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YY/T 1172-2010

Chinese Standard: 'YY/T 1172-2010'
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YY/T 1172-2010English239 Add to Cart Days<=3 Medical laboratory quality management term Valid YY/T 1172-2010
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Standard ID YY/T 1172-2010 (YY/T1172-2010)
Description (Translated English) Medical laboratory quality management term
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 12,110
Date of Issue 2010-12-27
Date of Implementation 2012-06-01
Quoted Standard GB/T 19000-2008; GB/T 22576-2008
Drafting Organization People's Liberation Army General Hospital
Administrative Organization National Standardization Technical Committee of Medical clinical testing laboratories and in vitro diagnostic systems
Regulation (derived from) State Food and Drug Administration Notice 2010 No. 97
Proposing organization National laboratories and in vitro diagnostic medical systems Clinical Laboratory Standardization Technical Committee (SAC/TC 136)
Issuing agency(ies) China Food and Drug Administration
Summary This standard specifies the medical laboratory quality management terms and definitions. This standard applies to medical laboratory management.

YY/T 1172-2010
Medical laboratory quality management term
ICS 11.100
People's Republic of China Pharmaceutical Industry Standard
Medical laboratory quality management terminology
2010-12-27 release
2012-06-01 implementation
State Food and Drug Administration issued
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The release of this document
The Agency does not assume responsibility for identifying these patents.
This standard is proposed by the National Medical Clinical Laboratory Laboratory and the Standardization Technical Committee for In Vitro Diagnostic System (SAC/TC136)
Go back.
The drafting unit of this standard. General Hospital of People's Liberation Army, Beijing Medical Device Testing Institute.
The main drafters of this standard. Deng Xinli, Cong Yulong, Liu Yi, Liao Xiaoman, Du Haiou.
Medical laboratory quality management terminology
1 Scope
This standard specifies the terminology and definition of medical laboratory quality management.
This standard applies to medical laboratory management.
2 terms and definitions
The following terms and definitions apply to this document.
A set of inherent characteristics meet the requirements.
Note 1. The term "quality" may be modified using adjectives such as poor, good or excellent.
Note 2. "inherent" (whose antisense is "given") refers to what is inherent, especially the kind of permanent character.
[GB/T 19000-2008, Definitions 3.1.1]
Customer satisfaction customersatisfaction
The customer has a feeling of satisfaction.
Note 1. Customer complaints are the most common expression of low satisfaction, but no complaints do not necessarily mean that the customer is satisfied.
Note 2. Even if the customer requirements are in line with the wishes of the customer and are satisfied, the customer is not necessarily satisfied.
Note 3. Medical laboratory customers include patients, clinicians and so on.
[GB/T 19000-2008, Definitions 3.1.4]
Organization, system or process to achieve the product and meet its requirements.
[GB/T 19000-2008, Definitions 3.1.5]
Laboratory capacity
The material, environmental and information resources required for conducting the corresponding tests, as well as personnel, technical and professional knowledge.
Note. The assessment of laboratory competencies may include the results of previous inter-laboratory comparisons, external quality assessment programs or operational pilot verification programs, or
Complete the results to confirm the measurement uncertainty, the detection limit, and so on.
[GB/T 22576-2008, definition 3.5]
Qualified (conformity) conformity
Fulfil requirements.
[GB/T 19000-2008, definition 3.6.1]
Unqualified nonconformity
Did not meet the requirements.
[GB/T 19000-2008, definition 3.6.2]
Related standard: YY/T 1182-2020    YY/T 1173-2010
Related PDF sample: YY/T 1175-2010    YY/T 1176-2010