ISO/IEC 17025:2005 Internal QMS Auditor Training Course

Course Category: Laboratory Quality Management Systems (QMS)  

Course Title: Internal QMS Auditor based on ISO 17025:2005

This Internal QMS Auditor Course based on ISO/IEC 17025:2005 focuses on giving delegates the knowledge and skills to conduct effective audits for a Laboratory Quality Management System.  The primary aim of this training course is to instruct Internal Medical Laboratory Auditors in the principles and practices specific to auditing for conformance with ISO 17025.

Experienced Tutors guide delegates through the internal audit cycle using the process approach to determine the degree of conformity, compliance, effectiveness and efficiency of the Laboratory Quality Management System being audited.

Two primary learning pathways are available to a delegate, namely competency evaluation using Recognised Prior Learning (RPL) or the traditional classroom.  Kelmac Group uses Accelerated Learning (AL) tools and techniques during all classroom training.  

Course Structure

This course is a 24 hour/3 day course.

There is an 8 hour pre course assignment that must be completed by all delegates in advance of attending. Completed assignments are to be handed to the tutor on day 1 of the training course.

Course Start: 08:45a.m & Course Finish: 17:30p.m

A detailed course breakdown is as follows:

Day 1

• Introduction and history of ISO 15189:2003 
• ISO 15189:2003 - The business case
• Interrelationship with ISO 9001 and ISO/TS 16949 Quality Management Standards 
• Process Approach 
• Requirements of ISO 15189:2003
• Accreditation and Certification

Day 2

• Introduction to Auditing (ISO 19011:2002)
• Roles & Responsibilities
• Planning an Audit
• Checklists
• Opening Meeting

   

  Day 3

  • Conducting an Audit
  • Collecting of Evidence
  • Questionning Technique
  • Handling difficult situations
  • Audit reporting
  • Final team meeting/Audit Report
  • Closing meeting
  • Follow up Audit/CAPA including effectiveness
  • Course Summary/Course Evaluation

Course Assessment

The delegate is assessed based on participation and performance throughout the duration of the course. This includes all exercises, role plays, case studies and all other activities during the course. Please note, full attendance is required during the training course.

Training Methodology

Accelerated learning is the most advanced teaching and learning method available today. Itʼs a total system of enhancing and speeding up both the design and learning process. What makes accelerated learning so effective is that itʼs based on the way we naturally learn. It does this by actively involving the whole person, using physical activity, creativity, collaboration among learners, variety that appeals to all learning styles, contextual learning with real-world immersion, the creation of a positive physical, emotional, and social environment and other methods designed to get people deeply involved in their own learning.

What's Included on the course

• Comprehensive Course Manual
• Expertise and Wisdom of Tutor (s)
• Additional Handouts