Course Dates: 13-15 August 2018
There is an increased need for use of accredited facilities in medical/health research, including clinical trials research. Although each organization has its own way of doing business, the organizational activities need to be standardized to build confidence in the quality of the data and subsequently information generated. Different standards are used for different organizational needs. The ISO 15189 international standard has been seen fit for medical research laboratories to receive international recognition. Implementation and maintenance of a quality management system is quite demanding, particularly for research organizations like BRTI, where projects are always at different stages of implementation, some starting and others coming to an end while the rest fall in between at various stages of their project periods. Maintaining ISO standards involves continuous surveillance by an accreditation body to ensure consistence in upholding those standards and this is sometimes a challenge due to changes in projects’ requirements
This training will assist those organizations intending to set up a quality management system.
Course Aim and Objectives
The aim is to share BRTI’s approach on the road towards accreditation and how it has managed to maintain the ISO 15189 accreditation certification.
The course will equip researchers, laboratory managers, quality coordinators and laboratory scientists with the knowledge and skills to enable them to set up a robust quality management system in their organizations.
Topics on Offer: By the end of the training participants will be able to:
- Understand ISO15189:2012 quality management system
- Develop quality policy manual from the ISO15189:2012 standard
- Develop quality procedures manual from the quality policy manual
- Develop standard operating procedures from quality procedures manual
- Develop forms and logs to generate records.
- Have an idea of identification of non-conformities, corrective & preventive actions (CAPA) and root cause analysis
- Generate check-lists for internal auditing
- Handle a mock audit
Course Coordinators/ Facilitators (Faculty)
The course will be taught by senior staff members of the BRTI who have had training and experience in quality management systems and ISO accreditation. To include the course Coordinators:
- Agness F Nhidza-Manjoro: (BRTI QMS Manager/ BRTI TESAII Coordinator)
- Beauty Makamure: (BRTI Laboratory Manager)
- Junior Mutsvangwa: (Senior Research Scientist &QMS Technical Advisor (BRTI TESA II PI)
What: Participants should have an understanding of general quality management system concepts but previous training in quality management system is not a pre-requisite. By combining lectures with hands-on examples participants will gain an understanding of the critical components in setting up a robust quality management system.
Who should attend:
Researchers, laboratory managers, quality coordinators and laboratory scientists with the knowledge and skills to enable them set up a robust quality management system in their organizations in preparation for accreditation.
Participants should have an understanding of general quality management system concepts but previous training in quality management system is not a pre-requisite. By combining lectures with hands-on examples participants will gain an understanding of the critical components in setting up a robust quality management system.
Registration: Registration package includes course materials/lecture notes, meals (lunch and refreshments) for the duration of the course. A maximum of 10 participants will be selected. Participants are expected to meet their own accommodation, travel costs while local transport will be made available by BRTI
Language: The course will be conducted in English
Registration deadline: 31 July 2018.
Contact the conference coordinator if you require a letter to support a travel visa application. Please note: letters will only be provided to confirmed registrants.