05 April 2005

The Quality Management System

In May 2005 Quansys Biosciences became ISO 9001:2000 registered. We were able to show commitment to the proper implementation and maintenance of a Quality Management System. The following Quansys Quality Policy is the statement of our commitment to customers and the quality management system.

“Quansys Biosciences is committed to providing high quality – low cost products, developing the company and its employees, maintaining high levels of customer satisfaction, and complying with and continually improving the quality management system.”

Using the Quality Policy, Quality Objectives were created to act as standards allowing the company to measure the progress and effectiveness of the quality management system. Each objective is listed and explained below.

Produce high quality product -100% of the product has passed Quality Assurance testing. All the products offered by Quansys have undergone extensive quality testing. Every component of each kit has been tested and compared with controls to ensure that the components meet or exceed performance specifications. Following individual testing, the components are tested together to ensure all the components within an assay kit work together and meet performance specifications.

Produce low cost products – Where competitors exist, the cost per data point of the assay will be lower than competitors. A goal of Quansys Biosciences is to lower the cost of biological research. Therefore, we are constantly trying to find innovative ways to reduce costs while maintaining the high quality of the products.

Develop employees – 100% of employees are trained and competent in their responsibilities and procedures. Employees are trained extensively upon initial employment and must pass assay competency tests before they are permitted to work with any product. Training and testing is done regularly within each department after the initial training to ensure all employees are still able to follow proper protocols and procedures and to meet requirements. Employees are encouraged to expand their critical knowledge base by furthering their education through different types of research.

Maintain high levels of customer satisfaction – Periodic surveys are sent to customers to assess their satisfaction. Surveys are read over and discussed by top management to ensure the company is doing everything possible to maintain high levels of customer satisfaction customer satisfaction. Customer complaints are taken very seriously and regarded as an important way to improve the company and its products.

Continual improvement of the quality system – Ensure 100% of corrective and preventative actions are closed within the due date. Corrective and preventative actions are generated through customer complaints, customer surveys, internal/external audits, quality testing, management reviews, or other observations. The root cause and plan are determined for each corrective or preventative action, and measures are taken to make the appropriate changes. The results are observed to ensure the effectiveness of the actions. Corrective and preventative actions are dealt with promptly to avoid further problems and to ensure that the quality system is constantly being improved.

The quality objectives are the goals or standards that Quansys Biosciences use to maintain the quality management system. Progress towards meeting the objectives is carefully and constantly monitored. Results of quality objective measurements are reported to top management in management review meetings, where findings are discussed and improvement is the top priority. The quality management system was implemented to help Quansys Biosciences determine and be more aware of customer’s needs, and to help meet the customers’ expectations.