Background and objectives: Identifying the readiness of hospital and its strengths and weaknesses can be useful in developing appropriate planning and situation analyses and management to getting effective in clinical audit programs. The aim of this study was to design and assess the validity of the Hospital Readiness Assessment Tools to conduct quality improvement and clinical audit programs.

Material and Methods: In this study, based on the results of a systematic review of literature, an initial questionnaire with 77 items was designed. Questionnaire content validity was reviewed by experts in the field of hospital management and quality improvement in Tabriz University of Medical Sciences. For this purpose, 20 questionnaires were sent to experts. Finally, 15 participants returned completed questionnaire. Questionnaire validity was reviewed and confirmed based on Content Validity Index and Content Validity Ratio. Questionnaire reliability was confirmed based on Cronbach's alpha index (α = 0.96) in a pilot study by participation of 30 hospital managers.

Results: The results showed that the final questionnaire contains 54 questions as nine category as: data and information (9 items), teamwork (12 questions), resources (5 questions), patient and education (5), intervention design and implementation (5 questions), clinical audit management (4 questions), human resources (6 questions), evidence and standard (4 items) and evaluation and feedback (4 items). The final questionnaire content validity index was 0.91 and final questionnaire Cronbach's alpha coefficient was 0.96.

Conclusion: Considering the relative good validity and reliability of the designed tool in this study, it appears that the questionnaire can be used to identify and assess the readiness of hospitals for quality improvement and clinical audit program implementation