ISO 9001:2006 - What is the future of ISO9000?

[Wes Bucey]

Personally, I like the way it [is] currently structured...it is in-line with a PDCA methodology which works hand-in-hand with our Business Management System. The format of ISO 9001:2000 fits, for the most part, very well with us.

Unfortunately, there is a lot of overlap in the Standard. For example, a bit of production maintenance here, a little bit there. Quite often during an audit, I'm checking off N/A on several checklists to get to the relevent portions covered in several clauses...lots of paperwork from an auditor's standpoint.

Control of Documents...well...I guess, but I still find it amusing that I need a document on how I control my documents. A procedure for Records Control is somewhat pointless...a master list, however, conveys so much more.

Internal Audits is the one I don't quite understand...if the tools are provided to do the audit, why is a procedure required.

The fact that they are done are reviewed at Management Review, as required by the Standard. Do we really need a procedure telling us how IA's are done within an organization? Perhaps...or maybe I'm just assuming (bad move, I know) that we'll all use common sense when it comes to scheduling, implementing, and conducting IA's.

Very thoughtful stuff, Roxane (correct spelling?)
When you say "lots of paperwork" - why not eliminate the extraneous stuff from your audit checklist before it reaches the auditor's hands?

"Control of Documents"

It's no secret I am a Document Management "aficianado." I think the point of a "Procedure" here is to establish you have a plan, so you can evaluate (audit) it from time to time to see how it's working for you. Based on the result of your audit matching the actuality against the plan, the organization can determine whether to maintain the procedure as is or modify it or [in the case of plan not followed] retrain the persons performing the activity to follow the original plan. Without the plan, how will you know when to retain or discard documents? Distinguishing between changeable documents (like designs and procedures) and unchangeable documents (like records) is pretty easy, but how do you arrange for a consistent method of revising the changeable ones if you don't have a procedure?

Which brings us to an audit "Procedure." Simply ask yourself the following and supply your own answers:

1. Without a procedure, what is the basis to have consistent audit from auditor to auditor and year to year?
2. Where did you get the plan to use which tools for the audit?
3. What curriculum did you use to train auditors to use the "tools?"
4. Is the Management Review covered by a procedure? Do the reviewers perform the activity consistently each time or do they "wing it?"
5. If they "wing it," do they expect the auditors to "wing it" too? Why not?

 

[Greg B]

My SoapBox

Hi All,

What would I do? This is 'off the cuff' and it is still early in the morning here in the land of OZ.

No 1: Remove ALL conflciting Information and ambiguity (harder than it seems)

Exexcutive and Management Review: Detail that managers must review the overall system and individual systems. Do not leave it up to management to weasel out of reviews and throw it in the lap of the QA Manager or Coordinator. Spell it out that ALL Managers MUST review THE system AND their Department/Process systems. It is not the responibility of the QA Guy/Girl.

Process Control: Detail, that again, it is THE Managers responibility to manage, review and improve their system. Show a guide of how a process should be presented. Process Flow, Inputs, Outputs, Review, NC Control, Specifications etc.

CAPA: Limit it to four minimum stages. The Issue/problem, Immediate control methods, Preventative Action Plan, Follow up and Close out.

Document, Data Control and Review: Simplify the control measures. Name Rank and serial number. These documents thta have a full history, revision status, page numbers, document numbers, Title, Sub title, references to nearly every document in the system and some that aren't are of NO use to the average Joe thta has to read them.


Internal Audits: Closing out CARs should be included as an audit. Explain that the only thing to be auidted is YOUR system not ISO9000. Leave the external audits of ISO to the regsitrars. If they find something then fix it. Management reviews should be addressing the System NOT internal audits. I want to make sure that my porocesses are working for us.

DO NOT HAVE SEPARATE MANUALS JUST TO MAKE MORE MONEY. ISO 9011, 9004 etc. Make a standard training matrix and requiements for levels of training, world wide.
Internal Auditor
External Auditor
Diploma
Degree
Masters

Explain the difference between Quality Assurance (Business Improvement) and Quality Control (Checking and Control) and that the two are NOT the SAME.
This is really good therapy. I have not proof read this post but i think it makes some sense. Anyway, it should probably stir up some action especially with the puritans. :mg:



Greg B

 

[RoxaneB]

Very thoughtful stuff, Roxane (correct spelling?)

Yes.

When you say "lots of paperwork" - why not eliminate the extraneous stuff from your audit checklist before it reaches the auditor's hands?

Easy to answer...when I started here 3 years ago the IA system was not too strong. I shadowed on an audit to view the process. The two auditors showed up and had a conversation that included statements/questions like:

• So, what are we auditing again?
• Do you have a spare copy of the checklist?
• I didn't bring a pen.
• What do you think?...10 minutes here?
• Who are we meeting with?
• ...and so on...

Yes, that situation could have be indicative of poor training and a lack of evaluation, but it prompted me to analyze the Auditor Pool...and I found it very shallow. With more training, more case studies, evaluations, and a totally revamped Internal Audit programme, the audits have become much more meaningful for all parties. However, it is a very structured, linear process...included everything from:

• Planning and preparation meeting (including checklist)
• Attendance sheets
• Audit questions checklist
• Auditor assessments
• Two part Internal Audit schedule
• ...and a few other items that I can't think of at the moment...

Now that some time has passed, however, I believe that I can lessen the stringent controls on our Internal Audits and I intend to again revamp the programme this year.

It's no secret I am a Document Management "aficianado." I think the point of a "Procedure" here is to establish you have a plan, so you can evaluate (audit) it from time to time to see how it's working for you. Based on the result of your audit matching the actuality against the plan, the organization can determine whether to maintain the procedure as is or modify it or [in the case of plan not followed] retrain the persons performing the activity to follow the original plan. Without the plan, how will you know when to retain or discard documents? Distinguishing between changeable documents (like designs and procedures) and unchangeable documents (like records) is pretty easy, but how do you arrange for a consistent method of revising the changeable ones if you don't have a procedure?

I'm not disagreeing with the need to have the process for document control documented....I've just always found it amusing and somewhat comparable to circular logic.

 

[Sidney Vianna]

Dont know if this will generate any interest, but here goes.......

Imagine you are on TC176 and you are involved in the re-write of ISO9001 for re-issue in 2006.

What would you put in ?

What would you take out ?

I would include a requirement for the Organization to monitor Financial performance ( a la Baldrige), or in other words, implement a process for tracking the economics of quality (ISO terminology), or as we call it over here, cost of (non) quality. Until you start making the connection to senior management about Q and $, they don't get it or do not get involved. This, imo, is a MUST.

Another area that I would totally revise is the preventive action requirements. Everybody agrees that preventing problems is better than correcting them. However right now, the concept seems to be very misunderstood, worldwide.

Great question. Simple and thought provoking.

 

[Randy]

Nice one Alf.

I went to an OHSAS 18000 seminar about a year or so ago, it was given by one of the major writers of this standard. He stated that it was not the intention of the standard writers to create an integrated Quality, Environmental and H&S standard, only to align the standards (i.e. give them similar structure).

By any chance was it Clive Stallwood or David Smith?


This is an interesting topic. I teach this stuff occasionally (having to humble myself and get away from the 14K & 18K tasks). Clause 7 with all the "stuff" is a pain in the fanny because it seems so repetitive (which it isn't, it just seems so). I like the idea of 2 major areas..Admin and Production, they make sense. "Work Environment" is hard to get folks to understand (I remember we tore into it rather well a couple of years ago here in the Cove).

Does anybody here participate in TC176? I've delayed joining the US portion of TC207 because they want you to pay for the honor.

 

[RoxaneB]

I would include a requirement for the Organization to monitor Financial performance ( a la Baldrige), or in other words, implement a process for tracking the economics of quality (ISO terminology), or as we call it over here, cost of (non) quality. Until you start making the connection to senior management about Q and $, they don't get it or do not get involved. This, imo, is a MUST.

The Cost of UnQuality (I keep thinking the UnCola here) is measured and monitored here...but seldom acted upon. I realized that after a while, the numbers were meaningless to those viewing them. So, the programme was simplied...still minimal action was taken. This resulted in me reviewing the system and, later this month, I'll be proposing a new methodology.

Our Key Indicators are reviewed every month and, for the most part, we know the dollar values associated with them. In our South American facilities they look at the Gap. The cost of performance this month versus our best every performances. The cost of performance this month versus the best performances within the company. *Those* numbers show how much improvement can earn/save us. I need to investigate this concept in more detail, so I apologize if I haven't been very clear here.

 

[The Taz!]

Firstly I'd wack in an apology for the structure, repetition of requirements and (as Hank said) scattering of requirements.

Then I'd restructure under the headings:
1. Administrative.
2. Productive.

The scope of the standard would read "If you don't like the requirements in this standard, or don't understand them, please visit Elsmar.com ". That'd bring ya some business Marc!

Hey Dave. . . I think you are onto something. . .change it to 1) "Value Added" and 2) "Non-value Added". . .

Then in 2011 they can eliminate the Non-Value Added stuff. . .that should get it down to about 3 pages including the cover and definitions. . . after all, isn't that what manufacturing is all about now?

 

[Paul Simpson]

Think systems not standards

I know I have said this before (I may be boring but at least I am consistent) , it is not the standard that matters so much as what you do with it. Flicking back through the thread there seem to be people who like the way the standard has changed from the previous edition and those that don’t. (Along the lines of the world is broken down into two groups of people, those that break the world down into two groups of people and those that don’t.)

Now some people like the fact that elements are grouped into the relevant 5 major clauses of the standard, so for example:

There is a requirement for management to demonstrate customer focus in the clause on management responsibility, there is a (small) reference to the provision of resources being directed to satisfying customers in that section, there is a larger section in product realization (horrible title) to the processes used to deal with customers and, under monitoring and measuring, there is a section on customer satisfaction as one of the measures for how well the system works.

Others would like to see all of these elements grouped under a single clause (contract review?).

Does it matter? I would say not. What matters is that the organisation embraces these ideas and puts them into place in a way that is relevant to the people who manage and work the processes. This is where the whole system starts to break down IMHO. Many people I visit as a consultant and auditor have a checklist mentality to ISO 9001, something I see a fair amount of on the cove I must say, and so long as they can tick a particular box related to customer satisfaction (for example) think they have an ISO 9001 system in place. The point of the clause is missed and the potential benefits of improving the processes and the organisation’s overall effectiveness have similarly not been taken.

 

[Claes Gefvenberg]

I know I have said this before (I may be boring but at least I am consistent) , it is not the standard that matters so much as what you do with it.

Yes, Paul... I suppose i must be pretty boring too, then...

/Claes

 

[sal881vw]

Hello all,

I've located the following and I thought it may be of interest..................quote from ISO website : The online feedback survey for users of ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000 aims to result in improvements to the standards, or to the development of supporting documents to help users understand and implement the standards. Any person with knowledge or experience of the standards may take part and there is no limit to the number of participants from any one organization. The survey is estimated to take about 15 minutes to complete. It can be accessed on the Web at http://isotc.iso.ch/webquest/tc176/index.html