5 Key elements of the ISO 13485 Medical devices Quality management system

Posted by Charles Wilson on February 26th, 2022

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to prove its capability to provide medical devices and related services that constantly meet customer and appropriate regulatory requirements. ISO 13485 is intended to help medical device manufacturers create a Quality Management System (QMS) that confirms quality and safety of complete products.

ISO 13485 internal auditor training provide that need to know about the Quality management system and fulfill all the requirements as an ISO 13485:2016 QMS auditor. ISO 13485 auditor training will guide management as well as employees of organization in the field of manufacturing, supply of a medical device or its components for Quality management system based on ISO 13485:2016 standard. The standard delivers a step-by-step framework for creating a QMS and evaluating gaps in current system in terms of monitoring and controlling processes.

5 Key elements of ISO 13485:

1.        Quality Management System (QMS):

General quality management system requirements, as well as the documentation required to implement and maintain an effective quality management system. According to ISO, organizations need to:

•          Control the processes the quality management system needs and what\'s required to apply these processes throughout the organization, taking into account the various roles involved.
•          Apply a risk-based method to the control of the appropriate processes required for the quality management system.
•          Determine the categorization and interaction of these processes.

1.        Management Responsibility:

The unique roles and responsibilities of management as it pertains to quality management system execution and maintenance.

Management should provide evidence of its assurance to the development and maintenance of the quality management system and its efficiency. to do that:

•          Communicate the importance of meeting regulatory requirements.
•          Create high-value quality policy.
•          Confirm that quality objectives are established.
•          Conduct management reviews.
•          Confirm availability of quality management system resources.

1.        Resource management:

The resources life sciences organizations should oblige to implement the quality management system and maintain system efficiency. It outlines the provisions required to meet major regulatory and customer requirements.

•          The provision of resources.
•          Human resources.
•          Infrastructure.
•          Work environment.
•          Contamination control.

1.        Product realization:

In a rush to get products into expansion as soon as possible, many organizations often overlook the planning stage. plan realization efforts properly.

•          Launch the quality requirements for products.
•          Describe what essential processes will be and what supporting documentation will be required for those processes
•          Framework the company infrastructure that will essential to be created and what the work environment should be like.
•          Describe employee qualification and training requirements.
•          Establish processes for verification, validation, measurement, monitoring, handling, inspection, storage, supply, and traceability.

1.        Measurement, analysis, improvement:

The organization shall plan and implement the monitor, measurement, analysis, and development processes, related to the quality management system and products.

Organizations need to:

•          Establish conformity of product.
•          Confirm conformity of the quality management system.
•          Maintain the efficiency of the quality management system.

Source:

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