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 different activities that he carries out. This ensures stability and consistency in performance to meet customer expectations.
quality management It 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.
See also: Risk management
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 consistent and stable performance, and avoid unexpected changes. The system also allows improvements to be established 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 personnel according to their functions and tasks, and is called an organizational chart.
- Strategy planning It is the set of activities that allows the organization's objectives and goals to be achieved.
- 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.
Principles of quality management
The principles of quality management are intended to direct and guide the organization to successfully meet its objectives. Eight principles or issues stand out to take into account:
- 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 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 objectives efficiently.
- The system approach to management Putting 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 to obtain 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 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 William Edwards Deming's quality control practices, also called “Deming circles” (continuous improvement spiral).
Total quality management It 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 “continuous improvement” with the aim of achieving optimal 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:
- Excess production 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 clear objective or reason, you do not invest 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 any distinction between its sector because it focuses on customer satisfaction and the ability to provide products and services that meet established requirements.
Is the most used standard in the world and it is updated regularly because it contemplates changes in organizational practices and applied technologies, which require a systematic review of the standard.
The ISO is the independent, non-governmental International Organization for Standardization, 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 homogenize, through established standards, aspects such as safety, health and the environment, in the production system worldwide.
See also: ISO Standards
Health quality management
Quality management in health It 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 contains modifications more appropriate for the health sector. Organizations can be certified that:
- They manufacture health products
- They distribute health products
- They provide technical assistance services for health products
- They provide electromedicine and clinical engineering services in hospitals
- Sterilization centers in hospitals
References
- «Quality Management System» at Universidad Cooperativa de Colombia.
- “What is ISO?” in Standards 9000.
- “Quality Management Systems according to ISO 9000” in ISO 9000 Quality.
- “Do you know the basics of quality management?” in New ISO 9001.
- «Quality Management: Kaizen Method» in Educ@dictos.
- «Total Quality and Kaizen Model» in Wideuna.
- “All about ISO” in ISO.
- “ISO 13485 Quality Management Systems for Medical Equipment” in Lloyd's Register.
- “ISO 13485:2016” in ISO.
