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GB/T 22576.3-2021: Medical laboratories - Requirements for quality and competence - Part 3: Requirements in the field of urine examination
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 22576.3-2021 | English | 259 |
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Medical laboratories - Requirements for quality and competence - Part 3: Requirements in the field of urine examination
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GB/T 22576.3-2021
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Basic data | Standard ID | GB/T 22576.3-2021 (GB/T22576.3-2021) | | Description (Translated English) | Medical laboratories - Requirements for quality and competence - Part 3: Requirements in the field of urine examination | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C30 | | Word Count Estimation | 14,154 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 22576.3-2021: Medical laboratories - Requirements for quality and competence - Part 3: Requirements in the field of urine 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 3.Requirements in the field of urine examination
ICS 03.120.10
CCSC30
National Standards of People's Republic of China
Requirements for the quality and competence of medical laboratories
Part 3.Requirements in the field of urine 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 Ⅰ
Introduction Ⅱ
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 4
5.4 Pre-inspection process 5
5.5 Inspection process 6
5.6 Assurance of the quality of inspection results 6
5.7 Post-inspection process 8
5.8 Results report 8
5.9 Results release 8
5.10 Laboratory Information Management 8
Appendix A (Normative) Morphological Recognition Requirements for Urine Test 9
Reference 10
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 3 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, Chinese People's Liberation Army General Hospital, Chinese Academy of Medical Sciences Peking Union Medical College
hospital.
The main drafters of this document. Deng Xinli, Hu Dongmei, Zhai Peijun, Zhou Yali, Li Junyan, Zhang Shimin, Cong Yulong.
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 number and names of the chapters and articles in GB/T 22576.1, which are relevant in the field of urine testing.
The requirements are given after the corresponding clauses.
Requirements for the quality and competence of medical laboratories
Part 3.Requirements in the field of urine testing
1 Scope
This document specifies the requirements for the quality and competence of medical laboratories in the field of general urine testing.
This document is applicable to medical laboratories that conduct urine formed component analysis, urine dry chemical analysis, and other qualitative testing of urine components.
Note. Refer to GB/T 22576.4 for the quantitative analysis of urine biochemical components, and GB/T 22576.5 for the requirements of urine immunological analysis, Urine microbiological examination
See GB/T 22576.6 for the requirements.
2 Normative references
The contents of the following documents in this document constitute an indispensable clause of this document through normative references in the text. Among them, dated
For referenced documents, only the version corresponding to the date is applicable to this document; for undated referenced documents, the latest version (including all amendments)
Applies to this document.
GB/T 22576.1-2018 Requirements for the quality and competence of medical laboratories
WS/T 348 Guidelines for collection and handling of urine specimens
WS/T 641 Clinical laboratory quantitative determination indoor quality control
YY/T 0996 Urine formed element analyzer (digital imaging automatic identification)
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 should 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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