The Quality Manual: Documentation RequirementsPrevious ISO 9000 versions were criticized because of the emphasis on documentation. Currently this requirement for documentation is focused on a few areas: control of documents and quality records; internal auditing records; nonconformance records, and correction actions. To maintain control, you must implement a structure, and this structure is reflected in the company's quality manual.
A quality system consists of two parts: documented and implemented. The documented element or quality manual includes all the documents (i.e. policies, plans, procedures or instructions) that affect the quality of the product or service. The manual should be a combination of printed material and software programs. All these documents must be defined and controlled to ensure availability yet managability.
The entire document assembly can be considered the quality manual. The ISO standard refers to the manual as all documentation used to specify the quality system. However, many companies collate documents and software as their total quality documentation and present just a small policy document that they call the "quality manual." The document is justified as a quality manual as long as it formally refers to the total quality system documentation.
To learn more about your QMS and Quality manual, we recommend the course 101 "Concepts of a Quality Management System".