April 22 – 26, 2024
This virtual instructor-led CQI/IRCA accredited course provides learners with the skills and knowledge that have taken many experienced auditors decades to develop. This course is fundamental to achieving CQI/IRCA Lead Auditor status. During the course, learners will plan, perform, and report audits based on case studies that simulate internal, supplier, and third-party audits utilizing MDSAP audit criteria. Learners will participate in simulated auditing exercises that include planning and performing audit activities, evaluating audit evidence, and documenting audit findings.
The course consists of five days of interactive instruction and auditing sessions followed by a comprehensive written examination on day six. Learners will have two hours to complete the exam, which is provided and proctored in a virtual format (additional time will be added for non-native English-speaking learners, and learners with disabilities).
Learners should enter the QMS Lead Auditor course with a basic understanding of ISO 13485:2016. Mandatory prerequisite reading and a prerequisite competency assessment will be provided upon enrollment. These prerequisites must be completed in advance of the course start date.
Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.
This class is helpful for all personnel involved in preparing, conducting, managing, participating in, or otherwise facilitating internal, supplier, or regulatory audits and their outcomes, as well as executive personnel with responsibility for the design and implementation of any aspect of a quality management system.
By the end of this course you should be able to:
· Describe the purpose of:
· Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011:2018
· Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485:2016 and MDSAP participating country-specific requirements.
Cleaning and Sanitation for Dietary Supplement Manufacturers
Top 10 Audit Findings & Ways to Get A Warning Letter - Recording
MDSAP Overview and Country-Specific Medical Device Regulations: 5-Course Bundle