Overview
This course provides an intensive training for medical device quality personnel to build on their current knowledge of ISO 13485 and establish effective auditing skills to evaluate the effectiveness of the medical device quality management system in their organization.
Our experienced facilitator who has more than 20 years of experience in medical device audit will guide participants through the medical device internal audit process, from planning an audit to reporting on audit results and following up on corrective actions.
Learning Objective
Detailed requirements of ISO 13485: 2016 and interpretation as an auditor and auditee.
Principals of auditing with reference to ISO 13485 and ISO 19011.
Responsibilities of auditors and auditees Basic auditing skills through understanding the processes, procedures, and techniques of auditing for compliance check against ISO 13485 requirements.
Preparing audit schedules and checklists to verify standard compliance.
Report writing to communicate audit findings Closing and following up on audit findings.
Target Audience
This course is tailored to Management Representatives, Consultants, and individuals who have been tasked or interested in conducting internal or supplier audits as
new auditors.
This course can also serves as a comprehensive refresher course that should be completed annually to keep medical device professionals up-to-date with the latest ISO 13485 knowledge.
Facilitation
This course can be run as a live classroom or virtual (synchronous) instructor-led training.
Certificates
Please contact us for details.