Course/Product Description Title: Internal Auditor Training for ISO 13485 Duration: 3 days Description: Learn the steps to develop, implement, and audit an internal quality system that efficiently and effectively meets the requirements of ISO 13485:2003 and ISO 9001:2008. Get your training from the industry leaders. We have been training auditors longer than any other training organization in the world. This 3-day version of our RABQSA-certified internal auditor course includes workshops tailored to the changing medical device industry and discussions of ISO 9001:2000 and ISO 13485:2003. Objectives Understand how to prepare, conduct, and follow-up on internal audits for ISO 9001:2000 and ISO 13485:2003. Introduction to Internal Quality Systems Assessment An introduction to the elements comprising a quality system, interpretation of the requirements of ISO 9001:2000 and ISO 13485:2003, and a discussion of what third-party assessment agencies look for The Three Audit Phases Planning, execution, and follow-up are examined closely using concepts detailed in ISO 19011 Planning and Auditing How to prepare for an audit and manage your resources effectively Conducting the Audit How to collect objective evidence and document observations, including techniques for effective questioning and listening Follow-On Activities How to verify effectiveness and adequacy of corrective action, close out an audit, and conduct follow-on surveillances Topics Analysis and interpretation of ISO 13485:2003 The quality system The quality audit cycle Preaudit activities Internal audit case study On-site audit activities Report writing-nonconformity reports Corrective action-case study Final examination (1 hour) Who Should Attend This course will be beneficial to you if you will be conducting, managing, or participating in internal (first-party) audits, or helping to develop an ISO 13485 quality system. This course is also a great fit for those involved in developing, implementing, and/or maintaining an internal audit system that meets the requirements of ISO 13485. This training course is certified by RABQSA and satisfies the training requirement for individuals seeking registration under the RABQSA QMS Internal Auditor Registration Scheme. Licenses / Designations / Educational Credits: CEU All US States: 2.5 All Canadian Provinces: 2.5 About The Provider: Founded in 1968, STAT-A-MATRIX is the world's leading consulting and training organization dedicated to improving business processes, management systems, and quality and regulatory compliance. We offer ongoing consulting and training in every aspect of business process improvement. Our approach is a unique blend of concepts, methods, techniques, and tools designed to transfer skills and knowledge to your organization's personnel. Our distinct approach integrates quality, regulatory, and business management systems to help improve your bottom line. Price: $1,195.00 More Info: Contact Us For More Information

Keywords For This Course:
ISO Standards, audit quality systems, RABQSA certifiection, RABQSA certified