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ISO/IEC 17025:2017 Internal Auditor Training for Laboratory Management Systems

ISO/IEC 17025:2017 Lead Auditor Training for Laboratory Management Systems

Seminar Content

This new ISO/IEC 17025:2017 aligns and harmonizes the requirements for a Laboratory Management System with ISO 9001:2015. The five-day course incorporates and explains the amendments to clauses where ISO determined that such changes were necessary. The technical requirements for laboratories who provide testing and calibration services are enhanced by the use of management systems that incorporate the requirements of ISO 9001:2015.

The acceptance of testing and calibration results between countries and industries should be facilitated if laboratories will comply with this International Standard. The use of this standard will also facilitate cooperation between laboratories and other bodies and assist in the exchange of information and experience, standards and procedures. The introduction of the Process Approach to Management Systems and a new auditing standard which allows efficient and effective auditing of these systems can be used by internal and external auditors to meet the requirements of laboratory and quality systems.

Who Should Attend

This seminar is designed for Management Representatives, ISO 17025 Implementation Teams, Internal Auditors and others who would like to develop judgment and decision-making in ISO 17025 and learn the auditing process for first, second, and third party auditors.

Recommended Training and/or Experience

General knowledge of functional management, quality systems, and laboratory practices is necessary. An understanding of the ISO/IEC 17025:2005 and/or ISO/IEC 17025:2017 as well as ISO 9001:2015 requirements and/or work experience in applying ISO/IEC 17025 is recommended.

Seminar Materials

Each participant will receive a seminar manual and a breakout workbook that includes auditing case studies.

Seminar Goals

  • Present requirements for a competent and compliant calibration/test laboratory.
  • Compile examples of documentation required for demonstrating compliance system.
  • Understand basics for implementing a sound laboratory system from quality, calibration, and test perspectives.
  • Understand the application of the principles, procedures and techniques of auditing.
  • Understand the conduct of an effective audit in the context of the auditee’s organizational situation.
  • Understand the application of the regulations, and other considerations that are relevant to the management system, and the conduct of the audit.
  • Practice personal attributes necessary for the effective and efficient conduct of a management system audit.
  • Establish, plan and task the activities of an audit team.
  • Communicate effectively with the auditee and audit client.
  • Organize and direct audit team members.
  • Prevent and resolve conflict with the auditee and/or within the audit team.
  • Prepare and complete the audit report.

Seminar Outline

Day One

  • Changes in ISO/IEC 17025:2017
  • Introduction to ISO/IEC 17025:2017
    • Breakout Exercise 1: Definition of a Laboratory
    • Written Exercise 1
  • ISO/IEC 17025:2017 Requirements
    • Breakout Exercise 2A: Key Processes
    • Written Exercise 2: Audit Scenarios
    • Written Exercise 3: Audit Scenarios

Day Two

  • Overview of ISO/IEC 17025:2017 Requirements (cont’d)
    • Breakout Exercise 2B: Risks and Opportunities
    • Written Exercise 4
  • Introduction to Turtle Diagrams and Audit Trails
  • Management of Audit Programs
  • Audit Planning and Preparation
    • Breakout Exercise 3: Creating an Audit Plan

Day Three

  • Performing the Audit
    • Breakout Exercise 4: Performing an Audit
  • Writing Nonconformity Statements
    • Breakout Exercise 5: Writing Nonconformity Statements
  • Closing Meeting
  • Completing the Audit Report
  • Corrective Action and Closeout
  • Management Systems Auditing Exam

Day Four

  • Leading Audit Teams
  • Writing Nonconformity Statements Management System Certification Scheme and Auditor Qualifications
  • Leading Management Systems Audit Teams Mock Audit Case Study

Day Five

  • Review of Audit Process and Audit Management Strategies
  • Leading Management Systems Audit Teams Exam
  • Practical Application of Audit Principles and Instructor Interviews

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