Quality Assurance

The objective of quality assurance is that we, through our quality management system maintains and expands our knowledge about equipment and processes so that we can provide a competent guide and a good service to our customers.

Ellab are certified to the ISO 9001 standard since 2004 and ATEX EN13980 standard in 2008. 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 (QA) is organised 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.
• Secure that Ellab has a common quality system and the necessary strategies for QA activities.
• Contribute to making Ellab an efficient and serious company.
• Define and communicate the level and responsibility for quality in Ellab.
• Be a serious and competent partner in matters of quality, including interpretation of the legislation.
• Harmonise the quality level in Ellab.
• Coordinate, support and develop Quality Management Systems in Ellab within GMP.
• Maintain and develop the 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 authorise validation documentation.
• Participate in projects as QA responsible.