Quality management according to ISO 9001:2008 guidelines includes infertility care quality assessment and improvement. This study aimed to describe the development process of a questionnaire for infertility management. A literature review, qualitative interviews with experts and patients resulted in a content-valid and face-valid questionnaire. Three cross-sectional surveys were performed in 2004, 2007 and 2008 in a tertiary university infertility centre. First (2004), the questionnaire – measuring eight a-priori dimensions of infertility management – was tested. Second (2007), improvement projects for infertility management were evaluated. Third (2008), factor analysis was performed and internal consistency was documented. The developed patient questionnaire to evaluate infertility management and pre-set desired levels of agreement served to set targets for and assess quality improvement projects. The final patient questionnaire to evaluate infertility management within an ISO framework was valid and reliable and contained 14 items covering four dimensions of infertility management: Telephone Access, Reception, Information and Patient-centeredness. ISO 9001:2008-certified infertility centres can evaluate infertility management with this 14-item questionnaire. This top-down approach to evaluate the patients’ perspective on quality aspects selected by health professionals can be complementary to the bottom-up approach evaluating the patients’ complete experiences of quality of care.