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  ISO 9001/4:2000
  Procedure Numbering Change?

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Author Topic:   Procedure Numbering Change?
energy
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Posts: 228
From:New Britain, CT
Registered: Nov 2000

posted 12 January 2001 09:08 AM     Click Here to See the Profile for energy   Click Here to Email energy     Edit/Delete Message   Reply w/Quote
I have tried to get an answer on this by posting to "Documentation", but to no avail.
So let me try it here.
With the decline of the number of written procedures in the new version of the standard, is there still the need for maintaining Level 1, 2, 3, documents. If so, please tell me where this is justified..In the old standard or the new one. Is this just accepted practice or is there a guideline that addresses this?

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gutieg
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From:Laredo, Texas
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posted 12 January 2001 11:34 AM     Click Here to See the Profile for gutieg   Click Here to Email gutieg     Edit/Delete Message   Reply w/Quote
The clause 4.2.1 (Documentation requirements - General) from the ISO 9001:2000 international standard reads :

"The quality management system documentation shall include

a) Documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures required by this international standard,
d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and,
e) records required by this International Standard (see 4.2.4)"

So, yes, the hierarchy of documentation needs to be followed, but the content and volume of each level may be shorter or different.If you read the ISO 9000:2000 Standard (Fundamentals and vocabulary) the point 2.7.2 Types of document used in quality management systems, it says : "Each organization determines the extent of documentation required and the media to be used. This depends on fators such as the type and size of the organization, the complexity and interaction of processes, the complexity of products, customer requirements,the applicable regulatory requirements,the demonstrated ability of personnel,and the extent to which is necessary to demonstrate fulfillment of quality management system requirements". Now, the vocabulary standard is a guide, it allows you to determine the size of the cake, but the general structure of it , is a "shall" on the new ISO 9001.

Regards

Gus Gutierrez

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energy
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Posts: 228
From:New Britain, CT
Registered: Nov 2000

posted 12 January 2001 01:35 PM     Click Here to See the Profile for energy   Click Here to Email energy     Edit/Delete Message   Reply w/Quote
Gus,

I think I understand the hierarchy as you so aptly pointed out, but, the Level 1,2,3, etc. continues to allude me. All courses and training directs themselves to the terms Level 1, etc., like they are something mandatory. Why not call them A,B,C or something equivalent. Maybe, I'm making too much of a thing out of it. Thank you for the response.

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Marc Smith
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From:West Chester, OH, USA
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posted 12 January 2001 02:31 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
By convention the document 'layers' in a 'typical' documentation structure are called levels or tiers. Instructors use the terms most associated which what they're discussing. Nope - I do not know when or who started the convention.

Why levels or tiers? Why numbers instead of letters? Why not? And why change now. Some companies use dates as revision levels for documents. Some use letters (rev A) while some use numbers (Rev 2).

Why call a car a car. We could just as easily call it a wombattlement. And if, in the mid- to late-1800's someone HAD called automobiles wombattlements and the name caught on, we'd probably be calling them that today.

See https://elsmar.com/ubb/Forum7/HTML/000125.html for the reast of my response.

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energy
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From:New Britain, CT
Registered: Nov 2000

posted 12 January 2001 02:37 PM     Click Here to See the Profile for energy   Click Here to Email energy     Edit/Delete Message   Reply w/Quote
Thanks Marc. You pretty much said what I thinking. Somehow, when you hear it from those in the business, it assures you that your're not missing something. Guess it was a good idea to change the topic forum. Shoot for the high profile topics and the response is guaranteed. By the way, this is the best ISO Forum out there. Believe me, I tried them all. Keep on truckin!

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Marc Smith
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From:West Chester, OH, USA
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posted 12 January 2001 02:45 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
It's not always the forum topic. You posted on 26 Dec - and it was sorta lost in the holiday fray. A few questions here go unanswered, but most are responded to. Actually the documentation forum was the best place for the question - but no big deal.

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isodog
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Posts: 51
From:Vernon Hills, IL, USA
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posted 25 January 2001 09:45 PM     Click Here to See the Profile for isodog   Click Here to Email isodog     Edit/Delete Message   Reply w/Quote
There is still the three levels, manual, procedures, instructions, and documents. It is traditonal and nothing in the ISO 9000:2000 standard would indicate otherwise.

However, if you include the manual with the procedures, as suggested in the new revisions, you only have one book (manual and procedures). you still have two levels,i guess.

In many small (> $1,000,000 sales)companies procedures and instructions get confused as managers wear many hats and it's difficult to compartmentalise topics.

But, conceptually, the four levels do exist, if only for us geeks that want to put everything in a catagory.

This has NOTHING to do with the success of your system. If it works and you can tell where the information to run the business is located, YOU HAVE A SYSTEM!!!!

My advice is make your system serve your customers and challenge your auditor to find out where it doesn't. That is what you really want from an auditor. That's what it's all about.

Dave

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barb butrym
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posted 28 January 2001 08:15 PM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
LOL...one of my favorite arguments is 'what makes sense to your company (ergo adds value????)

I actually had an auditor tell my client one of his level 3 work instructions SHOULD BE a level 2 procedure.... WOW did I have fun wrestling in the mud with that one!!!!!! levels are just a way to break off a type of control or maybe a drop in formality perhaps...as some people need that seperation formally defined....most companies do it cause they think they should??? DAH....if it deoesn't add value don't do it

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energy
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From:New Britain, CT
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posted 29 January 2001 08:05 AM     Click Here to See the Profile for energy   Click Here to Email energy     Edit/Delete Message   Reply w/Quote
Barb, That is a concern, as you state, that there is a thin line between designating a "Level 2" or a "Level 3" document. If in the "Level 2" document there are a couple of HOW TO's, one may say that we should create a "Level 3" document to cover this. As we are going forward in our ISO effort, I have not had the opportunity to be audited by an outside party. Just trying to get a feel, from those already certified, what to expect.
Energy

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David Mullins
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From:Adelaide, South Australia, Australia
Registered: Nov 1999

posted 29 January 2001 05:47 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote
If the level thing worries you that much, just think of there being two types of documents:

A. those that apply across the company/business/etc.

B. Those that only apply to a sub-group of the company, e.g. department/team/etc.

The workers and the CEO don't care about levels - only you do!

------------------

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energy
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From:New Britain, CT
Registered: Nov 2000

posted 30 January 2001 08:13 AM     Click Here to See the Profile for energy   Click Here to Email energy     Edit/Delete Message   Reply w/Quote
(If the level thing worries you that much)Sure it does. As the Mgt Rep., there are those that feel that certain documents should be classified as "Level 2", "Level 3" and they are actually argumentative in their interpretations. All I'm saying, as a QA Manager, show me where this stuff is coming from. This site has been very informative on the topic, and occasionally, I let them in to see a response or two. Marc's response regarding "wombattlement" and Barb's client's auditor encounter pretty much assuaged my concern on this topic. Thanks for the response.
Energy

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