ISO/IEC 17025 enables laboratories to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work both nationally and around the world.
It also helps facilitate cooperation between laboratories and other bodies by generating wider acceptance of results between countries. Test reports and certificates can be accepted from one country to another without the need for further testing, which, in turn, improves international trade.
Who should attend ?
This course is designed for professionals in the Pharmaceutical, Chemical, Food, and Medical Device industries.
The course will be especially beneficial to professionals in the Quality Regulatory Auditors
Course Topics:
Describetheprocess-basedapproachofthestandard.
ExplainimportantconceptsinISO/IEC17025suchas:
•ContinuousImprovement(usingPDCAandKPIs).
•Impartialityandconfidentiality.
•VerificationandValidation.
•Uncertainty.
•DecisionRules.
•Risk-BasedThinking.
3.Analyze scenarios to identify non-conformities, risks, and opportunitiesrelatedto thenewrequirementsinthestandard.
4.Analyze sample calibration records to demonstrate metrologicaltraceability.
5.List the areas where documents and records are required under the newstandard.