General Evaluation of Risk Management in research laboratories with Integrated Quality Systems

Abstract

Accreditation in Quality Systems in hospitals and clinical laboratories have been developed
significantly in the last two decades in Europe, the United States of America and Canada,
which now makes it indispensable in the health systems of industrialized countries. Recently,
the need to cover research areas has become relevant by taking the experience of diagnostic
laboratories. Unfortunately, in the countries of Latin-America, Asia, and Africa, these are poor
practices.
Therefore, in this study we analyzed the perception of the level of risk to which members of
three health research laboratories are exposed, based on the information collected derived
from the implementation of a quality management system with the requirements of ISO 9001:
2015, ISO 9001: 2008 and ISO 15189: 2012.
Our results identified the need to implement an Integrated Quality Systems (SIC) between the
ISO 45001: 2018 Standard "Occupational Health and Safety Management Systems" and the
Quality Standards already used ISO 9001: 2015 and ISO 15189: 2012, in order to reduce,
treat and maintain risks at an acceptable level, both for patients and for the organization's staff.
Our findings show the importance of the implementation of a SIC in areas where they have
scarcely been implemented in our country, such as the areas of research in the area of Health