RB/T 217-2017 Abolished Industry standards-Certification and accreditation

RB/T 217-2017 Competence assessment for inspection body and laboratory mandatory approval—Requirements for medical device inspection body

Publish Date: 2017-10-16 Implement Date: 2018-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: RB/T 217-2017

Standard Type: Industry standards

Standard Status: Abolished

is_force_gb: no

CCS Name: Standardized management and general provisions

ICS Name: Product certification, institutional certification, and conformity assessment

Publish Date: 2017-10-16

Implement Date: 2018-05-01

Pages: 9 pages

Scope

This standard specifies the requirements for the evaluation of the qualification and competence of medical device inspection institutions in terms of organization, personnel, facility environment, equipment and facilities, and management systems.
This standard applies to the evaluation of the qualification and competence of medical device inspection institutions that issue data and results with evidentiary value to the public, and also applies to the self-evaluation of medical device inspection institutions.

Development Information

Word Count: 12 Thousand words Pages: 9 pages

Referenced Standards

GB/T 19000-2000 Quality management systems—Fundamentals and vocabulary GB/T 19000-2008 Quality management systems—Fundamentals and vocabulary GB/T 19000-2016 Quality management systems—Fundamentals and vocabulary GB/T 19000.2-1998 Quality management and quality assurance standards—Part 2:Generic guidelines for the application of GB/T 19001、GB/T 19002 and GB/T 19003 GB/T 19000.3-2001 Quality management and quality assurance standards—Part 3:Guidelines for the application of GB/T 19001-1994 to the development, supply, installation and maintenance of computer software GB/T 19000.4-1995 Quality management and quality assurance standards—Part 4:Cuide to dependability programme management GB/T 27000-2006 Conformity assessment—Vocabulary and general principles GB/T 27000-2023 Conformity assessment—Vocabulary and general principles JJF 1001-1998 General Terms in Metrology and Their Definitions JJF 1001-2011 General Terms in Metrology and Their Definitions RB/T 214-2017 Competence assessment for inspection body and laboratory mandatory approval—Genaral requirements for inspection body and laboratory

Related Standards

GB/T 12707-1991 Abolished

GB/T 12707-1991 Directives for the grading of industrial product quality

Publish Date: 1991-01-05

GB/T 14237-1993 Abolished

GB/T 14237-1993 Manufacturer's declaration of export product conformity with standards

Publish Date: 1993-03-17

GB/T 14436-1993 Abolished

GB/T 14436-1993 General principles of industrial product guarantee documents

Publish Date: 1993-06-10

GB/T 15486-1995 Abolished

GB/T 15486-1995 Calibration and testing laboratory accreditation systems—General requirements for operation and recognition

Publish Date: 1995-02-14

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

Publish Date: 1999-03-08

GB/T 15483.2-1999 Replaced

GB/T 15483.2-1999 Proficiency testing by interlaboratory comparisons—Part 2:Selection and use of proficiency testing schemes by laboratory accreditation bodies

Publish Date: 1999-03-08