In the toll coating business, customers typically require adherence to the ISO 9001 quality management standard, which is sufficient in many cases. While Carestream Contract Manufacturing fully meets the qualifications of ISO 9001, the company often exceeds its level of quality assurance by also following protocols set forth within the ISO 13485 medical device quality management standard.

Due to Carestream’s roots in medical device manufacturing, most of the company’s technicians have worked to the ISO 13485 standard for years and are accustomed to the level of precision required to meet its demands. For example, Carestream uses Lean Six Sigma practices in process development work, measuring product quality in triplicate to prove that the product consistently meets established quality standards. Additionally, Carestream adheres to unusually high cleanliness standards derived from its medical device manufacturing origins.

What matters most is how Carestream’s depth of quality expertise benefits customers. Carestream technicians have an average of 14 years of experience in producing a wide variety of products, solutions and substrates. This expertise is applied to help customers determine exactly what level of quality is needed for their unique products, which is important in offering customers the maximum level of performance in the most cost-effective manner.

At the onset of a project, Carestream technicians work to understand what can go wrong with a product, and how to prevent it. As the product becomes more mature, technicians develop a greater understanding of its process, and continue working to reduce defects and increase quality yield. This continuous improvement effort ultimately benefits customers in terms of both time and cost savings.

Many of Carestream’s professional staff have also earned Master’s degrees, and bring a wide range of knowledge, skills and abilities to the business. With so much knowledge and experience, Carestream has figured out ways to do things that simply cannot be done anywhere else.

Carestream professionals are progressive thinkers, with a mindset that can quickly adapt and change. They are constantly on the cutting edge, coming up with new ideas and products that don’t even exist in the marketplace yet. With customers all over the world, and the variety of projects coming in, Carestream consistently has visibility into where the market is moving on a global scale. It is very exciting work!

Carestream’s professional expertise and experience with both ISO 9001 and 13485 standards assures customer that their process and product quality rests in good hands.