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By the successful completion of this course the candidate will be able to: · Display a good understanding of the ISO 17025:2017. · Demonstrate commitment to operational efficiency and quality management practices. · Verify the quality, capability, and expertise of the laboratory. · Evaluate skills, methods, equipment, calibration and reporting to guarantee test result validity. · Understand personal accountability and clearly delineate individual responsibilities. · Meet with regulatory and safety requirements in the operational of laboratories.
Course Content 1. What ISO 17025:2017 says about laboratory management. 2. Laboratory Management 3. Responsibilities with regards to health and safety 4. Finances 5. Documentation 6. Management review 7. Introduction to method validation 8. Finding and documenting non-conformities 9. Introduction to risk 10. Communication
Who Should Attend? · Quality Managers / Laboratory Managers · Quality Professionals · Quality Technicians · Quality Engineers / Laboratory Personnel · Procurement Personnel · Financial Personnel · Document Controllers · Internal Auditors
Day 1 · Introduction of participants and course objective · ISO 17025:2017 scope / requirements · Management systems requirements, technical requirements. · Uses of ISO 17025:2017 organisation · System, document control. · Review of requests, tenders and contracts · Subcontracting, purchasing services /supplies. · Service to customer, complaints. · Control of non-conforming T/C · Correlation/Preventive Action · Control/Technical Records, Internal Audits. · ISO 17025:2017 QMS Technical, Competency. · Factors affecting reliability of measurements, lab personnel, lab environment, traceability/sampling/test items, assuring the quality of test results review of requests, tenders and contracts, customer management documentation, quality audits. · NAMAS/NIS 35/STANDARDM10, productivity/quality auditsNAMASNIS45 · The road to quality –productivity, everybody must know. · Establish quality objectives, do a quality audit implementation of quality, maintaining quality. Day 2 · ISO 17025:2017 method validation, what must be validated? · Why it is important to produce quality measurements? · Validation of accuracy ruggedness · Reproducibility of analysis and instruments, robustness – influence of conditions. · Maintenance of validation CRM management · Evaluation of CRM providers, procurement procedure, storage procedures. · Monitor the use of CRM’s, inventory control. · Training policy / strategy · Set training evaluate/document the training goals/objectives, develop a training program. · Set a training schedule. · Laboratory management. · How would you produce/generate quality measurements and carry out/manage a method validation for your laboratory? |