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
- relationships between the processes of your quality management system.
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.
Definition of the scope is usually placed into the ?Scope? section of the manual. It simply states what activities your company performs. For example: ?My Company, Inc. designs, manufactures and distributes card board boxes for high volume customers? or ?My Company, Inc. provides ISO 9001 consulting and training services for service companies?
When the scope is defined and exclusions are determined, it?s time to describe used processes and determine reference to the corresponding procedures. As I found through my consulting and auditing work, the best way to start this step is to transform the standard from a set of applicable requirements into your company?s commitment to satisfy those requirements. For example: If the standard in element 5.6.1, requires that the "Top management shall review the organization?s quality management system at planned intervals, to ensure its continuing suitability, adequacy and effectiveness," our manual will state: "My Company, Inc.?s top management review the quality management system on at least a quarterly basis to ensure its continuing suitability, adequacy and effectiveness per the Management Review Procedure."
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.
Now, when we addressed the requirements of ISO 9001:2000 standard for quality manual, consider this. A well written and professionally designed quality manual may become a powerful marketing tool. It can communicate to your prospects and customers that your organization is not only a quality-conscious organization, but that it also knows how to document and communicate its commitment to quality through your quality manual.
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! - 15359
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
- relationships between the processes of your quality management system.
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.
Definition of the scope is usually placed into the ?Scope? section of the manual. It simply states what activities your company performs. For example: ?My Company, Inc. designs, manufactures and distributes card board boxes for high volume customers? or ?My Company, Inc. provides ISO 9001 consulting and training services for service companies?
When the scope is defined and exclusions are determined, it?s time to describe used processes and determine reference to the corresponding procedures. As I found through my consulting and auditing work, the best way to start this step is to transform the standard from a set of applicable requirements into your company?s commitment to satisfy those requirements. For example: If the standard in element 5.6.1, requires that the "Top management shall review the organization?s quality management system at planned intervals, to ensure its continuing suitability, adequacy and effectiveness," our manual will state: "My Company, Inc.?s top management review the quality management system on at least a quarterly basis to ensure its continuing suitability, adequacy and effectiveness per the Management Review Procedure."
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.
Now, when we addressed the requirements of ISO 9001:2000 standard for quality manual, consider this. A well written and professionally designed quality manual may become a powerful marketing tool. It can communicate to your prospects and customers that your organization is not only a quality-conscious organization, but that it also knows how to document and communicate its commitment to quality through your quality manual.
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! - 15359
