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ISO 13485

ISO 13485:2003 Medical devices-Quality management systems

ISO 13485 is the quality management system standard for organizations engaged in medical device manufacturing.

ISO 13485 is based on ISO 9001 and supplemented with additional quality management requirements relating to design, special processes, documentation, records, traceability, documentation records, and regulatory actions. Unlike ISO 9001, which requires organizations to demonstrate continual improvement, ISO 13485 requires only that an organization demonstrate that the quality system for medical device manufacturing is implemented and maintained.

Although being registered does not fulfill the requirements of the various industry regulators, such as those of the U.S. Food and Drug Administration (FDA), ISO 13485 is commonly used as the basis for regulatory requirements. As such, the ISO 13485 standard is an essential consideration not only for exporters but also for the local market, global suppliers, and subcontractors to prove that their medical device products are of the highest quality.