Saturday, January 24, 2009

What is a quality manual for ISO 9001?

By Mark Kaganov

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:

- the scope of the quality management system, including details of and justification for any exclusions;

- references to the documented procedures, and

- a specified interaction between the processes of your QMS.

Instructions above are really not that difficult to follow. We just need to ensure that our quality manual includes the sections to include the scope of your quality management system and exclusions; reference the procedures that describe your quality management system and define interactions of you QMS processes.

Typically, companies state the scope of their QMS in a scope or introduction sections of their quality manuals, similar to these: "ABC Enterprises, LLC assembles and distributes pre-cooked meals for elderly citizens in the St. Newtown region" or "ABC Enterprises, LLC designs, manufactures and services high poser vacuum cleaners"

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."

Following this simple method, we can answer to all the requirements of ISO 9001:2000 standard and reference procedures supporting corresponding elements of your manual and quality management system. SO we will comply with two first requirements of the 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.

Surprisingly, many companies do not recognize that their quality manual may be a powerful communication tool. These organizations mark their manuals with "internal use only" and "confidential" stamps, while those quality manuals can serve a company externally. We recommend to all our customers make their quality manuals public, assuming that your manual does contain proprietary information. - 15275

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