> MS ISO 9001:2000 - IMR
INTRODUCTION – MS ISO 9000
The Institute for Medical Research was awarded the MS ISO 9001:1994 certificate in March 2002. The certification ceremony was officiated by Y.B. Datuk Douglas Unggah Emba, the Deputy Minister in the Prime Minister's Department on 7 th May 2002 . The initial plans for the implementation of MS ISO 9001 started in 1998. A Quality Management Representative was nominated in 1999 to coordinate the activities of the Implementation Team (JKPP) during the process of documentation and implementation of the MS ISO 9000 in the IMR. Based on the advice of the Consultants (MAMPU) in May 2002, the IMR revised the MS ISO 9001:1994 document to the current MS ISO 9001:2000 standard. The documentation process was audited and the IMR received the MS ISO 9001:2000 certificate from the Certification Body (SIRIM-Private Limited) in August 2003. The MS ISO 9001 documentation process includes the following documents:
SCOPE FOR IMPLEMENTATION
The IMR has implemented the quality system for HEALTH RESEARCH, which is based on the requirements of the MS ISO 9001:2000 standard. IMR POLICY FOR QUALITY
The IMR Policy for Quality is as follows: • The IMR is committed to produce health research of quality, which will be reflected in client satisfaction and organisational excellence through a Quality Management System, where there is continual improvement as required by the ISO 9001:2000 Standard. • The IMR is committed to achieve the objectives of quality, which has been defined and which will be reviewed from time to time, in line with the organisation's mission . • The management will ensure that the policy is understood by all and is practiced by the staff of the IMR. QUALITY OBJECTIVES
In order to produce health research of quality in the IMR, the following objectives should be attained: • At least 80% of the research projects that have been approved are carried out using the budget allocated within the stipulated time. • At least one scientific write-up is produced within 12 months and there must be one scientific publication in a refereed journal for each completed research project. • At least one presentation is made in the duration of the research or within 12 months after completion of the research project. • Each Researcher and Medical Laboratory Technologist involved in research is required to accumulate a minimum of 30 and 15 points respectively for Continuing Medical Education (CME) or Continuing Professional Development (CPD) sessions every year. • Each Researcher and Medical Laboratory Technologist involved in research must undergo related training at least once every 3 years. • At least 80% of completed research projects should achieve a minimum of 60% of its objectives. LIST OF QUALIY MANAGEMENT SYSTEM PROCEDURES
GENERAL QUALITY PROCEDURE (PKU)
1. PKU/IMR – 01 – Document Control 2. PKU/IMR – 02 – Record Control 3. PKU/IMR – 03 – Internal Audit Quality 4. PKU/IMR – 04 – Non-Conformance Control 5. PKU/IMR – 05 – Corrective Action 6. PKU/IMR – 06 – Preventive Action RESEARCH QUALITY PROCEDURE (PKP)
1. PKP/IMR – 01 – Preparation of proposal for research projects 2. PKP/IMR – 02(1) – Review of research proposals for application by IRPA funding and other resources 3. PKP/IMR – 02(2) – Review of research proposal for application of funding by the Ministry of Health Malaysia 4. PKP/IMR – 03(1) – Collection of research data in the field and preparation of progress report 5. PKP/IMR – 03(2) – Collection of research data in the laboratory and preparation of progress report 6. PKP/IMR – 04 - Analysis of research data and preparation of final report 7. PKP/IMR – 05(1) – Dissemination of research findings through publications 8. PKP/IMR – 05(2) – Dissemination of research findings through presentations 9. PKP/IMR – 05(3) – Dissemination of research findings through other publications ADMINISTRATION QUALITY PROCEDURES (PKT)
1. PKT/IMR – 01(1) – Purchasing through tender 2. PKT/IMR – 01(2) – Purchasing through IMR Quotation Board Committee 3. PKT/IMR – 01(3) – Direct purchase 4. PKT/IMR – 02(1) – Maintenance and calibration of equipment and services 5. PKT/IMR – 02(2) – Repair of equipment and services 6. PKT/IMR – 03 – Staff training and competency management 7. PKT/IMR – 04 – Handling of customer complaints 8. PKT/IMR – 05 – Management of customer satisfaction 9. PKT/IMR – 06 – Management and grading of CME / CPD activities 10. PKT/IMR – 07 – Management review meeting 11. PKT/IMR – 08 – Preparation of budget proposal
Prepared by: the MS ISO 9001: 2000 Implementation Team, IMR Dated: 21 st April 2004
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