¼¯ÃÀÂ鶹

Quality Management in UMBI

By: Norshamsiah Hamim (Quality Manager N41)

The Quality Management Unit was established in 2007 and is spearheaded by the Head of Quality Management. The main focus in its early days was to undertake the process of laboratory accreditation for standard MS ISO/IEC 17025:2005 (Testing/Calibration Laboratory) and MS ISO 15189:2007 (Medical Laboratory). Currently, the quality management is led by the Head of Quality Assurance who is now in charge of planning, coordinating, implementing and monitoring all activities related to the Quality Management System (QMS) as a whole.

²¹)Ìý Certification and accreditation

 There are three accreditation standards that have been implemented in UMBI namely the MS ISO 9001:2008, MS ISO 15189:2007 (currently upgraded to version 2014) and MS ISO/IEC 17025:2005.

 The MS ISO 9001:2008 focuses on the processes involved in the post-graduate program ranging from the interview, the registration, the supervision, assessment of performance, submission of thesis and the viva examination. As with other accreditation standards, compliance to quality will ensure customer satisfaction. The post-graduate program in UMBI has received re-certification for standard MS ISO 9001:2008 on the 18^th January 2013 and will expire on the 17^th January 2016.

The MS ISO 15189:2007 (upgraded to version 2014 recently) is the main standard that define the requirements for quality management systems in medical laboratories. The laboratory accreditation in UMBI is for the Bioanalytical Laboratory (Haematology and Chemical Pathology) under The Malaysian Cohort Project Biobank. The laboratory has been granted accreditation on the 1^st November 2011 and has expired on the 1^st November 2014. Re-assessment for re-certification of accreditation has been conducted on the 13^th – 15^th October 2014.

 The MS ISO/IEC 17025:2005 is the main standard used for laboratories dealing with testing and calibration. The laboratory accredited in UMBI is the Genomic Laboratory [covering DNA extraction from Blood, polymerase chain reaction, gel electrophoresis, and DNA sequencing]. The laboratory has been granted accreditation on the 20^th March 2012 and will expire on the 20^th March 2015. Re-assessment for re-certification of accreditation is scheduled on the 22^nd – 23^rd January 2015.

The external organization which conducts the assessment for the certification of MS ISO 9001:2005 is SIRIM QAS International. For the certification of MS ISO 15189:2007 (upgrade to version 2014) and MS ISO/IEC 17025:2005 the assessment is conducted by Standards Malaysia. The secretariat of graduate program and accreditation will perform a self-assessment and internal audit at least once a year to ensure the system is implemented in accordance with established procedures.

b) Amalan 5S

The ¼¯ÃÀÂ鶹 Medical Centre approved the ‘5S PP¼¯ÃÀÂ鶹’ program on the 4th September 2006. A working committee was established on the 28th November 2006 followed by the appointment of the Malaysia Productivity Corporation (MPC) as the consultant on 29^th November 2006. PP¼¯ÃÀÂ鶹 received its first 5S certification on 20^th May 2010. The re-certification of the MPC is done every year. UMBI was involved the 5S activities from the 2^nd April 2007 with the launch of phase 1 ‘5S PP¼¯ÃÀÂ鶹’. UMBI has two 5S management zones 5S i.e. the administrative zone and the laboratory zone. One of the main activities is the ‘major spring cleaning’ held every last Friday of each month. All staff, research assistants and students are involved in this monthly activity.

c) Kumpulan Inovatif & Kreatif (KIK)

 The KIK refers to the innovative and creative group activity which has proven to be an effective mechanism to help realize the aspirations of the government to improve the efficiency and effectiveness of government agencies in delivering services to the people. The KIK UMBI was first established on the 10^th of October 2006. The group was named SENTROMER, which reflects the strong and solid relationship between the group members in UMBI. The KIK group in UMBI has successfully implemented two projects within the institute; (1) the inventory management system and (2) the research log book for post-graduate students.

d) Jawatankuasa Aduan dan Maklumbalas

This committee which deals with complaints and feedback was established on the 16^th of March, 2012. This committee is chaired by the Head of Quality Assurance and the members include 1 research fellow, 2 members of the management and 1 support staff. The committee is responsible for managing complaints and feedback from customers including those related to the scope of certification and laboratory accreditation. Complaints and feedback can be channeled using: (1) e-FACT system, (2) e-QUEST system, (3) Complaints Form, (4) e-mail/letters/Facebook and (5) phone calls.