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ISO 15189 Plus™ Diagnostic Imaging Accreditation

Requirements for the Diagnostic Imaging accreditation program are based on the following standards:

• ISO 15189:2012 Medical laboratories — Requirements for quality and competence
• ISO 15190:2020 Medical laboratories — Requirements for safety
• ISO 22870:2016 Point-of-care Testing (POCT) — Requirements for Quality and Competence
• CSA Z314.8-14 Decontamination of reusable medical devices

​Requirements for accreditation are grouped into sections for ease of preparation and assessment:

• Organizational Structure, Personnel Policies and Training, and Management
• Quality Management System
• Physical Facilities
• Equipment and Supplies
• Pre-examination Process
• Examination Process
• Quality Assurance
• Post-examination Process (Reporting)
• Information System including Picture Archiving Communications Systems
• Safety
• Point-of-Care Testing (Limited)

Modality-specific technical detail is incorporated within the requirements as “What To Look For” guidance, and represents application of the requirements to individual modality practice. This modality specific information encompasses key details that the peer assessors will consider, but it should not be considered all-inclusive. Individual assessors apply their own knowledge and expertise when assessing whether a facility meets requirements.

Modality-specific guidance is provided for the following:

• Bone Densitometry
• Computed Tomography Scanning
• General Radiography
• Interventional Radiography
• Mammography
• Magnetic Resonance Imaging
• Nuclear Medicine
• Position Emission Tomography
• Tele-mammography
• Tele-radiography 
• Ultrasound

• Accreditation Program Information (Renseignements sur les programmes d’accréditation)
• Accreditation Position Statements
• Guidance for Creating a Diagnostic Service Quality Manual (Conseils pour la création d’un manuel qualité pour service de diagnostic)
• Participant Steps to Accreditation
• Benefits of ISO 15189 Plus