The decision to move from a paper-based quality system to one that is on-line creates challenges for the traditional laboratory. The tendency is to recreate the same structure of cabinet file drawers, file folders, documents, chapters, and pages online; as opposed to rethinking the quality system in terms of the relationship between the requirements and their implementation. An excellent example of this is the concept of the "Master List" required by clause 22.214.171.124 of ISO/IEC 17025, which states "A master list or an equivalent document control procedure identifying the current revision status and distribution of documents in the management system shall be established".
All labs operating according to ISO/IEC 17025 are required to have a procedure (or procedures) for identification, collection, indexing, access, filing, storage, maintenance and disposal of quality and technical records. Clause 4.13 covers the control of records, while the control of data related to testing or calibration is covered by clause 5.4.7.
The definition of policy is: A proposed or adopted course or principle of action. This differs from a procedure (A series of actions conducted in a certain order or manner) in that specific steps are not provided in a policy, but the principle which the lab intends to follow is identified and recorded. According to clause 4.2.1, "The laboratory shall document its policies, systems, programmes, procedures and instructions to the extent necessary to assure the quality of the test and/or calibration results".
According to clause 4.2.5 of ISO/IEC 17025, "the quality manual shall include or make reference to the supporting procedures including technical procedures..." which simply means that the procedures called out by the various clauses within the standard must be referenced, in some manner, within the quality manual itself. This can be accomplished by referencing a Master List, including a list of procedures in the manual, or referencing the procedure within the clause that calls for the procedure. A combination of these could also be used. For example, the Quality procedures could be referenced directly within the clauses requiring them, while the technical (and other) procedures can be included in a separate list. For online, web-based systems, hyperlinks could be provided for the procedures and/or lists. We will reserve any discussion of non-quality procedures for another article, and concentrate on what procedures are required by ISO/IEC 17025
Job descriptions are an integral part of an ISO/IEC 17025 quality system. People are given titles when they go to work in a laboratory and no matter how hard one tries, the titles provided for human resources don't always align with the needed roles in a laboratory. To complicate matters even further, the responsibilities defined by employee titles and roles are seldom aligned (and often contradictory) with the responsibilities and authorities required by the quality system. This is often referred to as "wearing many hats", but is actually a problem that most laboratories need to solve.
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