ISO 9001:2015 – An Overview and Changes

ISO 9001 is a global standard used to establish a quality management system that is widely adopted across industries and organizations of any size. Using ISO 9001 allows a business to standardize its customer satisfaction results by ensuring consistent, high-quality products and services.

This one-day virtual training provides an introduction to the high-level structure of the ISO 9001:2015 standard, an overview of the basic requirements of the ISO 9001:2015 standard and an interpretation of the changes made to the standard in this latest revision.

The ISO 9001:2015 Overview and Changes training course offers attendees a strong foundational understanding of the concepts explained across the ISO 9000 series of standards and demonstrates how their requirements impact an organization’s day-to-day activities within any industry. It also explores the purpose and benefits of QMS and teaches you how to apply the ISO 9001:2015 requirements to your organization.

The training involves a number of interactive teaching methods, including presentations and discussions to keep students engaged.

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

• Recognize the primary elements of ISO 9001:2015
• Identify terms and definitions relative to the application of ISO 9001:2015
• Recognize the changes and revised requirements in the ISO 9001:2015 standard
• Identify key documents to help them understand ISO 9001:2015
• Apply the concepts and requirements as outlined in the ISO 9001:2015 standard
• Develop skills to evaluate the requirements of the organization against these requirements

This ISO 9001 course is perfect for professionals looking to build strong core skills around the ISO 9001:2015 requirements.

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, chemicals, pharmaceuticals and medical devices. She has conducted internal and supplier audits utilizing many different industry-specific standards, due diligence evaluations and 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 Cybersecurity 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.

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.

Robert Ruff - Robert Ruff has over 35 years of experience in the medical device and public health sectors, including working in orthopedic 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.