The term “culture of quality” is defined by the Harvard Business Review (HBR) as “an environment in which employees not only follow quality guidelines but also consistently see others taking quality-focused actions, hear others talking about quality, and feel quality all around them.” HBR was among the first to recognize that digital technology would heighten consumers’ quality expectations. Across many industries, from pharmaceuticals and oil and gas to food and beverage, mining and water/wastewater, businesses rely on software solutions to ensure product quality and remain compliant with a myriad of industry regulations. Given the role these systems play in ensuring data integrity and data quality, it is important to select informatics solutions that are developed to a high standard of quality. That is why our software solutions are developed under a Quality Management Systems (QMS) that conforms with ISO 9001:2015, ensuring continuous process improvement and use of best practices.
Why ISO Compliance?
Simply put, compliance with the ISO 9001:2015 standard demonstrates a commitment to quality. According to the International Standards Organization (ISO), “this International Standard is based on the quality management principles described in ISO 9000. The descriptions include a statement of each principle, a rationale of why the principle is important for the organization, some examples of benefits associated with the principle and examples of typical actions to improve the organization’s performance when applying the principle. The quality management principles are:
- customer focus;
- engagement of people;
- process approach;
- evidence-based decision making;
- relationship management.”
The QMS of Thermo Fisher Scientific’s Digital Science business is compliant with ISO 9001:2015 across all seven of its facilities worldwide. This continuing certification covers the design, development, sale, implementation and support of “computer-based laboratory information automation systems,” including Thermo Scientific™ SampleManager LIMS™, Watson LIMS™ and Nautilus LIMS™ software.
Quality Beyond the Software
As a trusted partner in your digital transformation journey, we provide a comprehensive range of professional services to help connect your lab. Available services include project management, consulting, instrument and systems integration, validation, and training. The Digital Science services team comprises over 200 service specialists located across the globe. In addition to a strong understanding of science and industry processes, the team has deep expertise in regulatory and industry guidance documents from organizations such as FDA, EMA, MHRA, ICH, ISBER, ISO, and HIPAA. As an organization, the Digital Science business is committed to helping transform your lab with a complete suite of solutions and services, including implementation, training, and technical support.
Visit our website to learn more about the full range of laboratory solutions and services available to help modernize your laboratory.