ensure we consistently fulfil our promise — to deliver high-quality goods in
compliance with relevant statutory and regulatory requirements —, we have
installed four International Organization for Standardization (ISO) management
Bruker BioSpin’s ability to produce high-quality goods and services depends on a number of factors: our people, our innovation and, our responsible practices all come together to deliver value and exceed the expectations of customers and scientific communities around the world.
To ensure we consistently fulfil our promise — to deliver high-quality goods in compliance with relevant statutory and regulatory requirements —, we have installed four International Organization for Standardization (ISO) management systems in all four Bruker BioSpin production sites in Germany, Switzerland and France.
ISO certification proves that we have met a range of international standards that ensure quality throughout the business. Furthermore, to maintain our ISO status, we will continue to demonstrate that we meet the requirements.
ISO 9001:2015 (Quality Management System) is probably the most recognizable and highly regarded standard in the world. Although it was introduced more than 25 years ago, the standard is revised every five years to ensure it remains relevant. This certification specifically defines our ability to apply a quality management system effectively, including processes for improvement. In addition, by meeting the requirements of this standard, Bruker BioSpin will be contributing to the United Nations Sustainable Development Goals, which are “a call to action by all countries — poor, rich and middle-income — to promote prosperity while protecting the planet”.1 As UN Secretary-General António Guterres states “We need to turn the recovery into a real opportunity to do things right for the future.”
Customers who work in the medical devices industry have to meet uncompromising safety and quality regulations. Bruker BioSpin operating units with responsibility for upcoming
in-vitro diagnostic products (medical devices) are based on ISO 13485 certification, which gives our customers, working in the regulated industries, the confidence that we adhere to best practice procedures and comply with industry-specific regulations (including GxP alignment).
We take our environmental responsibilities seriously and have, therefore, undertaken measures to earn ISO 14001:2015 certification, which demonstrates we have successfully implemented an effective environmental management system. By doing so, we assure company management, employees, and external stakeholders that our environmental impact across all sites is constantly monitored and improved. Becoming ISO certified has informed the creation of many of our stainability measures and builds upon our subscription to the EcoVadis CSR platform.2
Bruker BioSpin’s talented pool of staff is its greatest asset. Implementing ISO 45001:2018 enables us to establish, install and maintain a comprehensive occupational health and safety management system to provide safe and healthy workplaces by preventing injury and illness. It also provides a framework to integrate other aspects of health and safety, such as positive mental health and wellbeing.
We have comprehensive business continuity plans in place to manage the outcomes of disaster scenarios such as environmental impact, infrastructure or supply chain issues, or
IT breakdowns to ensure business continuity for our customers, our suppliers and our people — all with the ultimate goal of safeguarding the sector in which we work, as well as the wider community.
Internally, our management systems have brought clear definition to our processes, which also help with onboarding new staff. Continuous surveillance and auditing, corrective and preventative action projects generate updates, improvements and innovation, and provide the basis for product and service expansion.
Our proactive approach to ensuring quality by gaining multisite ISO certification gives our customers consistency and the confidence to work with us. We place this trust in high value in building mutually rewarding long-term relationships.
Incorporating high quality standards across Bruker BioSpin sets the foundation for everything
we do and everything Bruker stands for. Installing and maintaining ISO management systems enables us to approach new regulated markets and demonstrate our compliance to standards that identify us as reliable suppliers, as well as safeguard our customers, our staff, our environment, and our mutual future.