Abstract
Background and Objectives: A worldwide objective in the area of health is to offer high-quality services supported by certification strategies that contribute to improving standards for processes commonly used in medicine. However, few pulmonary function test laboratories (PFTLs) follow official standards in their daily operations or are organized around an integrated total quality management system (ITQMS) focused on their established processes. The aim was to determine the feasibility of implementing an ITQMS to accredit the International Organization for Standardization (ISO) 9001:2015 standard in a high-demand PFTL where 13 respiratory function tests are routinely performed together with teaching and research activities.
Methods: This project was conducted at the PFTL of the Instituto Nacional de Enfermedades Respiratorias in Mexico City from November 2014 to August 2017 and involved the implementation of an ITQMS guided by ISO 9001:2015 in 5 phases: (1) the establishment of a work team; (2) the elaboration of situational diagnoses; (3) the development of guidelines for the ITQMS; (4) the implementation of the ITQMS model; and (5) the evaluation of the ITQMS.
Results: Upon completing the 5 phases, an evaluation of the system by an internal audit identified 3 minor cases of nonconformity (NC), while additional observations and an external audit found 5 minor cases of NC. These issues were addressed through a root-cause analysis to establish an action plan for each one. At the end of the process, the institution was granted the ISO 9001:2015 certification for its 3 processes: medical attention in support of diagnoses, teaching, and research.
Conclusions: It is possible to implement an ISO quality management system as a routine operating methodology in a high-demand PFTL.