Course Content
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DAY ONE: INTERPRETATION AND APPLICATION OF ISO/IEC 17025:2017 REQUIREMENTS (Part 1) Introduction: Distinction Between First, Second and Third-Party Laboratories / Main Changes of ISO/IEC 17025 as compared to ISO/IEC 17025:2005
- Lecture1.1 Scope / Normative References / Terms and Definitions
- Lecture1.2 General Requirements (Impartiality / Confidentiality)
- Lecture1.3 Resource Managements (General / Personnel / Facilities and Environmental conditions / Equipment / Metrological Traceability / Externally provided products and services)
- Lecture1.4 Process Requirements (Review of Requests / Selection, Verification and Validation of Methods / Sampling / Handling of Measurement Uncertainty / Ensuring the validity of Results / Reporting Results / Complaints / Non- conforming Works / Control of data and Information Management)
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DAY TWO: INTERPRETATION AND APPLICATION OF ISO/IEC 17025:2017 REQUIREMENTS (Part 2)
- Process Requirements (Practical Session), Review of Requests / Selection, Verification and Validation of Methods / Sampling / Handling of Measurement Uncertainty / Ensuring the validity of Results / Reporting Results / Complaints / Non-Conforming Works / Control of data and Information Management. Practical Exercise a) Computation of measurement Error, Correction Factor, Z-Score, En Ration and etc. b) Interpretation and Application of Measurement Uncertainty (MU) in the context of a Calibration System and a Measurement System. c) Interpretation of Certificate of Calibration against the pre-determined Acceptance Tolerance derived from the intended use.
- Management System Requirements, Options / Management System Documentation/ Control of Management System Documents / Control of Records / Action To Address Risks and Opportunity/ Improvement / Corrective Actions / Internal Audits / Management Reviews. Practical Exercise: Application of Risk Management Methodology in the context ISO/IEC 17025:2017 Model – Risk Identification, Risk Estimation, Risk Evaluation and Risk Control. Class-room Exercises, Assignments & Discussions.
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DAY THREE: ISO 19011:2018 Guidelines & Discussion
- Lecture3.1 Terms & Definition: Audit, Audit Objective, Audit Scope, Audit Criteria, Audit Evidence, Audit Findings & Audit Conclusion
- Lecture3.2 Seven Principles of Auditing
- Lecture3.3 Audit Plan vs Audit Programme
- Lecture3.4 Management of An Audit Programme
- Lecture3.5 Six Steps In Performing An Audit
- Lecture3.6 Prepare Audit Plan and Audit Check Sheet
- Lecture3.7 Execution of Audit By Applying 6A Auditing Approach
- Lecture3.8 Documenting Non-conformity / Non-compliance, Corrective Action & Follow up Verification Audit
- Lecture3.9 Brief Outlines Of Internal Quality Audit Procedure
- Lecture3.10 Human Aspect of Auditing
- Lecture3.11 Preparatory Work for External Audit
- Lecture3.12 Group Assignment & Presentation
- Lecture3.13 Question & Answer / General Discussion
- Practical Exercise: (a) Draft the Non-conforming Statement based on the given non-conforming incidents & the associated ISO/IEC 17025:2017 Clause Nos. (b) Assess the given non-conforming incidents and then determine the corresponding non-conforming ISO/IEC 17025:2017 Clauses.