What is a quality manual?
It's an important part of your quality documentation.
So what's quality documentation?
'Documentation' means anything written down or captured in some form: written procedures, policies, checklists, forms, or graphics, drawings, flowcharts, diagrams, even IT systems.
'Quality documentation' means the documents that describe your quality system and say how it should operate.
A system must be documented to achieve ISO 9001 certification, because it's one of the mandatory requirements of the Standard.
The requirements in ISO 9001 for documentation are that it must include:
- a quality policy - the position or approach that your organisation takes on quality (and no, "we do quality work" won't do it)
- measurable 'quality objectives' - what you plan to achieve, and how you will assess or measure if you did or not
- documents that you need to control how things are done, such as procedures. This must include procedures for 6 mandatory areas.
What can confuse people is that actually you can choose what your documents look like, what format and structure you use, and what to put in them. Provided you meet these minimum mandatory requirements.
You can use one or many formats, from checklists and flowcharts to intranets, wikis or workflow embedded into IT systems. You can use any media, hardcopy or soft, including intranet, online, internet or wiki. So a 'quality manual' can be in hardcopy (paper) or softcopy: online documents like web pages, help files or IT systems.
And you can write your document in various ways, from easy and user-friendly to bureaucratic, verbose and very hard to follow.
And your quality manual may be the only document you have for your system, or it may be one of a number of documents. Or something in between.
What must a Quality Manual contain?
There's just no single simple answer to this question, despite many badly informed beliefs to the contrary. It all depends on what you need in your business. Just as a smart car, a delivery truck and a freight train are all vehicles, but will be right in different contexts, what is the 'right' quality manual in one company may be too much or too little in another. A small business may only need a single manual; a large company often will need more.
Widespread but ignorant and uninformed (mis)belief insists there is One Single Right and Proper format. Utter tosh. It's completely wrong to dictate than an ISO 9001 Quality Manual must always look like X, or that quality manuals must always have these specific headings or must be set out like this. If you've been told that, you've been misinformed.
Quality Manual mistakes - what not to do
If you've seen previous examples of quality manuals, you'll most probably only have seen bad examples of quality manuals. Such things proliferated, particularly in the late 20th century. But sadly, those old-style models are still hanging around: truly awful and of very little value.
How to recognise a bad quality manual.
- It's always thick and invariably ugly
- It makes your heart sink just looking at it
- It is hard to understand; you cannot imagine who would read it if they didn't have to (or be forced to )
- Has lots of numbered sections, strictly matching each clause of the Standard: 4.1, 4.2, 4.3 etc. (This of course makes absolutely no sense at all to anyone who didn't or doesn't know the clauses of the Standard inside out.)
- Uses lots of Special Quality Terminology throughout so it's littered with incomprehensible and wordy terms such as Contract Review, Process Control, Nonconformance, Corrective Action, Management Responsibility etc.
- The term QUALITY MANUAL will be liberally plastered everywhere (you certainly wouldn't have guessed it!). Usually IN CAPITAL LETTERS LIKE THIS. WHICH ARE VERY HARD TO READ.
- Full of 'shalls'. So may contain dreadful verbose things like: 'It is incumbent upon the organisation to ensure that management shall...
Too many so-called 'ISO quality systems' (far too many) still have copious quantities of Documents with a Capital D. Usually, few people can read and follow these, let alone use them.
So why do they exist? Because some people still think that's what a quality manual should be. And that a "proper" quality manual has a policy and matching procedures for each and every separate clause in the Standard. (That would mean an absolute minimum of 22 written policies and procedures, maybe more, no matter your type of company or your size! Which creates an awful lot of paperwork with little if any value, particularly when it refers to things you've never heard of, let alone understand.)
Do avoid that trap.
Because it really is a trap. You'll end up with a huge pile of obtuse and wordy documents, and you really don't need them.
Unless of course you like and want to use procedures with titles like "Design Control", "Management Review" or "Nonconformance"? And prefer procedures to be wordy, many pages long, and full of the same old dreary headings, beginning with a 'Scope' and 'Definitions' and 'Terminology'. Which you have to wade through to try and discover what you're actually meant to do and how.
And of course they must be hard to read. Clarity, simplicity and brevity dumped by the wayside as irrelevant to 'quality'. (Untrue and makes my blood boil.)
What's that? You don't want something like that?
No, of course you don't.
An 'ISO 9001 quality manual' that no one reads or uses is a very common mistake. To avoid that one (and others), read our free report.
How to get a good Quality Manual
The best way of understanding and figuring out what to do is to study a good example of a quality manual. Even better, more than one.
Good quality manuals are very different from bad ones. And usability research shows information that is well designed and clearly presented has measurable benefits, eg, one well designed intranet doubled employee productivity.
For hints on what to do, see How to write quality documents
See this short and clear sample quality procedure from one of our quality manuals. (Contrast that with the ghastly one above)
PS. Samples of clear and short Quality Manuals are in our DIY ISO 9001 Kit.
Author: Jane Bennett