Since becoming the director of Clinical Research Center Tokyo in October 2017, I have consistently worked to further strengthen the quality management system, reviewing the QMS (Quality Management System) annual plan and by actively promoting the revision and establishment of new SOPs (Standard Operating Procedures).
Quality management is not a full-time job of a specific person, but the responsibility of all members of the organization. Our hospital has established nine committees related to quality, such as the Quality Control Committee, the Technical Management Committee, and the Education and Training Committee, and almost all staff members participate in at least one committee. We are striving to improve quality from all angles.
Furthermore, in February 2018, three employees acquired the ISO 15189 internal auditor qualification as a foundation for future ISO 15189 certification. They are expected to play a leading role in our quality control activities in the future.
The ICH E6 (R2) guideline has been agreed and a risk-based QMS is now required. Based on the demands of the times, in order to be an organization that constantly evolves and grows, we will continue to make efforts in the future. We look forward to your continued guidance and support.