ISO 13485 Requirements from A to Z
This course helps you understand ISO 13485:2016 requirements. You’ll apply and interpret ISO 13485:2016 clause-by-clause and know what’s different about this standard from ISO 9001. The course is especially designed for auditors, supervisors, and managers in the medical device industry.
Learn about ISO 13485:2016 and ISO 9001 requirements, interpret the ISO 13485:2016 standard, and apply these requirements to your work by completing a series of lessons, illustrations, diagrams, interactive exercises and quizzes.
Access to this course is for 180 days from the date of purchase. Any assignment that is failed and retaken will incur a remarking fee.
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Course Data
- CEU Hours: 2
- Length: 20 Hours
- ASQ RU: 2
- Audience: Practitioner
- Provider: Quality WBT
Learning Objectives:
- Describe how the ISO 9000 family of documents was developed.
- Interpret ISO 9001 and ISO 13485:2016 requirements clause-by-clause.
- Describe the conformity assessment process.
- Analyze the quality management systems for nonconformities.
- Explain quality management system terminology.
Prerequisites:
Medical device industry experience is helpful.Materials: A handy Desk Reference (student textbook), QualityWBT Glossary, and other resources
More than 20 downloadable handouts such as: an ISO 13485 checklist, study tips, a before-class assessment, and after-class objective.
Online access to ISO 9000 (vocabulary standard) granted with the purchase of this course.
Certificate of Completion
Who Should Attend:
Auditors, supervisors and managers in the medical device industryIntroduction — Class Rules
Lesson 1: Terminology and Definitions
Lesson 2: Background, History and Rationale of Quality Management
Lesson 3: Introduction to ISO 13485:2016 (including ISO 9001)
Lesson 4-13: The Contents of ISO 13485:2016 (including ISO 9001)
Lesson 14: Final assignment to be completed
Format and Features
This Web-based, self-paced training involves combinations of lessons, illustrations, diagrams, examples, supplemental handout information, forms, interactive exercises, and quizzes. A handy Desk Reference (student textbook), QualityWBT Glossary and other resources, are included in the class.
Web-based courses require a computer and Internet access. You set the pace and are responsible for your individual learning experience.
- Intel Pentium processor/compatible l800x600 resolution color monitor or higher
- Minimum 32 MB of RAM recommended
- Internet connection (28.8 kbps modem acceptable, regular or high speed preferred)
- A standard browser such as Edge, Google, or Safari
- Acrobat Reader (plug-in to view class items)
- Must accept our training center’s cookies (used for class monitoring and progress)
- Must be able to view HTML5 (a security setting)
- JavaScript (allowed on most computers)
Enrollment Details
Internet-based, self-paced training modules, which may involve combinations of text, visuals, audio, interactive simulations and quizzes (see specific courses for features and tools). These web-based courses require a computer and Internet access.
| ISOMEDAZJPR | Self-Paced | English | 180 Days | List: $389 Member: $350 |
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