IMLABM 02

Background

The ISO 15189 standard refers to managerial and technical requirements to ensure the implementation of a management system to control the quality of biological analysis services delivered. In this context, one of the requirements of this standard is internal audit. This tool, which is a veritable tool of progress par excellence, makes it possible to check the conformity of and the efficiency of your management system and also to identify opportunities for improvement.

Goal

• Recall the key concepts and bases of quality management, which is the foundation of ISO 15189.
• Understand how to conduct an internal audit according to the ISO 15189 standard, while basing itself on the guidelines of the ISO 19011 standard (implementation of the internal audit of its preparation, its implementation at its closure);
• Study in particular the behavioral rules of the auditor to observe throughout the audit by practical simulation games. During this training, participants will understand the role of internal auditor through the practical simulation of the audit and will have gained autonomy and improved practice in carrying out internal audits.

Who is concerned

Quality Managers, Directors, Executives, Technical Managers and anyone concerned by ISO 15189 and its internal audit or in charge of the continuous improvement of the laboratory management system. Prerequisites: desirable knowledge of the requirements of ISO 15189

Content

Reminder of the concepts that form the basis of the quality management of the ISO 15189: 2012 standard:

• The principles of quality management, the concept of process approach, continuous improvement, ...
• The place of the importance of auditing in these basic concepts.

Identify the concepts and principles of auditing

• ISO 19011: Scope - Vocabulary - Principles of audit
• Brief reminder of the structure ISO 15189V2012- Structure - Operational requirements

PREPARE THE AUDIT: Establish an audit plan and guide taking into account its purpose and scope

• The audit mission
• Preliminary analysis
• The construction of the audit plan
• Development of the interview guide

REALIZE THE AUDIT

• The opening meeting
• The interview
• Preparation of audit findings
• The closing meeting

The training is based on the role play in real situation of audit between participants to allow the participants to be operational in internal audit of their own laboratory or external