Performance-Based Auditing Leader Certification
For medical device manufacturers, process performance – or lack thereof – can potentially result in noncompliance or liability for the organization, with damaging consequences to business sustainability. Good process management is the cornerstone of sound business performance, and Performance-Based Auditing ensures that you remain effective and efficient in managing your processes. As a result, Oriel STAT A MATRIX has created our Performance-Based Auditing Leader Certification Program.
About the Performance-Based Auditing Leader Certification Program
Designed specifically for Audit Program Managers and Lead Auditors engaged in internal audits and supplier audits, the program curriculum “raises the bar” of the audit program in three ways:
- It adds performance issues to the audit criteria (e.g., identification of waste)
- It provides a path for focusing the audit (scope, extent, and depth) based on its objective (e.g., assessing a problem supplier or qualifying a new supplier of a critical component)
- It enhances the auditor’s skills toward a deeper dive into monitoring and measuring processes through the application of quality and statistical tools that are relevant to auditing
Program Requirements
To earn your certification, you must complete the 3 required courses, pass each course examination, and successfully complete a capstone project. You will have up to 36 months to fulfill all program requirements.
Training Course Requirements
- ISO 13485 Lead Auditor Training – 5 Days
- Advanced Lead Auditor Training – 5 Days
- Statistics for Auditors – 5 Days
Each of the required courses is available for public registration. Course details and upcoming dates can be found by clicking on the courses listed above.
Project Requirements
For your required project, you will complete a Performance-Based Audit at your workplace using the concepts and tools taught in the courses, and document this audit in a formal audit report. We will review your audit report to verify that you have effectively applied Performance-Based Auditing techniques. Candidates will also complete a comprehensive interview with an Oriel STAT A MATRIX Master Trainer.
Who is this program intended for?
While this program will be of interest to anyone involved in Medical Device RA/QA, it may appeal most to individuals involved in the following areas: CAPA, Quality, Engineering, Product Development, Manufacturing, Service, R&D, RA/QA/CA, Supplier Quality, Internal Audit, and Distribution.
If I took one of the required courses in the past, can I take the exam and have that course count towards a program?
For non-auditor courses, if you took the course in the past 3 years, you can ask to take the online exam and “place out” of that course requirement. For our Lead, Internal and Advanced Auditor classes, if you have completed the course and successfully passed the exam within the past 3 years, you do not need to take another exam and the course will count towards your program certification.
How do I sign up?
First, contact us and tell us you want to pursue a certification. We will formally enter you as a candidate for your selected program. There is no cost to declare your intention and no obligation to enroll.
When you are ready to start your training, you can select a specific course from the links above or at orielstat.com/training and register for a session of your choice. We offer all of the courses that are in this program as open-enrollment classes--multiple times a year--in cities across the US. Sign up for each course individually, using a pay-as-you-go model. Alternatively, if you have 6 or more employees who would benefit from this program, we can offer the complete program on-site at your facility.
