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Safety Environment


Safety Environment


ISO 13485 : 2016

ISO 13485 : 2016

Duration (Days)



This course is designed for participants to understand revised ISO 13485 system and how it will impact the quality management system. Participants will learn about the major changes include an increased focus on rick management thoughtout the product life cycle, the supply chain, as well as device usability and post-market surveillance requirements.

  • Recognize the changes introduced in the new standard.

  • Assess the impact of the changes and new requirements on your current quality management system (QMS).

  • Recognize the opportunity to make quality management a strategic function within the organization one that improves the organization's ability to achieve compliance effectively and efficiently.Learn about the agreed-upon transition period for the revised standard and how it applies to your organization's current or future certification.

  • Recognize the impact of the new requirements on top management, auditors, and other relevant functions within your organization.

Course Outline
  • Reviewing each clause of ISO 13485:2016

  • Monitoring and measuring the performance of the QMS by reviewing process effectiveness

  • Raising the bar for QMS performance by connecting it to the organization's business strategy

  • Using process metrics to identify key performance indicators (KPIs) that have an impact on the organization's overall performance and ability to maintain compliance.

  • Planning your organization's transition to the revised standard

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