Understanding Quality Management Systems - ISO 13485 - Clause 6.3 - Infrastructure скачать в хорошем качестве

Understanding Quality Management Systems - ISO 13485 - Clause 6.3 - Infrastructure

Hello and welcome to our video on Clause 6.3 Infrastructure of ISO 13485:2016, the international standard for quality management systems for medical devices. In this video, we will discuss the importance of infrastructure and its requirements under Clause 6.3 of the ISO 13485 standard. Infrastructure is a critical aspect of any organization, and it is no different for companies involved in the manufacture and distribution of medical devices. The infrastructure requirements in ISO 13485:2016 are designed to ensure that the necessary resources are available to create a safe and effective product, and to maintain the quality of the product throughout its lifecycle. Clause 6.3 of ISO 13485:2016 states that the organization shall establish, implement, and maintain infrastructure needed to achieve conformity to product requirements. Infrastructure is defined as the organizational structure, resources, and facilities needed to perform work in support of product realization and to maintain the quality of the product. Let's take a closer look at the requirements of Clause 6.3: Organizational Structure: The organization shall establish and maintain an appropriate organizational structure to support the effective operation of the quality management system. This includes defining roles, responsibilities, and authorities of personnel involved in the management and operation of the quality management system. This structure should ensure that all personnel involved in the manufacturing and distribution of medical devices are aware of their responsibilities and have the necessary resources to carry out their roles effectively. Resources: The organization shall ensure that the resources needed to implement and maintain the quality management system are available. This includes personnel, infrastructure, equipment, and any other resources required to produce and maintain the quality of the medical device. The organization shall also ensure that personnel have the necessary training and skills to perform their duties effectively. Facilities: The organization shall ensure that the facilities used for the manufacturing and distribution of medical devices are suitable and maintained in a state of control. This includes ensuring that the facilities are clean, maintained, and in compliance with applicable regulations and standards. The organization shall also ensure that the facilities are suitable for the processes being performed, and that they are capable of producing medical devices that meet the required specifications. Work Environment: The organization shall ensure that the work environment is suitable for the manufacturing and distribution of medical devices. This includes ensuring that the temperature, humidity, lighting, and ventilation are appropriate for the processes being performed. The organization shall also ensure that the work environment is free from contamination, and that personnel are trained and equipped to maintain a clean and safe work environment. Documented Information: The organization shall establish, implement, and maintain documented information to support the effective operation of the quality management system. This includes procedures, work instructions, and any other documents necessary to support the infrastructure requirements of Clause 6.3. In conclusion, infrastructure is a critical aspect of ISO 13485:2016, and Clause 6.3 outlines the requirements for establishing and maintaining an effective infrastructure to support the quality management system. By implementing these requirements, organizations can ensure that they have the necessary resources and facilities to produce safe and effective medical devices, and maintain the quality of the product throughout its lifecycle. Thank you for watching, and we hope this video has provided you with a better understanding of the requirements of Clause 6.3 of ISO 13485:2016. 🌐 *Connect With Us:* https://patientguard.com If you are looking for Quality Assurance Templates to help you with your Quality Management System then head over to: https://qmsregs.com