Quality Management

For our worldwide client base, we recognize that reliability, functionality, and efficiency are key factors for running a stress-free and profitable production system. For over 50 years Minitube has delivered robust, high-performance, quality equipment and consumables to the assisted reproduction market.

As an industry leader, we accept the responsibility of providing products that do not compromise quality or safety. For this reason, all proprietary consumables and semen or embryo preservation media are manufactured in our own dedicated state-of-the-art facilities, supported by extensive in-house and external third-party QA testing you can trust. There are approximately 3,000 double checks performed during incoming inspections of samples per year. To put it in concrete terms: Narrow product tolerances apply here, such as a measuring length with an accuracy of up to 0.0001 mm! Minitube quality is not subjective but based on hard facts and decades of a successful track record.

Our total quality approach is underpinned by a long-term partnership strategy with our suppliers and customers. These long-standing relationships help build the trust and understanding required to ensure ongoing quality.

The same is true for our service team who are always striving to provide the best service within the industry. As a customer, the expert knowledge and know-how of Minitube staff is always available to you.
 
Certified quality
Minitube’s ISO 9001:2015 certification confirms that all internal processes are regularly audited by worldwide technical inspection authorities and comply with international quality management standards. This process-oriented standard emphasizes continuous improvement and customer satisfaction.

The German headquarters first received certification in 2004, and the system has been continuously optimized ever since. Following Minitüb GmbH, Minitüb Slovakia, and Minitub do Brasil, Minitube USA became the fourth subsidiary to achieve ISO certification in 2023, reflecting the group's consistent commitment to high-quality standards.

As of September 2025, Minitüb GmbH has been officially recognized as a medical device manufacturer according to ISO 13485. This confirms that Minitube develops and manufactures medical devices according to the highest quality and safety standards.

Our extender production in Germany has been GMP-certified (Good Manufacturing Practice) since 2011, setting the industry benchmark. Our facility, equipment, and processes meet strict pharmaceutical guidelines, ensuring excellent hygiene and uniform quality.
 

What are the advantages for Minitube customers?
Shortly stated: maximum safety, reliability and quality.

Minitube's aim is the continuous improvement of all processes within our company, particularly concerning product development, production, and product quality. This includes regular consultations with our customers, an effective feedback and complaint handling system, an employee suggestion system as well as internal and external audits. All these efforts mean that we can respond even faster and more effectively to the requirements and wishes of our customers.

For our clients worldwide, production reliability is a key factor for working profitably. Only sound and high-grade equipment will lead to constant, uninterrupted operation – working day by working day. Minitube consistently delivers reliable and quality products, as extremely low complaint rates prove.