The Preparedness of the Laguna Medical Center for the International Standard Organization (ISO) 9001:2015 Quality Management System

Abstract

This study aims to know the preparedness to ISO 9001:2015 QMS Standard of LMC, identify the challenges and limitations of the hospital in the preparation phase for ISO 9001:2015 QMS standards, and propose a QMS Improvement Plan in response to the level of preparedness of LMC to ISO 9001:2015 QMS Standards. The respondents of this study were the 70 process owners in different business units of LMC. The study is a descriptive method that was utilized with a survey questionnaire. The locale was confined with used non-randomly purposive sampling method from a total of 85 process owners in the different business units of the Laguna Medical Center (LMC). Through interviews conducted by ISO experts, an audit plan was formulated that determines the 70 process owners from different business units or the Laguna Medical Center (LMC), as follows; (3) top management, (7) nursing services, (6) pharmacy, (1) budget, (5) admitting, (2) dietary, (5) purchasing or central supply, (1) maintenance, (5) rehabilitation medicine, (2) human resource, (8) radiology, (3) infection control, (7) medical records, (8) laboratory, and (7) billing. Collected data was mainly analyzed through descriptive statistics for quantification of data using frequency, percentage, weighted mean, standard deviation, and single-factor analysis of variance. The top management and other business units moderately implement the context or organization (WM=4.11, R=4), moderately implement leadership (WM=3.99, R=6), fully implement planning (WM=4.36, R=2), moderately implement support (WM=4.16, R=3), moderately implement performance evaluation (WM=4.01, R=5), fully implement improvement (WM=4.47, R=1).LMC fully implements planning and improvement measures, but moderately implements the context of the organization, leadership, support, operation, and performance evaluation which are all relevant in ISO 9001:2015 QMS standards. The challenges and limitations encountered by the LMC in preparation for ISO 9001:2015 QMS are differing opinions, combating rumors, gossip, and unrest, poor connection of the QMS to the targets and strategy of the organization, irregularities of the QMS for practical functioning, little concentration on the organization’s improve, management mechanisms, superficial approach to the production process management, insufficient cohesion between certain documents, limited knowledge and skills of the QMS area among people having certain responsibilities in QMS, and budget constraints of the organization.