Understand The Technical And Management Requirements Of Iso 15189 For Medical Laboratories

By Author: john
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International quality guidelines for clinical and medical laboratories are outlined in ISO 15189. The standard established the criteria for quality management, technical procedures, and competency in medical laboratories in 2007 and will be updated again in 2022 with the most recent version. As a result, the ISO 15189:2022 standard fosters trust and superior quality in the analysis and result-generation processes used in medical laboratories.

While the ISO 17025 standard specifies criteria for testing and calibration laboratories, the ISO 9001 standard refers to requirements for quality management. The ISO 15189:2022 standard, on the other hand, is intended for medical laboratories, outlining the examination procedures and equipment needed to adhere to the standard and to deliver high-quality and dependable results.

The ISO 15189 standard underlines the importance of management committee participation while implementing a new quality management system. Naturally, before making any alterations or adaptations, one must study all of the requirements for putting in place the right procedures and processes to comply ...
... with the standard.

When a device maker contracts with a laboratory for testing of any kind, the process begins with what ISO 15189 refers to as a "service agreement." This is notably mentioned since customer (maker) expectations have a significant impact on defining quality or success; the process of confirming test results for one research may not work for another. The idea is that laboratory quality in medical research is determined by both the accuracy of data and the public view of the laboratory as high-quality, or in this case, competent.

One of the most important aspects of evaluating competency in medical laboratories is the staff. According to ISO 15189, all personnel within the organization must be fully involved and developed. The goal is continuous improvement, which translates to well-trained staff empowered by communicative and thorough supervisors in an ethical environment where test processes and findings can be confirmed in an ISO 15189-certified medical laboratory undertaking research and data reporting.

ISO 15189 emphasizes the need to establish a quality management system. To ensure quality, laboratories will need to develop repeatable processes for:
• ISO 15189 Documentation and Document Control
• Audits
• CAPAs
• Evaluation and Audits
• Nonconformity Occurrence Management

The management committee of the medical laboratory has a significant obligation and plays a crucial role in the planning, execution, and continual process improvement by offering the following:

• Adequate policy and management support
• The company's distribution duties and responsibilities
• All of the resources required to meet the standard
• Adequate training is necessary for the implementation of a QMS

It's natural to think of excellent laboratories as clean or sterile. This is a controlled atmosphere in which experiments are carried out without any bias being overlooked. In an ideal world, medical labs would function nearly as a vacuum, with the only things interacting with each other being the results of a well-designed test. However, that may be easier said than done because there are people involved as well as the tests in the lab. There are employees, technicians, and doctors, and each of these players, like all individuals, is capable of making mistakes. As a result, the technical side of ISO 15189 establishes a framework for analyzing every aspect of testing that may result in a problem.
ISO 15189 sets strict criteria for the environmental conditions under which samples are gathered and tested. Outlining equipment and reagents requires the same level of care, which includes verifying that the materials and machines utilized are both properly working and being used correctly. This brings us back to the need for people management and being up-to-date on training, competency evaluations, and audit schedules.

The emphasis of ISO 15189's technical requirement changes to precise sample collection and sample handling techniques once a test is underway. It focuses on the pre-examination process, such as collecting patient information and determining test eligibility, as well as how the sample will be collected, stored, and delivered. Finally, the technical requirements address the results evaluation methods as well as the process for reporting results to personnel or customers.
Medical Laboratories have to identify the following key technical requirements during ISO 15189 system implementation:

1. Nominate one person as Quality Manager for establishing, implementation and monitoring of effective implementation of the management requirements, and one person as Technical Manager for control, supervision and monitoring of the technical requirements,
2. Define the test parameters, range of detection, and limit of detection, % C.V. or MU,
3. Establishing quality assurance procedures and examination procedures, etc.