GB/T 22576.3-2021

Active

Medical laboratories—Requirements for quality and competence—Part 3: Requirements in the field of urine examination

医学实验室 质量和能力的要求 第3部分：尿液检验领域的要求

Standard Type
GBT
ICS
03.120.10
CCS
C30
Status
Active
Issue Date
2021-05-21
Implementation
2022-06-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies quality and competence requirements specifically for medical laboratories performing urine examination, covering pre-examination, examination, and post-examination processes. It is applied in clinical laboratories within hospitals, diagnostic centers, and healthcare facilities to ensure accurate urinalysis results for disease screening, diagnosis, and monitoring. The standard aligns with ISO 15189 principles, providing a framework for laboratory accreditation and quality management in urine testing.

Related Standards

GB/T 2828.1-2012 Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection GB/T 19000-2008/ISO 9000:2005 Quality management systems - Fundamentals and vocabulary GB/T 19011-2013 Guidelines for auditing management systems GB/T 19004-2011 Managing for the sustained success of an organization — Quality management approach GB/T 2828.1-2003 Sampling procedures for inspection by attributes--Part 1: Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection GB/T 19022-2003 Measurement management systems--Requirements for measurement processes and measuring equipment GB/T 6379.1-2004 Accuracy(trueness and precision)of measurement methods and results--Part 1:General principles and definitions GB/T 6379.2-2004 Accuracy(trueness and precision)of measurement methods and results--Part 2:Basic method for the determination of repeatability and reproducibility of a standard measurement method
Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.