Gain a better insight into the use of ISO 13485:2016 as the basis for a Quality Management System (QMS) implemented by medical device manufacturers.

This course prepares you for the implementation of ISO 13485 in your organization so that you can further pursue certification to show confidence of compliance to the standard towards stakeholders.

Confidently guide your organization towards preparation for ISO 13485:2016 certification thru frequent internal audits to check on your system's readiness. Our tutors will also cover auditing best practices, tips and tricks during the session.

This course provides an introductory understanding of Process Validation for general management system standards and regulations requirements including ISO 9001, ISO 13485, Food, Drug, and Cosmetic (FD&C) Act 21CFR 211 and 21CFR 820, ISO/TS 16949, AS 9100, ISO 17025, ISO 22000 etc, and overview on practical statistical methodologies for its analysis and guidance for its planning, implementation and maintenance.  Process Validation stages like Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification will be discussed during the training session.