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Management systems for quality in healthcare organizations

What is this standard about?

ISO 7101 is the first international standard dedicated to healthcare quality management, applicable to organizations of all sizes, structures, and locations. This standard provides a unique framework of requirements tailored for any healthcare system aiming to enhance the quality of its services.

The healthcare industry worldwide is confronting numerous challenges, including workforce shortages, rising inflation amid shrinking financial resources, and an increasing demand for services, particularly due to aging populations. The COVID-19 pandemic has revealed the critical importance of technological healthcare systems and the need for structured management approaches to deliver quality care.

The focus of the standard

ISO 7101 establishes a roadmap for healthcare systems to adopt a systematic approach, informed decision-making, and risk-based thinking. The standard outlines essential requirements designed to guide organizations in:

• Creating a culture of quality
• Embracing people-centered care, with respect, compassion, equity, and dignity
• Identifying and managing risks
• Ensuring the safety of patients and staff
• Controlling service delivery through documented processes
• Continuously monitoring and improving performance

What are the benefits of implementing?

ISO 7101 serves to improve patient safety and wellbeing, reduce costs, iImplementing ISO 7101 can lead to significant improvements in patient safety and well-being, cost reductions, enhanced efficiency, and a stronger reputation and market presence for healthcare systems. The key benefits include:

• Improved quality of healthcare delivery
• Enhanced patient safety
• Better planning for sustainable healthcare services
• Increased operational effectiveness and cost-efficiency
• Strengthened reputation and extended market reach

Organizations can demonstrate conformity to ISO 7101 through self-declaration, validation from interested parties, or obtaining certification from an external organization.