Standards supported
Colleag.ai provides compliance support for ISO 9001 (quality management), ISO 13485 (medical devices), IEC 61508 (functional safety), ISO 26262 (automotive), ISO 14001 (environmental), and industry-specific standards. The system maps your product requirements to relevant standard clauses and monitors compliance status.
Compliance as part of daily engineering work
Instead of preparing for audits in a rush, compliance is maintained continuously. When an engineer makes a design change, the system checks which standards are affected and whether the change creates compliance gaps. This catch-early approach is less expensive and less disruptive than discovering gaps during audits.
Documentation that satisfies auditors
Standards require specific documentation with specific traceability. Colleag.ai generates and maintains this documentation as part of normal engineering work. Traceability matrices, design history files, verification and validation records, and change management documentation are always current and always complete.
Staying current with standard revisions
Standards evolve. When a new revision of an applicable standard is released, Colleag.ai helps teams identify what has changed and which products or processes need updating. This prevents compliance drift that accumulates between audits.
Key benefits
- Compliance monitoring for ISO 9001, ISO 13485, IEC 61508, and more
- Automatic gap detection when design changes affect compliance
- Traceability documentation maintained continuously
- Audit-ready documentation without last-minute preparation
- Standard revision tracking and impact assessment
- Reduced cost and disruption of compliance maintenance