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The origin of clinical laboratory quality control certification ISO17043

The origin of clinical laboratory quality control certification ISO17043, Total:23 items.

The international standard classification for "The origin of clinical laboratory quality control certification ISO17043" includes: Medical Sciences and health care facilities in general .

The Chinese standard classification for "The origin of clinical laboratory quality control certification ISO17043" includes: Sanitation in general .


Professional Standard - Hygiene

  • WS/T 250-2005 Requirements of Quality Assurance for Clinical Laboratories
  • WS/T 420-2013 Verification of analytical performance of quantitative kits by clinical laboratory

中华人民共和国国家卫生和计划生育委员会

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

  • GB/T 20470-2006 Requirements of external quality assessment for clinical laboratories
  • GB/T 20468-2006 Guideline for internal quality control for quantitative measurements in clinical laboratory

卫生健康委员会

  • WS/T 641-2018 Internal quality control for quantitative measurement in clinical laboratory

RU-GOST R

  • GOST R 53022.3-2008 Clinical laboratory technologies. Requirements of quality of clinical laboratory tests. Part 3. Assessment of laboratory tests clinical significance
  • GOST R 53079.2-2008 Medical laboratory technologies. Quality assurance of clinical laboratory tests. Part 2. Guidelines for improvements of quality in clinical-diagnostic laboratory. Typical model
  • GOST R 53022.4-2008 Medical laboratory technologies. Requirement of quality of clinical laboratory tests. Part 4. Rules for development of requirements to timeliness of laboratory information submitting
  • GOST R 53133.1-2008 Clinical laboratory technologies. Quality control of clinical laboratory tests. Part 1. Limits of allowable errors of the results of the analyte measurements in clinical-diagnostics laboratories
  • GOST R 53079.3-2008 Medical laboratory technologies. Quality assurance of clinical laboratory tests. Part 3. Rules for interaction between personnel of clinical departments and personnel of clinical-diagnostic laboratory in medical institutions during fulfillment of clinical
  • GOST R 53133.3-2008 Medical laboratory technologies. Quality control of clinical laboratory tests. Description of materials for quality control of clinical laboratory investigations

ASHRAE - American Society of Heating@ Refrigerating and Air-Conditioning Engineers@ Inc.

Korean Agency for Technology and Standards (KATS)

  • KS P ISO 15198:2006 Clinical laboratory medicine-In vitro diagnostic medical devices-Validation of user quality control procedures by the manufacturer
  • KS P ISO 15198:2017 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer

International Organization for Standardization (ISO)

  • ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer

KR-KS

  • KS P ISO 15198-2017 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
  • KS P ISO 15198-2017(2022) Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer

SCC

  • DANSK DS/ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer

British Standards Institution (BSI)

  • BS ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer

US-HHS

US-CLSI

  • CLSI C28-A3c-2008 Defining, Establishing, and Verifying Reference Intervals in the Clinical laboratory

Indonesia Standards

  • SNI ISO 15198:2009 Clinical laboratory medicine - In vitro diagnostic medical devices - validation of user quality control procedures by the manufacturer