The ISO13485 is a quality system standard for organizations that design, develop, produce or service medical devices. It is intended to promote harmonization in the medical device industry and set a basis for quality system regulations worldwide. All requirements of ISO13485 are specific to organizations providing medical devices, regardless of the type or size of the organization. The certification of a quality management system, specifically for medical devices to ISO13485 proves advantageous, and in many cases essential, for medical companies which export their products to global markets. Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are more critical for the medical deviceindustry. An ISO13485 compliant management system adopts a risk management approach which includes assessment to identify & estimate risk, uses risk controls and techniques with a view to eliminate hazardous situations throughout product realization. Adopting this standard is beneficial to the organization in many ways: • It demonstrates the manufacturer's ability to supply medical devices and related services that are compliant with all regulatory requirements • Assures the customers that the product complies with all relevant product and service-oriented technical standards and regulations • Emphasizes the cleanliness and sterility in the production area, which in turn increases efficiency and enhances safety at the workplace • Organization establishes for risk management throughout the product realization.
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