Purpose and Strategic of WERKOMED (PTY) LTD / KLINICA SA is to distribute safe and performing medical devices to both the South African and African markets. We aim to provide high-standard medical devices to both the private and public healthcare sector, and by listening to our customers, to build first-class relationships to help us provide excellent standards of service and client satisfaction thereby effectively treating patients.
WERKOMED (PTY) LTD / KLINICA SA 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 any products being manufactured
– Certification to ISO9001 & ISO13485 with implementation of other relevant standards e.g. ISO14971
– 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, community and any other stakeholders
– Ensuring that employees are aware and trained regarding the above
– Ensuring that the above objectives are reviewed and measured during the management review to enable a sustainable policy of safe and effective products and good business practices
Signed : _______Signed by Monica Lucas__________
General Manager. WERKOMED (PTY) LTD / KLINICA SA
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 GM to ensure implementation of these policies and procedures.
Revision 11; 14.10.2024 - ML - Digitally signed by ML
Revision 10; 20.11.2023 - ML - Digitally signed by ML
Revision 9; 17.10.2021 - ML - Digitally signed by ML
Revision 8; 07.10.2021 - ML - Amended responsibility. Digitally signed 07.10.2021 by ML
Revision 7; 28.09.2021 - ML - Digitally signed 28.09.2021 by ML
Revision 6; 10.05.2021 - ML - Digitally signed 10.05.2021 by ML
Revision 5; 21.04.2021 - TNA - New format with Policy / Responsibilities / Revision History
Revision 4; Digitally signed 30.01.2020 by ML
Revision 1-3; unknown due to Google Site change to new Google site