One of the key standards for the medical laboratory sector is currently undergoing a revision.
ISO DIS 15189 – Medical Laboratories – Requirements for quality and competence
This standard specifies requirements for quality and competence in medical laboratories. The objective is to promote the welfare of patients and to provide confidence in the competence of the people that work in medical labs and systems used to ensure quality of service.
The focus is very much on patient safety and confidentiality and to support this the standard requires processes to be implemented to address topics such as treatment of samples with care and respect, maintaining integrity of retained samples and records, providing patients & users with information about the examination process, costs and when to expect results, obtaining informed consent, upholding the rights of patients to equitable care etc.
A management system is required to ensure objectives and policies are in place to ensure the needs of patients and users are met and that good professional practice is in place. Risk management processes are also required to identify risks of harm to patients and laboratories must develop actions to address any identified risks. Qualification, competence and training of laboratory personnel also forms part of the standard.
This standard is being revised to align with ISO/IEC 17025:2017 – General requirements for the competence of testing and calibration laboratories. The new draft included a comparison of ISO 15189:2012 in Annex B which will be a useful check for labs that are using the 2012 version.
This Draft or DIS standard is currently available on the NSAI draft standard portal – Your Standard Your Say – below
The deadline for reviewing the draft and submitting comments is December 12th, 2021.