ISO 13485 as an integrator of unified quality management system of medical devices production in accordance with the European standards and Technical Regulations requirements. The ISO 13485:2003 Standard relates to quality management systems in the field of Medical Devices, including IVD (In Vitro Diagnostic).
The standard can be used by an organization for the design, development, production, installation and servicing of medical devices as well as for the design, development and provision of related services

Gain the confidence to effectively audit a MDMS in accordance with internationally recognized best practice techniques. Demonstrate your commitment to quality by transforming existing auditor skills to ISO. Consolidate your expertise with the latest developments and contribute to the continuous improvement of the business.
You’ll grasp the key principles and practices of effective QMS audits in line with ISO 13485:2016 and ISO 19011 “Guidelines for auditing management systems”. Using a step-by-step approach, you’ll be guided through the entire audit process from initiation to follow-up. Over 5 days, you’ll gain the knowledge and skills required to undertake and lead a successful management systems audit. Learn to describe the purpose of an ISO audit and satisfy third-party
certification. You’ll acquire the skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance