Certification to new ISO 9001:2000 standard

Thermo Electron Corporation has announced it received ISO 9001 certification on 10th February 2003, following an assessment conducted by BSI in November 2002

Thermo Electron Corporation business and leader in laboratory informatics solutions and services, has announced it received ISO 9001:2000 certification on 10th February 2003, following an assessment conducted by BSI (British Standards Institution) in November 2002.

ISO 9001:2000 supercedes ISO 9001:1994 in December 2003, when informatics vendors such as Thermo serving regulated industries will be obliged to move to the newer standard, in order to retain ISO 9001 registration.

The Thermo certification to the new standard has been awarded for Business Management Processes at its product development headquarters at Altrincham, UK.

Thermo Informatics business was, until March 2003, doing business separately as Thermo LabSystems and Thermo Galactic.

Thermo Electron develops and supports LIMS (Laboratory Information Management Systems), CDS (Chromatography Data Systems) and solutions for analytical data archival.

Computer system vendors that serve industries in which their systems operate in a GLP, GMP or GAMP regulated environment are increasingly expected by industry to hold ISO 9001 certification from recognised accredited certification bodies.

Thermo has received certification from BSI, Quality Assurance, which itself is accredited by the United Kingdom Accreditation Service (UKAS).

The Thermo certification also includes the highly acclaimed TickIT scheme for software development organisations.

Certification of vendors to internationally recognised standards provides confidence to customers in regulated industries that the vendor has formal mechanisms and systems in place to consistently improve its products and processes.

The scope of the company registration is comprehensive - "The design, development, sales, implementation, and support of computer based laboratory information and automation systems".

Ian Herd, Quality Assurance Manager at Thermo Electron, commented: "We are one of the first lab informatics organisations to make the transition to the requirements of the new standard.

ISO 9001:2000 has a number of key enhancements over the 1994 standard, including increased management responsibility, increased customer focus, a commitment to measurable objectives and the implementation of measurement, analysis and improvement processes.

Regular surveillance audits and tri-annual full reassessment audits conducted by BSI, along with frequent 2nd party audits conducted by existing and prospective customers, help to ensure our products and business processes continue to evolve and improve".

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