Since the ISO 13485 Medical Devices Quality Management System standard is an international standard built on the ISO 9001 Quality Management System, the principles of this system also apply to the ISO 13485 standard. The basic principles of the ISO 13485 Medical Devices Quality Management System are therefore:
- To adopt process approach
The basic principle of ISO 13845 Medical Devices Quality Management System standard is to adopt process approach. All employees are expected to operate in accordance with the specified processes in all the jobs they are responsible for within the defined procedures, job descriptions, workflows, job descriptions and application instructions. Only in this way can the company use its resources effectively and at low costs. Possible risks are recognized in a timely manner, timely response to hazards and timely action can be taken to avoid unexpected situations. At the same time, processes that relate to each other should be handled in a system. In this way, processes are easier to understand and manage.
- Acting customer-oriented
The second basic principle of ISO 13845 Medical Devices Quality Management System standard is to be customer oriented. It is essential to meet customer needs and expectations. In order to create customer satisfaction and dependency, to gain a respectable and prestigious place in the market, to take the lead in the struggle with competitors, it is necessary to give importance to customers.
- Ensuring employee participation
The third basic principle of ISO 13845 Medical Devices Quality Management System standard is to ensure the participation of employees, ie teamwork. This principle is a common principle for all management systems. If the employees are incapable of teamwork, nobody owns the problems and nobody feels responsible for their solution. However, employees should be responsible for their own performance. Employees can be more active, innovative and creative if they feel they are part of a team.
- To adopt continuous improvement approach
Continuous improvement activities, which are a common principle in all management systems, are the basic principles of ISO 13845 Medical Devices Quality Management System standard. Continuous improvement activities are important for the permanent performance of the company. Every employee of the company must strive for continuous improvement of services, processes or systems. Otherwise, the company cannot be expected to act flexibly and react quickly to opportunities.
- Taking a realistic approach to decision making
An important principle of ISO 13845 Medical Devices Quality Management System can be realistic in the decisions taken. In order to make accurate and effective decisions, it is necessary to use all the data obtained from the activities and analyze them correctly.
All medical device manufacturers who want to establish ISO 13485 Medical Devices Quality Management System and have ISO 13485 Certificate, TÜRCERT Technical Control and Certification company, they will receive a fast, quality and reliable consulting service. As in all matters, you can immediately contact our company managers and employees to exchange opinions on the basic principles of ISO 13485 Medical Devices Quality Management System.