Quality System Practitioner Certificate
Adherence to the FDA's Quality System Regulation (QSR) and ISO 13485 is often the greatest challenge facing medical device manufacturers. The scope of QSR and ISO 13485 is large, and noncompliance is not an option. Medical device manufacturers need individuals who understand these requirements and know how to implement and maintain them. As a result, Oriel STAT A MATRIX has created our Quality System Practitioner Certificate Program.
About the Quality System Practitioner Certificate Program
As a Quality System Practitioner, you will have the knowledge to effectively interpret and apply the requirements of QSR 21 CFR 820 and ISO 13485. This includes knowing how to document, implement, and audit the Quality System as well as being able to help your company use its Quality System to improve overall performance.
Training Course Requirements
To earn your certificate, you must complete the following 3 courses and pass each course examination. You will have up to 36 months to meet these requirements.
- Quality Systems for Medical Devices: FDA’s QSR and ISO 13485 – 3 Days
- Developing and Maintaining a Compliance Document Management System
– 2 Days - ISO 13485 Lead Auditor Training for ISO 13485 – 5 Days
Each of the required courses is available for public registration, course details and upcoming dates can be found by clicking on a course listed above.
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: Quality, Quality Assurance/Control, Regulatory Affairs, Clinical Affairs, Marketing, R&D, Engineering, Product Development, Internal Audit, Compliance/Legal, and CAPA.
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, there is no need to take another exam, and the course will count towards your program.
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 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.
