To help achieve this, BSI has developed BS EN ISO 15189:2022+A11:2023 Medical laboratories - Requirements for quality and competence which specifies the needs for quality and competence within medical laboratories.
The A11:2023 amendment introduces several key updates to the 2022 version, enhancing its alignment with current regulatory frameworks and technological advancements. This amendment places a stronger emphasis on risk management, patient safety, and data integrity, addressing the evolving landscape of medical diagnostics.
Additionally, it encourages labs to adopt a systematic approach to continual improvement, focusing on optimizing workflows and reducing potential sources of error. With these refinements, the updated standard reinforces laboratory excellence, providing a framework for labs to meet accreditation requirements and maintain a high standard of care.
Since it was first published in 2003, the International Standard BS EN ISO 15189:2022+A11:2023 for quality and competence, has raised awareness of the importance of medical laboratories with governments throughout the world.
The standard, which has been developed with strong involvement from the medical, scientific, and clinical community, is for use by medical laboratories in developing their management systems and maintaining their competence. It has been used increasingly by medical laboratories to develop their quality management systems (QMS) and to assess their own competence.
The globally recognized standard has moved on from its predecessor, recognizing the excellence required at every touch-point of medical laboratories starting with the advice to clinicians, collection, transport, reception, and examination of samples and finishing with their reporting and interpretation.
This International Standard can be applied by medical laboratories to develop their quality management systems whilst assessing their own competence. It can also be used for recognizing the proficiency of medical laboratories by customers and regulating authorities.
BS EN ISO 15189:2022+A11:2023 is intended for use throughout the currently recognized disciplines of medical laboratory services, those working in other services and disciplines such as clinical physiology, medical imaging, and medical physics may also find it useful.
Medical laboratories that adopt the standard will benefit from industry-wide recognition that the latest best practice principles underpin their performance. BS EN ISO 15189:2022+A11:2023 is closely aligned to the requirements for testing and calibration laboratories BS EN ISO/IEC 17025 and the widely respected quality management standard BS EN ISO 9001. This makes it an attractive option for medical laboratories operating in the fields of clinical chemistry, microbiology, biochemistry, and other areas of pathology as well as those bodies involved in their assessment.
In addition, bodies engaged in the recognition of the competence of medical laboratories will be able to use this International Standard as the basis for their activities.
A medical laboratory’s fulfillment of the requirements of this International Standard means the laboratory meets both the technical competence requirements and the management system requirements that are necessary for it to consistently deliver technically valid results.
The standard offers insight into the arrangements for:
Examination requests.
Patient preparation & identification.
Collection of samples.
Transportation storage.
Safety & ethics in medical laboratory work.
It is acknowledged that a country could have its own specific regulations or requirements applicable to some or all its professional personnel and their activities and responsibilities in this domain.
Improve the performance of your clinical laboratory by adding standard BS EN ISO 15189:2022+A11:2023 to your collection today.
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