ISO 17025 Laboratory Standards

ISO 17025 laboratory standards outline the standards for best-practice technical competence in laboratory environments.

ISO 17025 laboratory standards include requirements regarding document control and management, supplier evaluation, the identification of deviations and nonconformance events, CAPA (Corrective Action Preventive Action) management, audit management, training management, change control and continued improvement.

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ISO 17025: What it Means for You and Your Laboratory

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Hundreds of companies around the world use MasterControl to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.

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Industry Brief: ISO 17025: What it Means for You and Your Laboratory Industry Brief: ISO 15189 Standards: For Medical and Clinical Laboratories Industry Brief: SOP Management as a Compliance Tool in FDA and ISO Environments
White Paper: Ten Signs Your CEO Still Has No Idea About ISO 9001 and Lean White Paper: 6 Must-Haves for a Quality Management System (QMS)
Summary: ISO 9001 Compliance Requirements

ISO 17025 Laboratory Standards: Document Control

Many of the ISO 17025 laboratory standards delineate the establishment of document control within laboratory environments. For example, Clause 4.2.1 states that "The laboratory shall establish, implement and maintain a management system appropriate to the scope of its activities. The laboratory shall document its policies, systems, programes, procedures and instructions to the extent necessary to assure the quality of the test and/or calibration results. The system's documentation shall be communicated to, understood by, available to, and implemented by the appropriate personnel."

MasterControl addresses this clause about ISO 17025 laboratory standards by providing the control and management of quality documentation throughout a company and all its locations. Quality plans, sampling/testing documentation, SOPs, pre-audit checklists, quality manuals, training records, test reports and calibration certificates can all be edited (with full-version control) by various approved users within a secure centralized collaboration environment.

Documentation can also be automatically routed and approved by specified personnel. The system also provides a complete electronic trail and automated analytics and reporting features to keep check on the procedures being implemented according to ISO 17025 laboratory standards. Follow-ups, escalations and the creation and delivery of reports are also automated. Documentation, when revised, and released can also be set to automatically trigger the release of training tasks or units which are related to the documentation in question (e.g, an SOP).