T/ZAMEI 0002-2024 Active

Scope: This document specifies the credit compliance objectives, basic principles, organizational environment, organizational management, risk identification, risk assessment, inspection and improvement, etc. of credit compliance management in the medical device industry. This document is applicable to organizations and relevant staff engaged in the research, development, production, and operation of medical devices in carrying out credit compliance construction. Main technical content: 1. Scope and purpose - Scope: This guideline specifies the objectives, principles, organizational environment, management, risk identification, evaluation, and inspection and improvement of credit compliance management in the medical device industry. - Purpose: It aims to enhance the credit compliance management capabilities of medical device organizations, improve overall enterprise performance, promote sustainable development, and ensure that organizations and their employees comply with laws, regulations, industry standards, and corporate rules in production and operation activities. 2. Normative references - It lists relevant national standards such as GB/T 22117, GB/T 23794, GB/T 31950, and GB/T 35770, which provide necessary terminology and definitions, as well as requirements for credit compliance and compliance management systems for this guideline. 3. Terminology and definitions - It defines key terms related to credit compliance in the medical device industry, such as credit compliance obligations, credit compliance, credit compliance risks, and credit compliance management, ensuring the accuracy and consistency of standard usage. 4. Overall credit compliance objectives - It clarifies the overall objectives of enterprise credit compliance management, namely enhancing enterprise credit compliance management capabilities, improving overall enterprise performance, and promoting sustainable development. 5. Basic principles - It outlin