Advanced Certificate in Navigating ISO 13485
-- ViewingNowThe Advanced Certificate in Navigating ISO 13485 is a comprehensive course designed to empower professionals with the necessary skills to excel in the medical device industry. This certificate course highlights the importance of ISO 13485, an international standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
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⢠Understanding ISO 13485: A comprehensive overview of the ISO 13485 standard, its purpose, and its role in the medical device industry.
⢠Key Principles of ISO 13485: An in-depth analysis of the key principles, requirements, and expectations of the ISO 13485 standard.
⢠Implementing ISO 13485: Practical guidance on how to implement the ISO 13485 standard in a medical device organization.
⢠Navigating ISO 13485 Clauses: A detailed exploration of each clause of the ISO 13485 standard, including its purpose, requirements, and best practices for compliance.
⢠Quality Management System (QMS) and ISO 13485: Understanding the relationship between a QMS and the ISO 13485 standard, and how to align the two for optimal results.
⢠Risk Management in ISO 13485: Examining the role of risk management in ISO 13485, including best practices for implementing and maintaining risk management processes.
⢠Internal Audits and ISO 13485: Learning how to conduct internal audits in accordance with the ISO 13485 standard, including the creation of audit plans, execution of audits, and the reporting of findings.
⢠Continuous Improvement in ISO 13485: Exploring the concept of continuous improvement in the context of ISO 13485, including strategies for implementing and maintaining a culture of continuous improvement.
⢠Preparing for ISO 13485 Certification: Practical guidance on how to prepare for ISO 13485 certification, including the creation of a certification plan, the execution of certification activities, and the management of the certification process.
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