Customers in today’s market are far more interested in the delivery and consistency of a product and require an assurance that the product ‘does what it says’. Organisations have had to introduce Quality Management Systems (QMS) to monitor and control all the stages of the production process, and ensure that their purchasers‘ demands for proof that an organisation is capable of producing quality products and services is satisfied in the form of independent third party certification.

History of QMS

Current QMS such as ISO9001:2000 date back to systems set up to investigate problems with military supplier difficulties in the 1950’s. However, it was the British Standards Institution (BSI) who in 1979 first produced auditable documents in the form of BS 5750 standards that were acceptable to both manufacturers and suppliers as the minimum level for quality assurance.

Preparing freeze-dried samples for use in a quality assessment scheme at VLA’s Quality Assurance unit, Sutton Bonington

In 1983, the International Organisation of Standardisation (ISO) produced a set of standards for use in all countries, which resulted in the publication of ISO 9000 in 1987. Immediately BSI republished it as the UK BS 5750 standard and the European Committee for Standardisation Commission adopted it as the European Standard. In 1994 ISO 9000 was updated to improve clarification resulting in the withdrawal of BS 5750 and similar standards to avoid confusion.

By the end of the millennium many small organisations were critical of ISO 9000 as they lacked the resources to implement all the requirements. The standard was significantly refined in 2000 to provide a better framework for continual improvement and drive customer satisfaction rather than solely concentrating on documentation.

Against this background and as a diverse business, VLA operates a number of discrete QMS across the Agency to align customer and regulatory demands.The Biotechnology department, TSE Archive and Neuropathology unit hold ISO 9000 certification.

The Biotechnology department also manufactures statutory biological products such as tuberculin and vaccines for anthrax and Johne’s disease using Good Manufacturing Practice (GMP) compliant facilities. GMP statutory requirements assures that medical products are consistently produced with both production and quality control relevant to their intended marketing authorisation and product specification.

Measuring tritium in food samples

Our Radiochemistry unit is accredited by United Kingdom Accreditation Service (UKAS) to ISO 17025. This standard represents the basic requirements for a QMS model but adds additional technical requirements needed for testing and calibration activities.

Our Virology department holds UKAS accreditation for testing performed under the Pet Travel Scheme which allows dogs and cats to enter the UK from EU Member States and specific rabies-free countries without having to undergo quarantine.

The Laboratory Testing department hold UKAS Group accreditation to ISO 17025 which encompasses one QMS across all the Regional Laboratories and a number of units at Weybridge.

The Scientific Services unit provides Good Laboratory Practice (GLP) compliant facilities and UKAS accreditation to ISO 17025 for its commercial laboratory services to support the development and licensing of veterinary products. GLP statutory requirements, administered by the Department of Health, are concerned with the conditions under which laboratory safety studies are reported and particularly focus on the robustness and integrity of the data.

VLA’s animal facilities are also GLP compliant, providing support to ethically justified science projects.

Auditing equipment, as part of VLA’s Quality Management Systems

All ISO 17025 accreditation is supported by inter-laboratory proficiency testing to maintain compliance to the standard by VLA’s Quality Assurance unit at Sutton Bonington.

VLA’s QMS will then provide a management framework to:

• implement the business plan
• monitor control processes
• manage business risks
• improve operating costs
• meet our Defra obligations

The benefits will include:

• better development and training of employees
• better communication for suppliers and employees
• improved customer satisfaction - the ultimate objective of any quality system
• greater confidence in the quality of VLA’s products

The future of quality at VLA

VLA intends to expand upon the current quality system (ISO 9001:2000) by certifying the rest of the Agency with a single corporate certificate. Third party auditing is planned for early 2005 and approval sought by the end of 2005.