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Background: High profile failures of care in the NHS have raised concerns about regulatory systems for health-care professionals and organizations. In response, the Care Quality Commission (CQC), the regulator of health and social care in England overhauled its regulatory regime. It moved to inspections which made much greater use of expert knowledge, data and views from a range of stakeholders, including service users., Objective: We explore the role of service users and citizens in health and social care regulation, including how CQC involved people in inspecting and rating health and social care providers., Design: We analyse CQC reports and documents, and 61 interviews with CQC staff and representatives of groups of service users and citizens and voluntary sector organizations to explore the place of service user voice in regulatory processes., Results: Care Quality Commission invited comments and facilitated the sharing of existing service user experiences and engaged with representatives of groups of service users and voluntary sector organizations. CQC involved service users in their inspections as "experts by experience." Information from service users informed both the inspection regime and individual inspections, but CQC was less focused on giving feedback to service users who contributed to these activities., Discussion and Conclusions: Service users can make an important contribution to regulation by sharing their experiences and having their voices heard, but their involvement was somewhat transactional, and largely on terms set by CQC. There may be scope for CQC to build more enduring relationships with service user groups and to engage them more effectively in the regulatory regime., (© 2018 The Authors. Health Expectations published by John Wiley & Sons Ltd.)