Become Familiar With The Iso 15189 Quality Manual For Medical Laboratories Accreditation

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The achievement of accreditation by the International Standard Organization (ISO) 15189 in the world of laboratory medicine strengthens the hopes of laboratory professionals about the potential outcome of demonstrating the importance of their involvement in providing safe care and improved outcomes.

The International Standard ISO 15189 is the best for medical laboratory accreditation, comprising both administrative and technical standards for assessing employee competency. As a result, ISO 15189 accreditation ensures that the laboratory has been assessed against internationally recognized standards to demonstrate the existence of a quality system, and competence and that the personnel is capable of producing technically valid results and appropriate information for the intended use of each test. Each country has its national accreditation organization, which is in charge of issuing accreditation and follows ISO 17011, the International Standard for accreditation bodies.

An increasing number of medical laboratories are voluntarily pursuing certification, ensuring practice and professional competency by the Laboratory ...
... Best Practice principle, and enhancing confidence in laboratory testing among all stakeholders, including patients and doctors.

In the ISO 15189 documents, the ISO 15189 quality manual is the most crucial component. ISO 9000 defines it as a document that specifies an organization's quality management system. The quality manual is a framework of the ISO 15189 documentation structure document. This documentary structure is frequently depicted in the form of a pyramid, with the quality manual at the top and the records at the bottom. Every organization is free to create its own tailored document structure, including document types, identification, and quality manual form. As a result, a small business may find it suitable to provide a thorough explanation of its quality system, including all recorded procedures needed by the standard, in the quality handbook. On the contrary, large organizations may require a greater number of documentary layers, such as national procedures, local procedures, sectorial methods of operation, and maybe several quality manuals such as group quality manuals, site quality manuals, and so on.

A quality manual, according to ISO 15189 clause 4.2.2, shall outline the quality management system and its documentation structure. Supporting processes, including technical procedures, should be included or referred to in the quality manual. It should illustrate the quality management system's documentation structure. The quality manual should also cover the technical director's and quality manager's roles and responsibilities, including their responsibility for conformity with this international standard. The entire team should be trained in the use and application of the quality manual, the relevant documents, and all of the implementation requirements. Under the authority and responsibility of a quality manager selected by the laboratory's director, the quality manual should be kept up to date.

The following are examples of the tables of contents of an ISO 15189 quality manual for medical laboratories, so every quality manual must have this listed content in the manual documents:
• Overview
• Laboratory description, its legal status, resources, and main activities.
• Quality policy of ISO 15189.
• Records, conservation, and archiving.
• Facilities and environment.
• Instruments control reagents and/or appropriate consumables.
• Qualification and staff training.
• Quality assurance.
• Documents control.
• Analytical procedures validation.
• Environmental aspects for example conveyance, consumables, and waste disposal, in addition, and independently of bullets
• Quality controls (including inter-laboratory comparison).
• Laboratory’s information system.
• Results review.
• Remedial actions and processing of complaints.
• Research and development.
• Procedures and analytical methods list.
• Prescription protocols, primary samples removal, sample collection, and processing.
• Results validation.
• Interactions and other communications with customers, medical experts, subcontracting labs, and suppliers.
• ISO 15189 Internal audits.
• Ethics
• References

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