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monipol has taken the decision to become registered ISO 9001:2000

	This ISO Standard is an international quality standard. This includes measures to enhance costumer satisfaction by meeting customer and applicable regulatory requirements ansto improve continously its performance.

Quality Management does mean:

• Quality is managed, actively controlled
• Quality is in the responsibility of Management

Quality Management is defined in ISO 9000:2000 § 3.2.8 as: "Coordinated activities to direct and control an organization with regard to quality."

The TÜV certification audit was completed on 26.08.2004. However monipol will be continuously supervised by yearly follow up aufits to achieve re-certification in 2007.

What can you expect from monipol under this new perspective?

• monipol has a set of tools in place to manage your project within realistic timelines
efficiently in a GCP compliant Polish enviroment.

• monipol has a communication system in place to ensure Good Communication Practise between you as a customer and our staff

• monipol addresses its standards to its Vendors in order to improve cooperation and quality of service. This includes Investigators, Translating Bureau, Clinical Laboratory and Courier Service.

• monipol takes all efforts to improve its own Quality System by regular Quality check and internal audits. A permanent QM position is established.

• monipol takes care to manage and react on compliants/findings by our Sponsors in a way that preventive actions are taken as a consequence.

• monipol improve quality awareness by internal (monipol staff) and external customers (Sponsors)

Which new elements are implemented within the monipol system as result of the ISO9001:2000 certification process?

A Quality Management Manual describes the system and is available in Polish and English language.

New Standard Operation Procedures and Forms were developed to implement General Management procedures such as:

• Internal Communication

• Data analysis (to document the efficacy of monipol's quality system by figures)

• Purchase of services and products

• Client satisfaction