A quality manual is a high-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) and compliance with applicable regulations. There are two definitions of what a quality manual for an ISO 13485 QMS should be:
ISO 10013, Guidelines for Developing Quality Manuals, element 4.2, provides 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 13485:2003, element 4.2.2 describes a quality manual as a document containing:
1 - the scope of the QMS
2 - description of processes that are excluded, including non-applicable elements;
3 - references to the documented procedures;
4 - a description of interaction between the processes of the QMS
5 - description of the QMS documentation.
Most companies I worked with, stated the scope of their quality management system in a scope or introduction sections of their manuals, similar to these: "ABC Nephrology, Inc. designs, manufactures, distributes and services dialysis equipment and accessories"
Now, after we established the scope of our ISO 13485:2003 QMS, we need to describe the processes we use to achieve the results stated in our scope. While we are doing this, we need to remember to reference corresponding procedures. Per my experience, the easiest way to do it is to transform the standard from a list of requirements into your organization's dedication to satisfy those requirements. For example: Element 5.5.2.c of ISO 13485:2003 requires a Management Representative to ensure "? promotion of awareness regulatory and customer requirements ?" our manual will affirm: "The Management Representative ensures that regulatory and customer requirements are clearly communicated throughout the organization per the Purchasing Procedure and Regulatory Compliance Procedure."
Looking at the paragraph above, you will notice that a reference to a specific procedure satisfies the third 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 requirements of the standard.
Various methods are used to document process interactions. Some companies utilize Figure 1 from ISO 9001:2000 standard to document relations between main processes. Use of such an illustration and references to your procedures, will define interactions between your processes. You can find additional models for process interactions on the Internet. Just, type "process interaction matrix" into your browser and you will find your answers.
The only requirement of the element 4.2.2 left is to describe the structure of your documentation. Some businesses I have consulted described their documentation tree as 4- or 5-level structure in the documentation management section of the manual.
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 and compliance with regulatory requirements.
I always wonder what companies achieve by stamping their quality manuals in bold capitol red letters "CONFIDENTIAL". As far as I am 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! - 16036
ISO 10013, Guidelines for Developing Quality Manuals, element 4.2, provides 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 13485:2003, element 4.2.2 describes a quality manual as a document containing:
1 - the scope of the QMS
2 - description of processes that are excluded, including non-applicable elements;
3 - references to the documented procedures;
4 - a description of interaction between the processes of the QMS
5 - description of the QMS documentation.
Most companies I worked with, stated the scope of their quality management system in a scope or introduction sections of their manuals, similar to these: "ABC Nephrology, Inc. designs, manufactures, distributes and services dialysis equipment and accessories"
Now, after we established the scope of our ISO 13485:2003 QMS, we need to describe the processes we use to achieve the results stated in our scope. While we are doing this, we need to remember to reference corresponding procedures. Per my experience, the easiest way to do it is to transform the standard from a list of requirements into your organization's dedication to satisfy those requirements. For example: Element 5.5.2.c of ISO 13485:2003 requires a Management Representative to ensure "? promotion of awareness regulatory and customer requirements ?" our manual will affirm: "The Management Representative ensures that regulatory and customer requirements are clearly communicated throughout the organization per the Purchasing Procedure and Regulatory Compliance Procedure."
Looking at the paragraph above, you will notice that a reference to a specific procedure satisfies the third 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 requirements of the standard.
Various methods are used to document process interactions. Some companies utilize Figure 1 from ISO 9001:2000 standard to document relations between main processes. Use of such an illustration and references to your procedures, will define interactions between your processes. You can find additional models for process interactions on the Internet. Just, type "process interaction matrix" into your browser and you will find your answers.
The only requirement of the element 4.2.2 left is to describe the structure of your documentation. Some businesses I have consulted described their documentation tree as 4- or 5-level structure in the documentation management section of the manual.
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 and compliance with regulatory requirements.
I always wonder what companies achieve by stamping their quality manuals in bold capitol red letters "CONFIDENTIAL". As far as I am 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! - 16036
About the Author:
ready to start working on your Quality manual? Visit our ISO 13485 page to learn more about Quality Management systems for medical device manufacturers
