ISO 9001:2008 Fundamentals: Basic Questions - Controlled Documents

[ScottK]

Thanks for the replies!
So in regard to document control, we decide what is essential for the effective operation of our business and those docs (as well as the ones specifically required by the standard) are all we need to control.

I saw some reference to "guidelines" which I take it are for non mission critical tasks. is that right?

And how about "reference documents"? I've seen that term used before as well, but am not sure how they apply.

How about things required by other governing bodies - like OSHA? OSHA mandates a lot of "programs" and instructions that a manufacturer has to follow, but it is easily arguable if they are essential to the effective operation of the business. Ladder inspection comes to mind. Respiratory protection...

I keep reading ISO articles about the tendency for companies to over-document because they think ISO requires EVERYTHING to be documented and I think that's where we are. We are a high mix low volume shop, so we do a lot of different things, but we only have about 20 people and we already have over 250 documents that are controlled (procedures, forms, WI's). Our old (based on mil-spec) QA manual is about 25 pages with about 30 addenda. So, thanks for helping me narrow things down.

Whether or ont to include documents required by OSHA is up to your organization. OSHA does require certain procedures and records. Some companies keep separate systems, some merge them.
I'm of the latter persuasion, particulary for smaller companies. Why run parallel systems with limited resources?

250 documents for a 20 people organization seems like a lot... perhaps there's a lean project there to reduce the number of forms by combining like with like?

 

[Wes Bucey]

Oh wow! Where to begin? I suspect your organization has the "big honkin' Quality Manual" which was ubiquitous in Quality Manager offices through the 1980s and 90s, often used as a door stop or a prop for a chair or table with a broken leg.

I further suspect that at some time in the past, a big honkin' Quality Manual was filched or borrowed from a giant customer with thousands of employees and recopied with your company's name and logo, incorporating all those detailed rules and processes necessary (it used to be thought) to keep order and sanity in a large organization, but totally unnecessary in an organization of 20 people.

Milspecs, (including Standards and other stuff in the chart below), by and of themselves, weren't bad, just idiotically written with convoluted sentence structures and not taking advantage of much modern quality profession thinking.

[FONT=Verdana, sans-serif]MIL-HDBK Defense Handbook[/FONT]
[FONT=Verdana, sans-serif]A guidance document containing standard procedural, technical, engineering, or design information about the material, processes, practices, and methods covered by the DSP. MIL-STD-967 covers the content and format for defense handbooks.[/FONT]
[FONT=Verdana, sans-serif]
[/FONT]
[FONT=Verdana, sans-serif]MIL-SPEC Defense Specification[/FONT]
[FONT=Verdana, sans-serif]A document that describes the essential technical requirements for purchased materiel that is military unique or substantially modified commercial items. MIL-STD-961 covers the content and format for defense specifications.[/FONT]
[FONT=Verdana, sans-serif]
[/FONT]
[FONT=Verdana, sans-serif]MIL-STD Defense Standard[/FONT]
[FONT=Verdana, sans-serif]A document that establishes uniform engineering and technical requirements for military-unique or substantially modified commercial processes, procedures, practices, and methods. There are five types of defense standards: interface standards, design criteria standards, manufacturing process standards, standard practices, and test method standards. MIL-STD-962 covers the content and format for defense standards.[/FONT]
[FONT=Verdana, sans-serif]
[/FONT]
[FONT=Verdana, sans-serif]MIL-PRF Performance Specification[/FONT]
[FONT=Verdana, sans-serif]A performance specification states requirements in terms of the required results with criteria for verifying compliance, but without stating the methods for achieving the required results. A performance specification defines the functional requirements for the item, the environment in which it must operate, and interface and interchangeability characteristics.[/FONT]
[FONT=Verdana, sans-serif]
[/FONT]
[FONT=Verdana, sans-serif]MIL-DTL Detail Specification[/FONT]
[FONT=Verdana, sans-serif]A specification that specifies design requirements, such as materials to be used, how a requirement is to be achieved, or how an item is to be fabricated or constructed. A specification that contains both performance and detail requirements is still considered a detail specification.[/FONT]

Of course, many Milspecs have been withdrawn over the years in favor of using commercial Standards and Specifications. Yet there are still many purchase orders which contain references to those long withdrawn specs, so it is no wonder that a small organization like yours managed to survive using them as the basis for your quality program.

Throughout the Cove, one can find long threads devoted to creating the minimalist Quality Manuals which incorporate references to International Standards for quality management and references to processes, procedures, etc. and thus can be reduced to essentially a one- or two-page "table of contents" for the file cabinet full of documents which organizations used to include in the big honkin' manual. One such thread [for reference] springs to mind:
QMS (Quality Management System) Manual - The Boss Wants a 4 Page Manual - What to Do?

Randy refers to the ISO Standard which your organization is aiming for, but I have a hunch nobody in your organization is really conversant with the Standard and you may not even have a copy yet. Transitioning to being compliant with the Standard really should come before trying to register to the Standard with a third party registrar. That means not only you, but a number of others in your organization should also be trying to get their heads around the philosophy and scope of the Standard.

You mention you've read a couple of books, but don't mention which ones. One of our Covers, Craig Cochran (ccochran), has written an excellent "starter" book, which I highly recommend. Learn about it in this thread:
ISO 9001 in Plain English by Craig Cochran - NEW BOOK

There used to be a theory about learning to swim by getting thrown in the deep end of the pool. I never saw it work. Don't try to jump into the deep end of ISO without learning to blow a few bubbles in the shallow water first.

 

[kgott]

Hi all. I work in a small manufacturing company where we're struggling to get an ISO push started.

Can you have documents that are controlled and others that are uncontrolled?

You've had some good advice on this thread so I'll get slightly off topic and suggest that you go through ISO 9000 and get the definition of quality, research it and develop a common meaning of the word for use in your company so everyone has the same understanding of what it means so when you talk about everybody is on the same page.

Then tell people your quality system is all those processes associated with the 'get the work-do the work-get paid' processes directly and the support processes indirectly.

Then I suggest you chose some nice easy definitions of quality assurance and quality control.

eg quality assurance - those process that support the production of the product
quality control - the process that build the product

Thereafter you talk mostly about your company's 'management systems' and tone down the use of the word quality.

 

[SATHYABALARAMAN]

Clause 4.2.1 tells you what documents you must include in your QMS. All documents that you determine under clause 4.2.1 to be needed for your QMS processes must be controlled.

The clause 4.2.3 provides requirements on how these documents must be controlled.

Documents outside the QMS need not be subject to these controls.

 

[FreeIndeed]

Thanks for all the great responses so far! To hit a couple of answers to questions; I've been reading a LOT of items from the web and going through "ISO 9001:2000 for small Businesses" by Ray Tricker and "ISO 9001:2000 for small and medium sized businesses" by Herbert C Monnich Jr.. The latter book is pretty good at showing how ISO requirements are scalable for different sizes of organizations, which seems to be one of my biggest and most questioned issues. The former is dictionary sized and I've been using it as a reference.

I've been spending all my free time (at work) going through threads here on the cove as the amount of information is staggering! I'm working on putting together a process map for our org and then will post that in the mapping section to get some feedback. I figure I'll take it a step at a time and eventually I'll get to dealing with our problem of too much documentation.

 

[John Broomfield]

"If in doubt leave it out". Do not control documented information just because you can. Be light at first and allow operation of the management system to tell you what more needs to be controlled.

By using the term "ISO documents" you are telling employees that this is a big push for certification. Name your management system for your company.

Instead, promote a noble cause. Our organizational management system to help us to determine and meet requirements. Or some other cause that engages the employees in developing, using and improving their "teamwork" system.

Avoid second-guessing the auditor and you'll avoid all sorts of unnecessary bureaucracy.

 

[TPMB4]

I got the Tricker book back awhile when I landed in a proper quality role. Interesting enough as a starter but I reckon I moved on quickly form that one and never really rated it too highly.

BTW there is an online resource for that book. You can actually download a sample QMS from the publisher, a link is in the book. A tip though, the link doesn't work as the real link is with a different publisher. I don't think it is worth looking for though as it seemed to me to be one of those re-hashes of the SIO9001 standard where they copy the clauses 1-3 almost completely then re-hash the rest of it, if you know what I mean. I am sure there are plenty who can explain the problem I have with these versions of QMS better than I can.