What is a quality manual? 

It might be an important part of your quality documentation.  Or... you may not even need or have one in the 'written stuff' that makes up your quality system.

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, IT systems.  This is called 'documented information' in the current version (2015) of ISO 9001. Confusingly, they have also decided to use the same term for what were formerly called 'records' - those things that showed what had been done, such as registers, logs, competed forms, reports, meeting minutes and so on.

'Documented information' in 9001 terms means both the 'written stuff' that describe your quality system and say how it should operate (eg, flowcharts, procedures, policies, checklists) and the 'written stuff' that shows what was done.

A system must be documented to achieve ISO 9001 certification, because having certain documented information is required by the Standard. 

The requirements in ISO 9001 for documentation are that it must include:

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 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.  

One often used way to do that was with a thing called a 'quality manual'.  And you can still do that, if you choose.  And it 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 such a 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 documentation must we have?  

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 documentation mistakes - what not to do

If you've seen previous examples of these, particularly quality manuals, you'll most probably only have seen bad examples of quality manuals.  Such things proliferated, including, alas for the previous version of the Standard (the 2008 ones).  And even though the requirement has now been dropped, I think some of those may hang around for quite some time, unfortunately. 

How to recognise one: 

Perhaps you've seen one like that?  If not, check this example quality manual  (*pdf format).  But take a deep breath first.  Then contrast that with this example of one of my quality procedures.

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 you have to do.  Wrong, wrong, wrong. 

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 useful 'written stuff' 

The best way of understanding and figuring out what to do is to study a good example.  Even better, more than one.

Good quality manuals (or handbooks, or whatever you want to call them) 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 documents, including manuals, are in our DIY ISO 9001 Kit.