When I audit ISO management systems – be they ISO 9001 for Quality, ISO 14001 for the Environment, ISO 18001 or AS/NZS 4801 for work, health and safety, or ISO 22000 for food safety – I see soooooo many Quality Manuals that are 20, 30, 40 Pages long. There is a better way.
The ISO 9001 Quality Management System Requirements Standard states:
4.2.2 Quality manual
The organisation has established & will maintain a quality manual that includes:
a. the scope of the quality management system, including details of & justification for any exclusions;
b. the documented procedures established for the quality management system, or reference to them, and;
c. a description of the interaction between the processes of the quality management system.
This doesn’t mean you need a Quality Manual in which you regurgitate the Standard. What’s the point? It does means you need to document:
Clause a – part 1
The scope of your system. You may choose to include only some of your organisation’s processes, products or services in your certified system or a portion of your business units or sites. Specify the scope of your organisation’s activities covered by the certification. This can be done in one sentence.
Clause a – part 2
Exclusions are the requirements of the Standard that your system doesn’t address. You can exclude requirements that are irrelevant to your organisation due to the nature of your activities, products or services. A simple explanation as to “why” must also be given (your justification). The requirement most commonly excluded is 7.6 Control of monitoring & measuring devices, better known as calibration. Your justification for exclusion may be as simple as “The organisation does not measure nor is it required to measure any processes or product with measuring devices.”
I normally cover this by creating a table that lists the Standard’s clauses in the first column & the names of the procedures that meet the requirements of that clause in the second column. It’s a good way of ensuring that you have indeed met all the requirements of the Standard. Plus if you win lotto & quit work, it’ll form a succinct explanation to the person who replaces you on how the system is structured. Auditors like it because it makes their job easier, but keep in mind you aren’t writing the system for them!
I read the clause as simply telling the company to make sure their system addresses how the requirements interact. The outputs of some requirements become inputs into others. For example audit results should be discussed in management review meetings; non-conformances should feed into corrective actions. This doesn’t mean you have to create a process map or flowchart of your organisation.
Having said that, I do like to use them when the organisation & I agree they’ll be beneficial. In this situation I identify the company’s key business processes such as purchasing, sales & marketing, production or service creation. This is the helicopter level 1 view. I take each of these in turn & expand on them to create level 2 processes & 2 levels may be all you need. At this point & using an electronic system, you hyperlink each step in the process map to a procedure & voila, you have an integrated system that is easy to navigate & follows the structure of your business, not ISO 9001. Believe me, that’s a good thing.
If you’d like to read more about the process approach for ISO management systems, here is some guidance from the International Organisation for Standardisation
If you’d like to see some great, easy to use, business process mapping software check out Promapp.
All the best – Liz.