It is assumed that different laboratories certified by ISO might not share the same technical requirements and may deliver varying levels of quality, even if the same tests are offered.
Pereira continues part 2 of a series on the ISO standards applicable to medical laboratories. The ISO is widely popular for laboratories, but many aspects are confusing, vague, and misunderstood. Pereira shows how to interpret the standard's requirements. Unfortunately ISO implementation is frequently accompanied by misunderstandings.
It will be divided into five parts: Part 1 - ISO Therefore, this essay is intended only to briefly discuss some specifications and to what is happening with ISO implementation in the world.
Customers, in this concept, are not only patients but any medical laboratory customers such as blood donors and athletes. For this purpose, the standard is based not only on a management system but also a set of medical laboratory technical specifications.
While the standard encourages the lab to implement sustainable practices, it is not mandatory. It quickly became a widely-accepted standard for accreditation of medical laboratories. When a medical laboratory chooses an accreditation plan, it should select an accrediting body which operates according to appropriate international standards and which takes into account the particular requirements of this field.
The framework provides a quality management system close to the ISO The standard quality management model is based on the Deming TQM approach   . Figure 1 displays a quality cycle applicable to a medical laboratory under ISO accreditation.
The leadership is critical to the success of all the cycle phases. This terminology is already revised in the current ISO edition 4. ISO technical requirements are applied for personnel, accommodation and environmental conditions, laboratory equipment, reagents, and consumables, pre-examination processes, examination processes, ensuring the quality of testing processes results, post-examination processes, reporting of results, the release of results, and laboratory information management.
Table 1 summarizes these stipulations. Summary of ISO specifications 5. Quality control procedures design to verify the attainment of the intended quality of results, quality control materials, quality control data, interlaboratory comparisons, analysis of interlaboratory comparison samples, evaluation of laboratory performance, and comparability of examination results.
Review of results, storage, retention, and disposal of clinical samples. Documented procedure, acceptance testing, instructions for use, calibration and metrological traceability, maintenance and repair, adverse indented reporting, and records. Documented procedure, reception and storage, acceptance testing, inventory management, instructions for use, adverse incident reporting, and records.
Report of examination results, the report attributes, and content. Documented procedures, automatic selection and reporting of results, and revised reports.
Authorities and responsibilities, and information system management. Measurement Precision random error analysis is also measured and verified.
Preferably, traceable metrological materials should be used. When these materials are not available, or its use is not significant to the estimate of accuracy, alternative materials could be used.
For a deeper discussion see . New tests are selected per its clinical purpose intended use. For instance, a screening test selection in a blood bank should assure that a method with a high diagnostic sensitivity  is chosen to minimize the residual risk 2.
ISO does not recommend any approach to select a new test. Usually, it is based on a literature review using validation cases of state-of-the-art methods.
All tests used without modification are verified using performance information data available from the manufacturer. The verification shall provide evidence that the laboratory performance claims have been met.
Therefore, the specifications, such as the allowable total error, diagnostic sensitivity, and diagnostic specificity are selected accordingly. The calculations are based on experimental data. ISO does not recommend a methodology to the measurement uncertainty evaluation, even though calcluating measurement uncertainty is required.Total Quality Management is an important task in organization’s processes.
Commitment, Communication, Control, Customer focus, Continuous improvement, and Cooperation are the six parts of TQM. Different Information Systems play a main role in improving TQM by reducing process time cycle, standardization, customer demands, and more precise.
Programme in Total Quality Management Qualification Code: The national quality policy focuses on quality of product (in which the SABS and many research institutions are active), quality or organisation (the area in which NPI and SABEF are active) and quality of life.
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ISO is a management system that creates to monitor the functions and data of an organization that works on monitoring basis to understand the proper balance required. It describes the functions and actions that have the minimum standard of quality systems.
Total Quality Management Total Quality Management (TQM) is a comprehensive and structured approach to organizational management that seeks to improve the quality of products and services through ongoing refinements in response to continuous feedback.