Document link: G_10_QMAN_1_A Laboratory Quality Manual 3Sep22 amended 27Mar23
The manual is to be read together with the Diagnostic Laboratory information for each laboratory. Access to associated quality documents for each LQM section is provided here.
- Introduction – see excerpt below
- Quality Systems Essential: Quality Policy
- QSE: Organisation
- QSE: Personnel
- QSE: Facilities and Safety
- QSE: Equipment
- QSE: Purchasing and Inventory
- QSE: Process Management
- QSE: Assessments (audits)
- QSE: Customer Service
- QSE: Nonconforming Event Management
- QSE: Continual Improvement
- QSE: Documents and Records
- QSE: Information Management
Excerpt: 1. Introduction to the Quality Manual
This quality manual provides a roadmap of the laboratory quality management system (LQMS) in place for public laboratories in PNG including all the necessary policies and procedures that support a quality management system as specified by the ISO15189 Standard for Medical Laboratories.
The quality management system aims to provide the necessary support processes to enable the laboratory to perform accurate and reliable analytical work that meets customer requirements (refer to Figure below). The laboratory aims for continuous improvement of the system, and prevention of the occurrence of nonconformities (unexpected wrong results or significant deficiencies of practice).
PNG has legislated that all laboratories will eventually be accredited against this ISO standard. Implementation of ISO15189 LQMS is a complex process that takes several years. The WHO Laboratory Quality Stepwise Implementation tool provides a 4 phase roadmap with a staged approach to all of the Quality System Essentials (QSE) described in this manual. The development of the LQM is described in phase 3 .
This manual is organized following the framework developed by the WHO. As most laboratories in PNG are just at the commencement of the LQMS journey, much of the content will not correspond to what is currently in place. The LQM provides detailed guidance for future action. Local laboratory management can steadily work through section by section, determining and giving priority/resources to action plans based on the required elements.
As a starting point, it is recommended that all Laboratory Managers read the LQMS Information sheet and enrol in the free WHO eLearning course on LQMS which focuses on the 5 very important initial challenges (approximately 30 minutes learning for each course): 1. Documents and records, 2. Personnel, 3. Purchasing and Inventory, 4. Equipment and 5. Facilities and Safety. Access is via this page and a certificate is provided upon completion of the five courses. It is possible to leave an individual course midway and then return to complete it. Elements from these courses have been integrated into the text and the assistance of WHO is gratefully acknowledged.