Global Certificate in ISO 13485: Building a Quality Culture
-- ViewingNowThe Global Certificate in ISO 13485: Building a Quality Culture is a comprehensive course designed to equip learners with the essential skills needed to excel in the medical device industry. This course focuses on the importance of establishing a quality culture within an organization, in compliance with the ISO 13485 standard.
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โข Introduction to ISO 13485: Understanding the Standard — This unit will cover the basics of ISO 13485, its purpose, and how it applies to the medical device industry. โข Building a Quality Management System (QMS) for ISO 13485: Key Elements — Explore the essential components of a QMS that adheres to ISO 13485 requirements. โข Documentation Control in ISO 13485: Guidelines & Best Practices — Learn about the documentation requirements for ISO 13485 and how to maintain accurate and up-to-date records. โข Risk Management in ISO 13485: Implementing a Risk-Based Approach — Understand the importance of risk management in ISO 13485, and how to integrate it into your QMS. โข Human Resources & Competence Management in ISO 13485: Building a Strong Team — This unit will focus on the human resources and competence requirements of ISO 13485, and how to build a strong team capable of maintaining a compliant QMS. โข Process Management & Improvement in ISO 13485: Continuous Improvement — Learn about process management and continuous improvement methodologies in the context of ISO 13485, and how to apply them to your QMS. โข Design Control in ISO 13485: Ensuring Compliance — This unit will cover the design control requirements in ISO 13485, and how to ensure compliance throughout the product development lifecycle. โข Production & Service Control in ISO 13485: Ensuring Quality — This unit will cover the production and service control requirements in ISO 13485, and how to ensure quality and compliance in manufacturing and service provision. โข Measurement, Analysis & Improvement in ISO 13485: Data-Driven Decision Making — Understand the measurement, analysis, and improvement requirements in ISO 13485, and how to use data-driven decision making to improve your QMS
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