CQI/IRCA-Certified QMS Lead Auditor Based on ISO 13485:2016 and MDSAP Requirements
Learners will plan, conduct, report and follow up on a QMS audit in accordance with ISO 13485:2016, MDSAP and EU MDR requirements. Learn how to apply the MDSAP audit approach adopted by Auditing Organizations in the MDSAP program, to identify and grade nonconformities and to prepare an audit report in accordance with MDSAP criteria.
This CQI and IRCA medical device lead auditor certified course is currently certified to include ISO 13485:2016 and MDSAP requirements.
About This Course
This course provides learners with the skills and knowledge that have taken many experienced auditors decades to develop. During the course, learners will plan and prepare audits based on case studies that simulate both supplier and third-party audits utilizing the MDSAP audit requirements. Learners will participate in simulated auditing exercises that include planning, preparing and evaluating audit evidence. Learners will also practice the application of ISO 13485:2016 and the MDSAP requirements.
The course consists of five days of interactive instruction and auditing sessions followed by a comprehensive written examination on day six. Learners will have two hours to complete the exam, which is provided and proctored in a virtual format (additional time will be added for learners who speak English as a second language and are taking the exam in English, and learners with disabilities). Our course requires highly interactive work and ongoing instructor assessment throughout the week.
Key Learning Objectives
By the end of this training, learners will be able to:
- Describe the purpose of:
- Quality management system
- Quality system standards
- Management system audit
- Third-party certification
- Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011
- Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485
This course represents one vital step required to become a certified CQI/IRCA Lead Auditor. Find out more
Prior Knowledge and Experience Requirements:
In order to sit the course, learners are required to demonstrate they fulfil the prior knowledge requirements, which includes knowledge of quality management principles and concepts, and the requirements of ISO 13485:2016.
- Knowledge of the requirements of ISO 13485 (which may be gained by completing a CQI and IRCA Certified MD-QMS ISO 13485:2016 Foundation (FD132) course or equivalent)
- Knowledge of the following quality management principles and concepts:
- The Plan, Do, Check, Act (PDCA) cycle.
- The relationship between quality management and customer satisfaction.
- Commonly used quality management terms and definitions within ISO 13485 and ISO 9000 (including 7 quality management principles, see ISO 9000)
- The process approach used in quality management.
- The Model of a Process Based Quality Management System, the structure and content of ISO 9001.
- Knowledge of at least 1 of the MDSAP country-based regulations, or similar e.g. WHO PQ requirements, EU MDR or EU IVDR etc.
- Medical device/IVD auditing background.
Learners will receive a pre-course questionnaire via email to share prior knowledge and experience, which must be completed and returned prior to the course date.
**Learners may be tested on the above prior knowledge as part of the course examination
Who Should Attend
This class is helpful for all personnel involved in preparing, conducting, managing, participating in, or otherwise facilitating internal, supplier, or regulatory audits and their outcomes, as well as executive personnel with responsibility for the design and implementation of any aspect of a quality management system.
Course tutors can include:
Robert Ruff - Robert Ruff has over 35 years of experience in the medical device and public health sectors, including working in orthopaedic implant manufacturing and completing a long, distinguished career with the U.S. FDA. His extensive regulatory experience includes leading the development of the Medical Device Single Audit Program as well as co-authoring the MDSAP Audit Approach and the Quality System Inspection Technique (QSIT). Since 2017, Rob has conducted audits relative to a variety of criteria for NSF. He is also responsible for NSF training on medical device manufacturing topics. In this role, Rob has developed courses on a range of subjects, including auditing against the EU MDR and EU IVDR, risk management, FDA inspection readiness, design controls, and more.
James Pink - James Pink has over 20 years of experience in the medical devices industry including 10 years as a health care technology expert and lead auditor for a leading European notified body. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assurance programs for active and non-active implantable and combination products. Mr. Pink is a contributor to several medical device standards committees including ISO 13485, ISO 14971 and various product-related standards.
Janet Book - Janet Book has worked in the field of quality for the past 35 years in a wide variety of industries, including blood banking, food processing, quality consulting, chemical, pharmaceuticals and medical devices. She has conducted internal and supplier audits utilizing many different industry-specific standards, due diligence evaluations as well as capability assessments. She has been involved with writing quality procedures; developing supplier, internal and corporate audit programs; developing quality management systems; and developing and presenting quality-related training and seminars. Janet is a certified Six Sigma Black Belt and served as an adjunct professor at Carnegie Mellon University. Recently, she earned her Certificate in Privacy Law and Cyber Security and worked in privacy providing guidance on quality, regulatory and compliance functions. She is a senior member of the American Society for Quality (ASQ), an ASQ Certified Quality Auditor (CQA), an ASQ Certified Quality Engineer (CQE), an ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) and an RABQSA Quality Systems Lead Auditor.
Christine Brown - Christine has over 30 years of experience working with regulated medical device, combination products, and pharmaceutical manufacturers and FDA class I, II and class III devices. Her areas of expertise include Post Market Quality, CAPA), Quality Systems, Quality Management, Product Development, Production and Process Control, and External Agency Inspections (FDA-483, warning letter, and consent decree situations). She has been an expert witness and participant in the FDA 510(k) premarket applications under the FDA Accredited Person Program for medical devices, as a third party-reviewer.
Christine holds a Bachelor of Science in Biomedical Engineering along with certifications as a Certified Software Quality Engineer, Certified Reliability Engineer, and Certified Quality Auditor from the American Society for Quality in addition to being a certified Quality Systems Lead Auditor for ISO13485:2016 and MDSAP.