T/CGCPU 021-2023 Active Group standards

T/CGCPU 021-2023 Quality Management Capability Evaluation Specification for Organizations

Publish Date: 2023-01-01 Implement Date: 2023-01-10 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CGCPU 021-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Integrated medical science and healthcare devices

Publish Date: 2023-01-01

Implement Date: 2023-01-10

Scope

Main technical content: 1. Preface and Introduction 2. Scope 3. Normative reference documents 4. Terms and definitions, abbreviations 4.1 Terms and definitions 4.2 Abbreviations 5. Evaluation content 5.1 Basic conditions and capabilities of quality management for clinical trial institutions 5.2 Evaluation content of quality management capabilities for clinical trial institutions 6. Evaluation experts 7. Evaluation process 8. Result determination 8.1 Determination of clauses in the evaluation content 8.2 Evaluation conclusion Appendix A (Normative) Evaluation content of quality management capabilities for clinical trial institutions Appendix B (Normative) Specific requirements for evaluation expert groups References

Development Information

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