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Accreditations

External assessment for trusted quality controls

Parafix hold a number of quality accreditations, the first of which was attained over 20 years ago. Since then, we have continually assessed our customers’ need for quality standards and have sought additional accreditation accordingly.

Our wide range of quality accreditations demonstrate our commitment to developing and manufacturing superior products for our customers; they can be viewed in more detail below. 

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ISO 9001:2008 - Quality Management - UK

ISO 9001 is the world’s most widely recognised quality management standard. The accreditation demonstrates our continual monitoring and management of quality across our manufacturing processes. It has generated and maintained greater efficiency, improved performance and quality to better meet our customers’ needs.

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ISO 9001:2008 - Quality Management - Hungary

ISO 9001 is the world’s most widely recognised quality management standard. The accreditation demonstrates our continual monitoring and management of quality across our manufacturing processes. It has generated and maintained greater efficiency, improved performance and quality to better meet our customers’ needs.

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ISO 13485:2003 & EN ISO 13485:2012 - Medical Devices - UK

ISO 13485 is the quality management standard for the manufacture of medical devices. The accreditation demonstrates our commitment to maintaining regulatory compliance, driving improvement, effectiveness and achieving customer confidence in the manufacturer of their medical products.

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ISO 14001:2004 - Environmental Management - Hungary

ISO 14001 is an internationally accepted standard that outlines how to put an effective environmental management system in place. The accreditation demonstrates our commitment to minimising the environmental impact of our business operations. It also complements our commitment to continuous improvement, of which waste reduction is a key feature.

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ISO 14644-1 - Class 7 Clean Room - UK

ISO 14644-1 is a classification of air cleanliness in clean rooms and associated controlled environments. The cleanliness of air is measured by the number of airborne particles per cubic meter at a specified particle size. Our clean room is class 10,000 meaning that particles are limited to 10,000 per cubic meter.

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ISO/TS 16949 - Automotive Quality Management Compliant - UK

ISO/TS 16949 is a globally recognised quality management standard for the automotive industry.

It is based on the ISO 9001 standard and promotes continual business improvement by emphasising defect prevention and reducing variation and waste in the supply chain.

We are not currently accredited to this standard; however, we have been fully audited by many tier one automotive companies who are satisfied we comply with the accreditation. We are compliant because we produce all of the documentation required of this standard and our management systems are able to meet the exact quality requirements of the automotive sector.

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FDA Registered - UK

FDA is an agency within the U.S. Department of Health and Human Services and is recognised worldwide as ‘the’ regulatory body relating to healthcare products. FDA registration demonstrates our commitment to understanding and meeting the needs of our healthcare customers producing or distributing medical devices intended for use in the U.S. FDA registration also provides customer reassurance that Parafix are committed to good practices in terms of service and quality, whether their products are being sold in or outside of the United States.

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