A new JCCLS standard on Molecular Methods, English version, is available and uploaded

An Approved Guideline for the Quality Management of Specimens for Molecular Methods: The Procurement, Transport, and Preparation of Specimens” This document provides guidance for addressing molecular diagnostic methods used in routine medical laboratories worldwide.

An Approved Guideline fo

An Approved GuideLine for Quality Management of Specimens for Molecular Methods
New Technologies and Sample Quality Control (See manual_part2 )

ISO 15189 Application Guidance Document for Molecular-Genetic Examination

It is useful to develop ISO 15189 application guidance on molecular-genetic tests for medical laboratories. Namely, the merits for medical laboratories include the implementation and improvement of quality management system and technical management system.

As mentioned above, this guidance document is useful for quality improvement of medical laboratories performing molecular-genetic examinations. Consequently, we sincerely hope that this guidance document will contribute to the promotion of high-quality practice of genome-based medicine through appropriate medical laboratory service. To use this guidance document as a supplement teaching aid in ISO 15189 Accreditation Support Course of the Training Program, as part of AMED Asian Cancer Clinical Trials Network (ATLAS) Project, the Japanese version was translated to English and edited in research project from FY 2020 to FY 2021.


This document was described by the cooperation of the listed members

Reference Standard-JSCC Enzyme, the JCCLS-CRM (JCCLS-Certified Reference Standard for Enzyme of JSCC method), can be purchased from JCCLS

  1. Standardization for enzymes in Japan are successful enough to converge within approximately 3% of CVs between laboratories, which is owing to the establishment of traceability chain with the JCCLS-CRM, a certified reference standard for enzymes, being composed of human recombinant enzymes.
  2. Reference measurement procedures (RMP) of enzymes in Japan (JSCC consensus method) are not always the same with IFCC RMP. Catalytic activities of 7 kinds of enzymes on the JCCLS CRM were measured by IFCC RMP in an accredited laboratory and compared with those of JSCC method (in detail, see PDF A and PDF B ).
  3. We received Rerence Material Producer Accreditation Certificate on March 29, 2013, and the JCCLS-CRM is produced under this certificate. This certificate is based on ISO guide 34:2009, and ISO 17025 regarding assignment of property values (see PDF C ).
  4. If you wish to purchase the JCCLS-CRM, please feel free to contact us as indicated below:

Japanese Committee for Clinical Laboratory Standards (JCCLS)

Email Address: jccls2@jccls.org

Mailing Address:

2-7-13 Uchikanda Chiyoda-ku,Tokyo 101-0047 , JAPAN

Phone Numbers:

TEL: +81-3-6206-9746

FAX: +81-3-6206-9747