This course is for delegates who are already experienced medical device auditors and need updated training to the new standard. The course is suitable for both internal and lead auditors.
Organisations seeking to update their Quality Management System for Medical Device Manufacture require to ensure their own auditors are prepared for the changes associated with the new ISO 13485:2016 Standard. Competent internal auditors ensure that your organisation is fulfilling all new requirements to give you a level of assurance that you are fit to host a visit from your Certification Body.
Aims and Objectives:
The QCS one-day auditor transition workshop is designed to give auditors the required knowledge of the new standard, together with an understanding of the additional evidence they now have to seek in order to check conformance.
The course is designed to give you a good, practical basis of the implications of auditing to the new Standard ISO 13485:2016 Course Contents:
- Introduction to the 2016 standard and its new requirements - Review of auditing new requirements such as: -- Risk management -- Validation processes -- New documents and records -- New product realisation requirements - What is required to update audit programmes - Identification of nonconforming situations relevant to the new standard - Case studies to enhance all learning objectives
All QCS trainers have extensive experience in the management of quality management systems for medical device manufacture and are experts in their field, which ensures they bring a wealth of knowledge to bring the course to life. QCS takes a practical approach to ensure that you learn through discussion, analysis and participation; this makes for a more beneficial learning experience.
The course either has new dates in data loading, or is only run as a dedicated or In Company course.