Certificate in ISO 13485: Actionable Knowledge
-- ViewingNowThe Certificate in ISO 13485: Actionable Knowledge is a comprehensive course designed to provide learners with the essential skills needed to excel in the medical device industry. This certification focuses on ISO 13485, an international standard for quality management systems specific to the medical device industry, ensuring that organizations consistently meet customer and regulatory requirements related to medical devices.
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โข Understanding ISO 13485: This unit will cover the fundamental concepts of ISO 13485, including its purpose, structure, and benefits for medical device organizations. It will also highlight the differences between ISO 13485 and ISO 9001. โข Scope and Application: This unit will discuss the scope and application of ISO 13485, including the types of medical devices and organizations that need to comply with this standard. It will also cover the exclusions and alternative solutions provided in the standard. โข Quality Management System (QMS) Requirements: This unit will outline the requirements for establishing, documenting, implementing, maintaining, and continually improving a QMS according to ISO 13485. It will cover the necessary documentation, resources, competence, and infrastructure. โข Management Responsibility: This unit will focus on the management's responsibility for the QMS, including top management commitment, customer focus, quality policy, quality objectives, organizational roles, responsibilities, and authorities, and management review. โข Resource Management: This unit will discuss the requirements for managing resources, including infrastructure, work environment, human resources, and controllable processes. โข Product Realization: This unit will cover the requirements for product realization, including planning, design and development, purchasing, production and service provision, and control of monitoring and measuring resources. โข Measurement, Analysis, and Improvement: This unit will outline the requirements for measurement, analysis, and improvement, including monitoring and measurement, customer satisfaction, internal audits, and management review. โข Control of Nonconforming Product: This unit will focus on the requirements for controlling nonconforming products, including investigation, corrective action, and disposal. โข Sterile Medical Devices: This unit will cover the specific requirements for sterile medical devices, including sterilization, sterile barrier system, and packaging.
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