Thursday, April 28, 2005

Implementation of an ISO-based Integrated Management System for Managing Quality and Environmental Requirements in the Clinical Laboratory

D. M. Périgo, A. S. E. Gonçalves, D. P. Santos, and R. Rabelo.

An Integrated Management System (IMS) based on ISO standards is a relatively new approach to manage the continual improvement of processes and quality in the clinical laboratory. The IMS allows the management of two or more ISO standards in a synergistic way.

To present the process of implementation of the IMS at Fleury Diagnostics, a large reference laboratory in Brazil, to manage the Quality and Environmental Systems based on ISO9001:2000 and ISO14001:1996 standards, respectively.

The IMS was developed using the PDCA (Plan-Do-Check-Act) cycle in order to define the steps needed to fulfill the ISO requirements. Management principles shared by both guidelines were completely integrated. Measurements of customer satisfaction, definition of personnel competencies, monitoring of management and operational indicators and identification of environmental aspects and impacts were essential tools for the implementation. The Balanced Scorecard (BSC) approach was chosen to monitor management indicators.

During 11 months, processes and related activities were evaluated against ISO requirements. As a result, a global measurement of customer satisfaction was performed. 75 basic and specific competencies were determined for 13 different areas. 182 environmental aspects and impacts were identified at the company. 33 environmental programs were established to reduce and control environmental impacts. 136 hours of training were provided to 900 employees. The BSC is currently monitoring 38 indicators.

The implementation of an IMS based on ISO requirements is a very good opportunity to improve the quality of all processes in clinical laboratories. The IMS can be considered one of the best ways to assure continual improvement and, as a bonus, it also makes it easier to evaluate management and performance. It suits perfectly the real world of clinical laboratories, making the difficult liaison between the quality-driven nature of laboratory services and the current performance-driven reality of the Health Care System.

Web Page:

See more of Poster Session
See more of The 2005 Institute for Quality in Laboratory Medicine Conference