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ISO 13485 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes is an International Standard that provides a quality management system model for medical device manufacturers to meet regulatory requirements. It includes particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
ISO 13485 is intended for organizations that design, develop and produce medical devices. It has been adopted by regulators internationally with the aim of harmonizing quality system requirements and, as a consequence, reducing conflicting and different demands on manufacturers.
SIRIM QAS International offers Quality Management Certification Scheme for the medical products sector based on ISO 13485 and is readily available to assist organizations for the transition from ISO 13485:2003 to ISO 13485:2016.
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