ISO 13485 (ISO 9001) Requirements from A to Z
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).
Learning
Outcomes
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Analyze the QMS for potential
nonconformities
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Technical Requirements
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MEET THE INSTRUCTORS: JP is an instructional designer in the areas of
auditing, standards, and improvement, has authored over 12 books on
process/systems auditing/continual improvement, edited the Quality Audit
Handbook 1st and 2nd ed, and the ASQ Auditng Handbook, and is a regular columnist for ASQ's
Quality Progress magazine. |
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Elizabeth Bild is a management consultant and trainer who specializes
in quality management systems. She has developed training courses for
SPC, ISO 9000, and TS/ISO 16949. She currently consults on ISO 9001, TS/ISO
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. Questions? Click here
to contact Elizabeth. |
Course
Providers:
International
Association for Continuing Education & Training (IACET) Authorized
Provider of CEUs. |
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