Your ISO 9001 Quality Manual must describe

The scope of the Quality Management System i.e. what's included in the Quality System

Details and justification of any exclusions (what's excluded)

Procedures (normally separate documents)

A description of the interaction of the processes e.g. a flowchart of relevant business

activities

Like any high-level document, the manual must be written in such a way that it provides
employees, customers, auditors and other interested parties with a sound overview of how your
organisation satisfies customer requirements.
Write the manual so it is useful, and in a tone that makes sense for your business (and market).
Use your house style and branding. Remember your different types of audience - a classic
mistake is writing a manual 'for the Standard' or 'for the auditor'. Don't.

What documentation hierarchy should I adopt?

How should I assign document numbers and their sequence?

How much detail should be in the Quality Manual?

Does it matter how big the Quality Manual is?

My boss wants a 4 page Quality Manual - what should I do?

Should I use hyperlinks?

Should I use separate documents for the QM, Procedures and Forms?

Should the quality manual refer to all procedures?

How do I show the interaction of processes in the quality manual?

What information should the procedures include?

What about translating the manual into different languages?

Does the Quality Manual need to be distributed to all employees?

Quality manual writing tips

Exclusions
Some exclusions are permitted but the exclusions are limited to the Product Realization
requirements (ISO9001:2008 Section 7). Where exclusions are declared, the quality manual
must clearly define which requirements have been excluded with detailed justification for their
exclusion.
Excluded requirements must not:
1. Affect the ability of the organisation to meet customer and regulatory requirements
2. Affect the ability of the organisation to provide conforming products or services
An sample of a justifiable exclusion might relate to design and development; if a company does
not undertake design and development activities then Clause 7.3 would not be applicable.
In order to exempt your company from a requirement; a statement such as the following would
suffice:
Our company does not engage in designing, developing or changing the design of the products
we manufacture. To this end, our quality management system does not encompass product design
and development processes and therefore, paragraph 7.3 is not applicable to our business and has
been excluded.
Exclusions are only permitted where an element of Section 7 is genuinely not relevant to the
company, an audit may ask for evidence!

What documentation hierarchy should we adopt?

It is common practice to follow this hierarchy:

Level 1: Policies - key system objectives

Level 2: Quality Manual - approach and responsibility

Level 3: Procedures - methods (Who, What, Where and When)

Level 4: Work Instructions - description of processes (How)

Level 5: Forms, Data and Records - evidence of conformance

How should I assign document numbers and their sequence?

We use the same numbering sequence as ISO 9001 in our quality manual templates. You are free
to replace these with a system that works best for your staff and for the business - as long as the
system is logical, documented and communicated, it should be more than adequate.

How much detail should be in the Quality Manual?

The amount of detail required is proportional the level of control needed to achieve product
conformance. The basic requirements are stated in Clause 4.2.2 of ISO 9001:2008:
The organization shall establish and maintain a quality manual that includes:
a) the scope of the QMS, including details of and justification for any exclusions
b) documented procedures established for the QMS, or reference to them
c) a description of the interaction between the processes of the QMS

Does it matter how big the Quality Manual is?

No.
The size and complexity of your organisation and its individual processes will determine the
volume of information required to successfully convey how the system works and what controls
are in place to manage each process.
We've prepared 10-page quality manuals and others with more than 150 pages. Each manual was
certified because it met the requirements not because they were a certain page length.
My boss wants a 4 page Quality Manual - what should I do?
Organisations often address the requirements of the standard by preparing a quality manual that
covers the requirements of the international standard and includes or makes reference to the
quality system procedures and outlines the structure of the documentation used in the quality
system. It would be difficult address all the requirements in 3 or 4 pages.
Most quality manuals are typically 30 or 40 pages in length. Our quality manual template
addresses these requirements in 20 pages of text, while the procedures carry the burden of
defining how compliance to a requirement is acheived at an operational level.
Ask your Suppliers and Customers for a PDF copy of their quality manual if they are ISO 9001
certified. It might be useful to go through these with your colleuges - particuarly those new to
ISO 9001.

Should I use hyperlinks?

Yes, we recommend using internal links/bookmarks within a document to aid navigation and
save scrolling.
We do not recommend using external hyperlinks between documents. Someone changing
filenames is always a hazard to maintaining links, especially on a live document such as a quality
manual. (People often append a version number or date to a filename as a matter of courtesy and the hyperlinks will no longer work!)

Should I use separate documents for the QM, Procedures and Forms?

Yes! Always use separate documents.

** Beware of people that recommend differently! **
Separate procedures allow you to revise a single small document as opposed to a larger,
combined document. It can quickly become burdensome to revise the entire manual each time an
operating procedure is amended. This approach also allows for tailored distribution of documents
relevant to the need of the recipient.
What about 'bureaucracy'?
One of the main arguments for keeping all documentation within one document is that it is easier
to manage. Some people say that separate documents are 'cumbersome', 'bureaucratic', and not
user-friendly.
We disagree.
Ask yourself - 'how are we going to use the manual'?
Will you distribute your Quality Manual externally?
Are you likely to publish your QM on the internet or send it to customers or potential customers
or suppliers? If so, would you like them to see all your procedures and processess? We do not
recommend this. There is no need for external people to know this amount of detail.
Internal use
Are different people responsible for different procedures? Would you like all of them to be able
to make ammendments/changes to the whole of the QM, or just their own procedure(s)?
From an internal point of view, very few people will need to have regular access to the QM
whereas they may need access to a specific procedure.
Think about how you will manage the documentation, who is responsible for what content (e.g.
procedures), and who you will be distributing the QM to externally.

Should the quality manual refer to all procedures?

Yes; it is common to include a master-list of procedures in the manual but don't put the revision
status in there, otherwise youll be revising the manual each time a procedure is revised. You
could have a separate list or spreadsheet which identifies the procedures and acts as the master
list. This can then show the current revision status of each procedure and is more easily kept up
to date.

How do I show the interaction of processes in the quality manual?

Include a simple process map showing all the process interactions. This is an effective way to
demonstrate how the interactions relate to individual core processes. You can also include the

names of process owners, as well as show how customer processes interact with organisational
processes.

What information should the procedures include?

Procedures should define; who does what and when they do it. The procedure should assign
appropriate responsibilities and define the process in order to achieve the stated organisational
policy.

What about translating the manual into different languages?

Many organisations trade in different countries, and it is useful to distribute the manual in
different languages.
We recommend you publish your quality manual (only the manual - not your procedures) in your
native language as a PDF on your website, and ask the viewer to view it in Google Chrome
browser. This will use Google Translate to automatically translate the PDF into their language.
The Translation is not 100% accurate - and you should state this carefully! But if a potential
supplier or customer has any specific questions, you can then use a professional translation
service to translate the relevant sections.

Does the Quality Manual need to be distributed to all employees?

No, it is not necessary to print and distribute the manual for use by individual departments or
employees.
We recommend you make a PDF version available on the company Intranet.

Quality manual writing tips

To pass a certification body audit, a Quality Management System must be an auditable

entity

Just writing about it is not enough the QMS must also be implemented

Aim for minimal documentation (especially if you're a small business)

Start with the assumption that you're currently doing all (or most) of what ISO 9001 asks

Use separate documents for each procedure

Use the same numbering as the standard

Ask your Suppliers and Customers for a PDF copy of their Quality Manual

Use a Quality Manual Template - start your documentation out on the right track!

>> View Quality Manual Template sample

>> View Quality Manual guidance sample

External links

4.2 Documentation requirements - BS EN ISO 9001:2008 standard

ISO 9001:2008 Documentation Requirements - www.iso.org