A common criticism of ISO 9001 is that it places too much emphasis on documentation, and the early versions of ISO 9001 and the way they were audited were guilty of this. Although the requirements for documentation are still a part of ISO:2008 (the latest version), a more balanced approach is now taken. Only six procedures must be documented, for the rest it is up to management to decide what needs to be documented to ensure that good quality products and services are provided in an efficient and effective manner. In other words, it is up to your organisation to decide what needs to be documented and communicated in order to defects and waste, improve quality, increase efficiencies and thus reduce costs.
It is also up to your organisation to decide how it communicates this information. It can be through flow charts, process maps, images, videos, and so on, it doesn’t have to be communicated in the “normal” written format. If you decide to write it the “normal” way then please make it succinct. No one wants to read a procedure that is several pages long.
Now I hate to state the obvious but . . . . . whichever format you choose it should tell people how to complete the tasks. I have read to the end of many procedures and then wondered “So how do I do it? What am I meant to do?” Procedures like that are a complete waste of time.
4.2 Documentation Requirements
What does ISO 9001 Say?
ISO 9001 has quite a lot to say about documentation.
The quality management system documentation shall include:
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures and records required by this International Standard, and
d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.
NOTE 1: Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.
NOTE 2: The extent of the quality management system documentation can differ from one organization to another due to:
a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.
NOTE 3: The documentation can be in any form or type of medium.
Why is this Necessary?
A fundamental principle of quality assurance is to be able to prove that you have control over the activities that impact the quality of the products and services you provide to customers. The proof is in the following objective evidence:
- State your customer’s requirements – this is done by documenting what they want you to produce, for example through specifications, drawings, service level agreements.
- Explain how you will produce it – this is most commonly done through procedures and work instructions but it can be through videos, photos, etc.
- Record that you have implemented it – through for example, completed checklists, other forms and minutes of meetings.
- Record that you have produced the products and/or services that meet your customer’s requirements.
Let’s break it down.
The quality management system documentation shall include:
a) documented statements of a quality policy and quality objectives
Clause 5.3 Quality Policy in ISO 9001 contains more detail on what a quality policy should contain and my communication Quality Policies: 5 Things You Must Know explains these requirements.
ISO Management Systems – 3 Tips for Meaningful Objectives and Targets is also relevant.
b) a quality manual
This requirement is covered in more detail in clause 4.2.2 Quality manual but the following is an overview.
This is a top level document that shows how the processes are interconnected and how they interact to deliver your products and/or services. This could be done through a high level process map, flow chart, or diagram of the processes in your organisation. A bird’s eye view of it from 5,000 metres. I like to keep it simple and I do so by listing the requirements of the Standard in the first column of a table and the names of the procedure/s that meet each requirements in the second column. More information on keeping Quality Manuals simple here.
c) documented procedures and records required by this International Standard
There is one word that you must understand in ISO 9001 (and in fact all the ISO management system standards). That word is SHALL. When you see SHALL think MUST. There are 6 procedures that ISO 9001 says you must have. I know this because the Standard says “A documented procedure shall be established to define requirements for . . . “. There are many more records that the Standard says you shall (must) have. Here is more information on records.
d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes
In addition to the procedures and records ISO 9001 says you must have you need to decide whether there are other documents and records you should keep. Why would you want more? Because they will help you to communicate to staff how to produce quality products and provide quality services or how to do things efficiently and therefore save money. Examples are purchasing procedures, service provision procedures, and work instructions that describe how to operate equipment.
NOTE 3: The documentation can be in any form or type of medium
As I said in my opening, it is up to your organisation to decide how it communicates this information. It can be through flow charts, process maps, images, videos, and so on, it doesn’t have to be communicated in the “normal” written format. If you decide to write it the “normal” way then please make it succinct. No one wants to read a procedure that is several pages long.