|
For a successful implementation
ISO 15189:2007
This course is based on the 2007 Edition of the ISO 15189 standard “Medical laboratories — Particular requirements for quality and competence”.
OBJECTIVES
A 3-day course aimed at:
developing an understanding of quality management concepts and key principles
helping to discover the relationship between ISO 15189 and other standards applicable to biomedical laboratories
knowing how to interpret the requirements of ISO 15189 and understanding the dynamics of these requirements in the Quality Management System (QMS) of a medical laboratory
assisting in appreciating the opportunities and challenges associated with a QMS and the direct and indirect implications for the operation of a biomedical laboratory
identifying the key steps necessary for implementing, maintaining and continuously improving a QMS and obtaining an official recognition.
WHO SHOULD ATTEND
This course is intended for those who need to understand the spirit of the standard requirements as well as for those personnel that will play a significant role in implementing the standard in their organization, particularly managers.
PREREQUISITE
Although there are no prerequisites for participating in this course, any prior exposure to either edition of ISO 15189 or other quality management or quality assurance standard may prove useful.
OUTLINE
Published in 2003 and revised/reconfirmed in 2007, ISO 15189 has become the reference for ensuring quality and structuring continuous improvement, essential conditions for medical laboratories to accomplish their mission and satisfy all interested parties. ISO 15189 is a polyvalent standard. At its core however, is improvement of the structure and organization of medical laboratories. As such, it has become a key element of the accreditation processes which aim at giving confidence that the laboratory is proactive in pursuing customer satisfaction and performance improvement.
This course covers among others the following key points:
Concepts related to quality management in a laboratory
The essential principles for a successful Quality Management System (QMS)
The standards applicable to a biomedical laboratory and their requirements
How to documenting a QMS
What the winning strategies are for successfully implementing a QMS
What the differences are between the notion of “agrément”, certification and accreditation and what are the implications of these differences
The practical approach to the course, the discussions, the exercises and the workshops contribute to the interaction with the instructor and exchanges with your peers from other laboratories.
INSTRUCTORS
Francine Bouchard or
Johanne Villeneuve
DETAILS
This course can also be presented in-house.
DURATION
3 days
CAD 1195
Taxes not included.
In-house session available on request.
|
 |
|
|
|
