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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.

 

April 11th, 2013

"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.

 

ISO 9001:2008 / ISO 13485 certificate

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.

 
For more information, please contact:

Quality

Anne Jensen

Tel.: +45 49 12 21 00
Fax: +45 49 12 21 99

Head of Sales

Christian Søeberg

Tel.: +45 49 12 21 00
Fax: +45 49 12 21 99

Contact sales

 

 
 
 
 

Carmo has a 60 year track record of delivering highly specialized technical and medical components.

We design, produce and sell quality injection moulded plastic components globally. We service industries as diverse as Medico, Maritime, Mining, Agriculture and Automotive.

Quality, Service and Flexibility are the key words of our production and in all aspects of our interaction with our customers. We are focused on minimizing hassle and maximizing service, while helping our customers turning ideas into products.

We are based in Denmark and run a highly automated production. By leveraging robotics and vision technology, we are able to deliver components with very high quality, well-defined properties and functionality at competitive prices.

We put all our knowhow and experience in ensuring our customers an easy integration and stability in their products and production.

From our sales offices and inventories in Denmark, France and the UK we are able to supply our core markets and customers within days.

Our core competency is components for High Frequency welding, with a special focus on valves, eyelets and components for medical bags. We maintain PVC as a special focus, however deliver 50% of our turnover in other plastic materials.

Our four main business areas are:

Technical Components Medical Components Modular storage boxes Product Development Services

Weldable eyelets and fittings

Valves for inflating, over pressure and vacuum

Threaded nozzles and caps

HF/RF welding machines

Market leader in drainage valves, connectors and fittings for medical bags

Customization and OEM production

Modular, high quality transparent boxes

Approved for storage of food and fragile objects

Sold under the brand UltraPlast

Product design and realisation

Pilot production, test and documentation

Ramp-up and production

In addition to above, our main manufacturing strength is quality injection moulding in all technical
plastics - including PVC. Carmo PVC products are made in a number of different PVC grades - all special and protected Carmo recipes.

We can manufacture in cleanroom down to class 10.000.
2K moulding

We have chosen quality to be the keyword for our production and
distribution. Since 1993 Carmo has been holding an ISO certification and we are today ISO certified according to ISO 9001:2008.

Carmo