YY/T 1172-2010Medical laboratory quality management term (English PDF)

2.1 Quality

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]

2.2 Customer satisfaction

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]

2.3 Capacity

Organization, system or process to achieve the product and meet its requirements. [GB/T 19000-2008, Definitions 3.1.5]

2.4 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]

2.5 Qualified (conformity) conformity

Fulfil requirements. [GB/T 19000-2008, definition 3.6.1]

2.6 Unqualified nonconformity

Did not meet the requirements. [GB/T 19000-2008, definition 3.6.2]