Overview
EN 18167:2026 - Quality Along the Patient Pathway for Medical Imaging in Radiology Services is a European standard developed by CEN to define the requirements for implementing a quality system along the complete patient pathway in radiology services. Its primary aim is to ensure high-quality delivery of medical imaging, focusing on both examination safety and patient care. EN 18167:2026 applies to procedures utilizing X-rays, ultrasonography, and magnetic resonance imaging (MRI), encompassing diagnostic and interventional radiology as well as remote practices such as teleradiology. The standard is relevant to all imaging departments and medical imaging organizations, whether standalone or part of larger healthcare facilities.
Key Topics
- Patient Pathway in Medical Imaging:
EN 18167:2026 structures the entire patient journey from the imaging referral, pre-examination preparations, the actual imaging procedure, to post-examination care and reporting.
- Human Resources & Competence:
The standard emphasizes the necessary qualifications, training, and entitlement of radiologists, radiographers, and related professionals to ensure procedural quality and safety.
- Technical and Medical Requirements:
Specifies the requirements for imaging equipment, facility standards, hygiene controls, information systems, and data management to support safe and effective imaging services.
- Quality and Risk Management:
Details best practices for quality management systems (QMS) and risk management within radiology services, including initiatives for continuous improvement and adherence to regulatory requirements.
- Auditing and Best Practice:
Provides a structured framework for internal and external peer audits, positioning the standard as a reference point for the assessment and improvement of clinical and operational processes in medical imaging.
- Scope Limitations:
Excludes radiotherapy, nuclear medicine, equipment and radiation control requirements, and research or educational aspects.
Applications
EN 18167:2026 offers practical value to a variety of healthcare organizations providing radiology and medical imaging services:
- Diagnostic Imaging Centers and Radiology Departments:
By adopting this standard, organizations can systematically manage and monitor every step of the patient care pathway, ensuring compliance with best practices and regulatory requirements.
- Hospital and Healthcare Facility Management:
Supports the establishment of robust quality management systems in medical imaging, facilitating safer and more efficient workflows.
- Remote and Teleradiology Practices:
Ensures that imaging procedures performed remotely or outside dedicated imaging centers, such as in operating theatres or using mobile units, meet consistent quality standards.
- Continuous Quality Improvement:
Provides a comprehensive framework for measuring performance, managing risks, and engaging in periodic audits, all crucial for ongoing enhancement of service quality and patient experience.
- Patient Safety and Satisfaction:
Focuses on transparency, informed consent, and optimization of procedures to minimize risks and improve outcomes.
Related Standards
Organizations implementing EN 18167:2026 may also consider compliance with or reference to the following standards and regulations for a fully integrated management approach:
- EN ISO 9001 - Quality management systems
- EN ISO 9000 - Fundamentals and vocabulary for quality management
- EN 60601 series - Medical electrical equipment safety and essential performance
- Council Directive 2013/59/Euratom - Basic safety standards for protection against exposure to ionising radiation
- EN ISO 15189 - Medical laboratories - Requirements for quality and competence
For radiology services aiming at delivering safe, effective, and patient-centered care, adherence to EN 18167:2026 establishes a respected benchmark for quality along the entire medical imaging patient pathway, supporting compliance, audit-readiness, and continuous improvement in clinical practice.
