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ISO/IEC 17025:2017 Lead Auditor Laboratory Quality Management System

Awarding Body
CQI & IRCA

Learning Method
Classroom

Duration
05 Days / 40 Hrs.

Rewards Points
500 Points

This practical, intensive and highly interactive ISO 17025 Lead Auditor training course is designed to develop delegates’ auditing skills to conduct Quality Management System (QMS) audits against the ISO/IEC 17025 requirements, in order to:

  • promote the role of audits within the management system programme and the role of auditors in supporting laboratory compliance and competency improvements
  • objectively assess compliance of laboratories to meet accreditation body requirements
  • fulfil the training requirements to register as an CQI and IRCA 17025 Lead Auditor.
This five day ISO 17025 Lead Auditor training course is designed to equip delegates with an in-depth knowledge of the requirements and principles of QMSs and how ISO/IEC 17025 is incorporated into the overall quality system. It is based around the new structure of ISO/IEC 17025:2017, aligned with other conformity assessment standards as well as the process approach and risk-based thinking from ISO 9001:2015.

Completion of this training course provides laboratory/quality practitioners and systems auditors with the understanding and skills necessary to professionally audit a laboratory management system.
  • This is a 5-day (45hr) learning event.
  • Start/Finish Times: 08:00am – 17:30pm (each day) with an earlier finish on the final day at 2pm.
  • Prior Learning Requirement: Learners are required to be familiar with ISO 45001:2018 Requirements or have completed a recognised OHSMS Fundamentals course based on ISO 45001:2018 prior to registering for this course.
Course Introduction
  • ISO/IEC 17025 Structure
  • New and Revised Terminology
  • The Relationship between External and Internal Issues, Interested Party Requirements
  • Risks and Opportunities
  • Leadership
  • Effective Communication and Life Cycle Thinking

Introduction to Auditing
  • Audit Terminology, Principles, LQMS Audits
  • Auditor Code of Ethics
  • Management of an Audit Program
  • Audit Terminology, Principles, LQMSOHS Audits
  • Audit Life Cycle (On-site & Off-site Audit Activities)
  • Auditor/Auditee Roles, Responsibilities
  • Desired Auditor Behaviors

Introduction to LQMS Auditing
  • Aligning the Business Processes and the LQMS Model
  • Process Terminology
  • LQMS Process Models/Methodology & Categories
  • Evaluation of the Effectiveness of a Process
  • Processes and the Application of PDCA and Risk
  • The OHS Certification Cycle & 3rd Party Certification
  • Special Conformity Audits
Audit Planning
  • Initiating & Preparing for the Audit
  • Audit Trails
  • Purpose and benefits for establishing initial contact and forms of contact
  • Case Study: Document Review
  • Audit Plan
  • Audit Checklist
  • Audit Protocol
  • Opening Meeting
  • Purpose, process and benefit of an Opening Meeting
  • Case Study – Opening Meeting
  • Onsite Activities
  • Lead Auditor Leadership and Supervision
  • Responsibilities of the Lead Auditor
  • Communication throughout the Audit Life Cycle
  • Monitoring Audit Progress
  • Consensus and Resolution Conflicts
  • Lead Auditor Leadership
  • Audit Reporting
  • Audit Follow-Up
  • Auditor/Technical Expert Coaching, Mentoring and Evaluation
  • Collecting and Verifying Information
  • Introduction to Audit Findings
Audit Reporting
  • Audit Findings
  • Case Study: Writing Audit Findings
  • Case Study: Writing the Audit Report
  • Completing the Audit
  • Evaluating Correction & Corrective Action including Root Cause Analysis and Audit Finding Closure
  • Audit Follow Up Strategies
  • Final Audit Team Meeting
  • Closing/Exit Meeting & Role Play

This course is fully recognised by CQI & IRCA (UnderProcessing).

CQI & IRCA Certified Course
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.
 
There is a 2 hour written examination at the end of the course. The exam is closed book in that a delegate is entitled to use only their copy of the International Standard (s) in question or dictionary if delivery language is not their native language. The minimum pass rate for the examination is 70%.
  • Individuals wishing to perform audits to ISO/IEC 17025
  • Companies seeking ISO/IEC 17025 accreditation
  • Laboratory Managers and Supervisors
  • Companies that recognize the value of operating effective laboratory management systems
  • Existing ISO 9001 / IATF 16949 auditors who are looking to expand their skills in the area of laboratory practices or who wish to audit laboratory environments
  • Supplier quality auditors wishing to evaluate laboratory service suppliers
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Course Pre-Requisite

Click here to learn more about prior knowledge requirements

What's Included

Comprehensive delegate folder and certificates. Public courses include, lunch, refreshments and our Residential option includes accommodation on the intervening nights of a course, plus dinner and breakfast.

Train Your Team In-House

Looking for training for 4 or more people? Choose our in-house training and our tutors will come to you so you save on travel and accommodation-related expenses.

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