Deploying quality management in trusted third parties within a medical environment: Towards ISO9000 compliance

Abstract

In this paper we present a complete reference framework for the operation of a Trusted Third Party (TTP) as an organization within a medical environment. The objective is to form an intermediate reference model, to which the TTPs will conform, towards the full compliance to the ISO-9000 quality standard. There are two dimensions of quality in respect of a TTP, which are related to specific medical environment issues: the first quality dimension regards the value-added security services and products it provides, which must fulfil the user requirements and be characterized by efficiency, reliability, security, credibility and trust. The second quality dimension refers to the internal organization, which must maximize its effectiveness by achieving efficient management, have a clear and strict structure and comply with the registered internal procedures. The guidelines for achieving the above mentioned quality objectives are reflected within the published Quality Policy Statement and the Certification Practice Statement (CPS). © 2002, Sage Publications. All rights reserved.