Our customers rely on our products and services to consistently meet their expectations and requirements, which is why we put quality at the center of all we do. We must always operate with integrity and transparency as we uphold the highest quality standards and ensure global regulatory compliance. Our corporate Quality Policy ensures that all Thermo Fisher colleagues around the world understand and take personal ownership of quality in their daily work and create a consistent customer experience.
Given the diversity of manufacturing at Thermo Fisher our sites hold different certifications. Over 93% of our sites hold either cGMP, ISO 9001, or ISO 13485 certifications. Some sites, where applicable, additionally hold ISO 17025 and ISO 14001 certifications. All sites maintain appropriate certifications and registrations required by the regulators of the markets in which we sell our products.
Visit our Site ISO Certifications page to find the latest industry standards certifications documents for Thermo Fisher Scientific locations around the globe.
Innovation is critical to helping our customers succeed. Across our Company, new products are developed within a stage gate design control framework, our product ideation and introduction process. Products are then verified and validated to meet customer expectations and international standards for quality, performance and safety. Our quality management ensures all processes are completed according to established procedures and that records are properly retained. Products are then registered according to country-specific requirements with the proper government and regulatory authorities.
Embedded within our business segments, quality control teams oversee product testing at various stages of manufacturing. In-process and end-of-line testing affirms that the product, equipment or medicine will perform as expected when it reaches the customer. If a defect is detected, the product is put on hold or quarantined until the issue is resolved. In our quality control labs, we conduct sample testing using a recognized statistical sampling approach to confirm a product’s performance before distribution.
When a customer contacts us with a concern, we immediately enter the complaint into our quality system, which alerts the relevant manufacturing site or business. Within the quality system, the issue is evaluated against regulatory requirements to determine whether authorities must be notified. After determining whether the defect or deviation can be replicated, an investigation determines the root cause and launches any corrective action or countermeasure to prevent the issue from repeating. We remain committed to transparency and keeping our customers informed throughout the process.
Policies, standard operating procedures and work instructions are managed through a selection of easily accessible platforms. For third-party audits or external audits, we demonstrate our training programs as part of the local compliance process.
In addition to mandatory site and job specific training, we introduce and inform all new colleagues of our quality management system through our “Introduction to Quality” onboarding learning module, which outlines our quality management systems.