Abstract Background The Maltese Department for Health Regulation sought the support of the Dutch National Health Care Institute in drafting acute hospital standards and in training respective inspectors in applying those standards. The aim was to create SMART standards for public and private hospitals thereby diminishing preventable suffering and waste. Objectives The project started in 2018 with a situational analysis of Maltese hospital care and of training needs, followed by interactive workshops with key stakeholders, and the subsequent development of draft standards. Due to COVID-19, the work was curtailed during 2020-2021. Over the course of 2022 draft standards have been finalized, a three-day training was delivered including mock inspections of Dutch hospitals, followed by a final session in January 2023 in which the inspectors received feedback from the Dutch faculty on their use of the draft standards in the Maltese setting. Results The licensing standards describe tasks and responsibilities of hospital leadership with respect to quality and safety, as well as reporting structures such as key performance indicators, and incidents that affect patient care. The training focused on the importance of Safety-II regulation. Interviews took place to explore inspectors’ experiences. Inspectors reported that using these standards facilitates open communication. They are in a better position to enter into a more meaningful and constructive dialogue with hospital management and professionals on how they can safeguard quality of care. Conclusions During the development of the hospital standards and the training, inspection team members have gained a clear vision on their role and position towards healthcare providers, and of their responsibilities in stimulating proactive quality and safety management and a learning culture in Maltese hospital care. The standards outline will support the licensing authority to protect patient safety through a collaborative regulatory approach. Key messages • The interactive work ...