T/CAS 843-2024 Quality Management Maturity Evaluation of Medical Device Medical consumables

Scope

Scope: This document defines the terms and definitions related to the maturity of medical consumables quality management in medical institutions, stipulates the evaluation content and procedures of the maturity of medical consumables quality management, and describes the evaluation methods. This document is applicable to medical institutions at the second level and above for implementing and conducting evaluations of the maturity of medical consumables quality management, as well as for improving their capabilities through the evaluation model of the maturity of medical consumables quality management. It provides an evaluation method for medical institutions to pursue excellence in medical consumables quality management. Main technical content: This document defines the terms and definitions related to the maturity of medical consumables quality management in medical institutions, stipulates the evaluation content and procedures of the maturity of medical consumables quality management, and describes the evaluation methods. This document is applicable to medical institutions at the second level and above for implementing and conducting evaluations of the maturity of medical consumables quality management, as well as for improving their capabilities through the evaluation model of the maturity of medical consumables quality management. It provides an evaluation method for medical institutions to pursue excellence in medical consumables quality management.

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