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Case Study: How Oceanz realises the benefits of ISO 13485 on top of ISO 9001.

ISO 13485 certification to help Oceanz champion both innovation and quality

Learn about Implementing ISO 13485

Client challenge

Founded in 2011, Oceanz provides high-quality, 3D printing solutions. Known for their relentless focus on innovation, our client’s services support a range of sector, from retail goods to complex industrial design, engineering and the medical industry. Today, there is a growing demand for 3D-printed medical devices, such as mobility aids and surgical models. Oceanz’s ‘Selective Laser Sintering’ printing technology is already revolutionising the industry, bringing with it the potential to manufacture medical devices more efficiently, cheaply and sustainably than conventional manufacturing processes.

The prosthetic arms and legs that Oceanz manufactures, for example, can be tailor-made with such precision that they are attuned to the patient’s unique anatomy and respond to even

the slightest physical need. Oceanz’s 3D printed models of vital human organs are also shifting the way that academic surgeons approach complex surgeries. Such models boost the success rates of high-risk operations, delivering more efficient healthcare solutions while also benefiting patients directly.

Oceanz had already achieved certification to ISO 9001 (Quality management systems – Requirements), but was keen to go further. The company turned to us for guidance and support.

How we helped

Embedding a culture of quality excellence within Oceanz’s operations was a very clear objective for the company. Our client already had a reputation for several quality ‘firsts’ in the Netherlands. We helped Oceanz’s executive management and quality management teams understand and realise the benefits that ISO 13485 would bring on top of ISO 9001. This was far from obvious as ISO 13485 is essentially based on ISO 9001 and also follows its process model approach.

Aside from overall manufacturing quality, several specific medical safety demands are also required within the ISO 13485 standard. Our support helped Oceanz in areas as broad-ranging as registrations involving customer and legal demands, research and development, packaging and labelling, product identification, and retracing possibilities.

In the months leading up to the final assessment, we worked with Oceanz’s dedicated quality team to develop a systematic quality enhancement policy, fully integrated with the company’s business model. This approach strengthened the quality management system by making sure it was aligned with the company’s key organisational objectives. We adopted the system’s unique risk-based assessment methodology to undertake a suitable risk assessment of the company and its products and services. The final assessment was extensive, with Oceanz demonstrating its ability to meet the demands of the ISO 13485 standard. Potential improvements were identified, based on the assessment.

Contact us to learn more about ISO 13485 certification.

Insight & Client feedback

Why have dual quality management systems? Erik van der Garde, Director of Oceanz, explains the business benefits: “ISO 13485 certification denotes our ability to 3D print medical grade plastics in an environment that meets all internationally-accepted production demands. But having certification to ISO 9001 also brings with it further business benefits as it reflects a commitment to customer service and continuous process improvement. Through our dual quality management systems, we are in a stronger position to offer our medical device clients more reliability and quality.”

Client feedback 

“We are very happy with the speed and quality of service that LRQA provided, which was evident at every stage of our certification journey, from our first enquiry through to the final assessment and beyond.”

Erik van der Garde

Director, Oceanz

Powerful results

ISO 13485 is a globally harmonised standard, meeting most regulatory requirements. Gaining certification here, as well as to ISO 9001, increases Oceanz’s opportunities to do business in the EU and beyond. In a highly regulated EU medical device industry, stringent quality and legal demands are placed on medical device manufacturers before selling products.

As well as a licence to operate, Oceanz’s clients have further assurance of the company’s commitment to delivering its products and services with a high level of quality, safety and consistency. This helps differentiate our client in a highly competitive, intensely regulated medical device market.

The process of obtaining ISO 13485 certification was beneficial in itself. This fostered an even greater sense of ownership in upholding the high-quality standards across the company. At the same time, the executive management team gained a deep understanding of medical devices regulations and their impact on Oceanz’s long-term business.

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