The structure and contents of ISO 15189 follow that of any ISO document. In particular, it contains both normative and informative elements. The normative
Table 2 Main differences between ISO/IEC 17G25 and ISO 151S9
Test and calibration
1. Patient preparation
2. Sample volume
5. Measurement uncertainty
6. Turnaround time
7. Clinical advice
Important issue Essential for particular tests Limited, mainly in particular patients (children, neonates, etc.) Methods are adapted to sample size In vitro diagnostics and developed ''in house''
Results used for patient care and subjected to three (technical, biological, and nosological) validation levels Related to analytical and biological quality specifications Extremely important Appropriateness of test request. Interpretation of results Increasingly important
Sample size adapted to the method
Methods standardized according to national and international standards
Pure analytical results and related measurement uncertainty
Related to analytical quality specifications Not relevant Not relevant
Limited to ''state-of-the-art'' measurement elements describe the scope of the standard and set out its provisions that can be expressed as requirements, recommendations, or statements. Informative elements can be preliminary or supplementary. Preliminary elements are those that identify the document, introduce its content, and explain its background, its development, and its relationship with other documents. Supplementary elements provide information intended to assist with the understanding or use of the document. In the introduction, some essential concepts are explained. Firstly, it declares that laboratory services ''include arrangements for requisition, patient preparation, patient identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent validation, interpretation, reporting and advice, in addition to the considerations of safety and ethics in medical laboratory work.'' A second important statement is that a second edition of the standard is anticipated, aimed at more closely aligning it with a second edition of ISO/IEC 17025 and with ISO 9001:2000. This emphasizes well the view of accreditation as a dynamic process and the nature of standards as ''a changing world.'' Scope, normative references, and terms and definition are described in
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