ISO 15189 Medical Laboratory Auditor/Assessor Training Workshop

Note this course has been designed to accommodate both Laboratory Internal Auditors and Assessment Body Assessors.

Workshop Objectives:

• Open discussion of the ISO 15189 standard to encourage better understanding.
• Understand how to review and obtain a working knowledge of the ISO 15189 standard.
• Working knowledge and use of the auditor vocabulary based on ISO 19011.
• Demonstrate a working knowledge of the practices, roles and responsibilities of an auditor based on ISO 19011.
• Develop the communication skills, team participation, leadership skills and attitudes necessary to facilitate audits.

 Who Should Attend?

• Current staff responsible for an organization’s management system.
• Individuals responsible for documenting management system processes.
• Current system internal auditors.
• Future system internal auditors.
• Accreditation Body assessors.

Prerequisite:

Students should have an Awareness of the contents of the ISO 15189 standard.

Note: If you have already trained your internal auditors and just want to brush up their training or take them to the next level, you might be interested in our Advanced Auditor Training.

Two Day Format – No Hands-on Auditing

Three Day Format – Includes Hands-on Auditing

Workshop Outline

Day One

Course Introductions and Objectives

Lecture                      Overview, Auditing and the Standard Requirements

Exercise 1                Understanding the Quality Management Standards - Part 1

Lecture                      Discuss beginning of Internal Auditing for Management Systems

Exercise 1                Understanding the Quality Management Standards - Part 2

Exercise 2                Reviewing an Organization’s Quality Management Documentation

Lecture (Cont)          Discuss remainder of Internal Auditing for Management Systems

Exercise 3                Developing an Audit Checklist

Day Two

Review of Day One Activities

Exercise 4                Auditing the Organization Case Study Scenarios

Lecture                      Audit Nonconformance

Exercise 5                For 2-Day Class - Auditing the Evidence Sample Documents and Records

                                   For the 3-Day Class - Start preparation of morning audit

Day Three (optional)

Practice Audit #1

• Documentation Review
• Prepare an Audit Checklist
• Conduct Audit
• Prepare Audit Summary Report

Practice Audit #2

• Documentation Review
• Prepare an Audit Checklist
• Conduct Audit
• Prepare Audit Summary Report

Review Audits and Conduct Closing Meeting

Training Grants - Help with available State and Federal Grants

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