Significant milestone of one hundred second party (customer) quality assurance audits in ten years for Lims supplier
Thermo LabSystems announces that it has reached the significant milestone of hosting one hundred customer quality assurance audits since it began keeping records in 1992.
This total comprises audits undertaken by customers, as well as prospective customers as part of their evaluation and selection process. Computer system vendors, such as Thermo LabSystems, are subject to vendor audits (2nd party audits) by customers in industries such as pharmaceutical and food production, where the system operates in a GLP or GAMP regulated environment.
These audits, which are mandated by regulatory authorities, are conducted to gain evidence that the vendor is designing, testing, supporting, and documenting the computer system in a controlled manner.
Ian Herd, head of quality assurance at Thermo LabSystems, commented: "Such regular independent scrutiny helps to ensure our quality management system continually evolves to meet both the needs of our customers and Thermo LabSystems itself.
I am confident that this is a record number of 2nd party audits for an organisation specialising in laboratory informatics.
Over the last ten years, audits have been carried out by a cross-section of our customers in terms of geography, industry type and regulatory environment.
These range from small academic or forensic labs through to the R and D divisions of large pharma. Here's to the next hundred!" In May 1993, Thermo LabSystems became the first laboratory informatics company in the world to achieve ISO 9001 accredited certification, using the highly acclaimed TickIT scheme for software vendors.
Thermo LabSystems received certification (number FM 24378) from the British Standards Institute, Quality Assurance; an independent certification body accredited by the United Kingdom Accreditation Service (UKAS).
Under the terms of its certification, Thermo LabSystems is also subject to 3rd party audits which include bi-annual surveillance audits and, every three years, full reassessment audits by the British Standards Institute. Additionally, through a team of fully trained internal auditors, Thermo conducts its own scheduled programme of internal QA audits.
The scope of the company's registration is "The design, development, sales, implementation, and support of computer based laboratory information and automation systems".
In short, this encompasses all of its business activities.
Such a comprehensive quality culture is unusual in the laboratory informatics market, where subcontracting (of implementation, for example) is common and where certification is often only gained for the production phase.
