Commitment to Quality
Quality is the cornerstone of a responsible, ethical and committed company. Quality assurance forms a key part of the organisation reflecting in all areas in which Neoss® operates.
Neoss® Quality Policy
Neoss® is committed to delivering satisfaction to our customers by anticipating their needs and offering value, quality, and reliability that exceeds their expectations.
The success of Neoss® and our customers is powered by our people, a culture of teamwork, innovative solutions, and by continually improving the effectiveness of our Quality System as a foundation for business performance.
We value safety, integrity and mutual respect, supporting our employees, communities and customers, complying with all applicable laws and regulations.
Neoss® maintains strict quality standards regarding the safety and supply of its products. The quality and safety processes and procedures are broad in scope and apply stringent quality and safety standards – from the quality of incoming materials through the design, development, manufacture, storage, handling and distribution of our products. Governing Standards include:
- FDA 21 CFR 820 – Quality System Regulation
- ISO 19011 – Guidelines for Quality Auditors
- ISO 13485 – Quality System for Medical Device
- MDD – Medical Device Directive – European Legislation
- TGA – Australian Therapeutic Goods Administration
- MHLW Ministerial Ordinance no 169 Japan Pharmaceutical and Medical Devices Agency
To monitor compliance with these standards, internal and third party assessments of our quality and regulatory systems are conducted. FDA has also conducted Good Manufacturing Practice (cGMP) inspections of our facilities, including manufacturing.
Our notified body, BSI, conducts annual independent assessments confirming our compliance with International Standards, including Conformity Europe (CE) marking.
Our Corporate Internal Audit Department conducts regular Quality and Regulatory audits, the results of which are reported into Executive Management Review.
Robust processes are in place to monitor and support compliance with product regulations worldwide, including design controls, review of product changes, labelling and advertising, marketing approvals, good manufacturing practice, and adverse event reporting requirements.
The following are copies of our certificates: