A Quality Manual is a high-level document that outlines your intention to follow operational procedures and achieve consistency throughout the organization, while also meeting customer requirements. The manual can be used in many ways, including:

• a communication and training tool that allows everyone in the business to see exactly how it fits together and operates;
• a document that allows third parties, such as BSI, to understand your business and assess your activities as they relate to ISO 9001:2000.
• a marketing tool—There is no reason why the manual cannot be sent to potential customers to prove that you take quality seriously and have systems in place that ensure quality (but be careful not to send confidential or proprietary information);

The Quality Manual sits at the top of the hierarchy of all quality documentation (quality procedures and work instructions) and outlines why you are in business, what your quality intentions are, that is how you are applying the standard’s requirements and how your business operates. A Procedures Manual is a second level document and outlines what you do to meet your intentions detailed in your Quality Manual (i.e., how you operate as an organization). Therefore, it is very important that the documentation you produce links together. This will be discussed in a later update issue.

Although the Quality Manual can be written solely by one person, to get the level of involvement required, it is best to gain the views of others in the business, especially the management team.

There are many ways to write a Quality Manual and BSI is flexible in this regard, but organizations should make sure that their approach is appropriate to their operations and includes all of the requirements of ISO 9001:2000. One method is to simply follow the sequence of the standard and its requirements. A second method of constructing a typical Quality Manual, which can range in length from 10 to 25 pages is described below:

Cover page - This should carry the name of the company, the title and identify the issue number.

Contents page - This should be a list of subject headings followed by the page numbers where the details can be found in the document.

Quality Policy statement - A Quality Policy is a statement of intent of about two or three paragraphs that is tailored to your business and covers the answers to the following questions. The answers should be relevant to your business and therefore describe your policy on quality (some possible answers are given after each question):

1. What does "quality" mean for your business and your customers?

   On-time deliveries; products and services that meet customers’ specified requirements; products that meet design specifications; or continually improving standards/methods of working.

2. How do you achieve "quality"?

   Listening to customers; using technology; working together; and training employees.

3. What do you expect from employees?

   Use the quality system to produce products and services consistently; commit to serving the customer in a professional manner; and contribute to continual improvement.

4. How do we achieve quality?

Having completed the questions, the answers can be brought together to form the Quality Policy. An example is shown below:

‘It is the policy of (your organization) and its staff to provide products and services that conform to the requirements of our customers, to deliver them on time and without defects. This will be achieved through the involvement of a well-trained team striving to continually improve what they do.’

Although not a requirement of the standard, the business owner should sign and date the Quality Policy to demonstrate commitment both to employees and customers. (Remember that quality policies are not set in stone. They should be regularly reviewed to confirm they still meet the needs of the business. Organizations work in a dynamic environment and hence are faced with continuous change; quality policies and quality systems should change as the business changes.)

Organizational chart - Traditionally, this is a tree diagram showing how the functional departments in the business are organized. Remember that you don’t want to keep changing your Quality Manual every time somebody joins or leaves the business, so you might want to use job titles only and not the actual names of the individuals concerned. Also, be sure to identify the Management Representative here as well.

Responsibilities and authorities of key personnel including the management representative - In this section, write down the responsibilities of key personnel with regard to the quality of the product or service delivered to your customers. Who is or is not "key" is dependent on your business. At a minimum, you should identify document controllers, internal auditors, top management, inspectors, the management review team, anyone measuring quality objectives, anyone conducting calibration and, of course, the management representatives, whose responsibilities are shown in the standard. Any additional responsibilities that you feel need to be added, can be.

Quality System procedures - Under this heading, simply list the procedures that you have identified. It is suggested that they be listed in numerical order together with their title. If you have decided to group these, for whatever reason, then use the same groupings here. Write a short description of what each procedure does under the appropriate title. This only needs to be one or two sentences.

Permissible Exclusions - Clause 7 allows permissible exclusions. If your organization has permissible exclusions, then add a statement explaining the need to NOT apply the clause’s requirements.

Compliance Matrix - This is a simple matrix that shows how the procedures relate to the standard.

Appendices - Appendices are not necessary but can be added if they give greater detail to the statements made in the main body of the Quality Manual.

With this approach, organizations should start by developing the first five sections as outlined above (through "responsibilities and authorities"). That will give you a good framework to use for the rest of the manual and the quality management system as well.

Having started the Quality Manual with the first five sections, the next stage is to identify the procedures that describe how you operate.

To complete your Quality Manual, you will need to identify your procedures. Organizations that are transitioning to the new standard should note that it is perfectly acceptable to use existing documentation in this vein, but many businesses find that creating new documentation often saves time in the long run.

Once the Quality Manual has been produced, make sure, using your Control of Documents procedure, that it is controlled. Typically, the Quality Manual will then show:

• an issue number;
• a date of issue;
• a record of who has a copy.