The process of management review |
| |
Authors: | Henrik Islin Torben Andersen |
| |
Institution: | (1) Department of Clinical Biochemistry, Hvidovre University Hospital, Kettegaard Allé 30, 2650 Hvidovre, Denmark;(2) Department of Clinical Microbiology, Hvidovre University Hospital, Kettegaard Allé 30, 2650 Hvidovre, Denmark |
| |
Abstract: | Management review of the quality-management system is an item in many quality standards and a requirement of the ISO 9001:2000
standard and of laboratory standards ISO 15189 and ISO 17125, and others. These reviews are conducted to ensure that the top
management is informed and involved in the quality-management system with respect to continuing adequacy and effectiveness,
and opportunities for improvement of the system. The management review is a process that should be conducted and audited utilizing
the process approach. A process approach is defined as “An activity using resources and managed in order to enable the transformation
of inputs into outputs” (ISO 9001:2000). All identified main processes in the quality system should be monitored through data
collection by appropriate methods, assuring that data are valid, representative, and adequate. For management review data
must be collected and presented in an accessible form so that processes can be evaluated according to objectives, goals, resources,
etc. On the basis of this information the laboratory management makes the necessary decisions and ensure that actions are
taken that improve the effectiveness of the quality-management system. As output from the management review process, there
should be evidence of decisions regarding: change of quality policy and objectives; plans and possible actions for improvements;
corrective actions as appropriate; increased customer satisfaction; and planning of resources needs. Identification of the
processes involved and using the process approach in the management review ensures the continual improvement of the quality
system.
Presented at the conference Quality in the Spotlight, March 2006, Antwerp, Belgium. |
| |
Keywords: | Process approach ISO standards Input Output Follow-up |
本文献已被 SpringerLink 等数据库收录! |
|