As an innovative company focused on developing products with the potential to benefit public health, quality is ingrained in everything we do. In order to maintain and promote the highest level of quality in our work, our various compliance standards ensure that our processes are in accordance with the recommended guidelines and are always improving.
The standards below are created and upheld by the British Standards Institute, who are the national standards body and are on a mission to “share knowledge, innovation and best practice to help people and organisations make excellence a habit.”
ISO9001 – Quality Management Systems
ISO 9001 sets out guidelines to help businesses to create and implement Quality Management Systems which help to improve the way they work by improving their products and services, provide a better service to clients and make their work practices and processes as efficient as possible by implementing the management system set out in the standard. Certification is achieved through a formal assessment by the British Standards Institution (BSI).
For Ventus Medical, complying with ISO 9001 ensures that we are able to conduct our work in the most effective, high quality manner possible.
ISO13485 – Quality Management Systems for Medical Device Manufacturers
Similarly to ISO9001, ISO 13485 helps businesses to perform better and more efficiently by setting our regulations for Quality Management Systems, however it requires a stricter system and is designed specifically for regulatory compliance with “Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.”
As we are in the business of developing medical devices to make nicotine safer to consumers and the general public, it’s crucial that our systems and procedures are effective while also complying with the standards required to make our products safe.
Good Manufacturing Practice (GMP) QC Release
All medicinal products which are intended for human use are required to be manufactured under GMP. GMP extends not only to the manufacturing of such products but also to the testing and release. Our internal laboratory is currently undergoing assessment for GMP licensing in order to fully internalise the company activities in relation to the conduct of clinical studies on our developments as well as enabling product release testing for future products entering the market.
ISO14001 – Environmental Management
At Ventus Medical, we work hard to ensure that our environmental footprint and impact on the planet are kept as low as possible. We demonstrate our commitment to environmental responsibility through our certification to ISO14001, which ensures that not only our working practices are considered to the environment but that our innovation is guided by a principle of environmental sustainability.
In addition to these compliance standards, we also uphold our high level of quality by following a quality testing process and continuously working to innovate and improve our work.