What ISO 13485 Certification Means for Clinical Sequencing Labs

Clinical research | Educational series

Clinical research sequencing labs operate in one of the most demanding environments in genomics. These studies generate high-quality data needed to advance biological research and future clinical research applications, so accuracy and consistency are critical. The standards a lab holds their tools and partners to matters as much as the specifications on the datasheet.

Element Biosciences recently achieved ISO 13485 certification for its Quality Management System (QMS). For labs evaluating sequencing platforms for clinical research applications—from comprehensive genomic profiling to minimal residual disease studies—that certification is worth understanding in depth.

Here's what it means, what it requires, and why it matters for the work you do.

What is ISO 13485?

ISO 13485 is the internationally recognized quality management standard for medical devices and in vitro diagnostic (IVD) products. Maintained by the International Organization for Standardization, it defines the requirements for a QMS that an organization must demonstrate across the full lifecycle of a product, from design and development through manufacturing, post-market surveillance, and corrective action.
It's distinct from ISO 9001, the more general quality management standard that governs many industries. ISO 13485 is specific to medical devices and IVDs, and it carries substantially higher regulatory weight in that context. Unlike ISO 9001, which centers on customer satisfaction, ISO 13485 centers on the consistent production of safe and effective devices that meet regulatory and customer requirements.

Achieving certification is not self-declared. It requires an independent, accredited certification body to audit the organization's processes, documentation, and systems against the standard's requirements — and to verify that those systems are operating as documented, not just described on paper.

What certification requires

To understand why ISO 13485 certification is meaningful, it helps to understand what organizations must demonstrate to earn it. The standard covers:

Design and development controls: The organization must show that design inputs (specifications, regulatory requirements, user needs) are formally captured, that design outputs are traceable to those inputs, and that design verification and validation activities are documented and reviewed. For sequencing platforms, this encompasses everything from chemistry development to software validation.

Supplier and component controls: Any component or service that affects product quality must come from qualified suppliers under formal quality agreements. This extends to raw materials, reagent components, and manufacturing services.

Manufacturing process controls: Processes that affect product quality must be validated, monitored, and controlled. Deviations must be documented and investigated. This is particularly relevant for sequencing reagents, where batch-to-batch consistency directly affects run quality.

Risk management: ISO 13485 requires systematic risk management throughout the product lifecycle, aligned with ISO 14971 (the companion standard for medical device risk management). Identified risks must be evaluated, mitigated, and tracked.

Post-market surveillance and CAPA: Organizations must have formal systems for monitoring field performance and responding to complaints, adverse events, and nonconformities through Corrective and Preventive Action (CAPA) processes.

Document and record control: Every quality-relevant process, specification, and outcome must be documented under controlled conditions, version-controlled, reviewed, and retained for defined periods.

Achieving all of this is a substantial organizational undertaking. It requires not just writing policies but demonstrating to an independent auditor that those policies are actually lived.

What certification requires

For labs running clinical research workflows, a sequencing platform's ISO 13485 certification has important benefits.

Consistency you can rely on: A certified QMS means that the reagents and instruments you receive are manufactured under controlled, validated processes. Lot-to-lot variability is monitored and constrained. When you're running a multi-site MRD study or a longitudinal tumor profiling program, that consistency directly affects your ability to compare results over time and across sites.

A foundation for your own quality systems: Many clinical research labs maintain their own QMS. When your sequencing platform supplier operates under ISO 13485, it simplifies your own supplier qualification process. You're building on a documented quality foundation rather than characterizing one from scratch.

Signal of organizational maturity: Perhaps less tangibly but no less importantly, a company that has earned ISO 13485 certification has demonstrated that quality is deeply embedded in its operations. That matters when you're evaluating a long-term platform partner, particularly one you expect to support you through your own quality certifications, data audits, or rigorous peer review.
 

Why it matters for clinical diagnostics labs

For labs running clinical diagnostic workflows, a sequencing platform's ISO 13485 certification has additional practical implications.

ISO 13485 and IVDR: For European labs or those working with partners subject to EU regulation, ISO 13485 certification has a specific regulatory relevance. The EU In Vitro Diagnostic Regulation (IVDR), which replaced the prior IVD Directive and is now fully in effect, requires that IVD manufacturers implement a QMS that meets ISO 13485. Certification to the standard is therefore a prerequisite for CE marking under IVDR.

This matters for diagnostics labs in two ways. First, it means that sequencing platforms with ISO 13485 certification are operating under a QMS that is already aligned with IVDR requirements, simplifying the path to regulatory-compliant workflows for European labs. Second, for labs involved in co-development of IVD assays targeting EU markets, a certified platform supplier is a regulatory requirement, not a preference.

CAP/ CLIA accreditation: Similarly in the United States, using a sequencer with ISO 13485 certification simplifies the supplier qualification process for diagnostics labs operating under CPA accreditation or CLIA certification, or those developing laboratory-developed tests (LDTs). 

Alignment with co-development pathways: Labs partnering with developers or engaging in co-development of IVD sequencing-based assays increasingly require their platform suppliers to operate under ISO 13485. It's a prerequisite for many quality agreements and a standard expectation in regulated co-development programs.

Why it matters for clinical diagnostics labs

Element Biosciences has operated with a commitment to data quality since its founding. Cloudbreak UltraQ™ delivering over 70% Q50 data in human genome sequencing is a direct expression of that commitment. ISO 13485 certification extends that quality ethos from the chemistry and instrumentation to the organizational systems that produce them.

As Jeff Labbadia,  SVP of Operations at Element Biosciences describes it, “It's not just about satisfying regulators. The discipline we're building makes us better at how we design and develop products.”

For clinical research labs currently running workflows on AVITI™, whether for solid tumor profiling, MRD research or rare disease studies, the certification provides a formal, audited basis for the quality you've been relying on in practice. It also positions Element as a platform partner capable of supporting the most rigorous clinical research environments as your programs evolve. According to Jeff Labbadia, “We've built a quality system that's designed not just for today's products, but for the clinically focused products we'll bring to market in the future.”

Finally, ISO 13485 is a significant milestone in Element’s future plans to release IVDR certified products, including the AVITI Dx™ later this year. AVITI Dx will be a Class A IVDR sequencing platform, designed to bring all the advantages of ABC™ sequencing to clinical diagnostics labs in select European countries. It also signals our readiness to engage with customers and partners developing sequencing-based diagnostics, including ongoing IVD co-development work with Revvity for newborn screening.

Labbadia explains, "This is a first major step that signals we're intentionally moving from being a research tools company to providing solutions in regulated diagnostics. Passing the audit isn’t the finish line. The hard work starts now as we continue strengthening our quality systems and supporting clinical customers."

For labs evaluating platforms for clinical research applications, it answers a question that datasheet specifications alone cannot: does this company's quality system match the demands of the work?

The answer, now formally documented and independently verified, is yes.

Learn more

To learn more about Element's clinical research sequencing capabilities, including our workflow solutions for MRD research, comprehensive genomic profiling, and rare disease studies, visit our Clinical Research page.

To read the full ISO 13485 announcement, see our press release.
 
The AVITI system from Element Biosciences is intended for research use only. It is not intended for use in diagnostic procedures.