ISO 13485– QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES
An accredited ISO 13485 certificate creates a global acceptance and reputation for companies in medical sector including manufacturers, storage, semi-finished product and service suppliers SZUTEST, a Team NB-member notified body, provides accredited ISO 13485:2016 medical devices quality management system certification services. – medical quality management system with its experienced staff.
A modern health system relies on health technologies and human resources. Medical devices, one aspect of health technologies, equip health care providers with tools to perform their functions effectively and efficiently. Although medical devices provide an opportunity for a better service, the lack of a national system for selection, procurement, use and management may lead to a disproportionate escalation in health care delivery costs. Member States need to establish systems for standardizing and regulating the selection, procurement, use and management of these tools.
The majority of the world’s population is denied adequate, safe and reliable access to appropriate medical devices within their health systems. The regional situation is difficult to assess given the current gaps in knowledge and scarcity of data. Nevertheless, several studies indicate a number of problems relating to medical device management, at a time when the regional market for medical devices is growing. Without proper management of demand, through actual needs assessment, adequate procurement, proper installation, preventive maintenance, rational usage and quality assurance, it will be difficult for health care providers to contain the burgeoning costs.
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
Regulatory authorities in most major markets (including the European Union, United States, Canada, Japan, and Taiwan) require, or strongly prefer, that manufacturers marketing medical products in their countries have a third-party audited and certified quality management system in place. An ISO 13485-compliant system expedites access into those countries that require it.
In some markets medical device distributors are also supposed to fulfill the regulatory requirements there. That is why, these distributors prefer to implement an 13485 compliant quality management system.
SZUTEST is accredited by the Turkish Accreditation Agency (EA member) and IAS for ISO 13485 according to EN ISO 17021.