At Chalice, Quality permeates every aspect of our business; from the products we supply to the unmatched customer service that supports them. Our philosophy on quality motivates us to exceed expectations, allowing us to simultaneously satisfy the high standards demanded by our customers, along with the industry standards that we are required to do as a responsible manufacturer. It encourages a symbiotic relationship between us, our suppliers and our customers, helping us to implement quality-driven processes and systems. 

 

Each individual at Chalice is employed sharing the Company's philosophy towards quality and with a willingness to participate in it, with every department sharing the responsibility and contribution to providing excellence.

 

Chalice are annually audited by our notified body, BSI to ensure that we continue to comply with all standards and regulations, and as such we hold and maintain the following quality standards:

Directive 93/42/EEC
Ensuring that our products meet the essential requirements of the medical device directive, allows us to CE mark our product range within Europe. This enables that all quality, safety and regulatory requirements are being met.

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ISO 13485:2012
Compliance with this medical device specific standard is of paramount importance to Chalice, in achieving our aims to continually improve our systems and processes, ensuring both quality of products and customer satisfaction. 

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ISO 9001:2008
Compliance with this quality standard helps us to achieve and improve our customer satisfaction. This ensures that customer requirements are consistently met.

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ISO 14001:2004
We are fully certified to this environmental standard ensuring that we continually strive to improve our carbon footprint and reduce the amount of waste generated. 

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ISO 13485:2003
Chalice also comply with, and are accredited to the Canadian Regulations, and hold the appropriate certification provided by SGS. Canadian Licences are held for Tubing Packs, Paragon Oxygenators and ParaGlide Cannula.

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Directive 93/42/EEC - ParaTherm

Compliance with this standard also allows licence for the ParaTherm heater/cooler for use during extracorporeal bypass procedures. 

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We are now participating in the Medical Industry Accredited (MIA) scheme click here for more details.