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GB/T 22576.1-2018: Medical laboratories -- Requirements for quality and competence -- Part 1: General requirements
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Medical laboratories -- Requirements for quality and competence -- Part 1: General requirements
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Medical laboratories -- Particular requirements for quality and competence
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Basic data | Standard ID | GB/T 22576.1-2018 (GB/T22576.1-2018) | | Description (Translated English) | Medical laboratories -- Requirements for quality and competence -- Part 1: General requirements | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 03.120.10;11.100.01 | | Word Count Estimation | 50,528 | | Date of Issue | 2018-12-28 | | Date of Implementation | 2019-07-01 | | Older Standard (superseded by this standard) | GB/T 22576-2008 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 22576.1-2018: Medical laboratories -- Requirements for quality and competence -- Part 1: General requirements
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Medical laboratories--Requirements for quality and competence--Part 1. General requirements
ICS 03.120.10; 11.100.01
C30
National Standards of People's Republic of China
Replace GB/T 22576-2008
Medical laboratory quality and competence requirements
Part 1. General requirements
Part 1. Generalrequirements
(ISO 15189.2012, Medicallaboratories-Requirementsforqualityand
Competence, IDT)
Published on.2018-12-28
2019-07-01 implementation
State market supervision and administration
China National Standardization Administration issued
Content
Foreword III
Introduction V
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Management requirements 5
4.1 Organization and Management Responsibilities 5
4.2 Quality Management System 7
4.3 File Control 8
4.4 Service Agreement 9
4.5 Inspection by the entrusted laboratory 9
4.6 External Services and Supplies 10
4.7 Consulting Services 10
4.8 Resolution of complaints 10
4.9 Identification and control of non-compliance 10
4.10 Corrective Action 11
4.11 Preventive measures 11
4.12 Continuous Improvement 11
4.13 Record Control 11
4.14 Evaluation and review 12
4.15 Management Review 14
5 Technical requirements 15
5.1 Personnel 15
5.2 Facilities and environmental conditions 16
5.3 Laboratory equipment, reagents and consumables 17
5.4 Process before inspection 20
5.5 Inspection process 22
5.6 Quality assurance of inspection results 24
5.7 Post-test process 26
5.8 Results Report 26
5.9 Results released 27
5.10 Laboratory Information Management 28
Appendix A (informative) Relevance to ISO 9001.2008 and GB/T 27025-2008 30
Appendix B (informative appendix) This section is in contrast with the article number of GB/T 22576-2008
Reference 39
Foreword
The GB/T 22576 "Quality and Competency Requirements for Medical Laboratories" program consists of the following components.
--- 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 immunology;
--- Part 6. Requirements in the field of clinical microbiological testing;
--- Part 7. Requirements in the field of transfusion medicine;
--- Part 8. Requirements in the field of cytopathology;
--- Part 9. Requirements in the field of histopathological examination;
--- Part 10. Requirements in the field of molecular biology testing;
--- Part 11. Requirements for laboratory information systems.
This part is the first part of GB/T 22576.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces GB/T 22576-2008 "Special requirements for quality and capability of medical laboratories". And GB/T 22576-2008
In comparison, the main technical changes are as follows.
---Modified the standard name, delete the "dedicated" in the original name;
--- Revised the scope and expanded the use of the standard;
--- Added terminology. warning interval, automatic selection of results and report results, capabilities, documentation procedures, interlaboratory comparisons, discrepancies
Combined, bedside inspection, process, quality, quality indicators, quality policy, quality objectives, turnaround time, validation, verification (see Chapter 3);
--- Removed terminology. measurement accuracy, laboratory capability, measurement, quantity, traceability, measurement accuracy, measurement uncertainty;
--- Increased the "management commitment" and refined the duties of the "lab director" (see 4.1,.2008 edition 4.1);
---Modified the "Service Agreement" (see 4.4,.2008 edition 4.4);
--- Modified "Record Control" to increase the enumeration (see 4.13,.2008 version 4.13);
---Modified "assessment and review", and added "user feedback review", "risk management", "external agency review" and other content (see
4.14,.2008 edition 4.14);
--- Revised "laboratory equipment, reagents and consumables" to increase the management requirements for "reagents and consumables" (see 5.3,.2008 edition 5.3);
--- Modified the "pre-inspection process" and expanded the content (see 5.4,.2008 edition 5.4);
---Modified the "inspection process" and expanded the content (see 5.5,.2008 version 5.5);
--- Revised the "guarantee of the quality of inspection results" and expanded and refined the content (see 5.6,.2008 edition 5.6);
---Modified the "post-inspection process" and expanded the content (see 5.7,.2008 edition 5.7);
---Modified the "results report", splitting part of the content to form a "result release" (see 5.8, 5.9,.2008 edition 5.8);
--- Added "laboratory information management" (see 5.10);
--- Removed Appendix B "Recommendations for the Protection of Laboratory Information Systems" and Appendix C "Laboratory Medical Ethics", with some relevant content
Placed in the standard body;
--- Added a comparison of this part of Appendix B (informative appendix) with the previous version of the standard chapter.
This section uses the translation method equivalent to ISO 15189.2012 "Quality and Competence Requirements for Medical Laboratories".
The documents of our country that have a consistent correspondence with the international documents referenced in this part are as follows.
--- GB/T 20000.1-2014 Standardization work guide Part 1. General terms for standardization and related activities (ISO /IEC
Guide2.2004, MOD)
---GB/T 27000-2006 Conformity assessment vocabulary and general principles (ISO /IEC 17000.2004, IDT)
This section has made the following editorial changes.
--- To be consistent with the existing standard series, change the standard name to "Quality and Competence Requirements for Medical Laboratory Part 1. General
Claim".
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is under the jurisdiction of the National Medical Clinical Laboratory and the In vitro Diagnostic System Standardization Technical Committee (SAC/TC136).
This section drafted by. Beijing Medical Device Inspection Institute, China National Accreditation Center for Conformity Assessment, National Health and Family Planning Commission clinical examination
Center, General Hospital of the Chinese People's Liberation Army.
The main drafters of this section. He Xueying, Yan Peijun, Hu Dongmei, Chen Wenxiang, Guo Jian, Deng Xinli, Cong Yulong.
The previous versions of the standards replaced by this section are.
---GB/T 22576-2008.
Introduction
Based on GB/T 27025 and ISO 9001, this section proposes specific requirements for the capabilities and quality of medical laboratories 1). Public
It is well known that in this field, different countries have specific regulations or requirements for some or all professionals and their actions and responsibilities.
The service of the medical laboratory is necessary for the patient's health care, so it is necessary to satisfy all patients and the clinical person responsible for the patient's health care.
The needs of the staff. These services include acceptance of applications, patient preparation, patient identification, sample collection, shipping, preservation, processing and testing of clinical samples.
Interpretations, reports, and recommendations for results; in addition, consideration should be given to the safety and ethical issues of medical laboratory work.
As long as national laws and regulations and related standards require permission, the medical laboratory's services are expected to include diagnosis and patient management, including
Patients in the consultation cases were tested and actively involved in disease prevention. Each laboratory should provide appropriate education and research for its professionals.
opportunity.
This section applies to all disciplines currently recognized in the field of medical laboratory services; in other service areas and disciplines, such as clinical students
Similar work in science, medical imaging, and medical physics is also applicable. In addition, institutions that recognize the capabilities of medical laboratories can
Part of it is the basis of its work. If a laboratory seeks approval, it should first choose to operate according to ISO /IEC 17011 and consider medical practice.
The accreditation body for the special requirements of the laboratory.
This section is not intended for certification purposes, although the medical laboratory's compliance with the requirements of this section means that the laboratory is compliant with ongoing releases.
The technical capabilities and quality management system requirements necessary for the technical results. Chapter 4 management requirements in terms of medical laboratory operations
Expressed in words and in accordance with the principles of ISO 9001, consistent with its relevant requirements.
The full text of this section has environmental requirements related to medical laboratory activities, especially in 5.2.2, 5.2.6, 5.3, 5.4, 5.5.1.4 and
5.7.
1) In other languages, the equivalent term corresponding to the English "clinicallaboratories" may be used.
Medical laboratory quality and competence requirements
Part 1. General requirements
1 Scope
This part of GB/T 22576 specifies the requirements for the quality and competence of medical laboratories.
This section applies to medical laboratories to establish quality management systems and assess their own capabilities, as well as for laboratory customers, regulatory agencies and
The accreditation body recognizes or recognizes the capabilities of the medical laboratory.
Note. International, national or regional regulations or requirements may also apply to the specific content of this section.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 27025-2008 General requirements for testing and calibration laboratory capabilities (ISO /IEC 17025.2005, IDT)
ISO /IEC 17000 Conformity Assessment Vocabulary and General Principles (Conformityassessment-Vocabularyandgeneral
Principles)
ISO /IEC Guide 2 Standardization and related activities General vocabulary (Standardization and relatedactivities-General
Vocabulary)
ISO /IEC Guide 99 International and vocabulary basic and general concepts and related terms [Internationalvocabularyof
metrology-Basicandgeneralconceptsandassociatedterms(VIM)]
3 Terms and definitions
The following terms and definitions, as defined by ISO /IEC 17000, ISO /IEC Guide 2, and ISO /IEC Guide 99, apply to this document.
3.1
Accreditation accreditation
The process by which an authority gives formal recognition of an organization's ability to perform a specific job.
3.2
Warning interval alertinterval
Critical interval criticalinterval
The range of test results for a warning alert (critical) test indicating the patient's immediate risk of injury or death.
Note 1. This interval can be an open interval that only specifies one threshold.
Note 2. The laboratory develops a list of appropriate alert warning tests for its patients and users.
3.3
Automated selection and reporting of results automatedselectionandreportingofresults
Patient test results are sent to the laboratory information system and compared to the acceptance criteria specified by the laboratory, in the process, within the prescribed standards
The results are automatically entered into the patient report in the prescribed format without any additional intervention.
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