1. Excellent Healthcare Service: A structured approach through ISO Accredited Biomedical Laboratory
17 February 2016
Presented:
Roziah Abdul Latiff

2. Scope Of Presentation 2.0 Setting Up Accreditation
1.0 Introduction
2.0 Setting Up Accreditation
Biomedical Calibration Laboratory
3.0 Flow Chart Of Work Process
4.0 Accreditation Flow Chart
5.0 Conclusion

3. INTRODUCTION
COT
2010 – Set up Centre of Excellence in Technology for the field of Medical Electronic known as Centre for Medical Electronic Technolgy (CMET)
Vision
To emerge as the Centre of Excellence and achieving the highest standards in Medical Electronics for the nation
Mission
Transforming CMET as the leader in Technical Vocational Education and Training

4. ??? ACCREDITED BIOMEDICAL LABORATORY IS NEEDED
* Medical equipment requires corroboration and must comply with the specifications and safety regulations prior usage in healthcare facilities
*Department of Standards Malaysia (2013) stated that an accredited medical equipment calibration laboratory is indeed vital in the healthcare quality system environment.
*This International Standard is applicable to all laboratories regardless of the extent of the scope of testing and calibration activities
*This shows that excellent health service is achievable by accreditation of biomedical laboratory.

5. ISO 17025 Management requirements
* The main standard used by testing and calibration laboratory. 2 main sections are:
Management requirements
Related to the operation & effectiveness of the quality management system
Technical requirements
Factors that determine the correctness & reliability of the tests & calibration performed

6. Related research in setting up BMCL
Determinants of Customer Acceptance towards accredited MS ISO/IEC Biomedical Calibration Laboratory (BMCL)
To identify characteristics affecting laboratory customers’ acceptance related to accredited calibration laboratories by ISO / IEC 17025
Quantitative method, conducted on 220 respondents from government infirmaries, private and biomedical industries
The results showed significant relationship with the level of customer acceptance of the biomedical industry for calibration laboratory accredited of safety, professionalism, reliability of equipment and calibration method

7. Related research in setting up BMCL
Developing Process Flow to Establish Measurement Traceability for Biomedical Testing equipment : Patient Simulator
To develop process flow in establishing measurement traceability of testing equipment in biomedical calibration laboratory
This study is the outlined process to go through to develop the calibration procedure and technical requirements that to be fulfilled as figure traceability of testing and calibration equipment calibration uncertainty table towards laboratory accreditation ISO / IEC
In conclusion, this study has proposed the process flow as a guideline to develop the calibration of test equipment for calibration activities.

8. Related research in setting up BMCL
Establishing Quality System In Accredited Biomedical Calibration Laboratory (BMCL).
The study is conducted for obtaining information about the factors to be considered for setting up and running a biomedical calibration laboratory
Physical condition :
- Operate in a safe condition
-Calibration equipment must function properly.
- Laboratory environment
- The equipment must be adequate and well maintain
Reliability - each calibration laboratories need to have certificates of accreditation and certification standards body governing the use of electronic equipment. It should also keep records of a tool properly and systematically, the software must be updated and verified, and the need to adopt a quality management system.
Responsiveness - each calibration laboratory must provide efficient and safe delivery service.
This qualitative study used interviews and focus groups to collect data
Assurance - each Calibration laboratory must have sufficient numbers of staff, experienced, and qualified personnel. The laboratory also requires appropriate calibration method or procedure, systematic record keeping and client confidentiality as the consumers’ rights.
Empathy -Each Empathy laboratory must attach great importance to the quality of services to satisfy customers need and build partnerships with clients.

9. Related research in setting up BMCL
Establishing Quality System In Accredited Biomedical Calibration Laboratory (BMCL).
The study is conducted for obtaining information about the factors to be considered for setting up and running a biomedical calibration laboratory
Physical condition :
- Operate in a safe condition
-Calibration equipment must function properly.
- Laboratory environment
- The equipment must be adequate and well maintain
Reliability - each calibration laboratories need to have certificates of accreditation and certification standards body governing the use of electronic equipment. It should also keep records of a tool properly and systematically, the software must be updated and verified, and the need to adopt a quality management system.
Responsiveness - each calibration laboratory must provide efficient and safe delivery service.
This qualitative study used interviews and focus groups to collect data
Assurance - each Calibration laboratory must have sufficient numbers of staff, experienced, and qualified personnel. The laboratory also requires appropriate calibration method or procedure, systematic record keeping and client confidentiality as the consumers’ rights.
Empathy -Each Empathy laboratory must attach great importance to the quality of services to satisfy customers need and build partnerships with clients.

10. Branding CMET as calibration of electronic medical center and as a hub of research and development in biomedical
General Criteria
Recognized certification & accreditation
Efficient service
One stop centre
Business entity
Promotions
More promotional activities
Additional staff for promoting
Outreach program
Signage & signboard at strategic location
Collabora
tion
Seriously collaborate with industries & institutions in niche areaIn managing staff
Complement each others in providing service to customersFinancial requirements
Autonomy
In managing staff
Financial requirements

11. Commitment of the top management Review structure
Branding CMET as calibration of electronic medical center and as a hub of research and development in biomedical
Management
Commitment of the top management
Review structure
Support and cooperation of all departments
Human Resource
Allocated adequate staff & equipment for operation
Number of technician to be added
Staff from various department
Proper training to ensure effectiveness
Research
Scope must be broad & multidisciplinary
Based on the needs of industries & communities
Collaborative research
Flexible time table for CoT lecturers
Improved skill in research grant proposal
Accredited Training
Mandated to be accredited training
Train and issue certificates of competence in calibration

12. Flowchart of Work Process

13. MS ISO/IEC 17025 Accreditation Flow Chart (Source: DSM)

14. Conclusion
The first to be an accredited biomedical laboratory recognised by the Department of Standards to calibrate medical equipments in infirmaries as it met the international standards.
Setting up Biomedical Calibration Laboratory, it addresses the critical areas to ensure the quality and safety of the medical equipment
Enable the biomedical industry in the country to grow rapidly in providing better quality technical services to patients and the community
Guidelines or flowchart of work process discussed in this paper can be used by any healthcare industries to establish the traceability of the medical devices
This technical service can also be offered to healthcare industries locally and internationally.

15. Thank you