Quality Assurance | Governance and Integrity | Taiwan Blood Services Foundation ESG
Governance and Integrity
Quality assurance
ISO 9001 Quality Assurance System established in 2001
TBSF has established the ISO quality assurance system and passed the ISO 9001 certification in 2001, and continues to obtain the UKAS certification. Currently, the version has been updated to the ISO 9001:2015.
Accredited institution for infectious disease testing since 2010.
The Laboratory Section of the Taipei and Kaohsiung Blood Centers was approved by the Centers for Disease Control and Prevention of the Ministry of Health and Welfare in 2010 as an "Accredited Institution for Infectious Disease Testing". Accredited tests include: confirmation of Human Immunodeficiency Virus Infection (HIV), Acute Hepatitis C, Syphilis, and HIV screening. The accredited tests are being updated on a yearly basis.
In 2023, the Technical Team of the Hsinchu Blood Donation Center was approved by the Ministry of Health and Welfare's Centers for Disease Control as an "Infectious Disease Testing Accreditation Institution." The accredited testing items include: dengue fever and severe special infectious pneumonia (complications).
Accredited ISO 15189 medical laboratory since 2012
We have introduced the relevant ISO 15189 medical laboratory specifications. TBSF’s blood consulting laboratory and the laboratory section of the Taipei and Kaohsiung Blood Centers were also accredited with ISO 15189 by the Taiwan Accreditation Foundation (TAF) in 2012 and listed as an accredited laboratory in the medical field. The accreditation continues to be renewed.
Passing the Food and Drug Administration's GMP assessment since 2012
Since 2007, the Foundation has commissioned the CSL plasma factory in Australia to produce plasma derived products. As the requirements for blood products and medicines are different, in 2012, TBSF’s blood center passed the GMP assessment for the preparation of plasma raw materials from the Food and Drug Administration, Ministry of Health and Welfare, and found that it was in line with the PIC/S GMP. TBSF continues to receive such assessment.
FDA-approved GDP assessment in 2018
We have introduced the Good Distribution Practice (GDP) to ensure that the correct drugs are delivered to the user within a reasonable time, trace the flow of drugs, and effectively handle emergency drug recalls. In 2018, TBSF passed GDP assessment by the Food and Drug Administration.
ISO 27001 : 2013 in 2022
Since December 2020, our organization initiated the ISO 27001 Information Security Management System implementation project. In 2021, we re-examined the standard operating procedures and their compliance with ISO 27001 and the "Information and Communication Security Management Act" regulations. In February 2022, we obtained the ISO 27001:2013 certification, and successfully passed the reassessment in 2023.
