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Quality CRO Platform

CNAS

Introduction to CNAS 

The China National Accreditation Service for Conformity Assessment conducts reviews on conformity assessment institutions engaged in activities such as certification, testing and inspection in accordance with relevant international standards or national standards to confirm that they meet the requirements of relevant standards and further prove that they have the technical capabilities and management capabilities to engage in activities such as certification, testing and inspection, and issue accreditation certificates.

Consulting services are available  Recognition criteria for corresponding application qualifications Scope of application
CNAS Laboratory accreditation

CNAS-CL01 Test and Calibration Laboratory Accreditation Criteria (IDT:ISO /IEC 17025)

In-house corporate laboratories, universities, research institutes, and third-party laboratories engaged in testing, calibration, and R&D activities. 
CNAS-CL02 Criteria for Quality and Competence Accreditation of Medical Laboratories (IDT:ISO 15189) 

Laboratories conducting medical examinations, including medical laboratories in public healthcare institutions, third-party independent medical laboratories, and scientific research/teaching laboratories.

CNAS-CL05 Laboratory Biosafety Accreditation Criteria Biosafety Level 3 and 4 laboratories; Level 1 and 2 laboratories may refer to these criteria. 
CNAS-CL09 Research Laboratory Accreditation Criteria (Equally adopts GB/T27425-2020 "Good Practice for Research Laboratories")  Laboratories conducting scientific research, such as those in universities and research institutes. 
CNAS-CL10 Biospecimen Bank Quality and Competence Accreditation Criteria (IDT:GB /T37864-2019 General Requirements for Biospecimen Bank Quality and Competence ISO 20387) 

Legal entities planning to preserve biological samples (including acquisition and storage) of human, animal, plant, or microbial origin.

CNAS inspection agency accredited/CNAS Inspection Body Accreditation 

CNAS-CI01:2012 Competence Accreditation Criteria for Inspection Bodies (IDT:ISO /IEC 17020:2012)

Inspection institutions that carry out inspection work in specific fields/ Inspection bodies conducting inspections in specific fields. 
Certificate Example



 Elements  Requirements

Organization

A legal person or other organization established in accordance with the law and capable of bearing corresponding legal responsibilities.

Premises

A fixed workplace with an environment meeting inspection and testing requirements.

Equipment

Possession of inspection and testing equipment and facilities necessary for conducting activities.

Personnel

Qualified inspection/testing technicians and management personnel appropriate for the activities.

System

An effectively implemented management system ensuring independent, impartial, scientific, and ethical inspection/testing activities.

Standards

Compliance with special requirements stipulated by laws, regulations, standards, or technical specifications.

 

 

 

 

 

 

 

 

 

 

 

 

 

Review process 

Service process