Quality
At Biofortuna, quality is not a standalone function, it is embedded into every aspect of our work.
We support organisations across the life sciences sector with development, manufacturing, storage and QC service, all delivered within a single, robust Quality Management System (QMS). Our approach ensures consistent quality standards across every service, project and customer interaction.
Rather than applying different standards to different areas of the business, our quality framework spans everything we do – because every sample, project and customer matters.
Our accreditations and certifications
We operate under a comprehensive quality and regulatory framework designed to support highly controlled scientific and clinical environments as a FDA CFR21 part 820 compliant company. We are:
ISO 13485 certified
Our ISO 13485 certification demonstrates compliance with internationally recognised quality standards for medical devices.
Building upon the principles of ISO 9001, this standard is specifically designed for organisations operating within regulated medical and diagnostic environments. It ensures our QMS is robust, controlled and fully suited to the development, manufacture and delivery of life science products and services
ISO 17025 accredited
ISO 17025 demonstrates technical competence within laboratory operations.
This ensures our dedicated team are appropriately trained, methods are validated and testing is performed to the highest recognised standards of accuracy, reliability and reproducibility.
Data integrity
We treat data as a regulated asset. Our systems, processes and behaviours are designed to ensure that every data point we generate is accurate, complete, consistent and traceable throughout its lifecycle.
From controlled documentation and ALCOA+ principles, to secure electronic systems, audit trails, access control and validated processes, we maintain a QMS that protects data against loss, manipulation or unauthorised access.
Our teams follow Good Documentation Practice, structured review, and risk‑based controls to ensure data remains reliable and inspection‑ready at all times
Service specific regulatory approvals
In addition to our core accreditations, Biofortuna maintains several licences and approvals that support specific service areas:
This licence supports the storage of human tissue and underpins multiple services across Biofortuna, including:
- Cell line quality control services
- Controlled environment storage
- DNA testing services under our NorthGene™ brand
We maintain APHA approved storage facilities for animal and animal by-product materials, supporting secure and compliant sample management.
We operate as a Biosafety Level 2 laboratory with HSE approval for the handling and storage of genetically modified organisms (GMO) up to Classification 2.
We hold a Home Office licence permitting the secure storage of controlled drugs in accordance with the Misuse of Drugs Regulations 2001.
Biofortuna is approved by the Ministry of Justice to provide DNA testing for legal and immigration purposes under our NorthGene™ brand.
Validated process and control
Quality extends beyond accreditation alone. Our processes are continuously monitored, validated and maintained to ensure reliability and consistency. This includes:
- Method validation for our quality control and DNA testing services
- Continuous temperature and environmental monitoring paired with audio and visual alarms
- 24/7 security and power monitoring, and on call response team
- Ongoing quality assurance and risk management activities
- Dual layer security access to the facility
Quality of service, not just compliance
At Biofortuna, quality is not limited to regulatory compliance, it also defines the service experience we provide to our customers.
Our Customer Engagement Managers work closely with customers from initial enquiry through to project delivery, ensuring clear communication and responsive support throughout. They act as the link between your team and our laboratory operations, helping ensure timelines, technical requirements and expectations are managed efficiently and transparently.
A culture of continuous improvement
We continually enhance our systems, processes and expertise to stay ahead of evolving scientific, technological and regulatory expectations.
Our team undertakes ongoing training and skills development, and we routinely review our procedures to identify opportunities for optimisation.
By embracing innovation and proactive improvement, we ensure our services remain reliable, efficient and future‑ready.
