Abstract
AbstractThe ISO 15189 standard is evolving - and like any evolution, this will bring about a number of changes both in form and substance. Some of these changes are structural and thus challenge current organizational models, while others will merely require a measure of adaptation. Nevertheless, a new approach is being proposed, that of risk management. Its core objective is to place the patient and the quality of care at the heart of the procedural framework again.It will enable laboratories to establish their own quality assurance policy by molding it to their specificities and thereby implementing solutions tailored to their needs (allowing for more freedom in the solutions implemented). However, this transition can only move forward with a significant effort from everyone, both in terms of workload and of adaptation to this new approach. Laboratories that have overcome challenges in the past should also be able to overcome this one. Optimism is warranted, especially considering that the transition phase we are faced with will be a lengthy one.
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