This course is a complete step-by-step certification guide to ISO 13485. ISO 13485 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. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities
Requirements of ISO 13485 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
Section 1 Scope: This section reviews the ISO 13485 Standard’s aims and concepts and defines the scope of application of the standard to your quality management system
Section 2 Normative References: The meaning and purpose of the normative references is to indicate that terminology and nomenclature specified in this standard is not open for debate or an interpretive discussion.
Section 3 Quality Management System: This section provides the general requirements and main principles of a quality management systems. This section is a foundation for self-evaluation of whether the organization’s quality management system follows the general requirements.
Section 4 Management Responsibility: This section lays out the requirements of top management regarding the quality management system. It specifies the principle that will construct the commitment of top management
Section 5 Resource Management: Resources are one of the foundation stones of the quality management system. The standard requires us to define, manage, and control our resources. The standard relates to three kinds of resources: human resources, infrastructures, and work environment. These are responsible for critical areas and scopes of the realization processes, especially when it comes to medical devices.
Section 6 Product realization: The section initiates the master planning of the realization of the medical device and refers for the first time to the term “quality plan”. Planning of this will cover the entire life cycle of the medical device.
Section 7 Measurement Analysis and Improvement: The objective of the measuring processes is to collect, analyze, and report data that are relevant to the medical devices and realization processes. The analysis shall strive to support the processes and maintain the effectiveness of your quality management system, as well as the quality of the medical devices
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