315 E. Eisenhower Pkwy.

Suite 214
Ann Arbor, MI 48108 To Register
Fax: (734) 761-4966 (734) 761-4940
www.omnex.com

ISO/IEC 17025:2017 Internal Auditor Training

for Laboratory Management Systems
Seminar Content Seminar Goals
This new ISO/IEC 17025:2017 aligns and harmonizes the  Present requirements for a competent and compliant
requirements for a Laboratory Management System with ISO calibration/test laboratory.
9001:2015. The three-day course incorporates and explains the  Compile examples of documentation required for
amendments to clauses where ISO determined that such changes demonstrating compliance system.
were necessary. The technical requirements for  Understand basics for implementing a sound laboratory
laboratories who provide testing and calibration services are system from quality, calibration, and test perspectives.
enhanced by the use of management systems that incorporate the  Understand the application of the principles, procedures
requirements of ISO 9001:2015. and techniques of auditing.
The acceptance of testing and calibration results between  Understand the conduct of an effective audit in the context
of the auditee’s organizational situation.
countries and industries should be facilitated if
 Understand the application of the regulations, and other
laboratories will comply with this International considerations that are relevant to the management system,
Standard. The use of this standard will also facilitate and the conduct of the audit.
cooperation between laboratories and other bodies and  Practice personal attributes necessary for the effective and
assist in the exchange of information and experience, efficient conduct of a management system audit.
standards and procedures. The introduction of the
Process Approach to Management Systems and a new Seminar Outline
auditing standard which allows efficient and effective Day One
auditing of these systems can be used by internal and  Introduction and Welcome
external auditors to meet the requirements of laboratory  Introduction to ISO/IEC 17025:2017
and quality systems.  What’s Changed and Improved
 Overview of ISO/IEC 17025:2017 Requirements
Who Should Attend o Group Exercises: Audit Scenarios (cont’d)
This seminar is primarily designed for internal auditor
candidates, but can also be valuable for laboratory managers, Day Two
responsible company/corporate management, lab personnel,  Overview of ISO/IEC 17025:2017 Requirements (cont’d)
persons responsible for documenting, implementing, o Group Exercises: Audit Scenarios (cont’d)
maintaining or auditing the laboratory systems; and 2nd or 3rd  Introduction to Turtle Diagrams and Audit Trails
party auditors.  Management of Audit Programs
Recommended Training and/or Experience  Audit Planning and Preparation
General knowledge of functional management, quality systems, o Breakout Exercise 1: Writing an Objective and
and laboratory practices is necessary. An understanding of the Scope Statement
ISO/IEC 17025:2005 and/or ISO/IEC 17025:2017 as well as o Breakout Exercise 2: Documentation Review
ISO 9001:2015 requirements and/or work experience in o Breakout Exercise 3: Creating an Audit Plan
applying ISO/IEC 17025 is recommended. Day Three
Seminar Materials  Performing the Audit
Each participant will receive a seminar manual and a breakout o Breakout Exercise 4: Performing an Audit
workbook that includes auditing case studies.  Writing Nonconformity Statements
o Breakout Exercise 5: Writing Nonconformity
Statements
 Closing Meeting
 Completing the Audit Report
 Corrective Action and Closeout

Driving Worldwide Business Excellence

Course Catalog #1700-03