Excellent Healthcare Service: A structured approach through ISO 17025 Accredited Biomedical Laboratory 17 February 2016 Presented: Roziah Abdul Latiff

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

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

??? 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.

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

Related research in setting up BMCL Determinants of Customer Acceptance towards accredited MS ISO/IEC 17025 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

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 17025. In conclusion, this study has proposed the process flow as a guideline to develop the calibration of test equipment for calibration activities.

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.

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.

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

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

Flowchart of Work Process

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

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.

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