What is a quality manual for ISO 9001?

A quality manual is the main, top-level document of a quality management system. It is similar to a constitution of a country or a manifesto of a party. This type of document establishes the policy level position of a government, party or in the case of a quality manual, a company. There are two published definitions of what a quality manual for an ISO 9001 quality management system should be:

ISO 10013, Guidelines for Developing Quality Manuals, element 4.2, gives detailed suggestions for creating a quality manual. It defines a quality manual, among other requirements, as a document that should “consist of, or refer to, the documented quality system procedures intended for planning and administration of activities which impact on quality” ISO 9001:2000, element 4.2.2 describes a quality manual as a document containing:

– your QMS scope and justified exclusions;

– references to the documented procedures, and

– a description of interaction between the processes of the QMS.

If we follow the requirement 4.2.2.a of ISO 9001:2000 Standard, we simply need our quality manual to clearly define the scope of our QMS, exclusions, if any; reference our procedures and define interactions between the processes.

Most companies I worked with, state the scope of QMS in a scope or introduction sections of their manuals, similar to these: “XYZ Corporation designs, develops, manufactures and sells industrial application flow meters” or “XYZ Corporation provides paper and plastic recycling services to municipalities in the Great Newtown area”

Since the scope defines our activities and we established our scope, we can define the processes that we need to achieve the results stated in the scope. Also, remember referencing corresponding procedures for those processes. The easiest way to do it, is to transform the standard from a list of requirements into your organization’s commitment to satisfy those requirements. For example: Element 5.4.1 of ISO 9001:2000 requires that “Top management shall ensure that quality objectives, including those needed to meet requirements for product are established at relevant functions and levels with in the organization.” our manual will state: “ABC Enterprises, LLC’s top management ensure that quality objectives, including those needed to meet requirements for product are established at relevant functions and levels per the Quality Objective Matrix.”

As you can see, a reference to a specific procedure satisfies the second requirement for a quality manual. Following this approach by addressing all applicable elements of the standard and referencing corresponding procedures, we will establish a manual that meets the requirements of ISO 9001:2000 standard.

Now we need to choose a method to document interactions between our processes. There are a few ways to do it. One typical method is to utilize Figure 1 in ISO 9001:2000 standard. This figure shows a model of a process-based QMS. In addition to that, referenced documents will show what processes are “attached to those listed in our quality manual. Some models are available on the Internet. Just, type “process interaction matrix” and you will find your answers.

Another important function of a quality manual, very often overlooked, is as a marketing tool. Well written and professionally published, a quality manual may become a powerful marketing instrument. It can communicate to your potential customers, suppliers and subcontractors that your company is not only a quality-conscious organization, but that it also knows how to document and communicate its commitment to quality.

I always wonder what companies achieve by stamping their quality manuals in bold capitol red letters ?CONFIDENTIAL?. As far as I?m concerned, a quality manual is a company?s resume for quality, and if you hide your resume, there is a very good chance that you will never get a job! All our customers are encouraged to make their quality manuals public!