Reference standardISO 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 services.
It is the only standard internationally used by medical device manufacturers. The implementation of ISO 13485 allows the reduction of risks for companies that manufacture or supply medical devices and related services at all stages of implementation
Advantages of the quality management for medical devices system certification
- meeting the customer and business partners requirements and the legal requirements
- evidence of adherence to legal and regulatory or contractual requirements
- minimize and manage risks in the organization's processes
- preventing errors in making products and / or services
- improved performance quality
- transparency and clarity of internal processes
- time and cost savings
This standard is addresses to:
- companies operating in the field of medical devices: designers, producers, distributors / suppliers;
- organizations performing installation, maintenance, service and training in the field of medical devices;
- companies that produce subassemblies for medical devices
Upon the certification process successfully completed, SRAC certified organizations:
- have the right to use SRAC and IQNet conformity marks for advertising purposes;
- are regularly informed on the evolutions in the quality for medical devices and certification areas, by accessing SRAC website, events organized by SRAC.
Every successful organization should:
- identify and satisfy the needs and expectations of its customers, as well as of its stakeholders, respectively employees, suppliers, owners, society, in order to obtain a competitive advantage, and to achieve this in an effective way;
- obtain, maintain and improve on a continuous basis its general performances and capabilities;and the strong commitment to achieve the quality is the key.