GB/T 43449-2023Forensic sciences—Specifications for quality control in toxicology laboratory (English PDF)
法庭科学 毒物分析实验室质量控制规范
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
November 27, 2023
Implementation date
June 1, 2024
Scope
GB/T 43449-2023 is the English-translated version of 法庭科学 毒物分析实验室质量控制规范.
GB/T 43449-2023 sets out the quality control a forensic toxicology laboratory has to run.
It covers the resource requirements for personnel, facilities and environmental conditions, equipment and metrological traceability, and the process requirements covering acceptance of a commission, method selection, verification and validation, management of exhibits and samples, the examination itself, measurement uncertainty, assuring the validity of results, the report, and data control and information systems, followed by management system and safety clauses.
Its appendices give analytical instrument configuration and interim verification parameters, the normative method validation parameters and an uncertainty assessment method.
Among the standards it quotes are GB/T 27025-2019, GB/T 27417, GA/T 122, GA/T 1900 and JJF 1059.1. Issued on 27 November 2023, it has applied since 1 June 2024.
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Document preview — GB/T 43449-2023
National Standard of the People's Republic of China
- ICS
- 07.140
- Classification
- A 92
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- PrefaceI
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Resource Requirements
- 4.1 Personnel
- 4.2 Facilities and environmental conditions
- 4.3 Device
- 4.4 Metrological traceability
- 5 Process Requirements
- 5.1 Entrustment acceptance
- 5.2 Method selection, verification and validation
- 5.3 Inspection material and sample management
- 5.4 Inspection
- 5.5 Measurement uncertainty
- 5.6 Ensure the validity of results
- 5.7 Inspection report
- 5.8 Data control and information management system
- 6 Management system requirements
- 7 Safety requirements
- Appendix A (informative) Analytical instrument configuration and period verification related parameters
- Appendix B (Normative) Method Validation and Validation Parameters
- Appendix C (Informative) Uncertainty Assessment Method
- Reference
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents" Drafting.
1 Scope
This document specifies the resources, processes, management systems and safety requirements for quality control in toxicological analysis laboratories in the field of forensic science.
This document is applicable to quality control in toxicological analysis laboratories in the field of forensic science.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, the latest version (including all amendments) applies to this document. document.
GB/T 27025-2019 General requirements for testing and calibration laboratory capabilities
GB/T 27417 Guidelines for Validation and Validation of Chemical Analysis Methods for Conformity Assessment
GB/T 27420 Application Guide for the Evaluation and Expression of Measurement Uncertainty of Biological Samples for Conformity Assessment
GB/T 32464 Internal quality control in chemical analysis laboratories using control charts to verify and analyze the system
GA/T 122 Toxicological analysis terminology
GA/T 1900 General requirements for qualitative and quantitative testing methods for poisons and drugs in forensic biological materials
JJF1001 General measurement terms and definitions
JJF1059.1 Evaluation and expression of measurement uncertainty
3 Terms and definitions
The terms and definitions defined in JJF1001, JJF1059.1 and GA/T 122 apply to this document.
4 Resource requirements
4.1 Personnel
4.1.2 Appraisers should have at least the following qualities and abilities.
a) Have legal awareness, confidentiality awareness and professional ethics;
b) Master the inspection standards (methods) and technical performance of instruments and equipment used in this laboratory, and pass the assessment;
c) Receive training, supervision and assessment in technical methods, professional skills, etc., and keep records.
4.1.3 The appraiser should have the ability to perform quality control and ensure the validity of the results, and be responsible for the inspection report issued.
4.1.4 Appraisal assistant personnel should have corresponding job capabilities and assist the appraiser in completing various inspection tasks.
4.1.5 The laboratory should have a dedicated person responsible for technical management and develop administrative documents. The contents of the documents include but are not limited to the following:
a) Determine the scope of laboratory capabilities;
b) Develop laboratory technical documents and supervise their implementation;
4.1.1 Appraisal personnel include appraisers and appraisal assistants
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 27025-2019General requirements for the competence of testing and calibration laboratories
- GB/T 27417Conformity assessment—Guidance on validation and verification of chemical analytical methods
- GB/T 27420Conformity assessment—Application guide for evaluation and expression of uncertainty in biological sample measurement
- GB/T 32464Internal quality control for chemical analysis laboratories applying control graphic
- GA/T 1900Forensic Science General Requirements for Quantitative Inspection Methods of Toxic Substances and Drugs in Biological Materials
GA/T 122
Similar standards
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