Implementation of an Integrated Total Quality Management System in a Pulmonary Function Laboratory

Area of Science:

• Medical Laboratory Science
• Quality Management Systems
• Respiratory Medicine

Background:

• Pulmonary Function Test Laboratories (PFTLs) often lack integrated total quality management systems (ITQMS) and adherence to official standards.
• High-demand PFTLs face challenges in maintaining quality across diagnostic, teaching, and research activities.
• Certification strategies are crucial for improving healthcare service standards.

Purpose of the Study:

• To determine the feasibility of implementing an ITQMS for International Organization for Standardization (ISO) 9001:2015 accreditation in a busy PFTL.
• To assess the integration of an ITQMS within routine operations, including 13 respiratory function tests, teaching, and research.
• To establish a quality management framework for enhanced PFTL services.

Main Methods:

• A 5-phase implementation of an ITQMS guided by ISO 9001:2015 was conducted from November 2014 to August 2017.
• Phases included team establishment, situational diagnosis, guideline development, ITQMS model implementation, and evaluation.
• Internal and external audits were performed to identify and address nonconformities.

Main Results:

• The implementation resulted in a low number of minor nonconformities (3 internal, 5 external) identified through audits.
• Root-cause analysis and action plans were utilized to resolve identified issues.
• The PFTL successfully obtained ISO 9001:2015 certification for medical attention, teaching, and research processes.

Conclusions:

• Implementing an ISO quality management system is a viable routine operating methodology for high-demand PFTLs.
• The study demonstrates the successful accreditation of a PFTL using an ITQMS.
• This approach can enhance the quality and standardization of services in specialized medical laboratories.