Learn how laboratory management systems work, how to interpret and apply the requirements of ISO/IEC 17025, and how to conduct and lead process and system audits using ISO/IEC 17025.

Laboratories carry out testing, calibration or both. Testing relies upon a measurement system using calibrated gauges to determine characteristics in relation to a target.  Measurement uncertainty is quantified as the observed process variance attributed to the measuring system.  The measuring system is the combined effort of controls, resources, information and material used to assign values to measured characteristics.

Laboratories develop, implement and continually improve their process-based management systems to ensure they understand, quantify, control and continually improve their measuring processes.

ISO/IEC 17025 has been developed and agreed as the international laboratory management system standard.  This standard recognizes the importance of how competent individuals contribute to controlling measurement uncertainty through their interaction with measuring equipment.  ISO/IEC 17025 provides a framework of good management practices for laboratories performing testing and calibration, but conforming to the standard does not guarantee operational excellence.  The best laboratories in the world not only seek accreditation to ISO/IEC 17025, they also develop their process-based management systems to ensure continual process improvement.

This course is intended particularly for laboratories or organizations that work closely with laboratories to develop effective management systems that conform to ISO/IEC 17025.

  • Interpret and apply the requirements of ISO/IEC 17025
  • Identify and implement the controls necessary for ensuring the QMS translates customer needs into satisfied customers
  • Relate fiduciary concerns to the performance of the QMS
  • Develop reliable and pliable systems, particularly effective for organizations where process objectives are constantly changing
  • Determine and communicate the resources necessary for the system to work as planned
  • Communicate the roles and responsibilities within the QMS to the organization
  • Relate the capabilities of the organization to the expectations of customers, top management and shareholders
  • Use the QMS to work proactively and not re-actively
  • Professionals working in or with a Laboratory
  • ISO Managers/Management Representatives
  • Auditors (Internal, 3rd Party, and Supplier)
  • Process Owners
  • System Professionals or People who want to study how Management Systems work
  • Improvement Specialists
  • Buyers/Procurement Professionals

DAY 1

  • Introduction: Lead Auditor with ISO 17025
  • Lecture: Intro to Management Systems
  • Lecture: Quality Standards
  • Workshop: Terms and Definitions ISO 19011
  • Lecture: ISO 17025
  • Workshop: ISO 17025 Clauses
  • Workshop: Analyzing Processes

DAY 2

  • Exam: ISO 17025 Self Study
  • Lecture: Developing Process-Based Management Systems
  • Lecture: Auditing Management Systems
  • Lecture: Lead Audit Planning and Preparation
  • Workshop: ISO 17025 – Review System Docs and Prep Audit Schedule
  • Workshop: ISO 17025 – Reviewing Processes and Preparing Checklists

DAY 3

  • Lecture: Performing the Lead Audit Investigation
  • Workshop: Verifying Facts
  • Lecture: Concluding the Audit
  • Workshop: Determining Nonconformities
  • Workshop: Writing Nonconformity Statements

DAY 4

  • Workshop: Interviewing Auditees
  • Workshop: Closing Meeting Preparation
  • LMS Practice Exam
  • Workshop: Closing Meeting and Report

DAY 5

  • Lecture: Corrective Action and Follow-up
  • Workshop: Corrective Action
  • Lecture: Certification, Registration, Accreditation
  • Class Wrap Up
  • LMS Exam

Students who have successfully completed QMII’s 5-day ISO 17025 Lead Auditor training course and passed the Final LMS Examination provided in conjunction with this course, receive a Certificate of Attainment for the following Exemplar Global Training Course Certification (TCC):

TCC Course: ISO 17025 Lead Assessors Course

 

The Certificate of Attainment provides evidence that the student have been deemed qualified in the knowledge and experience requirements defined by Exemplar Global in the TCC Course as a 17025 Lead Assessor.