Quality, regulatory and clinical affairs

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, meeting the highest ethical standards and strictly adhering to global regulatory compliance. 

The promotion of medical devices and diagnostic products is subject to strict global regulations, including the US Food, Drug and Cosmetic Act. Our policies require that our sales practices, product descriptions and marketing practices must always be fair, accurate and consistent with product labelling.

We prohibit promotion of our products for uses that have not been approved by the appropriate regulatory body, and promotional claims must be based on valid scientific evidence and provide accurate, objective and complete information about the product. 

Our company Quality Policy requires all Thermo Fisher colleagues worldwide take personal ownership of quality in their daily work and create a consistent customer experience. Additional procedures, including corrective and preventive action (CAPA), document retention practices, and competence and awareness training provide minimum performance expectations for our quality management system.

During the colleague onboarding process, all new quality team members are provided with training on our quality management system and related policies. Reinforcing individual and collective accountability at every stage of the process, we optimize performance through internal auditing managed by each of our businesses and required, ongoing education. 
 
Our Making Quality Personal learning program elevates the message that quality is everyone’s responsibility. It helps our teams gain insights into the impact of their roles on quality and compliance, and teaches our colleagues on how to implement the latest tools and techniques. As of 2024, 50% of our colleagues have participated in the program.

Quality management certifications

Given the diversity of our operations, our sites maintain various certifications and registrations as required by regulators of the markets where we sell our products. Of our eligible regulated sites 100% adhere to current Good Manufacturing Practices (cGMP)*. Where certification is voluntary, 94% of our sites have a certified quality system such as ISO 9001, ISO 13485 or other ISO certification, demonstrating our unwavering commitment to meeting the highest quality and ethical standards. 

Visit our Site ISO Certifications page to find the latest industry standards certifications documents for Thermo Fisher Scientific locations around the globe. 

We also expect high-quality standards from our suppliers and aim to source from those compliant with cGMP or possessing ISO certifications where applicable. 

Product compliance, testing and recalls

Across Thermo Fisher, 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 system tracks all processes to completion according to established procedures, including proper record retention. Products are then registered according to country-specific requirements with the appropriate government and regulatory authorities. 

Within our businesses, we conduct rigorous, systemic product quality control evaluations to enhance detection of potential emerging quality and safety concerns. Using state-of-the-art equipment, our well-trained quality control teams oversee product testing at different stages of production. In-process and/or end-of-line testing affirms that the product, equipment or medicine will perform as expected.**

Within our quality control labs, we conduct sample testing using a recognized, scientific and statistical sampling approach to verify a product’s performance before distribution. If a concern is identified, the product is put on hold or quarantined until the issue is resolved. Our robust testing protocols constantly evolve, assuring the highest standards of product quality for our customers. 

When a customer contacts us with a concern, we immediately enter the complaint into our quality system, triggering an alert to the relevant manufacturing site or business. Within the 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 identifies the root cause and launches a corrective action or countermeasure to prevent the issue from recurring. To maintain transparency in response to product concerns, we keep our customers informed throughout the process.