The ISO 13485 standard is a highly effective solution developed for businesses that produce medical devices that meets the requirements of a Quality Management System. The publication of the ISO 13485 Medical Devices Quality Management System standard has filled an important gap for manufacturers and suppliers to operate in compliance with medical device directives and national legal regulations published in the European Union countries, as well as to fulfill their responsibilities and fulfill commitments to the safety and quality of medical devices. .
ISO 13485 standard is the world's most popular and most common standard for quality management of medical devices. Originally developed by the International Standards Organization (ISO) in 2003, this standard was last revised in 2016. The current version is ISO 13485: 2016.
ISO 13485 standard, which is accepted all over the world, is an independent management system standard based on ISO 9000 Quality Management System standard. Therefore, the processes of this system are based on the plan, implement, control and precaution cycle and require the processes to be designed in accordance with the legal regulations in force. The ISO 13485 standard is highly descriptive and supports medical device manufacturers. The standard aims to design, develop, manufacture, deliver and install safe medical devices.
All kinds of medical device manufacturers, whether they want to expand locally or want to compete internationally, can obtain ISO 13485 Medical Devices Quality Management System Certificate. With this document, enterprises increase their performance, eliminate uncertainties in processes and pursue market opportunities more easily. But most importantly, these enterprises are committed to quality on the one hand to their customers and official institutions.
The benefits of ISO 13485 Medical Devices Quality Management System Certificate can be listed as follows:
Businesses can reach more markets and compete in world markets
The processes in the business are reviewed and reconsidered with the quality approach
Business productivity increases, costs fall, and supply chain performance improves
Safer and more effective medical devices are produced
Responsibilities arising from legal regulations are fulfilled
Customer demands and expectations are met
ISO 13485 Medical Devices Quality Management System is the best internationally recognized model that can be applied by a medical device company to support compliance with laws and regulations in the medical devices sector. This standard is a quality management system standard which is accepted as the basis of CE marked medical devices under the directives in force in the European Union countries. Today, the ISO 13485 standard is needed worldwide in the medical device industry.
In fact, the ISO 13485 Certificate is not an absolute requirement for CE-marked medical devices according to the European medical device directives. Nevertheless, it is accepted as a harmonized standard by the European Commission.
ISO 13485: 2016 February 28 has been granted a transition period for medical device manufacturers to upgrade to 2019. To maintain the current ISO 13485 documentation, manufacturers must meet the requirements of the ISO 13485: 2016 version by this date. This latest version complies with the medical devices directives of the European Union. Standard harmonization allows manufacturers to use their compliance with the standard as proof of compliance with the requirements of the relevant legal regulations. Companies which will send medical devices to European Union countries will be evaluated according to EN ISO 1: 2019 version starting from April 13485 date.
EN ISO 13485: The harmonization of the 2016 standard is an important step in the In Vitro Medical Diagnostic Devices Directive which will replace the existing directives.
The purpose of ISO 13485 Medical Devices Quality Management System is to ensure that organizations in the medical devices sector have an internationally recognized standard. The system primarily aligns medical device manufacturing requirements with quality management systems. In this system, which is widely accepted at one time, 2015 document was issued in 26255 worldwide.
In short, ISO 13485 Certificate proves that the companies operating in the medical devices sector apply a quality management system that complies with the standard. This approach includes not only medical device manufacturers but also supplier companies, company representatives and consultancy firms serving in this field. As the ISO 13485 standard is developed, the profiles of companies and organizations that can implement this standard expand. Quality Management System is a living system. The changes and developments affecting the markets are monitored and they support the regulation and strengthening of the processes and procedures in the enterprise.
It was mentioned above that the ISO 13485 standard focuses on the harmonization of quality management systems within the framework of the requirements for the design, development, manufacture and installation of medical devices. Today, many government agencies are seeking and even demanding ISO 13485 Certificate from medical device manufacturers. In foreign countries, regulatory authorities require an ISO 13485 Certificate as part of their requirements to ensure the sale of medical devices in their home country.
For example, Canada requires manufacturers to obtain ISO 13485 Certification for market approval for certain medical devices. In addition, companies must select a recognized certification company only in accordance with Canadian regulations to obtain this certificate.
In general, compliance with ISO 13485 Medical Devices Quality Management System voluntarily is a management system that manufacturers must implement to reach international markets. Having the ISO 13485 Certificate gives the company partners the confidence that the company strives to comply with the standard.
The requirements of this international standard may also be used by manufacturing or serving third-party suppliers, such as raw materials, components, sub-assemblies, medicines, sterilization materials, calibration services, distribution services and maintenance services. Suppliers or other third-party companies may voluntarily agree to comply with the requirements of the ISO 13485 standard or may be required by the manufacturer to comply. As a result, the standard requires that businesses comply with the requirements of the relevant legal regulations.
First, it is determined whether the organization meets the mandatory requirements of the standard and whether to proceed to the next stage.
It is checked whether necessary procedures and audits have been developed and your institution's readiness for evaluation is reviewed.
The findings that arise in the first two stages are evaluated and after all corrective actions are reviewed, document preparation is started.
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