Introduction to Writing Effective Nonconformity Statements During Medical Device Manufacturer QMS Audits

About This eLearning

In this approximately 30-minute self-paced course, you will be introduced to the importance of writing effective nonconformity statements during audits of medical device manufacturer quality management systems.

Learners will identify the fundamentals of medical device QMS auditing that influence the writing of effective nonconformity statements. Learners will recognize when to communicate nonconformities during an audit and identify tools and tips for writing effective nonconformity statements.

Learners will also demonstrate how to assess nonconformity statements to confirm they are free from opinion and bias.

Key Learning Objectives

  • Identify valuable techniques to apply when writing effective nonconformity statements
  • Review fundamental terminology important to writing effective nonconformity statements, including “audit,” “objective evidence,” “audit criteria” and “nonconformity”
  • Evaluate the use of the acronym FOCAL as a tool for developing an effective nonconformity statement
  • Apply the three key principles when writing a nonconformity statement

Who Should Attend

This online course is vital for 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 will help ensure that the auditee organization clearly understands the nonconformities, so that they can identify and implement effective investigations and subsequent containment, correction, corrective action and systemic corrective actions, as appropriate.

White Paper: Tools and Tips for Writing Effective Nonconformity Statements During Quality Management System Audits of Medical Device Manufacturers

As a medical device quality management system auditor, one of the most important (if not the most important) responsibilities of your role is to effectively communicate identified nonconformities to the auditee organization.
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