Disease Prevention and Control Bureau (DPCB)

Quality Management System (QMS)

DOH Philippines

A quality management system (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A Health QMS helps coordinate and control a company’s activities to meet customer and regulatory requirements and continuously improve its effectiveness and efficiency.

The international standard that establishes requirements for quality management systems, is the best-known approach to quality management systems. While some use the term “QMS” to describe the ISO 9001 standard or the group of documents that detail the Health QMS, it actually refers to the entire system. The documents are used only to describe the system.

  • Advantages of QMS
  • ISO 9001: 2021 and other QMS standards
  • Elements and requirements of a QMS
  • Establishment and implementation of a QMS
  • Industry impact on quality and standardization
  • Health QMS resources
  • QMS on ASQ ™ TV

Benefits of Health QMS

Implementing a quality management system impacts every aspect of an organization’s performance. The benefits of a documented quality management system include:

Meeting customer requirements helps build confidence in the company, which in turn leads to more customers, more sales and more repeat business.

Meeting the needs of the business, ensuring regulatory compliance and the delivery of products and services in the most cost-effective and resource-efficient manner, creating room for expansion, growth and profit.

These benefits provide additional advantages including:

  • Define, improve and control processes
  • Reduce waste
  • Avoid errors
  • Reduce costs
  • Facilitate and identify training opportunities
  • Engage employees
  • Set organization-wide direction
  • Communicate readiness to achieve consistent results

Other standards related to quality management systems include the rest of the ISO 9000 series (including ISO 9000 and ISO 9004), the ISO 14000 series (environmental management systems), ISO 13485 (quality management systems for medical devices) and ISO 19011 (audit management) systems) and ISO / TS 16949 (quality management systems for automotive products).

Elements of the Health QMS Philippines

Each element of a quality management system contributes to achieving the overall objectives of meeting customer and organizational requirements. Quality management systems should address the specific needs of an organization. However, elements common to all systems include:

  • The organization’s quality policy and quality objectives
  • Quality manual
  • Procedures, instructions and records
  • Data management
  • Internal processes
  • Customer satisfaction through product quality
  • Improvement opportunities
  • Quality analysis
  • Principles of the Quality Management System (QMS)

Define and Implement the Health QMS in the Philippines

Before establishing a quality management system, your company needs to identify and manage various related multifunctional processes to ensure customer satisfaction. The QMS design should be influenced by the company’s various goals, needs, and products and services offered. This structure is largely based on the Plan-Do-Check-Act (PDCA) cycle and allows for continuous improvement of both the product and the QMS. The basic steps to implement a quality management system are as follows:

  • Design
  • Build
  • Deploy
  • Control
  • Measure
  • Review
  • Improve
  • Design and Build

The design and build parts are used to develop the structure of a QMS, its processes, and plans for implementation. Management should oversee this part to ensure that the needs of the business and the needs of its customers are a driving force for system development.

Deploy

Deployment is best done in a granular manner by breaking each process into sub-processes and training staff on documentation, training, training tools, and metrics. Enterprise intranets are increasingly being used to support the deployment of quality management systems.

Control and measure

Control and measurement are two areas for establishing a QMS that are largely achieved through routine, systematic audits of the quality management system. Specifics vary greatly from organization to organization depending on size, potential risk, and environmental impact.

Review and improve

Review and improve in detail how the results of an audit are handled. The goal is to determine the effectiveness and efficiency of each process against its objectives, communicate those results to staff, and develop new best practices and processes based on the data collected during the audit.

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