We explain what quality management is and what a quality management system is. Principles, total quality management and ISO 9001 standard.
What is quality management?
Quality management is a series of systematic processes that allow any organization to plan, execute and control the different activities it carries out. This guarantees stability and consistency in performance to meet customer expectations.
Quality management varies according to each business sector for which its own “standards” are established , that is, reference models to measure or assess the level of performance of the organization.
Quality Management System (QMS)
The quality management system of an organization is determined by all the elements that make it up in order to guarantee a constant and stable performance, and avoid unexpected changes . The system also allows improvements to be made by incorporating new quality processes as necessary.
Some examples of elements that make up the quality management system are:
- The structure of the institution. It is the distribution of the personnel according to their functions and their tasks, and is called organization chart .
- The planning of strategies. It is the set of activities that allows to achieve the objectives and goals of the organization.
- The resources. They are everything that the organization needs to function, for example, personnel, infrastructure, money and equipment.
- The procedures. They are the details, step by step, of how to perform each activity or task. Depending on the complexity of the structure , the procedures may be established in writing.
Principles of quality management
The principles of quality management are aimed at directing and guiding the organization to achieve its objectives successfully. There are eight principles or issues to consider:
- The customer . Understanding their needs and meeting their expectations is the key to meeting the demands of consumers and maintaining their loyalty .
- Leadership . The internal climate of the organization depends on the management or command strategy established. The main leader can delegate tasks to other designated managers, depending on the type of structure.
- Staff participation The motivation of the members of the organization generates greater commitment , better performance of their tasks and reduces uncertainty in times of crisis.
- The process based approach. Guiding each area of the organization is part of the overall development of the institution to achieve the objectives efficiently.
- The system approach to management. Bringing into action or practice the procedures established by the organization generates interaction between each element of the quality management system.
- Continuous improvement. The evaluation of the quality management system (according to appropriate standards for each item) is useful for obtaining improvements in procedures.
- The fact-based approach to decision making . The analysis of qualitative and quantitative data serves to measure the performance of the organization.
- The relationship with the suppliers. It is important to maintain a beneficial and reciprocal relationship between the organization and suppliers such as alliances, discounts, payment plans, etc.
Total Quality Management
Total quality management is a strategy originated in Japan in the 1950s , driven by the quality control practices of William Edwards Deming, also called “Deming circles” (spiral of continuous improvement).
Total quality management is aimed at creating quality awareness in all organizational processes , not just following procedures. Contemplate the organization globally, along with the people who work in it.
The concept of “total quality” refers to a “continuous improvement” with the aim of achieving optimum quality in all areas of the institution: from the philosophy , culture , strategy and style of the organization, all people They study, practice, participate and encourage continuous improvement.
In Japanese culture, continuous improvement is called Kaizen (kai means “change” and Zen means “good”). Total quality management implements the Kaizen method to generate improvements:
- In small actions.
- Without requiring large investments .
- With the participation of all members of the organization.
- To act and implement responses quickly.
In addition, the Kaizen philosophy avoids waste, waste or inefficiencies that may arise in the production system, such as:
- Excess production (produces on demand).
- Defects (reinforces pre-sale quality control).
- Inventories (organizes, in detail, each resource of the organization).
- Transport (optimizes trips and makes several orders in the same shipment).
- Delays (strictly respects internal processes in order to avoid errors or production delays).
- Unnecessary processes (if there is no clear objective or reason, there is no investment in them).
ISO 9001 quality standard
The ISO 9001 quality standard is an international guideline that takes into account the activities of an institution without making a distinction from its category because it focuses on customer satisfaction and the ability to provide products and services that meet the established requirements.
It is the most widely used standard in the world and is regularly updated because it contemplates changes in the practices of organizations and in the technologies applied, which require a systematic review of the standard.
The ISO is the International Organization for Standardization (“International Organization for Standardization”), independent and non-governmental, which emerged in 1946 with the consensus of twenty-five countries and today has one hundred and sixty-four nations. The objective of the organization is to standardize, through established standards, aspects such as safety , health and the environment, in the production system worldwide.
Quality management in health
Health quality management is regulated by the ISO 13485 standard for medical equipment manufacturers and related service providers. It is based on the ISO 9001 standard, due to customer satisfaction requirements and continuous improvement, but it contains more appropriate modifications for the health sector. Organizations can be certified that:
- They make sanitary products
- They distribute sanitary products
- Provide technical assistance services for medical devices
- Provide electromedicine and clinical engineering services in hospitals
- Hospital sterilization stations