MedAccred Audit Criteria Preparation: Sterilization
PRI Training's - The MedAccred Sterilization Audit Criteria Preparation course is designed for sterilization, quality, and supplier management professionals who are responsible for, or directly involved in, sterilization processes, oversight, and supplier management – especially those who are new to the MedAccred approach to industry-led audit oversight. This course will provide a complete overview of MedAccred requirements related to the Sterilization audit and the Auditor, Auditee and Task Group Responsibilities. MedAccred represents a fundamental shift in how sterility assurance suppliers are evaluated. Unlike traditional regulatory or customer audits, MedAccred audits are driven by industry Task Groups, apply heightened technical rigor, and focus on process effectiveness, risk management, and systemic control rather than checklist compliance alone. Organizations that approach MedAccred using legacy audit mindsets are often unprepared for the level of scrutiny applied. This course provides a clear, practical introduction to the MedAccred Sterilization audit model, explaining not only what the requirements are, but why they exist and how they are interpreted by auditors and Task Group. What You Will Learn Participants will gain a clear understanding of how MedAccred differs from ISO, FDA, and customer audits, and why the industry is increasingly relying on this model for sterilization supplier oversight. Insight into the roles and expectations of Auditors, Auditees, and the Sterilization Task Group, including how Task Group interpretations influence audit outcomes. A guided walkthrough of MedAccred audit criteria AC8113 (ISO 13485based QMS) and sterilization specific supplemental checklists, including: Ethylene Oxide (AC8113/2) ISO 11135 Radiation (AC8113/1) ISO 11137 series; ASTM E61 Sterilization Laboratory Testing (AC8113/3) ISO 11737 series; harmonized USP Practical examples of common nonconformances, what acceptable MedAccred responses look like, and why many organizations fail to meet expectations despite having compliant procedures. A step-by-step understanding of what actually happens during a MedAccred Sterilization audit, from preaudit planning and self-assessment through Task Group review and closure. Who Should Attend? Quality and compliance professionals new to MedAccred Individuals responsible for sterilization process oversight or supplier management Supplier professionals preparing for their first MedAccred Sterilization audit Those transitioning into MedAccred liaison or audit support roles Executives and leaders who need a clear understanding of the rigor and expectations behind MedAccred Sterilization audits Those interested in being an auditor for MedAccred Sterilization Those who may be taking over direct liaison responsibilities in companies with experience of MedAccred and need to confirm their understanding Are new to MedAccred and will be responsible for managing or directly supporting MedAccred audits Task group and Management Council representatives that are new to MedAccred
