Management Systems

ISO 15189: 2022

ISO 15189:2022 is the latest version of the international standard for quality and competence in medical laboratories. It was published in December 2022 and supersedes the previous version, ISO 15189:2012. This updated standard sets out the requirements for laboratories to ensure they are delivering reliable and accurate test results that contribute to effective patient care.

Scope:

Applies to all medical laboratories regardless of size, ownership, or type of testing performed.

Covers all aspects of laboratory operations, including management, technical processes, personnel competence, and quality management systems.

Key Changes From ISO 15189:2012:

  • Increased focus on risk management: Laboratories must identify and address potential risks that could impact the quality of their results.
  • Enhanced requirements for information management: Laboratories must have robust systems for managing data and records.
  • Greater emphasis on continuous improvement: Laboratories must demonstrate a commitment to ongoing improvement of their quality management systems.
  • Additional requirements for specific laboratory procedures: These include requirements for pre-examination, examination, and post-examination processes.

Benefits of Accreditation to ISO 15189:2022:

  • Demonstrates commitment to quality and competence
  • Improves patient safety and confidence in results
  • Enhances laboratory efficiency and effectiveness
  • Facilitates international recognition and cooperation

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