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.
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!
It is common practice to follow this hierarchy:
We use the same numbering sequence as ISO 9001 in our quality manuals. 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.
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
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.
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!)
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.
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.
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.
Yes; it is common to include a master-list of procedures in the manual but don't put the revision status in there, otherwise you’ll 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.
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.
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.
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.
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.