What are the Changes in the New ISO 15189:2022 Standard?

Through confidence in the quality and competence of medical laboratories, ISO 15189:2022- Medical Laboratories – Requirements for Quality and Competence seeks to enhance patient welfare and laboratory user satisfaction. Ten years later, technical updates have been made to ISO 15189.

The Medical Laboratory Quality and Competence Standard, ISO 15189 Medical laboratories must adhere to strict quality and competency standards, as outlined in ISO 15189:2022. The medical laboratory must follow this standard to plan and carry out corrective measures for risks and areas that could use improvement.

ISO 15189 is applying to medical laboratories in the process of building their management systems and evaluating their competency. It is also relevant to users, regulatory organizations, and ISO 15189 accreditation bodies that verify or acknowledge the proficiency of individual medical laboratories. Among the advantages of this standard’s methodology are:

  • Increasing the management system’s efficacy
  • Reducing the likelihood of inaccurate outcomes
  • Minimizing possible risks to patients, lab staff, the general public, and the environment

Changes in ISO 15189: 2022

The previous edition, ISO 15189:2012, is cancelled and replaced by ISO 15189:2022.

The principal modifications are as follows:

  • Conformity to ISO/IEC 17025:2017-Overall Standards for the Proficiency in Testing and Calibration. The management requirements are now found at the end of the document as a result of laboratories.
  • The scope of ISO 22870:2016 has expanded to include requirements for point-of-care testing (POCT), which have been added.
  • A stronger focus on risk management

Quality Management Changes

The quality management section of ISO 15189:2022 has a more precise. It indicates that the laboratory’s internal or external staff members are in charge of the management system, which includes reporting on any areas that require improvement, spotting irregularities, and guaranteeing the efficiency of laboratory operations. ISO 15189:2012 identified a quality management system that concentrated on laboratory processes, including their sequencing, operations, and evaluation, as opposed to personnel.

A significant change in the new ISO 15189 standard is the focus on risk management within the laboratory’s Quality Management. Here is what risk management in ISO 15189 includes:

  • Risk management in ISO 15189:2022 consists of the following: To identify patient safety hazards and possibilities for better patient care related to its examinations and activities, laboratory management must develop, implement, and maintain procedures. Then, it must create plans to address these risks and opportunities.
  • The head of the laboratory will make sure that these procedures are assessed for efficacy and adjusted if they prove to be inefficient.

The Equipment Updates

To ensure proper functioning and prevent contamination or deterioration, ISO 15189 outlines procedures for the selection, procurement, installation, acceptance testing (including acceptability criteria), handling, transport, storage, use, maintenance, and decommissioning of laboratory equipment. Equipment-related risk management practices are emphasized in ISO 15189:2022. These precautions include putting in place processes for reporting bad incidents to any manufacturer’s recall and making sure the laboratory has the right safeguards in place to prevent accidental adjustments of equipment that could invalidate examination results. Furthermore, the following new standard makes particular reference to “Equipment Requirements

  • The laboratory has access to equipment needed for the correct performance of laboratory activities
  • Where the equipment is used outside the laboratory’s permanent control, or equipment production functional requirements, the laboratory Management shall ensure the requirements of this ISO 15189 document are met.
  • A register must be kept for each piece of equipment that has the potential to affect laboratory operations. Each item must be uniquely labelled, marked, or otherwise identified.
  • To guarantee the calibre of test results, the laboratory will replace and maintain its equipment as needed.

Management Changes

The new ISO 15189 document categorized general requirements of management system documentation with the following subsections: ready to use ISO 15189 documents, personnel access, commitment, competency and quality, amendments of records and retention of records. Another important update to ISO 15189:2012 said that the laboratory must create and maintain a quality manual, however, ISO 15189:2022 says that the management system documents may be included in a quality manual but are not required to.

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