 9000 registeration process should require a self assessment proforma that should include reference to evidence or justification in support. This might help improving the integrity aspect of the process.

 

[Sidney Vianna]

Besides what has been suggested in response to original question, I have the following two cents to add:
I find the standard still lacking in its direct relevance to non-manufacturing areas. For example, its interpretation and application to a 'distribution' business require an expert in ISO 9000 that every (particularly) small company cannot afford.

The 2000 Edition of ISO 9001 had, as one of the primary goals, minimize the manufacturing slant in the document. I believe that they succeed, to an extent. ISO 9001 implementation will always require interpretation, no matter what business sector the organization is in. It is a natural consequence of having an international standard, which attempts to be universal in it's application target.

ISO 9000 registration process should require a self assessment proforma that should include reference to evidence or justification in support. This might help improving the integrity aspect of the process.

Oh, but it does. It is called INTERNAL AUDIT.

 

[florin pirvulescu]

As a third party auditor I think the new pair of 9001 standard should make more clear terms as QMS processes.
I guess there are a few reasons for confusion in ISO 9001:2000.
The first suggestion about the QMS processes we found in the Note of 4.1 clause. The processes recommended are almost the same as chapter 5 - 8 of the standard. “Almost” because the name of the processes in the Note are slightly different then the name of chapters. The matching of the processes in the Note with the chapters is suggested also by the figure 1. So we have all the reasons to believe that processes of the QMS are actually the chapters 5 to 8 of the standard. But I wouldn’t consider “Management responsibility” a process. Inputs, outputs of an activity and measurable criteria define a process. I see chapter 5 as a requirements clause to comply with. Of course I audit what I find at clients, but I'm not satisfied, as most of management analyses - the part of internal audit at top management - are obviously fake. How many top managers let themselves realy audited by a subordinate or a group of...?
I think what is interesting is expanding the 7th Chapter (product realization). Why? As long as we are aloud to consider exclusions limited to requirements within clause 7, it means the other chapters (processes) should look the same in all organizations in the world. So why should we bother to represent them in a map (or some other method)? I found in www.bin.co.uk the Process Classification Framework. I like it very much and it seems to be inspired from the real business world. I found also on the Internet a very challenging point of view regarding what I am concerned about (I can't remember where, maybe right here, maybe the ideea belongs to Mr. Jim Wade I'm not sure). The figure 1 represents the linkages between chapters of the standard not the processes. I guess is right. If this is also the ISO’s point of view it means the representation in figure 1 and the Note of 4.1 it is not the best solution. I found a large variety of QMS processes maps. On the Internet the most often found solution for identification of processes and map representation is the Figure 1 of the standard expanded in a deeper detail.
Then we know also that if we seek improvement we should take into account the "should" 's in 9004:2000, which recomend us to consider the processes as key processes and support processes. Nice and very academic but I found many beginners asking me "which way? the four kind of processes from 9001 or the two from 9004?"
The best way to figure out if the solution of the establishment of processes is good or bad is the integration of QMS with other management systems, like BS 7799. But how many companies have this luck?
If we want to develop theories in quality management we can do it in books, but I guess a standard should be more specific.
Concluding: I would emphasize the importance of processes subject of chapter 7 in the actual version of standard.
I would like to emphasize that this is not only my dilema, but rather debates meet at tens of clients.
Can you comment?

Florin Pirvulescu, Romania

 

[Sidney Vianna]

Can you comment?

Looks like you and the tens of clients can gain some insight through the APG website, with emphasis on this document Identification of processes which links to N544 ISO 9000 Introduction and Support Package: Guidance on the Concept and Use of the Process Approach where it is stated:

- Processes for management of an organization. These include processes relating to strategic planning, establishing policies, setting objectives, providing communication, ensuring availability of resources needed and management reviews.

- Processes for managing resources. These include all those processes for the provision of the resources that are needed for the processes for managing an organization, for realization, and for measurement.

- Realization processes. These include all processes that provide the intended output of the organization.

- Measurement, analysis and improvement processes. These include those processes needed to measure and gather data for performance analysis and improvement of effectiveness and efficiency. They include measuring, monitoring and auditing processes, corrective and preventive actions and are an integral part of the management, resource management and realization processes.

 

[florin pirvulescu]

Thank you for your replay.
I found the documents since the time of their publication and there was good guidance for me. It doesn't mean a agree with them. I just implement them.
In my previous message I say the same thing as you did.
If a law is issued with some mistakes or the efects have not been fully initialy predicted, there are procedures for imediat revisions.
Unfortunately this not the case of ISO. We have to wait 8 years. 9001 or any other standard is a human creation, it is not perfect.
I saw solutions trying to integrate the four kind of processes with the two form 9004. In that way I guess the debate is getting far off the bussines.
Once again: the processes that bring added value are those from chapter 7.
Of course a minority (those thinking like me) has to comply with the majority's decision.
I am one of the Jim Wade's solutions upholders. Look for them. I found them more pragmatic..

 

[Peter Fraser]

Looks like you and the tens of clients can gain some insight through the APG website, with emphasis on this document Identification of processes which links to N544 ISO 9000 Introduction and Support Package: Guidance on the Concept and Use of the Process Approach where it is stated:

Could be quite a challenge, though, given that section 1 of the paper "Identification of Processes" (Distinguishing between the concepts of a process and an activity) tells you what to do "If an auditee cannot distinguish between the concepts of a process and an activity..." and yet the ISO9000 definition of a process is "an activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process". Maybe it should explain what other types of activity there are...?

And Section 2 states that a process must have defined objective(s), although I cannot find where ISO9001 requires this. I am a strong believer in the need for the objective(s) of a process to be recognised (in fact, my definition of a business process includes the concept of an "objective") - but why "defined"? The "inputs" and "outputs" don't have to be defined for every process - but then I wouldn't define a process in those terms anyway.

PS I am making my first visit to the US on Monday - how cold is it in Chigago just now?!