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:

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.

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.

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.