ISO9001 & 13485

Africawide Health (Pty) Ltd, imports globally and distributes a range of Medical Devices (In Vitro Diagnostic/IVD and non-IVD) within South and Sub-Saharan Africa.

Africawide Health is committed to the establishment and maintenance of a “Quality Management System” suitable for the adherence to regulatory requirements.

Its Quality manual is being implemented to meet the requirements of ISO 9001:2015 and ISO 13485:2016, and all employees adhere to the various procedures and Work instructions as supported by the policies outlined in its

The Management System is currently being implemented against the requirements as documented for the ISO 9001:2015 standard requirements. The Quality Management system includes controls and base requirements of Clause 4.2.6 a & b of the Guideline for a License to Manufacture, Import, Export or Distribute Medical Devices & IVDs (July 2016).

The Quality Management system includes basic controls relating to the requirements of the ISO 13485 standard. ISO 13485 implementation will be planned for implementation before 2024. The following clauses are defined as not Applicable:

  • Clause 7.3 Design and Development is excluded (Non-Applicability) – No design and development functions are performed as part of the scope of operations.
  • Clause 7.5.9.2 – Particular requirements for active implantable medical devices and implantable medical devices – The organisation does not supply implantable medical devices. This clause is therefore not applicable.
  • Clause 7.5.10 Customer Property – The organisation does not in normal day to day activities handle customer property

Procedures referred to in Africawide’s manual are maintained as part of the quality management system and will be available for review during certification site audits.