Both Hitma BV and our assembly partner UltraPure International successfully renewed their ISO 9001 certification in January 2025. Several departments were visited by auditor Henk Ricke and the audit was completed positively, without any findings and with valuable suggestions for improvements. This certification is not only a recognition of our hard work, but also a guarantee for our customers.
What is ISO 9001?
But what is ISO 9001 certification actually? It is a globally recognized standard for quality management, drawn up by the International Organization for Standardization (ISO). This standard means that organizations demonstrate that they can consistently deliver products and/or services that meet the quality required by customers and other stakeholders.
A nice bit of history: NATO already drew up quality standards for its suppliers in 1959, to ensure that the right materials with the right quality arrived at the front on time. This resulted in the first quality standard, called AQAP, in 1969, after which other industries started to develop similar standards. Ultimately, they wanted a globally applicable standard, which led to the first official ISO standard in 1987. Since then, this standard has been updated regularly, most recently in 2015. In the Netherlands, the NEN partnership is responsible for the management and publication of standards applicable to the Netherlands.
Why ISO 9001?
Hitma BV has ISO 9001:2015 certification and we would like to keep this, to show that we have our affairs in order and to demonstrate that we value reliability, quality and customer satisfaction. Without this certification, we cannot do business with biopharmaceutical customers, because it is a minimum requirement to be allowed to supply products to them. Our main goal is to ensure that our products and services meet the needs and wishes of our customers. The procedures we follow are aimed at helping the customer as good and quickly as possible, preferably according to a standard procedure. For example, when making a quote, we always fill in certain fields, because these provide useful information about the product to the customer in a clear manner.
In addition, ISO 9001 certification indicates that we comply with applicable laws and regulations. For example, we are required to send the quality and production certificates of our single-use products with every order. If there is something wrong with them, it is easy to trace which batch from the supplier this concerned and if necessary, it can be further investigated. However, these papers sometimes get lost at the customer's. Because we digitize them ourselves, we can provide this information again on request. This way, we can always meet this requirement and it is a useful service for the customer!
It is also good to review and test all processes annually, because it provides insight into the various activities of our company and the relationship between them. This gives management information about whether everything is running smoothly or whether there is still room for improvement. As a company, it is important to continuously improve, because the world around us is also constantly changing and we must continue to respond to this in order to keep our customers satisfied and stay ahead of competitors.
Audits
A certified external agency comes to investigate annually whether we still meet the ISO 9001 standards, the so-called audit. First, it is examined whether and which procedures there are and whether these are clear and accessible to everyone. Then, on the basis of a practical example, various departments are examined to see whether the applicable procedures have been followed. It is therefore important that everyone is aware of the standards and requirements with regard to the work they do. It ultimately also makes the work easier, because if you do everything according to the applicable procedures, you know that it is work with good quality. And that is what we strive for every day for our customers!
