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SQI
- ISO Standards
- 21 hours
Objectives
- To equip the participants with the basic knowledge and skills to interpret and to integrate the new requirements into their current Quality Systems effectively.
- To introduce the application of Risk-based Thinking in establishing QMS.
- To enable the participants to understand the application of Measurement Uncertainty (MU) in the context of a Calibration System and a Measurement System.
- To enable the participants to conduct their internal audit based on ISO/IEC 17025:2017 in accordance with ISO 19011:2011 Guidelines.
Duration
3 days | 9am – 5pm | 21 hours
Who Should Attend
This program is designed for Top and Middle level management and any other personnel who is involved in Internal Audits. The appointed auditees are also recommended to attend the above programme with a view to equip them with the necessary audit know-how and audit checklists in preparing for their internal and external audits exercise effectively.
Special Note
GR&R Training Course: GR&R Studies is an integral part of ISO/ IEC 17025 Standard. Refer to Clause No.: 5.4.6: Estimation of Uncertainty of Measurement & Note 3: Emphasise the understanding of ISO 5725-2: Basic Method for the Determination of Repeatability and Reproducibility of a Standard Measurement. See GR&R Course Brochure.
Course Fees
Member: S$1212.84
Non-Member: S$1263.60
Registration Fee of S$17.28 apply.
SDF funding & Skills Future applicable
All fees stated are inclusive of 8% GST
Award of Certificate
Certificate of Completion will be issued to participants who have attended at least 75% of the course.
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.
Trainer
