ISO 13485 Medical Devices Quality Management System

What Is the ISO 13485 Medical Devices Quality Management System?

The ISO 13485 standard guides manufacturers on what to pay attention to when establishing their processes, such as purchasing, storage, production, sales, installation, maintenance and other post-sales activities, and customer feedback (customer requests, complaints, suggestions, etc.), on how to manage these processes and on how to record them. The ISO 13485 standard requires all of these processes to be designed and managed within the framework of a quality management system. It also requires the manufacturer to review its processes continually and to carry out improvement activities to prevent these processes from being disrupted or disrupted processes from recurring.

Where other relevant standards apply to the management of these processes, for example the matters to be considered when preparing labels or when preparing user manuals, the requirements of those standards must also be integrated into the quality management system to be established and be operated accordingly.

Because the ISO 13485 quality management system to be established will also form the basis of the technical files for medical devices, all requirements relating to the product must be known, planned and carried out by the company.

ISO 13485 is an international quality management system standard tailored for organizations serving the medical sector. The standard specifies quality management system requirements so that an organization can demonstrate its ability to consistently provide medical devices and related services that meet customer requirements and regulatory requirements.

Companies that manufacture or sell medical devices, supply services or raw materials, or provide storage, technical service and maintenance must have all their processes under control. Production, quality control, purchasing, sterilization, storage, sales and similar processes must be carried out in accordance with the requirements of the ISO 13485 standard.

The ISO 13485 Standard also guides companies in the sector in carrying out processes such as post-sales activities and customer requests, complaints and suggestions.

For ISO 13485 certification, documentation must be created in accordance with the clauses of the standard, and all processes must be put in writing. The company must establish its policies on medical devices in accordance with the standard. It is necessary to build the technical infrastructure required by the standard, to complete the implementations, and to bring personnel activities into line with the medical device regulation.

ISO 13485 certification is asked for as a prerequisite in the technical specifications of many public tenders, and it is a requirement sought in many countries when the export of products is planned.

Benefits of ISO 13485 Certification

• It demonstrates compliance with current legal requirements.
• With ISO 13485 certification, the organization gives its customers confidence by documenting that it operates in line with an internationally recognized standard.
• By meeting the requirements of the ISO 13485 standard, the organization can reduce customer complaints.
• By meeting the requirements of the ISO 13485 standard, the organization can reduce product defects.
• With the ISO 13485 system, the organization can increase its profitability through continuous analysis.
• ISO 13485 certification is frequently requested when exporting.
• Thanks to the ISO 13485 system, the organization's activities can be monitored systematically by top management.
• The ISO 13485 Quality Management System for Medical Devices enables the organization to identify and eliminate shortcomings.