ISO 13485 Medical Devices Quality Management System
The concept of quality, which expresses the level of meeting a product or service´s customer expectations, has become one of the most important parameters in today´s world. Regardless of whether it operates in the public and private sectors or in what scale it is, quality has become the top priority for every business. In this context, ISO 9001 Quality Management System has been published as one of the most basic quality standards that can be applied to all sectors and businesses. Although some revisions were brought and developed in certain periods, ISO 9001 was published in the sector, product or service specific in time. ISO 13485 Medical Devices Quality Management System is a standard created to meet this need in medical devices.
What is ISO 13485 Medical Devices Quality Management System?
As it can be understood from its name, ISO 13485 provides the establishment of a quality management system in companies with services such as medical device production, import, supply, etc. It sets the rules for the implementation, monitoring and continuous improvement of the system after its commissioning. ISO 13485 Medical Devices Quality Management System can be considered as the form of ISO 9001 adapted to medical devices. This internationally valid standard is also among the main arguments for regulations requiring CE certification, such as the 93/42 / EEC Medical Devices Directive.
Scope of ISO 13485 Medical Devices Quality Management System
We can list the topics of ISO 13485 as follows:
2 Cited standards and / or documents
3 Terms and definitions
4 Quality management system: The basic conditions about quality and the documents that need to be prepared for the follow-up and development of ISO 13485 Medical Devices Quality Management System are described.
5 Management responsibility: As in many other quality standards and related regulations, management has serious responsibilities in ISO 13485 Medical Devices Quality Management System. At this point, an explanation about the establishment of a company operating in the medical device industry, establishing a quality policy, developing plans and strategies based on customer orientation and other powers.
6 Resource management: This is where there is the necessary information for the best use and management of resources such as workforce, infrastructure facilities and working environment.
7 Product realization: It is the section where the explanations about the processes such as designing, producing, developing, purchasing etc. of a product or service are made.
8 Measurement, analysis and improvement: It is one of the most important parts of ISO 13485 Medical Devices Quality Management System. The rules required for monitoring medical devices, performing the necessary measurements, analysis and tests, and most importantly, are described under this heading.
Advantages of ISO 13485 Medical Devices Quality Management System
This system has been made compulsory for many businesses. Although there is no obligation to apply under normal conditions, it is one of the primary conditions to have ISO 13485 Medical Devices Quality Management System in enterprises in various public and private sector tenders. This system benefits businesses in many ways. We can list the highlights of them as follows:
• It ensures customer satisfaction to be increased sustainably. While customer complaints are decreasing, there is a serious increase in the number of customers.
• It provides continuous improvement of processes such as production, purchasing, sales, after-sales service, R&D, etc. in the business.
• The suppliers, subcontractors, especially the management and employees of an enterprise; It helps to increase the awareness of quality among its stakeholders with legal personality such as trade , professional chamber, trade chamber etc., of which it is a member.
• Facilitates the process of compliance with other standards and laws on medical devices.
• Costs arising from quality issues are minimized.
How to Get ISO 13485 Medical Devices Quality Management System Certificate?
Businesses wishing to obtain ISO 13485 certification communicate with accredited certification bodies. However, in the enterprise, a preparation process should be followed to ensure the requirements of the ISO 13485 Medical Devices Quality Management System. ISO 13485 trainings are at the top of these preparations. After creating the team that will work on standardization and making the necessary planning, a quality manual related to ISO 13485 Medical Devices Quality Management System should be created. The requirements of the system should be applied, taking into account the field and processes of the business.
After all these preparations, the necessary application process is made for ISO 13485. After the necessary contract is made with the certification body, the quality inspectors inspect the applicant company and determine the missing and wrong practices or procedures, if any. It requests business representatives to eliminate them. After the regulatory / preventive actions are developed for these deficiencies, the applicant is given an ISO 13485 certificate.
Keywords: ISO 13485 Medical Devices Quality Management System
Meta article: In this article, information about ISO 13485 Medical Devices Quality Management System; There are explanations about the certification process.