ISO 13485 is an enhanced quality management system specifically targeted toward the medical device world. It incorporates a risk management approach to product development and product realization. Process validation is greatly enhanced, which aids to improve the quality of the design and the manufactured product. In addition, product traceability is greatly enhanced in that it is completed to the component level. ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised, with the new version published in March 2016. ISO 13485:2016 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 and applicable regulatory requirements. ISO 13485:2016 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 and applicable regulatory requirements. ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization. The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes. The standard provides an effective framework to meet the comprehensive requirements for a medical devices quality management system; for manufacturers and service providers to both comply and demonstrate their compliance to regulatory requirements. The standard supports the design of a quality management system that establishes and maintains the effectiveness of a manufacturer’s processes to ensure the consistent design, development, production, installation, and delivery of medical devices, or related services, that are safe for their intended purpose. The new edition is applicable across the whole supply chain and seeks to address the entire lifecycle of a medical device. The requirements in ISO 13485 are used by suppliers or other external parties providing products or services to medical device manufacturers. By using ISO 13485, organizations will be able to demonstrate compliance with regulatory requirements, manage risk, ensure best practice for quality and safety, improve processes and provide confidence to patients.
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