Internal Auditor – ISO 15189:2012

Introduction:

The goal of this training is to give professionals the self-assurance they need to take part in and contribute to an internal audit that complies with ISO 15189. You will be responsible for establishing and upholding an effective quality management system for your medical laboratory in your capacity as an internal auditor for ISO 15189. Your laboratory will have a defined framework to streamline its operations, staff, equipment, and service offerings once it achieves conformity with ISO 15189. You have the power to guarantee that ethical behavior and patient safety come first.

Course Objectives:

• Gain understanding of the ISO 15189 standard
• Acknowledge the objective & significance of an ISO 15189 audit
• Appreciate the role and accountability of an ISO 15189 Internal Auditor
• Interpret the requirements to establish conformity to ISO 15189
• Plan for and engage in an internal audit for ISO 15189, review audit data, communicate results, propose recommendations and initiate follow up audits
• Formulate strategy to boost the effectiveness of laboratory procedures, equipment & personnel
• Assist the laboratory to achieve conformity with ISO 15189

Course Outlines:

·       Introduction to Course

·       Introduction to standard & Terms & Definition

·       Quality related concepts

·       Process Mapping

·       Conformity Assessment

·       Management Requirements

·       Technical Requirements I

·       Technical Requirements II

·       Understanding the terms and Definition of Auditing

·       Guidelines for auditing management system