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Quality & Environment Assurance

The objective of Quality Assurance & Environment is that we, through our quality management system maintain and expand our knowledge about equipment and processes so that we can provide a competent guidance and qualified support to our customers.

Ellab A/S is ISO 9001, ISO 14001 & ATEX IEC 80079-34 certified. Ellab A/S Calibration laboratories are accredited according to ISO 17025 by DANAK under registration no. 520.

Certification to these standards is a part of the effort to meet and exceed international quality standards. Ellab believes that top management commitment and active involvement are essential for developing and implementing effective quality systems that will benefit both customers and the Ellab organization worldwide.

Corporate Quality Assurance & Environment (QA & E) is organized as a unit directly under the President, CEO. The objectives for Quality Assurance are among others in corporation with the responsible departments:

  • Contribute to making Ellab products safe, efficient and available.
  • Ensure that Ellab has a common quality system and the necessary strategies for QA & E activities.
  • Contribute to making Ellab an efficient and professional company.
  • Effectively define and communicate the level and responsibility of quality within Ellab.
  • Be a serious and competent partner in matters of quality, including interpretation of pertinent legislation.
  • Harmonize the quality level in Ellab.
  • Coordinate, support and develop Quality Management Systems within Ellab according to GDP, GMP and GLP.
  • Maintain and develop a system for handling of Standard Operating Procedures including work instructions.
  • Plan and perform audits of key suppliers.
  • Plan and perform self-inspections.
  • Maintain and develop change control systems.
  • Review and authorize validation documentation.
  • Participate in projects as QA & E responsible.
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DS/EN ISO/IEC 17025:2017 - Hilleroed - Danish
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EN ISO/IEC 17025:2017 - Hilleroed - English
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DS/EN ISO/IEC 17025:2017 - Lyngby - Danish
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EN ISO/IEC 17025:2017 - Lyngby - English
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Joint ISO IEC 17025 Communique - English
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Approved science-based target - SBTi
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ATEX

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ATEX EU Notification
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ATEX UK Notification
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ATEX EU Certificate
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ATEX UK Certificate
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ISO 9001:2015

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ISO 9001:2015 - Danish
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ISO 9001:2015 - English
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ISO 9001:2015 - USA
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ISO 9001:2015 - Benelux - Dutch
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ISO 9001:2015 - Benelux - English
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ISO 9001:2015 - Ellab GmbH - German
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ISO 9001:2015 - Ellab GmbH - English
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ISO 14001:2015

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ISO 14001:2015 - Danish
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ISO 14001:2015 - English
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WEEE & RoHS Declarations of Conformity

Product Certificates

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Canada 8758A_SKYAP1
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Canada 8758_SKYDL1
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Canada 8758A-LYOAP1
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Canada 8758A-LYODL1
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Canada 8758A-LYORS1
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Japan SKYAP 204WW10900900
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Japan SKYRF Module 204WW10901000
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Japan LyoPro Data Logger 20-111064
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Japan LyoPro Reader Station 20-111065
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Japan LyoPro Access Point 21-111310
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Russia Certificate for type approval of Measuring System TrackSense Pro (48827-12/2016-12-30)
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Russia Certificate for type approval of Measuring System E-valTM Flex (58786-14/2014-10-20)
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Russia Certificate for type approval of Measuring System E-valTM Pro (70460-18/2018-02-26)
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Russia Certificate for type approval of Measuring System E-valTM ETI (67591-17/2017-05-30)
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Russia Certificate for type approval of Measuring System E-valTM ETS (7119218-18/2018-05-21)
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