Quality, regulatory and clinical affairs
Our customers rely on our products and services to consistently meet their expectations and requirements, which is why at Thermo Fisher Scientific we put quality at the center of all we do.
“Quality isn’t just about meeting standards; it's about caring enough to exceed them, ensuring that every decision and every process reflects our best effort and shared purpose.”
Amy Amrine
Associate Director, Operational Process & Compliance, Thermo Fisher Scientific
We are committed to operating with integrity and transparency and adhering to applicable regulations worldwide.
Our company Quality Policy requires all Thermo Fisher colleagues worldwide to take personal ownership of quality in their daily work and create a consistent customer experience. Additional procedures, including corrective and preventive action, 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 colleague 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 trains our colleagues on how to implement the latest tools and techniques.
As of 2025, more than 70,000 colleagues have engaged in the Making Quality Personal program.
For colleague Katy Cairo, quality is deeply personal. As the parent of a child living with a rare genetic disease, Katy knows how accuracy and attention to detail can impact lives. Her story shows why Making Quality Personal matters: every dataset, decision and product helps enable reliable diagnoses, advance therapies and support families who depend on our customers’ work.
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)1. 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. See the full list of certified sites here.
% eligible regulated sites adhering to cGMP
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 verified and validated to meet customer expectations and international standards for quality, performance and safety. Our quality management system tracks processes 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 is designed to affirm that the product, equipment or medicine will perform as expected.2
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.
Photo credit: Thermo Fisher colleague Trung Samuelson Le, Lead QA Technician, provided this photo from our Laboratory Products site in Rochester, New York
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 seek to keep our customers informed throughout the process.
Endnotes:
- cGMP refers to the current Good Manufacturing Practice regulations enforced by the Food and Drug Administration.
- Depending on the production technology, both testing methods may not apply.
Last updated: July 2026
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
For more information, please visit www.thermofisher.com
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