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

[Jim Wynne]

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...?

At some point the standards must assume that people will be able to think these things through for themselves. If an auditee can't be made to understand what a process is, there's a problem that ISO 9001 can't help. I suspect that sometimes the problem might not be the auditee, but rather an auditor who doesn't understand. There's a relationship in this regard between processes and documents with regard to control; sometimes the need for control can be argued, and in those cases, where the line isn't clear, the auditee should probably be given the benefit of the doubt so long as there is a clear line of reasoning involved.

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.

If inputs and outputs don't need to be controlled, then you're not dealing with a process in the sense that the word is used in the standard. It's a bit tautological; processes need to be controlled, and you identify a process by the level of control needed. Nonetheless, one man's ceiling is another man's floor. If two processes are chained together, then the requirements for output in the first process are the requirements for input in the second. That's a large part of the rationale behind the process approach--insuring that the outputs of process "A" meet the input requirements for process "B."

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

I live about an hour north of Chicago, and lived there for many years. The weather for the week is supposed to be fairly normal for this time of year, with temperatures in the mid-forties (F). They have a saying in Chicago, though: If you don't like the weather, stick around for an hour--it'll change. It's especially volatile this time of year and in the spring.

 

[Yew Jin]

It is good that it can include more human resource elements.

 

[Denis9001 - 2007]

David

I agree with Paul in that it covers the same ground (end purpose) but from different aspects.

7.4.1 focuses on the process and the supplier not the product. This is BEFORE you order.

7.4.3 basically says you check what you get (ie the product.) AFTER you get it (goods-in inspection in 1996)

7.4.1 is broader in that it does not just apply to the product. If a delivery is late it would still pass the 7.4.3 test but not the 7.4.1.

The reference to QMS in 7.4.2 means the purchaser could/should control IF/HOW the product is controlled by the supplier. A supplier may deliver conforming product (as verified in 7.4.3) without ever checking it. This would leave open a risk of getting a non-conforming delivery and cause potential delays in the product realization process which in turn may mean your quality to your customer suffers.

So basically we are saying make sure:

1) PROCESS - The process is right
2) SUPPLIER - The supplier is right and can supply
3) REQUIREMENT - What you order is what you (your customer) want
4) ORDER - The supplier knows what you want & the purchase terms
5) CONTROL - If needed, you control the product throughout the suppliers processes
6) DELIVERY - What you get is what you ordered

It’s all clear to me but this highlights a problem with the standard and maybe an option IS missing from the poll. We are all ISO professionals and are discussing what a few sentences mean. Surely it must be possible to change (not add/delete as per poll) the wording to make it clear to all. The structure could be better eg giving suppliers (Supplier Control) their own sub-clause.

 

[Denis9001 - 2007]

Sure. And I'd like free food, free wine, free housing, free everything.

No such thing as a free lunch.

And ultimately... with free, you gets what you pays for.

Don't be such a pessimist. Some things are free like this forum for example.

But seriously, how can national governments (ie standards organisations)expect to improve the quality of the nations products (exports, revenues, jobs etc) or protect the environment when they charge for simply giving knowledge on how to do improve. I can understand a charge for printed documents but for electronic documents it scandalous. Imagine if they followe dthe same principle with everything eg charging for information on effective Aids prevention.

 

[aerospaced]

The standard should explicitly require assessing performance against established Quality Objectives as an input to Management Reviews.

 

[JaneB]

It’s all clear to me but this highlights a problem with the standard and maybe an option IS missing from the poll.

Good suggestion: perhaps a poll on 'which section(s) need to be clearer'?

We are all ISO professionals and are discussing what a few sentences mean. Surely it must be possible to change (not add/delete as per poll) the wording to make it clear to all.

In many ways, I agree with you and think it would be highly desirable to have the wording 'make it clear to all'... But I honestly don't think it's entirely possible.

I've read or written (or heard) things that I think are crystal clear, and yet other people extract quite different interpretations.

Another example: huge amounts of time, effort & money (and extremely skilled people) argue what particular bits of legislation mean. Why would a generic Standard be different?

One person's ceiling is another person's floor, as Jim said -leaving aside the gender specifics

And then there's the quite massive amount of consultation, review and discussion and consensus required to get a Standard accepted and released. Lord save me from things written by a single Committee, let alone multiple ones! Sure, we argue what things mean, just as the various stakeholders involved in it.

I think that the Standard itself is no small miracle of achievement, reaching agreement on what the broad requirements are for a QMS, and the more I work with it, and see how useful it can be when applied & audited intelligently, the more I respect it.

 

[JaneB]

Some things are free like this forum for example.

Hmm. In some ways, yes. In others, not.

But seriously, how can national governments (ie standards organisations)expect to improve the quality of the nations products (exports, revenues, jobs etc) or protect the environment when they charge for simply giving knowledge on how to do improve.

Agree that the charge for the Standards appears high.

There is a widespread belief that standards organisations and national governments are the same thing around the world, but this isn't so.

From the ISO website:

Who ISO is

ISO is a network of the national standards institutes of 157 countries, on the basis of one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system.

ISO is a non-governmental organization: its members are not, as is the case in the United Nations system, delegations of national governments. Nevertheless, ISO occupies a special position between the public and private sectors. This is because, on the one hand, many of its member institutes are part of the governmental structure of their countries, or are mandated by their government. On the other hand, other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations.

 

[Tym Tucker]

Hmm. No mentions of the Quality Policy. This will probably make me a pariah, but I’m on my soapbox to say: Remove any mention of a quality policy!

Like mission statements, vision statements, etc., a quality policy is pure academic drivel. In my experience there are three kinds of people working in any plant, anywhere:

1. Those who always have and always will care about quality – the success of both themselves and their employer is very important to them. These people have no need for a quality policy. It’s ingrained in their most basic methodology.

2. Those that never have given, and never will give, a rat’s behind about anything other than collecting the paycheck. These people have no need for a quality policy. They need to put J1 into P1 until 5 PM. They’ll be glad to recite it to your auditor, but it means nothing. They know this, as well as you.

3. People new to the workforce who have not yet adopted either of the above attitudes. These people have no need for a quality policy. The need to be exposed to as many real value-adding quality practices as they can get. What they don’t need is for the whole process to be trivialized by the existence of an obtuse policy that is little more than the subject of jokes around the plant. (Jokes that were born out of sheer reality – whatever these folks are, they’re not idiots and I can sing and dance very convincingly about the value of the policy – they’re not buying it.)

Now I know the academics and others who may audit quality systems but never have to assist in actually making a business function will be up in arms about my assertions here. Granted, I could carefully craft this into a detailed paper with data to back my assertions, but it’s Friday, I’m tired, and I finally decided to sit down and complain about the ridiculousness that is a quality policy. Flame me if you must, but I’d rather dissenters come over here to my plant, look at our processes, agree that our performance is world class, and THEN let’s go out on the floor and find someone who believes in the quality policy.

Ain’t gonna happen. Do they believe in the system? You bet, they helped build it. They know the results. The Policy? Who you kidding?

Tym “not nearly as pessimistic as that sounded” Tucker

 

[Sajjad Chaudhry]

Let me first clarify; I am not a 'theoratical' quality professional and have spent considerable time of my work life in handling practical situations including in manufacturing.

I think Tym has made a valid point: The taste of pudding is in eating it. A well thought over recipe, given by an experienced chef and having all resouces to cook it are not definite indicative of quality of final product. However, are these steps in preparation alongwith delibrate focus in effort with final output in mind not necessary? The expression of such directed, focused efforts is Quality Policy. I am pretty sure Tym's company has a policies to coordinate company operations to achieve the claimed successes. It does not have to be learnt by heart but all should understand it as ISO 9K-2K requires it.

 

[JaneB]

Like mission statements, vision statements, etc., a quality policy is pure academic drivel.

Can be, but shouldn't be. Like anything else, the garbage in, garbage out rule applies. Meaning, if no one gives it a lot of thought, or it has no real meaning, heart & soul behind it, then I'm with you: it's drivel.

But I don't support throwing it out just because it's often badly done. Let improvement rule.

Over-riding principles (policy) are important. A short, clear and most of all real policy on quality is important, ie, what is the position that this company or organisation takes on quality?

Here's a couple of recent examples that did mean something to the companies, and which they can remember, and use to guide them:

Our members are our number one priority. (A non-profit professional organisation).

We care about the people who use our products (A company making industrial cleaning products).

Out with those 'blah... blah...' statements. OK, now I'll get off my soapbox too.