Quality Policy

BioMAdvanced Diagnostics aims at developing, manufacturing and commercializing innovative, impactful and meaningful in vitro diagnostics Medical Devices internationally. Innovative, for us means that there is no pre-existing equivalent. Impactful means that the products improve significatively the standard of care while not adding any burden (and if possible at all, improving) on the total cost of care. Meaningful means that the products provide solutions to major health problems.

More specifically, under the overarching control of our Regulatory Authorities (and in agreement with the rules – ISO 13485, etc. – they enforce or promote) in all the geographies we operate in, our stakeholders are: our clients, our employees, our partners, our shareholders and the Earth.
No stakeholder shall prevail over anyone of the others.
This Quality Policy applies at all stages of the product lifecycle, from development to post commercialization. It applies to the whole company and its contractors.

• Quality for regulatory authorities means that we operate at the highest ethical standards and meet or exceed all applicable regulatory requirements.
• Quality for our company means we drive a continuous improvement culture that is enabled by our company’s quality system and corporate culture which are designed to adequately cope with a changing environment.
• Quality for patients and our customers means we commit to offer them reliable and efficient products, error free from design through use.
• Quality for our colleagues means we establish a safe and wellbeing work environment ensuring personal development of everyone and a high-quality standard at every level.
• Quality for our partners means we commit to develop respectful relationships with the most appropriate ones to ensure meeting all stakeholder’s requirements.
• Quality for our shareholders means we inform them as often as needed (beyond the legal requirements) on the company affairs, that we relentlessly execute the plans we will have agreed on and that we will balance short-term and long-term interests in all the company activities.
• Quality for the Earth means we will continuously seek to reduce our impact on the environment (global warming, water pollution, waste generation) in all of the company activities as long as it will not hamper the products’ ability to deliver on their promises. As an example, BioMAdvanced Diagnostics is fully digital and paperless.

The Corporate Culture is action driven and rests on 4 pillars:
• Teamwork
• Fact based, collegial and timely decision making
• Continuous improvement
• Appropriate Reward

This Quality Policy and all the relative developments will be reviewed and assessed periodically to keep the best control possible and take corrective actions whenever necessary.

Frédéric PETTE – President