Quality
PAUL HARTMANN Pty Ltd is accredited in AS/NZS ISO 9001:2000 and as a medical manufacturer we conform to the standard of ISO 13485.
Our quality system is focused on the supply, distribution and in-market support of medical products into hospitals, aged care facilities and the community. Accreditation for PAUL HARTMANN means a continuous process of improvement in our systems and procedures to be better able to service our valued customers.
As a medical manufacturer we must be able to demonstrate that both our devices and our manufacturing processes used to make the device conform to the requirements of the therapeutic goods legislation.
The Conformity Assessment Certification is a certificate that is awarded by the TGA or another regulatory body to the manufacturer to demonstrate that a conformity assessment procedure has been adequately applied to the device and that the device complies with the essential principles.
HARTMANN is accredited with a Schedule 3 Part 4 (Production quality assurance procedures ) Conformity Assessment Certificate.
A number of systems are currently in place to ensure ongoing quality of our products and distribution operations. These include: monitoring of customer feedback, delivery lead time audits, management reviews and monthly sales and operations meetings.
All PAUL HARTMANN Pty Ltd products sold in the Australian market conform to TGA requirements. As members of the Medical Technology Association of Australia (MTAA), PAUL HARTMANN Pty Ltd agrees to comply with the MTAA Code of Practice.
PAUL HARTMANN Pty Ltd manufactures and supply/distribute sterile Customised Procedure Packs that are routinely sterilised using an approved validated Ethylene Oxide sterilisation cycle.
We also confirm that the development and validation of the sterilisation cycle was based on a methodology that is fully compliant with AS ANZS 11135.
All HARTMANN’s Ethylene Oxide sterilisation is performed offsite by Australia’s leading sterilisation company, Steritech.
