We can take a look at some of the specific areas within ISO 17025 where Document Manager can meet the requirements. Section 4 covers all the management requirements for the standard, while Section 5 addresses the technical requirements. There are numerous sub sections where Document Manager is relevant.
Part of Section 4.2.1 requires that the system’s documentation shall be communicated to and available to the appropriate personnel. Section 4.3 requires the laboratory to establish and maintain procedures to control all internal and external documents that form part of its management system. From Section 22.214.171.124 comes the need to establish a master list or an equivalent document control procedure identifying the current revision status and distribution of documents in the management system to preclude the use of invalid and/or obsolete documents. Document Manager also fulfills the requirement of Section 126.96.36.199 to have a procedure that describes how changes in computerized documents maintained are made and controlled.
From Section 188.8.131.52 laboratories must establish and maintain procedures for indexing, access, filing, storage, maintenance and disposal of quality and technical records. Moving to the technical requirements, Section 5.4.1 specifies that all instructions, standards, manuals and reference data relevant to the work of the laboratory must be kept up to date and made readily available to personnel (see 4.3). Any accepted deviation from a test and calibration method must be documented. Finally, in Section 5.5.5 there is a requirement to maintain records of each item of equipment and its software significant to the tests and/or calibrations performed.
The Matrix Gemini Document Manager can fulfill of the requirements outlined above.
In the next article in this series, we will look at how Matrix Gemini handles Corrective and Preventative Action (CAPA) requirements.