GB/T 12707-1991
Abolished
RB/T 161-2017
Active
Industry standards-Certification and accreditation
RB/T 161-2017 Quality management systems—Healthcare equipment distribution services—Requirements
RB/T 161-2017 Quality management systems—Healthcare equipment distribution services—Requirements
Basic Information
Standard Code:
RB/T 161-2017
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Standardized management and general provisions
ICS Name:
Product certification, institutional certification, and conformity assessment
Publish Date:
2017-05-27
Implement Date:
2017-12-01
Pages:
28 pages
Scope
This standard specifies the requirements for a quality management system for health device distribution and service organizations. This standard applies to health device distribution and service organizations (hereinafter referred to as "organizations") in establishing, implementing, maintaining, and improving their quality management systems. It can be used as a basis for organizations to conduct self-evaluations and self-declarations, and it can also serve as a basis for external evaluations and certifications of the organizations' quality management systems for health device distribution and services.
Development Information
Referenced Standards
Related Standards
GB/T 14237-1993
Abolished
GB/T 14237-1993 Manufacturer's declaration of export product conformity with standards
GB/T 14436-1993
Abolished
GB/T 14436-1993 General principles of industrial product guarantee documents
GB/T 15486-1995
Abolished
GB/T 15486-1995 Calibration and testing laboratory accreditation systems—General requirements for operation and recognition
GB/T 15483.1-1999
Replaced
GB/T 15483.1-1999 Proficiency testing by interlaboratory comparisons—Part 1:Development and operation of proficiency testing schemes
GB/T 15483.2-1999
Replaced