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.
- 01APPLICATIONSCOPE AND MAN-DAYS DEFINED UP FRONT
- 02AUDITFINDINGS EXPLAINED AS THEY ARE FOUND
- 03INDEPENDENT REVIEWYOUR REVIEWER IS NEVER ON YOUR AUDIT
- 04DECISIONAN INDEPENDENT CERTIFICATION DECISION
- 05CERTIFICATEISSUED, SEALED, ENTERED IN THE REGISTER
WHAT WE AUDIT · IND-05
What the audit covers.
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 · QSI E-PROFILE
PUBLISHED MARKS
Marks in this sector.
Healthcare and government marks from the published roster. Historical marks, not testimonials.
SECTOR QUESTIONS
Frequently asked questions.
Common questions from this sector, answered directly.
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.
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.
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
Discuss healthcare certification with a lead auditor.
Get the standard, the scope and the man-days confirmed by a lead auditor before you commit.