8/23/2023 0 Comments Iso 13485 2016 free download pdfHowever, it contains additional requirements for medical devices and reformulates some of the requirements of ISO 9001 for its own purposes. In substance, ISO 13485 is similar to the ISO 9001 standard. In addition to QMS requirements, the standard also includes customer requirements and the regulatory requirements of the European Union (EU), Canada, and other major markets worldwide. For this reason, national and international regulatory agencies require medical device manufacturers and providers to demonstrate that they have a quality management system (QMS) that has been audited and certified by an external body.Ĭertification bodies generally base their audits on the EN ISO 13485 standard "Medical devices: Quality management systems - Requirements for regulatory purposes." This addresses the requirements that medical device manufacturers and suppliers must meet in developing, implementing, and maintaining quality management systems. The quality and effectiveness of medical devices affect the safety of patients, users and others more than many other products. Why use checklist to audit for ISO 13485 certification?
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