A quality manual is the top-level definition of a quality management system of your company. It is similar to an expanded mission or vision statement. Quality manual establishes the policy level position of your management in the area of quality management system (QMS). There are two definitions of what a quality manual for an ISO 9001 QMS 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 specified interaction between the processes of your QMS.
Let's follow these simple instructions and see how easy it is to create a quality manual to document the scope of your quality management system and exclusions; ensure that procedures are referenced and specify relationships or interactions between your 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.
Interaction between the processes may be documented in a number of ways. Some companies choose to define top-level interaction by using derivatives of Figure 1 in ISO 9001:2000 standard. Combining such a diagram with references to procedures, will define interactions between your processes. For more detailed process interaction tools, type "process interaction matrix" into your browser and you will find numerous examples.
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.
It was always a mystery to me why some companies mark their quality manuals with a big red stamp "FOR INTERNAL USE ONLY". Our clients are strongly encouraged to make their quality manuals public, assuming that your manual did not include any proprietary information.
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