European Union quality management

EC (1998b), Quality management, In The Rules Governing Medicinal Products in the European Union, Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, vol. 4, Eudralex. Available at http //pharmacos.eudra.org/ F2/eudralex/vol-4/pdfs-en/caplen.pdf (accessed October 2006). 

B. Ballantine, Improving the Quality of Risk Management in the European Union Risk Communication, The European Policy Centre Brussels, Belgium, 2003. 

Council Directive 96/62/EC of 27 September 1996 on ambient air quality assessment and management, Official Journal of the European Union, EC, 1996, No.L.296. 

Because of such uncertainties, each supplier should be audited at the start of the project to establish whether a Quality Management System (QMS) exists that will support the validation of the equipment or process. Where none exists, an agreement must be reached with each supplier as to what quality measures will be used. This should be outlined by each company in their Quality Plan. In our case, we decided that all companies concerned should comply with the GAMP Guide, as this outlines validation documentation that is suitable for the U.S. Food and Drug Administration s (FDA) requirements and may also be used to support the European Union s CE mark accreditation (see Table 40.1). The device was to be released in both the American and European markets. 

The aims of the European Union s Water Framework Directive (2000/60/CE) (WFD) are similar to those of the equivalent legislation in Australia, Canada and the United States of America and have been discussed thoroughly in earlier chapters of this book. However, it is worth stressing that the main aims are to improve and protect the quality of all water bodies across Europe, and to achieve sustainable use of water resources. The quality of surface waters is to be managed at river basin level, and there is a tight deadline (2015) for the achievement of tlie main aims. In iJiis context, this chapter will deal witli the methods that are available, or in some cases under development, for use in monitoring the chemical and biological quality of water, and... 

Food supply chains are also subject to rules, regulations, and quality management systems that exist to ensure food safety. Rules, regulations, and quality management systems can be found on European Union (EU), world, and national... 

Christianson T H et al. (1994) Attentuation of landfill leachate - pollutants in aquifers. In Critical reviews in environmental science and technology 24(2) 119-202.CRC Press Inc Crawford J, Smith P (1985) Landfill technology, Butterworths, London EEC Draft Directive 0995) 4103/95. General Secretariat of European Union, Bmssels Ehrig H J (1983) Quality and quantity of sanitary landfill leachate. Waste Management Resource, 1,53... 

The EFQM (European Foundation of Quahty Management) award is derived from America s Malcolm Baldridge National Quality Award. There are similar accolades available in other countries, such as the Canadian Excellence Awards and the Austrahan Quality Award. The EFQM Award was established in 1991. It is supported by the European Union and the countries in the EU have their own support unit (e.g. British Quality Foundation in the UK). The EFQM model provides a set of cheddist questionnaires under nine categories, each containing maximum points. They are ... 

Rothery, B. 1995. ISO 14000 and ISO 9000. Brookfield, VT Gower. This book explains the difference between the two international series of standards so vital to companies that want to be recognized for quality control and European Union certification. While the ISO 9000 series provides guidelines and emphasizes the implementation of quality management systems, the ISO 14000 series extends to environmental and safety issues. 

---