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Integration Management System
 
ISO9001:2015 Quality Management System

To ensure that the BTS provides efficient and effective services that are comparable to the best anywhere in the world, a decision was taken in 1997 to seek for ISO9002 Certification on quality management. This was achieved in March 1999. The BTS is among the pioneer group of blood centers worldwide to adopt ISO9002 quality management system (QMS) on blood collection, testing, processing, storage and distribution, and is the first blood center in this region to achieve this distinction.

 
In 2002, the BTS successfully upgraded from ISO9002:1994 to the more demanding ISO9001:2000 quality standard. In addition, compliance with the Code of Good Manufacturing Practice (cGMP) was achieved in the audit conducted by the Therapeutic goods Administration of Australia (TGA). The BTS’ constant faith and commitment to the pursuit of service excellence also achieved recognition by winning the Asian Hospital Management Award (The Special Award Category) in 2002.
 
 
 
In February 2009 and May 2018, the BTS had successfully obtained the ISO9001:2008 and ISO9001:2015 QMS certificates respectively after the recertification audit.

 

Quality Management System Certification
 
ISO15189:2012 Medical laboratories — Particular requirements for quality and competence
   
Medical Laboratory Management System Accreditation
 

 

 

 

To keep abreast with global trends and development in good laboratory practice and management, the BTS has decided to extend the scope of its Integrated Management System to encompass ISO15189:2003 requirements in 2015. In April 2007 the BTS’ Reference Laboratory was firstly awarded of ISO15189 accreditation certificate by HOKLAS. The Cord Blood Bank and other five laboratories were also accredited to ISO15189:2007 Standard in 2008, 2010 and 2012 to ensure effective implementation of the laboratory service.
 
The BTS has upgraded the System to ISO15189:2012 in 2015.

 

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