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ISO Overview

ISO 9002 is an internationally accepted standard for quality assurance. Registration by an accredited registrar signifies that a working quality system is in place that effectively meets the 18 prerequisites of a quality management system as defined by the International standards organization. The Novozymes Biologicals, Inc. manufacturing facility in Salem, VA achieved registration in November 1993 by Lloyds Registrar of quality assurance (LRQA). Based on LRQA’s accreditation, this registration encompasses accreditation by RvC (Holland), DAR (Germany), and NAB (England), all of which are recognized worldwide. Inherent to the ISO 9002 registration, the Salem facility is submitted to routine audits by the LRQA registrar every six months and the registration will be fully reviewed every three years to determine that it successfully meets all 18 standards required. These standards include evidence of management support by providing the leadership and resources required to define a quality system and monitor it effectively. The facility must demonstrate that all procedures are adequately documented and that testing, handling of materials, quality records, training, and correct use of statistics must be demonstrated. The key to the success of the process is a system of audits whereby periodic internal audits are conducted to determine system compliance. Corrective action must be implemented whereby the system is corrected and continuous improvement attained. To maintain registration each facility is required to meet improved standards as they are promulgated by the ISO organization. There are many effective quality management systems. ISO has elements which build in effective monitoring and continuous improvement. Registration not only represents a guarantee of a well-defined standard of quality but it provides a quality system that is readily audited.

1 1994, M.H.Gerardi, Wastewater Biology, The Life Processes

Novozymes Biologicals, Inc. 111 Kesler Mill Road Salem, VA 24153

Laws, regulations and third party rights may prevent customers from importing, processing, applying and/or reselling certain products in a given manner. It is the responsibility of the customer that their specific use of products of Novozymes does not infringe relevant laws and regulations and, furthermore does not infringe patents or other third party rights. The contents of this document are subject to change without further notice. BI-CHEM ® is a registered trademark of Novozymes Biologicals, Inc. Revised 04/02/02 Novozymes Biologicals, Inc.

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