T/CGCPU 021-2022 Active Group standards

T/CGCPU 021-2022 Quality Management Capability Evaluation Specification for Organizations

T/CGCPU 021-2022 Quality Management Capability Evaluation Specification for Organizations

Publish Date: 2022-12-13 Implement Date: 2022-12-26 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 021-2022
Standard Type: Group standards
Standard Status: Active
is_force_gb: no
CCS Name: -
ICS Name: Integrated medical science and healthcare devices
Publish Date: 2022-12-13
Implement Date: 2022-12-26

Scope

Main technical content: Foreword Introduction 1. Scope 2. Normative reference documents 3. Terms and definitions, abbreviations 3.1 Terms and definitions 3.2 Abbreviations 4. Evaluation content 4.1 Basic conditions and capabilities of clinical trial institutions for quality management 4.2 Evaluation content of clinical trial institutions' quality management capabilities 5. Evaluation experts 6. Evaluation process 7. Result determination 7.1 Determination of clauses in the evaluation content 7.2 Evaluation conclusions Appendix A (normative) Evaluation content of clinical trial institutions' quality management capabilities Appendix B (normative) Specific requirements for evaluation expert groups References

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