This class is for auditors, supervisors and managers in the medical device industry who want to 1) learn about ISO 13485 and ISO 9001 requirements, 2) interpret the standard, and 3) apply requirements to their work situation. The class is based on a portion of an RABQSA-approved ISO 13485 Certified Lead Auditor class. This class provides on-line access to ISO 9000 (vocabulary standard) and over 20 downloadable handouts such as: an ISO 13485 checklist, a Student Textbook, Study Tips, a before-class assessment and after-class objectives, and so on. Students must apply what they learned by completion of an assignment for marking by an instructor. If students want a copy of the ISO 13485 standard, they must provide their own, however, the standard is not a material requirement for the class. The class consists of a series of lessons, illustrations, diagrams, interactive exercises, and quizzes. Successful completion of the class will result in a certificate for 20 contact hours (2.0 CEU's). The subscription period for the class is 180 days (plus one free 30-day subscription extension, if needed).
Students will be able to:
- Describe how the ISO 9000 family of documents was developed·
- Interpret the ISO 13485 (ISO 9001) requirements clause-by-clause·
- Describe the conformity assessment process
- Compare the differences between ISO 13485 and ISO 9001
- Analyze the QMS for potential nonconformities
- Explain QMS terminology
J.P. Russell is owner of JP Russell and Associates and director of operations for QualityWBT Center for Education. He is an ASQ Fellow, an ASQ Certified Quality Auditor, and former RAB QMS Lead Auditor. He is a member of ASQ, Institute of Internal Auditors, Standards Engineering Society, US TAG TC 176 and Secretary of TG 9001-9004.
He is an instructional designer in the areas of auditing, standards, and improvement, has authored over 12 books on process/systems auditing/continual improvement, edited theQuality Audit Handbook 1st and 2nd ed, and the ASQ Auditng Handbook, and is a regular columnist for ASQ's Quality Progress magazine.
Elizabeth Bild is a management consultant and trainer who specializes in quality management systems. She has developed training courses for SPC, ISO 9001, and ISO/TS 16949. She currently consults on ISO 9001, ISO/TS 16949, and SAE AS9100. She has had over 30 years in business in quality management and supervision. She has a BS and an MS in Chemical Engineering from Purdue University.