Documents include both internal, such as SOPs, quality manuals, and training plans and external documents, such as regulations, standards, test methods, and instrument operating manuals.
Policies and Quality Manualĭevelopment and maintenance of documentation should be controlled through document control and management procedures that are part of the management system. For example, each change should be authorized and logged, and the updated document should get a new revision number or code. Records are generated on a day-by-day basis, such as analytical results from product tests or calibration records of a balance.Īll documents should be properly controlled.
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Standard operating procedures (SOPs) or Working Procedures are step-by-step instructions for how to exactly perform a specific task, such as calibrating a specific instrument. For example, it describes how the requirement ‘Personnel should be competent for the assigned task’ can be implemented. For example, a policy statement could be: All personnel involved in calibration and testing should be competent for the assigned task.Ī process or generic procedure describes how various quality requirements can be achieved. It also includes policy statements describing the laboratory’s intention to conform to ISO/IEC 17025 requirements. It describes the approaches to achieve quality data.
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The Quality Manual is the top tier of the document hierarchy. This ensures that the manual has the strongest authority and also shows, to the accreditation body, a commitment on the part of the senior management to the quality system.Ī policy documents the laboratory’s intent to implement ISO/IEC 17025. It should, however, be formally authorised for issuing from as high a point in the management hierarchy as possible chief executive, director general, chairman are typical points. The quality manual is, typically, prepared and checked by laboratory management, usually under the overall co-ordination of the quality manager. The key piece of quality documentation is the quality manual, describing its policies, the structure of Quality system documentation and compliance to ISO/IEC 17025:2017 & relevant accreditation specific criteria. Because the major obstacle that you see when you decide to adopt a formal quality system is the production of the documentation, it is easy to fall into this trap. Documentation is important but it is critical to realise that it is not, in itself, the quality system.
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