Elevating the Reliability of Clinical Testing to Global Standards!

The Japanese Standards Association (Headquarters: Minato-ku, Tokyo; President: Hiroshi Asahi) published the Japanese Industrial Standard (hereafter referred to as JIS) for "Medical laboratories - Requirements for quality and competence" on March 25, 2026.

JIS Q 15189 was formulated based on the international standard ISO 15189:2022, aiming to standardize clinical testing and improve the quality of healthcare in Japan.

JIS Q 15189:2026 Medical laboratories-Requirements for quality and competence Price including tax: 12,320 yen, A4 size, 94 pages

[Background of Establishment] In Japan, the "international standard test management addition*" was newly established during the medical fee revision in fiscal 2016. Along with this, the number of clinical laboratories acquiring certification based on ISO 15189 is increasing, but until now, a bilingual version containing simplified translations has been the main point of reference. Moving forward, to deepen the understanding of requirements including highly advanced tests such as genetic testing systems, and to promote the widespread introduction of Quality Management Systems (QMS) from university hospitals to relatively small facilities, there was a strong demand for the establishment of a JIS based on international standards.

*Medical remuneration that can be added when a clinical laboratory has acquired certification proving it meets the criteria of the international standard ISO 15189.

[Main Provisions] The following items are described in this standard:

1. Requirements for Organizational Structure and Governance: The establishment of a management system that prioritizes the clinical laboratory's legal responsibilities, ethics, and patient benefits is required.

2. Resource Requirements: Management of "people, facilities, and equipment" that influence the quality of testing is required. Specifically, this includes staff competence evaluation, maintenance of appropriate environmental conditions, and maintenance/inspection of analytical equipment.