ISO 19011:2018 - Applying Principles to Medical Device QMS Audits

This fast-paced instructor-led one-day course covers the basic concepts of planning, conducting, and reporting a medical device quality management system (QMS) audit in accordance with ISO 19011:2018. It is a must for auditors at all levels of the organization, as well audit program managers.

This course covers how to apply fundamental auditing strategies to any QMS scheme, as well as how to identify and grade nonconformities and prepare a medical device audit report in accordance with the identified criteria. The course also focuses on applying these fundamental principles when auditing a medical device manufacturer’s quality management system.

By the end of this training, learners will be able to:

• Describe the purpose of:
  • A quality management system
  • Quality system standards
  • Quality Management system audits

• Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011:2018

Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with audit criteria (e.g., ISO 13485:2016)

This ISO 19011:2018 audit training is helpful for all auditors and all management personnel with responsibility for medical device regulatory life cycles, including involvement with the design and implementation of quality management systems or oversight of an internal or supplier auditing program.

Course tutors selected from the following:

Robert Ruff - Rob has over 30 years’ experience in the medical device and public health sectors, including completing a long, distinguished career with the U.S. FDA. His extensive regulatory experience includes co-authoring the MDSAP Audit Model and the Quality System Inspection Technique (QSIT). He also developed the FDA’s computer-based training for QSIT, the Quality System Regulation and the Medical Device Reporting Regulation.

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.

Deborah Baker-Janis - Deborah joined NSF after working in the medical device industry for over 10 years, in both regulatory affairs and product development. Her experience includes domestic and international regulatory strategies and submissions, design control documentation development, quality management system and regulatory affairs procedure development and remediation, and training development and execution. Deborah has supported the development and commercialization of a wide range of products including cardiovascular devices, general and plastic surgery devices, gastroenterology devices and general hospital devices. Her educational background is in biomedical engineering.

Ashley Kelleher - Ashley has more than 14 years of professional experience in the medical device, pharmaceutical and certification industries. Her experience includes program management and project management of global, third-party, and notified body certifications for the medical industry. In addition, Ashley has expertise in reviewing technical file documentation (CE marking) and holds lead auditor certifications for ISO 13485, GDP, MDSAP, EU-MDR, ISO 14971, ISO 9001, and ISO 15378. Her educational background is in veterinary science.

Gert Sorensen - Gert Sorensen has worked in the field of Medical Device quality for the past 22 years in different roles; as a QA specialist within global companies producing class I, II and III Devices also including electronics and software. Gert has also worked as a consultant specialized in FDA 21 CFR compliance, Process Validation and Software Validation and as Notified Body Auditor. Gert has conducted internal audits, supplier audits and third-party audits under ISO 9001 and 13485, MDD 93/42/EEC, MDR 2017/745 and MDSAP. He has also conducted due diligence evaluations as well as capability assessments. He has been involved with writing quality procedures; developing supplier, internal and corporate audit programs; developing global quality management systems; and developing and presenting quality-related training and seminars.

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 And holds 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 Auditor for ISO13485:2016 and MDSAP.

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.