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ISO 13485
Clause-by-Clause Update

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Course Overview
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  • Duration: 2 modules × 2 hours + 4 hours homework = 8 total hours

 

  • Target Audience: Professionals familiar with ISO 13485 seeking updates and detailed implementation guidance

 

  • Certificate: Professional Development Certificate of Completion

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Learning Outcomes

Upon completion, participants will be able to:

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  • Master detailed requirements of each ISO 13485 clause

  • Identify implementation gaps in existing systems

  • Update procedures to current standard requirements

  • Enhance audit readiness and compliance

Module 1:
Clauses 1-5 (Foundation, Context, Documentation & Management)
(2 hours)

  • Scope and application updates (Clause 1)

  • Quality management system requirements (Clause 4)

  • Documentation control detailed requirements

  • Management responsibility and commitment (Clause 5)

  • Quality policy development and management review processes

  • Homework : Complete comprehensive documentation control audit and management review agenda template creation

Module 2:
Clauses 6-8 (Resources, Product Realization & Measurement)
(2 hours)

  • Resource management and competence requirements (Clause 6)

  • Product realization process mapping (Clause 7)

  • Monitoring, measurement and improvement (Clause 8)

  • Internal audit program development

  • CAPA and nonconformity management

  • Homework (2 hours): Develop competence matrix, performance indicators, and CAPA effectiveness assessment framework

If you are interested in booking onto our next online course, please get in touch with us to discuss the next available dates.
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