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:
- the scope of the QMS and 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"
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."
Looking at the paragraph above, you will notice that a reference to a specific procedure satisfies the second requirement for a quality manual. Continuing in a similar way, addressing all applicable elements of the standard and referencing corresponding procedures, we will develop a quality manual satisfying ISO 9001:2000 requirements.
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.
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! - 15431
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 QMS and 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"
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."
Looking at the paragraph above, you will notice that a reference to a specific procedure satisfies the second requirement for a quality manual. Continuing in a similar way, addressing all applicable elements of the standard and referencing corresponding procedures, we will develop a quality manual satisfying ISO 9001:2000 requirements.
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.
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! - 15431
About the Author:
Thinking of simplifyeing your ISO 9001 QMS manual? Check our ISO 9001 Quality Manual programs and ISO 9001 Quality Management System Manuals.
