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

ISO/IEC 17025:2017 Internal 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 three-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 primarily designed for internal auditor candidates, but can also be valuable for laboratory managers, responsible company/corporate management, lab personnel, persons responsible for documenting, implementing, maintaining or auditing the laboratory systems; and 2nd or 3rd 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.

Seminar Outline

Day One

  • Introduction and Welcome
  • Introduction to ISO/IEC 17025:2017
  • What's Changed and Improved
  • Overview of ISO/IEC 17025:2017 Requirements
    • Group Exercises: Audit Scenarios (cont’d)

Day Two

  • Overview of ISO/IEC 17025:2017 Requirements (cont’d)
    • Group Exercises: Audit Scenarios (cont’d)
  • Introduction to Turtle Diagrams and Audit Trails
  • Management of Audit Programs
  • Audit Planning and Preparation
    • Breakout Exercise 1: Writing an Objective and Scope Statement
    • Breakout Exercise 2: Documentation Review
    • 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
  • Corrective Action and Closeout

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