I met the quality culture with my business life when I started in the Quality Management Department of a Medical Device producer company after I graduated from Karabük University Medical Engineering in 2018.
I think that “after starting to learn the Quality Management System, I think that it is an endless knowledge community. For companies, the Quality Management department is a department that needs to develop the knowledge formed by standard/legislation changes and keep itself constantly up to date.
What is Quality?
No matter how familiar the concept of quality sounds, it can be defined as 'the realization of production or service in accordance with the standards in order to meet customer demands and expectations with the definition that is most widely known and adopted by companies.
Quality is to provide satisfaction by responding to customer expectations and requests according to standards.
What is the History of Quality?
It is accepted that the concept of quality first appeared in the laws of Hammurabi at 2150 BC. This specification, which specifies the points to be considered in house construction, goes down in history as a record that determines how the punishment will be in case of non-compliance with the necessary conditions.
It is known that the Romans regulated the construction of buildings made of concrete, urban planning, traffic congestion, and the production of cisterns and water channels with laws in the form of specifications.
In the periods when there was no continuous production and people generally benefited from goods or services by ordering, quality could emerge in the form of face-to-face relations between the master who produced the goods and the customer who benefited. When defining the quality of a good, the craftsmanship of the person producing that good was also taken into consideration.
It is accepted that quality entered the development process with the industrial revolution. The most important benefit of this process is that it has contributed to the development of the concept of quality by bringing the concepts of customer concept and customer satisfaction to control efficiency. Since the second half of the 19th century, the emergence of the industrial system and the great increases in production have brought quality to the forefront and led to important developments in this field.
The country that has embraced and implemented the concept of quality the most in real terms has been Japan in the post-World War II period. In this period, the philosophy of "Total Quality Management", which was born in the USA but found its opportunity to develop in Japan, added very wide dimensions to the concept of quality and identified it with every concept that shapes existence and healthy life rather than a technical concept. Following Japan, which aimed at quality in the production of goods and services after the 1970s, total quality management has started to be implemented in the USA and European countries.
What is Quality Management System for Medical Devices (ISO 13485:2016)?
ISO 13485 Quality Management System for Medical Devices is an international standard prepared for all medical device manufacturing and service companies and specifies the requirements of the system.
Quality Management System can be defined as a system that directs and controls an organization in terms of quality.
In order to provide goods or services to the institution, it constitutes the manual of the institution for the establishment of a systematic and planned structure with technical methods for all stages of the production process starting from the design stage. The Quality Management System aims to create continuity in which the same quality result will be obtained at each process stage.
Documentation of the Quality Management System
To run an organization successfully, it is necessary to manage and control it systematically and transparently.
Shows our thoughts; Plans, Goals
Shows what we do; Procedure, Instruction, Forms
Shows our progress; Revision, Statistics, Reports
Objective evidence! Committee / Board decisions
Contribution of Quality Management System of the Organization
Standardization of process procedures,
Minimization of staff dependency,
Reducing the orientation and adaptation period of new employees,
Evaluation can be made on the same, measurable, comparable metrics,
Incorporating preventive activities into the corporate culture,
Ensures a healthy flow of information within the organization.
Quality is the common goal and responsibility of all company employees, as well as the task of the specialists involved.
It should not be forgotten that the Quality Management System is the ART OF ERROR PREVENTION by going directly to the source of the error and eliminating it, instead of eliminating the errors made in the process.
In an organisation, “QUALITY IS EVERYONE'S BUSINESS!”
Kübra ÇELEN
Medical Engineer / Quality System Manager
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