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GB/T 22576.4-2021: Medical laboratories - Requirements for quality and competence - Part 4: Requirements in the field of clinical chemistry examination
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Medical laboratories - Requirements for quality and competence - Part 4: Requirements in the field of clinical chemistry examination
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GB/T 22576.4-2021
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Basic data | Standard ID | GB/T 22576.4-2021 (GB/T22576.4-2021) | | Description (Translated English) | Medical laboratories - Requirements for quality and competence - Part 4: Requirements in the field of clinical chemistry examination | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C30 | | Word Count Estimation | 14,137 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 22576.4-2021: Medical laboratories - Requirements for quality and competence - Part 4: Requirements in the field of clinical chemistry examination
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Medical laboratories-Requirements for quality and competence-Part 4.Requirements in the field of clinical chemistry examination
ICS 03.120.10
CCSC30
National Standards of People's Republic of China
Requirements for the quality and competence of medical laboratories
Part 4.Requirements in the field of clinical chemistry testing
Released on 2021-05-21
2022-06-01 implementation
State Administration of Market Supervision and Administration
Issued by the National Standardization Management Committee
Table of contents
Foreword Ⅲ
Introduction Ⅳ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Management requirements 1
4.1 Organization and Management Responsibilities1
4.2 Quality Management System 1
4.3 Document Control 1
4.4 Service Agreement 1
4.5 Inspection by the entrusted laboratory 1
4.6 External services and supplies 2
4.7 Consulting Service 2
4.8 Resolution of complaints 2
4.9 Identification and control of nonconformities 2
4.10 Corrective action 2
4.11 Preventive measures 2
4.12 Continuous improvement 2
4.13 Record Control 2
4.14 Evaluation and audit 2
4.15 Management Review 2
5 Technical requirements 2
5.1 Personnel 2
5.2 Facilities and environmental conditions 3
5.3 Laboratory equipment, reagents and consumables 3
5.4 Pre-inspection process 4
5.5 Inspection process 4
5.6 Assurance of the quality of inspection results 5
5.7 Post-inspection process 6
5.8 Results report 6
5.9 Results release 7
5.10 Laboratory Information Management 7
Reference 8
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
This document is part 4 of GB/T 22576 "Requirements for the Quality and Capability of Medical Laboratories". This document and GB/T 22576.1
Cooperate and use together.
GB/T 22576 has released the following parts.
---Part 1.General requirements;
---Part 2.Requirements in the field of clinical hematology testing;
---Part 3.Requirements in the field of urine testing;
---Part 4.Requirements in the field of clinical chemistry testing;
---Part 5.Requirements in the field of clinical immunological testing;
---Part 6.Requirements in the field of clinical microbiology testing;
---Part 7.Requirements in the field of blood transfusion medicine.
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying patents.
This document was proposed by the State Drug Administration.
This document is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
Drafting organizations of this document. China National Accreditation Center for Conformity Assessment, Beijing Hospital, Chinese People's Liberation Army 302 Hospital, Chinese Medicine
Academy of Sciences Peking Union Medical College Hospital.
The main drafters of this document. Guo Jian, Li Junyan, Zhai Peijun, Hu Dongmei, Zhou Yali, Mao Yuanli, Qiu Ling.
Introduction
The services of medical laboratories are necessary for patient healthcare, so it is necessary to satisfy all patients and clinical personnel responsible for patient healthcare.
The needs of the staff. These services include application acceptance, patient preparation, patient identification, sample collection, transportation, storage, clinical sample processing and inspection
And the interpretation of the results, reports and recommendations; in addition, the safety and ethical issues of medical laboratory work must also be considered.
As long as national laws and regulations and relevant standards require permission, it is expected that the services of medical laboratories include diagnosis and patient management, as well as
Examination of patients in consultations and active participation in disease prevention. Each laboratory should provide its professionals with appropriate educational and scientific research
opportunity.
GB/T 22576 stipulates the capabilities and quality of medical laboratories in all disciplines in the currently recognized medical laboratory service field.
The requirements are to be composed of 11 parts.
---Part 1.General requirements. The purpose is to specify general requirements for the quality and competence of medical laboratories.
---Part 2.Requirements in the field of clinical hematology testing. The purpose is to regulate the quality and capacity of medical laboratories for clinical hematology
Specific requirements in the inspection field.
---Part 3.Requirements in the field of urine testing. The purpose is to regulate the quality and capacity of medical laboratories in the field of clinical urine testing
Specific requirements.
---Part 4.Requirements in the field of clinical chemistry testing. The purpose is to regulate the quality and capability of medical laboratories for clinical chemistry testing
The specific requirements of the field.
---Part 5.Requirements in the field of clinical immunology testing. The purpose is to regulate the quality and capacity of medical laboratories for clinical immunology
Specific requirements in the inspection field.
---Part 6.Requirements in the field of clinical microbiology testing. The purpose is to stipulate that the quality and capacity of medical laboratories are important for clinical microbiology.
Specific requirements in the field of physical inspection.
---Part 7.Requirements in the field of blood transfusion medicine. The purpose is to stipulate that the quality and capacity of medical laboratories are important for the field of blood transfusion medicine.
Body requirements.
---Part 8.Requirements for laboratory information systems. The purpose is to regulate the quality and capability of medical laboratories to the laboratory information system
Specific requirements.
---Part 9.Requirements in the field of molecular diagnostics. The purpose is to stipulate that the quality and capabilities of medical laboratories are important for the field of molecular diagnostics.
Body requirements.
---Part 10.Requirements in the field of cytopathological examination. The purpose is to regulate the quality and capacity of medical laboratories for cytopathology
Check the specific requirements of the field.
---Part 11.Requirements in the field of histopathology examination. The purpose is to regulate the quality and capacity of medical laboratories for histopathology
Check the specific requirements of the field.
The numbers and names of the chapters and articles of this document adopt the chapter and article numbers and names of GB/T 22576.1, which are relevant in the field of clinical chemistry testing.
The specific requirements are given after the corresponding clauses.
Requirements for the quality and competence of medical laboratories
Part 4.Requirements in the field of clinical chemistry testing
1 Scope
This document specifies the requirements for the quality and competence of medical laboratories in the field of clinical chemistry testing.
This document applies to medical laboratories that carry out clinical chemistry tests, as well as medical laboratories that carry out clinical immunological quantitative tests.
2 Normative references
The contents of the following documents constitute the indispensable clauses of this document through normative references in the text. Among them, dated quotations
Only the version corresponding to that date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
This document.
GB/T 21415 Metrology traceability for measurement of calibrator and control substance assignment in biological samples of in vitro diagnostic medical devices
Origin
GB/T 22576.1-2018 Requirements for the quality and competence of medical laboratories Part 1.General requirements
WS/T 403 Analytical Quality Index of Routine Items of Clinical Biochemistry Test
WS/T 407 Guidelines for the Comparability Verification of Quantitative Test Results in Medical Institutions
3 Terms and definitions
The terms and definitions defined in GB/T 22576.1-2018 apply to this document.
4 Management requirements
4.1 Organization and management responsibilities
It shall meet the requirements of 4.1 in GB/T 22576.1-2018.
4.2 Quality Management System
It shall meet the requirements of 4.2 in GB/T 22576.1-2018.
4.3 Document control
It should meet the requirements of 4.3 in GB/T 22576.1-2018.
4.4 Service Agreement
It should meet the requirements of 4.4 in GB/T 22576.1-2018.
4.5 Inspection by the commissioned laboratory
It should meet the requirements of 4.5 in GB/T 22576.1-2018.
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