ISO/ IEC 17025:2017 Laboratory QMS – Internal Auditor Training

Overview

ISO/IEC 17025 is the internationally recognized standard relating to the competence of testing and calibration laboratories. It specifies criteria for the development and assessment of management systems and laboratory technical controls that provide confidence in the results obtained. The standard can be applied to a wide range of laboratory activities including analytical, clinical, forensic, destructive/non-destructive testing and instrument/equipment calibration.

This course is to provide participants with the understanding of the ISO/IEC 17025:2017 Laboratory Quality Management System standard and in particular the internal auditing process of the system. ISO/IEC 17025 training course prepares the internal auditor to clearly understand technical issues relating to an audit. Attendees of this ISO/IEC 17025 training course will learn how to coordinate a quality management system audit to ISO/IEC 17025:2017, collect audit evidence and document observations, including techniques for effective questioning and listening.

Who is this course for?

This course is designed for personnel involved in implementing ISO/IEC 17025 QMS such as Laboratory Manager, Supervisors, Technical Staff, Consultants, and Technicians as well as for Internal Auditors who need to perform internal audits within their organization. This course is also suitable for existing Internal Auditors who are looking to expand their skills in laboratory practices as well as for Supplier.

Duration: 2 days

Mode of Delivery: Trainer Led Virtual class

Prerequisite: Prior good understanding on laboratory practices. Reasonable awareness on measurement uncertainties & basic requirements of ISO/IEC 17025 may be an added advantage.

Learning Outcome

  • Able to develop understanding on the structure & requirements of ISO/IEC 17025, its interpretation, documentation & implementation
  • Good understanding of Key concepts & principles of auditing
  • Imparting and enhancing auditing skills

Course Outline

  • Understand the ISO/IEC 17025:2017 requirements
  • Learn how to coordinate a quality management system audit against ISO/IEC 17025:2017
  • Develop an understanding of the technical systems and issues of the accredited laboratory
  • Impart better understanding of measurement system Analysis & uncertainty
  • Obtain an overview of the principles and concepts of ISO 19011 & ISO 17021
  • Know how to collect audit evidence and document observations, including techniques for effective questioning and listening
  • Learn how to report the findings and conclusions
  • Purpose and Benefits of Internal Programme, Audits
  • Preparation & Planning of Internal Audits
  • Auditing & Review of Lab Quality Manual
  • The Role of the Auditor & Auditee
  • Effective Auditing Techniques
  • Risk Based approach in Implementation of the Internal Audit
  • Witnessing Tests and Calibrations
  • Evaluating the Significance of Audit Findings
  • Methods for Improving Communication Skills during the Audit
  • Common Non-Conformities
  • Corrective Action & Follow-Up
  • Preparation of Audit Report
  • Case Study Scenario of Non-compliances
  • Sources of Information and Further Development

The training comprises presentations Highly participative and interactive, group discussions, practical exercise, critique sessions, handouts, course templates and case studies to provide hands-on understanding of the process audit approach and its application.