Writing Effective Nonconformity Statements During a Medical Device QMS Audit
December 13, 2022
In this one day course, learners will be introduced to the importance of writing effective nonconformity statements during medical device manufacturer quality management systems audits. Learners will also identify the fundamentals of medical device quality management system auditing that influence the writing of effective nonconformity statements. Learners will recognize when to communicate nonconformities during an audit, as well as, identify tools and tips for writing effective nonconformity statements. Learners will identify how to assess nonconformity statements to confirm they are free from opinion and bias. In addition, learners will apply the knowledge gained during the course through practical application of concepts learned.
Who should attend:
This course is vital to anyone who conducts or manages internal, supplier, or third-party audits within the medical device manufacturing space. The tools and tips shared in this training should help assure that nonconformities are clearly understood by the auditee organization so that effective investigations and subsequent containment, correction, corrective action, and systemic corrective action (as necessary) can be identified and implemented.