A quality manual is a top-level document necessary for creating a Quality Management System (QMS). It was first required by ISO-9001. A quality manual can be used both internally and externally, and it is frequently reviewed by an auditor looking to get a sense for a company’s QMS. The policies contained in a quality manual can include all areas of the business, particularly those that impact manufacturing and ISO requirements. These policies define how departments in the organization will implement procedures, communicate expectations to employees, and demonstrate fulfillment of Clause 5.3 (that organizational roles, responsibilities, and authorities are assigned, communicated, and understood).
A good quality manual should detail the quality policy, the scope of the QMS, the quality system processes that occur at purchasing, manufacture, testing, etc., as well as management involvement with the QMS.
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