Quality Manual Organization and Structure including Numbering

6 of one, half a dozen of the other

We decided to use the standard as a guide / starting point when writing our manual. In this, we hoped to be able to systematically address all of the necessary standard requirements. We could have gone to a 4 page manual if we wanted, but we decided to incorporate a lot of details in the manual and clarify how our systems are set up... We probably could have incorporated all these details into our System Procedures and just had the QM reference those documents, but this method makes sense for us at this time. We also used several process overview flowcharts and an org-chart in our QM, the end result is about a 48 page QM, but it covers a lot of ground. Then again, our old QM used to be a lot larger than our current 48 pages...

Also, regardless of the preference of the auditors, I think each organization needs to do what makes sense for their organization. For us, this means having a 48 page QM which is structured along the lines of the standard.

Good on you Groo,

As long as the layout fits you and you do it for your own sake... ...all is well. It's your manual, after all.

/Claes

Groo3 said:

We decided to use the standard as a guide / starting point when writing our manual. In this, we hoped to be able to systematically address all of the necessary standard requirements. We could have gone to a 4 page manual if we wanted, but we decided to incorporate a lot of details in the manual and clarify how our systems are set up... We probably could have incorporated all these details into our System Procedures and just had the QM reference those documents, but this method makes sense for us at this time. We also used several process overview flowcharts and an org-chart in our QM, the end result is about a 48 page QM, but it covers a lot of ground. Then again, our old QM used to be a lot larger than our current 48 pages...

Also, regardless of the preference of the auditors, I think each organization needs to do what makes sense for their organization. For us, this means having a 48 page QM which is structured along the lines of the standard.

Click to expand...

I voted that my organization's QM follows the numbering of ISO9k2k.
I'm a plain language guy and I like LOTS of white space, with big headlines, so mine appears to have a lot of pages. I also had to incorporate the FAA "Fabrication Inspection System" in a seamless manner to placate the regulatory gods (devils?) This necessitated a redundant recap of some of the ISO9k2k sections because the FAA guy "with the ink" [to approve or deny our status as Certified Parts Approval Holder] wanted it "just like his chart."

I added an appendix which gave a capsule summary of each Procedure included in our QMS plus a glossary (an adjunct to Section 3 Definitions) which explained our usage of terms in our industry.

Here's our phrasing for Section 3.1:
3.1 Industry definitions and acronyms


Every industry uses terms (including acronyms) which have a particular meaning within the industry. We try to clarify the meaning of such terms by including a definition or a spelled out title of an acronym with its first usage in our manual. We have included these terms in our Glossary and Index for handy reference. By using the index, the reader can see how the term is used in context.

Our objective is to use simple technically accurate terms, and to the greatest extent possible, rely on common dictionary definitions. As with most technical subjects, some terms have a very specific meaning different from their commonly used dictionary definitions. In this case, the appropriate technical definition is provided in our Glossary.

We use the manual as part of our orientation of new hires. I am proud to say everyone in our organization has a copy and can answer any newbie or auditor's query about it and define any term in the glossary and describe where he fits in a Procedure which pertains to him or his job. Only the text and the glossary are a Controlled Document. The Appendix describing the Procedures is merely a "convenience" report - only the Procedures, themselves, are Controlled. I also included a copy of the FAA guy's "chart" in the Appendix as a "convenient" non-controlled exhibit. [he LOVED it!]

Wes Bucey said:

We use the manual as part of our orientation of new hires. I am proud to say everyone in our organization has a copy and can answer any newbie or auditor's query about it and define any term in the glossary and describe where he fits in a Procedure which pertains to him or his job.

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Wes,

How do you test the knowledge and understanding of your organsiation in relation to the manual? We too give every one an induction into QA, including the manual (if we can keep them awake) but I could not guarantee that everyone could answer every 'Newbie's or Auditor's' query.
Why does everyone need a copy of the manual? Are these ALL controlled? We spend more time training our people on their Procedures and Work Instructions than the manual. IMHO our manual is nothing more than an auditors reference sheet. Our procedures are our bread and butter.
Sorry, I am not having a go at you or your company I just don't think that there (IMO) is a real need for quality manuals but I put up with them. I'm a less is more type of guy.

Greg B

Greg & Wes,

What we have for orientation is a five page summary of our QMS with a quiz at the end to test their comprehension, which is turned in to me within 10 days of hire.

We have only ONE hard copy Quality Policy Manual - and I keep that. The manual and all other documents (procedures, work instructions, forms) are available on a corporate intranet site available to everyone. If they print them out, it's their responsibility to make sure they're current.

Rob Nix said:

Greg & Wes,

What we have for orientation is a five page summary of our QMS with a quiz at the end to test their comprehension, which is turned in to me within 10 days of hire.

We have only ONE hard copy Quality Policy Manual - and I keep that. The manual and all other documents (procedures, work instructions, forms) are available on a corporate intranet site available to everyone. If they print them out, it's their responsibility to make sure they're current.

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Rob,

I envy your system and hope to attain the same level soon. Our guys also take responibility for anything they currrently print. I just worry about the master copies on the intranet.

Greg B

Confused

I've only read the first and last few entries in this thread but I'm having a problem understanding what is going on.

I thought that the ISO9001:2000 requirements for a quality manual were to have:

1. the scope of the quality management system, including details of and justification for any exclusions

2. the documented procedures established for the quality management system, or reference to them

3. a description of the interaction between the processes of the quality management system (not the standard)

Everytime I try to simplify our manual the auditor or our coporate headquaters says that's wrong.

Why?

Why does an auditor look for a restatement of the standard in the quality manual? Why restate the standard when a simple statement in the manual that you will meet the standard is enough.

Confused and Abused

dbzman said:

Everytime I try to simplify our manual the auditor or our coporate headquaters says that's wrong.

Why?

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A large part of this might come from a misreading of ISO 10013 (I think that is the standard -- I don't have a copy in my immediate possession). If my memory serves me correctly it discussed things like company history, your "means of communication", etc.

You are correct in what 9K2K requires. Some auditors freak if you provide just what the standard requires.

Edited by SSwanson

SSwanson said:

Because a "simple statement in the manual" is not enough.

By restating the requirement in your manual, everyone in the organization knows the requirement, and not just the QM who has a copy of the standard. It is the easiest way to ensure that all ISO requirements are indeed documented in your system. Otherwise, it is certain that you will not adequately document some requirement and that may result in some future error.

Why fight a losing battle? Just do it.

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I have to respectfully disagree. While they meet the standard, I cringe at manuals that restate the standard. To me this emphasizes that a company requirements is in place "only to meet ISO" not because the company management has made an operating decision. You need to cover the requirements either IN the manual or reference to procedures. Restating the standard creates an unnecessarily lengthy manual....making employees less likely to read.

My last quality manual to ISO9001 was 5 pages long. A summary of how management establishes and reviews the quality system, explanations of how customer satisfaction is determined and is the focus, followed by a flow chart of the quality system referencing the various procedures. This makes sure the company "processes" are determined, that in the end meet the ISO standard. I was told by the registrar that this was "The best interpretation of the intent of ISO9001:2000 that he had seen." Another manual that I inherited at another company, which primarily restates the standard, then references procedures applicable to the section of the standard was recently audited and the auditor stated "You know, this works and meets the standard, but you can certainly make it shorter. Go back to the standard and look at the minimum requirements of a QM - since the procedures cover the detail, you may want to make the manual more user friendly."

I guess it comes down to personal preference of the company, but to say "just do it" doesn't work for me. The new standard gives companies the flexibility to write a quality manual in 'their language' and to be used by more than the auditor during the audit. I would take advantage of that flexibility and make you manual unique.

Laura