We explain what quality management is and what a quality management system is. 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 that carries out. This guarantees stability and consistency in performance to meet customer expectations.
Quality management varies according to each business sector for which they set their own “standards”, 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 ensure constant and stable performance and avoid unexpected changes. The system also enables improvements to be made by incorporating new quality processes as needed.
Some examples of elements that make up the quality management system are:
- The structure of the institution. It is the distribution of personnel according to their functions and tasks, and is called an organization chart.
- Strategy planning. 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 carry out each activity or task. Depending on the complexity of the structure, the procedures may be established in writing.
Quality management principles
The principles of quality management are intended to direct and guide the organization to successfully meet its objectives. Eight principles or issues to consider are highlighted:
- The client. Understanding their needs and meeting their expectations is the key to meeting consumer demands and maintaining their loyalty.
- The leadership. The internal climate of the organization depends on the established management or command strategy. 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 a greater commitment, a 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. Putting the procedures established by the organization into action or into practice 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 to obtain improvements in the 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 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 to follow procedures. Look at 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 study, practice, participate and promote 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:
- Production surpluses. Produce to order.
- Defects. Strengthens pre-sale quality control.
- Inventories. Organize, in detail, each resource of the organization.
- Transportation. Optimize trips and make several orders in the same shipment.
- Delays Strictly respect internal processes to avoid errors or delays in production.
- Unnecessary processes. If there is no objective or a clear reason, it is not invested 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 of its area because it focuses on customer satisfaction and the ability to provide products and services that meet established requirements.
Is the most widely used standard in the world and it is regularly updated because it considers changes in the practices of the organizations and in the applied technologies, which require a systematic review of the standard.
The ISO is the International Organization for Standardization (from the English “International Organization for Standardization”), independent and non-governmental, which emerged in 1946 with the consensus of twenty-five countries and today it 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
Quality management in health is regulated by the ISO 13485 standard for medical equipment manufacturers and related service providers. It is based on the ISO 9001 standard, for customer satisfaction requirements and for continuous improvement, but it contains more appropriate modifications for the health sector. Organizations can be certified that:
- They manufacture sanitary products
- They distribute sanitary products
- They provide technical assistance services for medical devices
- They provide electromedical and clinical engineering services in hospitals
- Sterilization centers in hospitals