BackgroundQuality in healthcare is a fundamental pillar of health systems performance, leading to improved health outcomes and reduced waste. The World Health Organization recommends that countries establish a national quality policy and strategy (NQPS) to steer the provision of safe and high-performing healthcare services and foster a quality culture. This paper describes the development process and key content of Malaysia’s new 5-year National Policy for Quality in Healthcare.MethodsThe development process was managed by a technical working group led by the Institute for Health Systems Research in the Ministry of Health. Situational analysis was conducted through a multi-pronged approach, underpinned by a review of the past and present healthcare sectoral and quality plans and guided by the WHO NQPS framework. This approach involved: (i) review of quality-related policy documents, (ii) online surveys of healthcare providers and the public, (iii) key-informant facilitated discussions and (iv) mapping of existing quality improvement initiatives (QIIs). Data gathered from these approaches informed the content of the new policy. Following thematic analysis, the findings were grouped into specific domains, which were then organized into a strengths, weaknesses, opportunities, and threats (SWOT) framework. ResultsTen key areas of concern identified were (i) a people-centred holistic approach, (ii) governance for quality, (iii) resources, (iv) quality culture, (v) stakeholder engagement, (vi) health management information system, (vii) workforce competency, (viii) knowledge exchange, (ix) quality indicators and (x) monitoring and evaluation of quality activities. These led to the formulation of seven strategic priorities for the planning of improvements aimed at addressing the key areas of concern. The national definition of quality was affirmed. A total of 40 QIIs were mapped and grouped into three broad categories, namely (i) regulatory, (ii) domain-specific QIIs and (iii) Quality Improvement (QI) method.ConclusionsThe National Policy for Quality in Healthcare for Malaysia was developed through a comprehensive situational analysis using a multi-method approach that identified priorities across national, state, institutional and community levels. This evidence-informed approach led to meaningful contextual adaptation of the NQPS framework to shape the strategic direction to advance quality and achieve effective and safe outcomes for all Malaysians.