Is an ISO Certificate just a piece of paper?

Trust and quality

In today’s world full of certificates, seals, and accreditations, a legitimate question often arises:

Is an ISO certificate truly proof of quality, or is it merely an expensive piece of paper hanging on an office wall?

For those of us who are at the beginning of implementing the international standard ISO 20387, the answer is clear. This process is not a goal in itself. It is a way to transform a biobank into a world-class institution that both donors and researchers can fully trust.

More than just a sample storage facility

To the general public, a biobank may appear to be little more than a cold room filled with freezers. In reality, however, it is above all a steward of values. Every sample stored in a biobank represents the decision of a real person, a donor, to contribute to science, research, and future generations.

Stored samples hold enormous potential for medical research, the development of new therapies, and a deeper understanding of diseases that we are still unable to cure today. ISO 20387 exists precisely to ensure that this potential remains protected. It provides a framework for demonstrating that a biobank operates competently, impartially, and with the highest possible standards of quality in handling biological materials and associated data.

Documentation as a map, not a burden

Once the requirements of the standard are thoroughly understood, the next crucial step is the creation of documentation – the “DNA of the biobank.” This is the phase where theory becomes practice.

The standard clearly defines what must be fulfilled to ensure quality processes, while leaving flexibility regarding how these requirements are implemented within the specific conditions of a particular biobank.

Creating documentation means critically reviewing every single step. Questions must be asked:

• Are our facilities and equipment truly suitable?
• Do we have clear rules for sample collection and transportation that preserve sample integrity?

Every document written today becomes a promise of future traceability – from the moment a sample is collected to its eventual use in research.

Expertise and processes: The heart of biobanking

For biobanks, researchers, and the scientific community, ISO 20387 represents a guarantee of professionalism. The standard requires not only modern technologies, but above all qualified and competent personnel.

Quality in biobanking is not accidental, it is the result of carefully designed material lifecycle management.

Process requirements form the very heart of a biobank. Properly established processes ensure that samples and data are handled consistently, safely, and reliably. Key pillars include:

• Traceability – the ability to continuously track where a sample is located and what procedures have been performed on it.
• Method validation – assurance that methods used are scientifically sound, correct, and reproducible.
• Data integrity and confidentiality – ensuring that donor and sample information remains accurate and protected from misuse throughout the entire process.

Quality as a common language

Why is it important to strive for compliance with this standard from the very beginning of a biobank’s operation?

Because ISO 20387 is the common language spoken by biobanks and researchers worldwide. A biobank operating according to these standards produces samples that are valued not only nationally, but also within international research consortia.

Imagine a researcher discovering after years of work that the study results are unreliable simply because a sample was collected incorrectly, for example, into the wrong tube containing an inappropriate reagent, or because the sample was exposed to excessive temperatures during transport.

This is known as an error in the pre-analytical phase.

To prevent such failures, processes are designed to minimize randomness and human error as much as possible. Quality is not an endpoint, but a continuous path toward precision, order, and reliability.

Building a quality management system enables institutions to prevent errors, manage risks, and continuously improve. This is the essence of modern biobanking.

More than just a certificate

So, is a certificate merely a piece of paper?

To some, it may seem like little more than a formality or administrative requirement. In the context of biobanking, however, ISO 20387 carries much deeper meaning. It represents a commitment to doing things correctly, responsibly, and with respect toward donors, researchers, and society as a whole.

Behind every process stand people whose work directly affects sample quality, and every properly processed sample may one day contribute to a major medical breakthrough.

QM Coordinator BBMRI.sk
Lenka Kohútková