The presentation will explain the difference between qualification and validation. The qualification of a cleanroom system is explained. The User Requirement Specification (URS), the Qualification Master Plan (QMP), the Design Qualification (DQ), the Installation Qualification (IQ), the Operational Qualification (OQ) and the Performance Qualification (PQ) will be discussed. The relevant standards and guidelines are presented and the determination of all relevant qualifications by means of a basic risk analysis is explained. Finally, the benefits and advantages of qualification management are discussed.