American Association for Laboratory Accreditation

Must the quality manual include all of the laboratory’s policies?

Section 4.2.2 states that the laboratory’s management system policies must be defined in the quality manual and A2LA views the word “define” to mean describe, specify distinctly or delineate the outline or form; therefore, the policies themselves must either be contained within the manual or the manual must clearly describe or delineate the outline or form of a policy with a reference or link to the more extensive policy itself. It is important to keep in mind, however, that Section 4.2.2 also qualifies the term “quality manual” with the parenthetical phrase “however named”. So, for example, a laboratory may choose to design their quality manual as a single, physical document, or they may choose to design it as a directory within their electronic management system. (NOTE: These examples are not meant to be an inclusive list of all possible options.)

In the case of the former, all of the elements that ISO/IEC 17025 requires to be defined, within the quality manual must be defined within the physical “document” itself.

In the case of the latter, the directory may include a series of electronic documents that, together, comprise the “quality manual”. One such electronic document may be a general document that describes the overall structure & outline of the management system and that provides links to other documents within the electronic directory that are required by ISO/IEC 17025 to be defined within the “quality manual”.

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