Quality Policy

Last updated: 02 April 2025

IVC Pathology Kirsten Medical Technologist and Associates Inc. is a medical laboratory, and as the management of the laboratory, we are committed to the principles of the ISO 15189:2022 International Standard, SANAS and HPCSA, thus providing our users with a professional and consistent testing service in line with good business practice.

We perform laboratory activities in accordance with stated methods and ensure that the quality of work and service to users always conforms to their requirements. The resources necessary to manage and perform these laboratory activities shall always be provided.

Competency

We shall ensure that all laboratory personnel are competent and familiar with the documented management system by providing appropriate training and assistance in testing activities.

Internal Quality Control

The Laboratory has an IQC procedure for monitoring the ongoing validity of examination results, according to specified criteria, that verifies the attainment of the intended quality and ensures validity pertinent to clinical decision making.

External Quality Assessment

The Laboratory monitors its performance of examination methods by comparison with the results of other laboratories. This includes participation in EQA program(s) appropriate to the examinations and interpretation of examination results, including POCT examination methods.

Impartiality, Confidentiality and Ethics

We shall remain impartial, independent and ethical towards our users in every aspect of our testing service. All information obtained or created during the performance of laboratory activities, except as required by law, shall be kept confidential.

ISO 15189:2022

We shall conform to the requirements of the ISO 15189:2022 International Standard, regulatory authorities, user, SANAS and HPCSA requirements as documented and adopted in the laboratory management system.

Our quality policy is thus directed toward achieving the following objectives:

  • Maintain accreditation to ISO 15189:2022 to ensure the competence, impartiality, and consistent operation of the laboratory.
  • Address risks.
  • Ensure continuous user satisfaction.
  • Ensure accurate and reliable results.
  • Continuous improvement of the management system.
  • Evaluate and improve the effectiveness of the management system.