Medical Thermoformer Achieves ISO 13485 Certification

Dordan Manufacturing recently achieved ISO 13485: 2016 certification, an internationally recognized standard for organizations that design, produce, and service medical devices. The certification process involved comprehensive evaluations of the company’s quality management system (QMS) to identify areas that needed improvement or enhancement.

To ensure compliance with the standard, Dordan updated its procedures, documentation, and processes. It also invested in employee training and education to ensure everyone understood their roles and responsibilities in maintaining the QMS. Additionally, the manufacturer collaborated closely with Perry Johnson Registrars Inc. throughout the process to ensure that it was on track and addressed potential issues or concerns that arose.

According to quality manager Daniel Haavig, the process took about six months.

“The first few weeks were devoted to going through the standard and getting a full understanding of it. Then, about two months were spent evaluating Dordan’s quality management system and determining how to integrate the ISO 13485 requirements,” he says. “The next two months worked to incorporate the ISO 13485: 2016 standard into our QMS; and lastly, one month was dedicated to prepping and conducting audits.”

From humble beginnings.

Dordan Manufacturing started as a family business in a Chicago storefront in the early ’60s. Today, the full-service thermoforming company designs and manufactures medical device trays, blisters, kits, and assembly trays.

Dordan Manufacturing

Dordan’s entry into the medical packaging market came with the construction of its onsite ISO Class 8 cleanroom in 2018. Before 2000, the bulk of Dordan’s business was consumer, automotive, and electronics packaging.

“Dordan has spent over 60 years crafting expertise in high-quality thermoform design, tooling, and manufacturing — skills that transfer naturally into the development and production of medical packaging,” says Daniel Slavin, president and CEO. “As a family-owned and privately held company, Dordan used its foundational commitment to long-term growth to catalyze pursuit of ISO 13485 certification.”

The certification provides assurance that Dordan’s packaging is manufactured under strict quality control measures and adheres to regulatory standards, minimizing risks and ensuring patient safety.