The Quality Manual.

Information & Training. | Quality Assurance. Quality Management.

Details the commitment to quality from the most senior management within the organization. This commitment will be outlined in the Quality Policy which will be included in the manual.

Provides information on the structure of the business, including the roles and responsibilities of all functions within the organization, including those involved in the “quality” activities.

Makes a very clear statement on the role and responsibilities of Quality Management.

Provides details on the scope of coverage of the quality system across the business and across products and services provided.

Quality Manual

The Quality Manual. Auditing. Supplier Management. CAPA. Documentation. Design Quality. Etc. Etc.. Information & Training presentation.   >>>

Allows customers, suppliers and all stakeholders an opportunity to understand the structure of the organization and the commitment to “quality” practices. The Quality Manual will be a publicly available document, that demonstrates capability and confidence in the quality and integrity of the organization’s processes, products and services.

Is a document which details how the quality management system has been developed within the business and sets direction for future development.

It is a means to communicate the Vision, Values, Mission, Policies and Objectives of the organization.

Will outline the structure of Policies, Procedures, Specifications, Standards and detail how these documents are approved, released, controlled and implemented across the organization.

Will detail the commitment to and practices applied towards continuous improvement. The means of identifying improvement opportunities, the approach to problem solving.

Will seek to outline the desired organizational culture, will detail the commitment of management to achieving the culture and outline the approaches being implemented to support and develop the desired culture.

Will be used as a method of demonstrating compliance with internal and external standards and regulations.

The Quality Manual needs to be a concise, easy to read and easy to understand document with a clear focus on detailing the above “purposes”. Reading the Manual must be a short exercise. There is no room for detailed analysis, discussion or extensive explanations within a Manual. Those charged with drafting and maintaining the Manual must have crystal clear Vision of the purpose for the Manual and concisely document.


Information & Training. | Quality Assurance. Quality Management Systems.

        • Auditing. Supplier Management. CAPA. Documentation. Quality Manual & Policy. Design Quality. Etc. Etc..
        • GMP’s. Quality Cost Analysis. Calibration. Quality Policy. Validation. 
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ISO 10013:1995. Guidelines for developing Quality Manuals. Provides guidelines for the development, preparation and control of quality manuals tailored to the specific needs of the user.