ISO 13485:2016: Medical Devices— Quality Management Systems— Requirements for Regulatory Purposes

This chapter describes the origin, implementation and use of the quality management system requirements in medical device globally based on a commonly used standard ISO 13485. Standards are created by bringing together the experience and expertise of all interested parties such as the producers, sellers, buyers, users and regulators of a particular material, product, process or service. Standards are designed for voluntary use and do not impose any regulations. ISO 13485:2016 is published by various organizations and when it is published by those organizations this is recognized by letters being placed before the ISO 13485:2016. Quality Management Systems consist of common elements that are expressed as the organizational structure, processes, procedures, work instructions and resources needed to implement quality management.