INTRODUCTION:
Understand the elements that constitute a quality system, and the audit evidence necessary to comply with ISO 13485 requirements. The course includes hands-on workshops that allow you to replicate the working environment of the medical device industry. The curriculum will reinforce key topics critical to your success in this field. The training requirements for certification of individual QMS auditors, QMS senior auditors, and QMS lead auditors. Successful completion satisfies the training requirements for individual auditor certification by accrediting bodies.
With an emphasis on hands-on training, this course features workshops tailored to the working environment of the medical device industry. You will discuss a range of topics including ISO 13485 Medical devices—Quality management systems—Requirements for regulatory purposes, as well as ISO 9001:2000. Workshops reinforce key topics including documentation of audits, opening and closing meetings, and auditor interpretations, listening and questioning techniques, checklists, and nonconformance reports.
LEARNING OBJECTIVE:
• Understand the elements that constitute a quality system.
• Interpret the requirements of ISO 13485.
• Compare and contrast ISO 9001 and ISO 13485.
• Understand the audit evidence necessary to comply with ISO 13485 requirements.
• Apply the skills necessary to develop an ISO 9001:2008/ISO 13485 auditing system based on the ISO 19011 auditing requirements.
• Learn how to plan audit activities, develop checklists, and perform pre-assessment visits.
• Demonstrate the skills needed to conduct opening and closing meetings tailored to the medical device industry.
• Practice the skills needed to collect audit evidence, handles confrontations, and improves listening and questioning techniques.
TEACHING METHODOLOGY:
This course has been designed with input and feedback internationally from a number of trainers, customers and training consultants. The course design reflects a high level of interaction between the trainer and the participants. It is built upon the participants input all throughout the course. This input by being mapped on the classroom walls will help the participants follow and remember the course structure and content.
BENEFITS
• Understand the changes impacted by the ISO 13485:2003 standard and discuss what
they mean to you and your quality management system
• Understand the process by which ISO standards are reviewed and revised
• Establish a planned approach to reviewing and modifying your own documents
• Review and understand the requirements of ISO 13485:2003 for setting measurable
objectives
• Understand what is meant by a “process approach” and how to establish a program to
ensure compliance with the requirements
• Audit Workshops to review compliance examples
CERITIFICATE:
On successful completion of the course, a certificate will be issued to the participant. The certificate is valid for three years for the purpose of auditor certification.
