Two years of targeted work gives a bonus to Carmo A/S now, which has just been certified according to the internationally recognised ISO 13485 standard.
 

Carmo A/S secures much coveted quality stamp – ISO 13485

Two years of targeted work gives a bonus to Carmo A/S now, which has just been certified according to the internationally recognised ISO 13485 standard.

ISO 13485 is an ISO standard that describes the requirements to an extensive quality system, which covers design and production of medical equipment. This is an independent certificate, but it is generally harmonised with ISO 9001. In relation to ISO 9001, ISO 13485 focuses more on product safety, traceability, documentation, validation and risk analysis.

“The new certificate imposes higher requirements for ongoing documentation in our development work. The quality of our products, which will continue to maintain their usual high standard, will not be affected immediately, but we will have the opportunity to work on entirely new projects within medical technology,” clarifies Director Claus Ishøy.

ISO 13485 is an ISO standard that describes the requirements to an extensive quality system, which covers design and production of medical equipment. This is an independent certificate, but it is generally harmonised with ISO 9001. In relation to ISO 9001, ISO 13485 focuses more on product safety, traceability, documentation, validation and risk analysis.

“We can now use our production capacity to an even greater extent in order to take part in medical technology production processes. Rather than mass production, we now have more opportunities to develop as a knowledge-intensive product- and production-development company,” says Claus Ishøy.

A natural progression and response to market demand

It has taken Carmo A/S two years of targeted work to become certified, and this allows the company to easier cooperate with new partners who also have to live up to the same requirements.

“This is a quality stamp that we can show as proof that we are part of the premier league. It does not change so much the way we do things, but when we have to live up to one and the same standard, we speak the same language more often,” explains sales director Christian Søeberg.

“The market is developing to a direction where more and more of our customers become ISO 13485-certified, and we notice a growing demand from many of our existing customers and especially from new customers and partners,” adds Carmo’s CEO and owner Steen Ishøy.

The new quality stamp will also impose internal requirements on Carmo’s employees to be constantly at the cutting edge of the field.

“It has always been part of our standard procedure to be up to date, but with the certification our employees are even more determined to purposefully work towards delivering the most outstanding quality. The arrival of the new form of constant focus on meeting the requirements will give the whole company a boost”, says quality manager Anne Jensen.

Based in Denmark, Carmo delivers competitively priced, high-quality injection moulded plastic and PVC components at short notice using cutting-edge technology. Their aim is to provide outstanding customer service world-wide. Their customers are to be found within industries as diverse as medico, maritime, mining, agriculture and automotive.

Author: Peter Yde Jensen