Compliance Reporting

Requify supports automated compliance reporting for four major ISO standards. Easily generate comprehensive compliance reports that track your organization's adherence to industry standards and regulatory requirements.

Dashboard view

Supported Standards

ISO 14971 - Medical Device Risk Management

ISO 14971 is the international standard for the application of risk management to medical devices. This standard establishes a framework for identifying, analyzing, evaluating, and controlling risks associated with medical devices throughout their lifecycle.

What ISO 14971 looks for:

  • Systematic risk management processes
  • Risk analysis documentation
  • Risk evaluation and acceptability criteria
  • Risk control measures implementation
  • Post-production risk monitoring
  • Risk management file maintenance

Report Generation: Our application generates ISO 14971 compliance reports based on risk analysis completion. The system evaluates the completeness and quality of your risk management documentation to determine overall compliance status.

ISO 13485 - Medical Device Quality Management

ISO 13485 specifies requirements for a quality management system specifically designed for medical device organizations. It ensures consistent design, development, production, and delivery of medical devices that are safe for their intended use.

What ISO 13485 looks for:

  • Quality management system documentation
  • Management responsibility and resource management
  • Product realization processes
  • Design and development controls
  • Risk management integration
  • Regulatory compliance verification
  • Corrective and preventive action systems

Report Generation: ISO 13485 compliance is calculated using a weighted formula:

  • 40% Reviews - Documentation reviews and management assessments
  • 30% Tests - Verification and validation testing activities
  • 30% Risk Management - Risk analysis and mitigation processes

ISO 9001 - Quality Management Systems

ISO 9001 is the world's most recognized quality management standard, providing a framework for organizations to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements.

What ISO 9001 looks for:

  • Customer focus and satisfaction
  • Leadership and engagement
  • Process approach implementation
  • Evidence-based decision making
  • Continuous improvement culture
  • Stakeholder relationship management
  • Performance monitoring and measurement

Report Generation: ISO 9001 compliance is determined through:

  • 50% Reviews - Quality system reviews and audits
  • 30% Tests - Product and process testing validation
  • 20% Risk Management - Risk-based thinking and mitigation

ISO 27001 - Information Security Management

ISO 27001 is the international standard for information security management systems (ISMS). It provides a systematic approach to managing sensitive company information and ensuring data remains secure through people, processes, and technology controls.

What ISO 27001 looks for:

  • Information security risk assessment
  • Security control implementation
  • Incident management procedures
  • Business continuity planning
  • Access control and user management
  • Security awareness and training
  • Regular security audits and reviews
  • Compliance monitoring

Report Generation: ISO 27001 compliance assessment focuses on:

  • 60% Risk Management - Information security risk identification and treatment
  • 40% Security Approvals - Implementation and verification of security controls

Example Standard View

This is what an example project looks like for ISO 9001:

Generating Compliance Reports

Each compliance report provides:

  • Overall compliance percentage based on the standard-specific criteria
  • Detailed breakdown of contributing factors and their scores
  • Gap analysis highlighting areas needing attention
  • Actionable recommendations for improving compliance
  • Export capabilities for audit and regulatory submissions
Last update at: 08/11/2025