ISO certification for Diagnostic Imaging Services and how Pacific Certifications can help

For diagnostic imaging services, achieving ISO certifications are critical for demonstrating compliance with international best practices, enhancing operational effectiveness, and building trust with stakeholders and patients. Here are some relevant ISO standards for diagnostic imaging services and how we at Pacific Certifications can assist in the audit and certification process:

Relevant ISO Standards for Diagnostic Imaging Services

ISO 9001:2015 - Quality Management Systems

  • This is a general standard applicable to any organization that wants to establish, improve, or maintain a quality management system to enhance customer satisfaction. For diagnostic imaging services, ISO 9001 can help ensure consistent quality in services provided.

ISO 13485:2016 - Medical Devices - Quality Management Systems

  • Specifically designed for organizations involved in the design, production, installation, and servicing of medical devices, including diagnostic imaging equipment. This standard focuses on meeting regulatory requirements and managing risks associated with medical device manufacturing and services.

ISO 15189:2012 - Medical Laboratories - Requirements for Quality and Competence

  • Although more commonly associated with medical laboratories, ISO 15189 can also apply to diagnostic imaging services that involve laboratory-like operations. It covers aspects like test validation, staff qualifications, equipment calibration, and patient safety.

ISO 27001:2022 - Information Security Management

  • Essential for diagnostic imaging services that manage sensitive patient data. This standard helps protect digital images and patient data from security threats, ensuring confidentiality, integrity, and availability of information.

Click here to find out more applicable standards to your industry

How we can Assist

Audit Preparation:

  • Gap Analysis: Conduct a preliminary assessment to identify gaps in your current management system that need attention to meet the chosen ISO standard requirements.
  • Documentation Review: Help ensure that your documentation meets ISO standards, including quality manuals, SOPs, and quality records.

Certification Process:

  • Stage 1 Audit: Evaluate your readiness for certification by assessing the documented management systems against the ISO standard requirements.
  • Stage 2 Audit: A more detailed and thorough assessment, including an on-site audit, to verify that your operational practices conform to both your documented systems and ISO standards.

Post-Certification Support:

  • Surveillance Audits: Conduct regular audits to ensure ongoing compliance with the ISO standards and continuous improvement of the system.
  • Re-certification: Assist with the re-certification process every three years to ensure your certification remains valid and reflects any changes in ISO standards or business processes.

We ensure that all aspects of the operation meet international standards and demonstrating a commitment to excellence and continuous improvement in healthcare services.

Requirements & benefits of ISO certification of Diagnostic Imaging Services

To achieve ISO certification, a diagnostic imaging service must comply with several key requirements, which may vary slightly depending on the specific standard (e.g., ISO 9001, ISO 13485, ISO 15189):

Quality Management System (QMS) Implementation:

  • Establish, document, implement, and maintain a QMS and continually improve its effectiveness in accordance with the requirements of the chosen ISO standard.

Leadership and Commitment:

  • Top management must demonstrate leadership and commitment to the QMS by ensuring the integration of the system requirements into business processes, providing resources, and promoting continual improvement.

Customer Focus:

  • Ensuring that customer and applicable statutory and regulatory requirements are determined, understood, and consistently met.

Risk Management:

  • Especially for ISO 13485, there is a need to apply a risk management process to all stages of product design, development, manufacturing, and deployment.

Process Control and Operational Planning:

  • The organization must effectively plan, implement, and control the processes needed to meet requirements for the provision of services.

Performance Evaluation:

  • This includes monitoring, measurement, analysis, and evaluation of the effectiveness of the QMS. Diagnostic imaging services must establish what will be monitored, the methods for doing so, and the criteria against which success will be judged.


  • Identifying nonconformities and taking corrective actions is a fundamental requirement, as is the ongoing focus on enhancing the QMS based on performance data and outcomes.

Benefits of ISO Certification

Enhanced Regulatory Compliance:

  • Certification helps ensure compliance with industry-specific regulatory requirements, which is crucial for medical and diagnostic services.

Improved Quality of Services:

  • The process of achieving and maintaining ISO certification requires facilities to streamline their processes and ensure high-quality outputs, thereby directly improving the service quality provided to patients.

Increased Patient Trust:

  • Certification is often seen as a mark of credibility and reliability, which can enhance patients' trust in the safety and quality of the imaging services they receive.

Operational Efficiency:

  • ISO standards help in defining clear protocols for all operational processes, reducing the scope for errors and increasing efficiency, which can lead to cost savings.

Market Differentiation:

  • Being ISO certified can distinguish a facility from competitors, showcasing a commitment to maintaining global standards.

Enhanced Risk Management:

  • With a focus on continual improvement and proactive risk management, ISO standards help diagnostic imaging services predict and mitigate potential risks before they become critical.

Data Security Improvement:

  • For standards like ISO 27001, implementing strong information security management systems protects patient data, an increasingly critical concern in the digital age.

We at Pacific Certifications can assist diagnostic imaging services through the entire process of obtaining ISO certification from initial consulting and gap analysis to final audits and ongoing compliance checks.

Pacific Certifications is accredited by ABIS, in case you need support with ISO certification for your Diagnostic Imaging Service business, please contact us at support@pacificcert.comor +91-8595603096

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