FAQ
Is ISO 13485 audited like ISO 9001?
The discipline is similar but the standard adds device-specific requirements: risk, traceability, sterile barriers and regulatory files carry real weight.
// sector.file · IND-05
Healthcare
Hospitals, device suppliers and health services carry quality, traceability and data obligations at the same time. The audit follows the patient-facing risk, wherever the record lives.
// what.we.audit
Where the auditors actually look.
Device quality files
Design, production and traceability records for medical devices and their suppliers.
Clinical support processes
Sterilisation, hygiene, maintenance and the controls behind safe service delivery.
Information security
Access, confidentiality and continuity controls where patient and business data live.
Supplier qualification
How critical suppliers and outsourced services are approved and monitored.
Regulatory records
The documentation trail regulators and buyers will ask for, kept audit-ready.
IND-05 // PROOF · E-PROFILE PUBLISHED FIGURES, WHOLE REGISTER
850+
BRANDS CERTIFIED
4K+
AUDITS CONDUCTED
3K+
TRAININGS DELIVERED
20+
YEARS OPERATING
// published.marks
On the roster.
Healthcare and government marks from the published roster. Historical marks, not testimonials.
Ministry of HealthKing Salman HospitalKing Fahad Medical CityDallah HospitalsHikmaAljeel
// sector.questions
Questions this sector asks.
Straight answers, because the audit will find the truth anyway.
FAQ
Can data security be added to a quality scope?
ISO 27001 is a separate standard with its own audit, but integrated planning is possible when the systems overlap.
FAQ
Do you audit public-sector bodies?
The published roster includes government and public-health organisations. The audit rules are the same for everyone.
// scope.this.sector
Scope your sector with an auditor who has walked it.
Get the standard, the scope and the man-days confirmed by a lead auditor before you commit.