![]() ![]() ![]() It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry. This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle. ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry.
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