ISO Certification for Diagnostic Imaging Services and How Pacific Certifications can help

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:

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