What is ISO 7101?
ISO 7101 is the first international consensus standard for healthcare quality management. It prescribes requirements for a systematic approach to sustainable, high quality health systems, enabling organizations of any scale, structure, or region to:
- Create a culture of quality by starting with strong top management.
- Embrace a healthcare system rooted in people-centered care, respect, compassion, co-production, equity, and dignity.
- Proactively identify and address risks.
- Ensure the safety and well-being of both patients and the workforce.
- Control service delivery through documented processes and information.
- Monitor and evaluate clinical and non-clinical performance.
- Continually improve processes and results.
Benefits of ISO 7101
- Refined quality of healthcare delivery.
- Improved patient safety.
- Cost-efficiency.
- Enhanced operational effectiveness.
- Strengthened reputation and extended market reach.
Implementing ISO 7101
- Understand the Standard: Review the standard and train key staff.
- Conduct a Gap Analysis: Assess current practices and identify gaps.
- Develop an Implementation Plan: Define objectives and create a roadmap.
- Engage Leadership: Secure management commitment and allocate resources.
- Design and Document Processes: Develop policies and control documentation.
- Implement Processes: Roll out new processes and train staff.
- Monitor and Evaluate Performance: Establish metrics and conduct reviews.
- Address Non-Conformities: Identify and rectify issues.
- Promote Continuous Improvement: Use feedback and data for ongoing improvements.
- Prepare for Certification: Conduct internal audits and engage a certification body.
- Maintain Compliance: Continue monitoring and periodic reviews.