Quality Assurance

Quality Assurance

Our comprehensive quality control system ensures accurate and reliable results through regular and systematic surveillance of all critical components of our activities; inclusive of training, instrumentation, logistics and management. Our laboratories comply and cooperate fully with the appropriate national and international quality control programmes for all tests offered. With compassionate awareness of the highly sensitive nature of patient care and confidentiality, we adhere to strict protocols governing a patient’s personal and confidential information in our laboratories.

The implementation and continual improvement of the Quality Management System is coordinated by the Total Quality Management (TQM) department reporting directly to the Chief Operating Officer (COO). Certified by the South African National Accreditation System (SANAS), our services comply with all relevant ISO specifications. All laboratories are ISO 15189:2012 accredited, transitioning to ISO 15189:2022 accreditation. Ampath was the first laboratory in South Africa to have successful assessments against the updated ISO 15189:2022 standard. Our Non-clinical Genetics laboratory was the first in the country to be accredited to ISO 17025:2017 Forensics for DNA testing.

Assessment by SANAS involves the implementation of quality standards, as well as assessment of competence of the laboratory and staff to perform designated duties and testing. Internal audits, performed by well trained and competent internal auditors, ensures the upkeep of the quality management system in all laboratories.

The total quality management department is independent from work processes performed in the laboratories. The department is managed by the Group Total quality manager, assisted by five regional quality managers. Each manager is responsible for assuring that the laboratory participates in the monitoring and evaluation of the quality and appropriateness of services rendered, within the context of the quality assurance program, and to implement and maintain the Quality management system. Internal auditors perform extensive system audits at laboratories at regular intervals. These internal audits consist of vertical audits, as well as witnessing of test performance. Proficiency coordinators ensure that all laboratories are registered on appropriate external quality assurance (EQA) programmes, and they coordinate Ampath inter-laboratory comparison programmes. The SHE manual is controlled and coordinated by the Total Quality Management department, the function being to ensure a safe and healthy working environment for all Ampath employees.

Ampath Laboratories values the health and safety of all stakeholders and protection of the environment in which we operate.