POLICY

Purpose and Strategic of IMPLANTCAST is to distribute safe and performing medical devices to both the South African and African markets We’re in the business of providing high-standard medical devices to both the private and public healthcare sector and listening to our customers to and building first-class relationships so as to help us provide excellent standards of service and client satisfaction thereby effectively healing patients

IMPLANTCAST is committed to implementing, maintaining and continually improving a quality management system that meets the requirements of the customer and regulatory and legislative requirements, for Good Manufacturing Practices (GMP) for medical devices. The Company is committed to the highest standards of product quality, performance and safety in all aspects of our business.

The Company endeavours to achieve its objectives by:

• Compliance with all local and national regulations pertaining to the products being distributed

• Certification to ISO13485 with implementation of SOP using other relevant standards e.g. ISO14971 where required or as a guide

• Placing systems and procedures in place to manage and improve or comply to the safety, performance and quality of it’s products and good business ethics and practices

• Implement GMP ensuring Safety, Health and Hygiene to the products, employees and community and any other stakeholders as relevant

• Ensuring that employees are aware and trained in regards to their roles and responsibilities and QMS

• Ensuring that the Quality objectives are reviewed and measured during the management review to enable a sustainable policy of safe and effective products and good business practices       

approved by Managing Director. IMPLANTCAST SA

Digitally Signed by Henry Manyike

Revision 6. 07.03.2024

Responsibilities

It shall be the responsibility of the Top Management Team to establish and maintain policies and procedures and to bring these procedures into effect. 

It shall be the responsibility of the Managing Director to ensure implementation of these policies and procedures.

REVISION HISTORY

Revision 6; 07.03.2024 - HNM - approved - removed IDSO9001 certification

Revision 5; 07.03.2024 - HNM - signed off SOP

Revision 4; 11.11.2021 - NT - signed off from TNA

Revision 3, 03.02.2021 New format with Responsibilities, Risk based approach, Records added and new googlesite format.  

Revision 2, Digitally signed on 11.05.2018 by TNA

Revision 1, unknown due to googlesite change to new googlesite