ISO 13485
Quality management built specifically for medical device manufacturers.
ISO 13485 takes the quality-management logic of ISO 9001 and rebuilds it around the specific demands of medical devices — risk management under ISO 14971, design controls, sterile-product requirements, and the regulatory traceability that device manufacturers must maintain across the full product lifecycle. It covers everything from design and development input through to production, installation, servicing, and post-market surveillance, with particular weight on documentation that can withstand regulatory scrutiny long after a product has shipped. For manufacturers selling into regulated healthcare markets, certification is frequently a market-access requirement, not an optional quality signal.
How It Works
Tell us about your organisation and its scope — we review fit against the standard and respond with a clear, itemised quotation.
A documentation and readiness review confirming your management system is designed to meet the standard before any on-site assessment begins.
An on-site (or remote, where permitted) assessment of how the system actually operates in practice, checked against every applicable clause.
A reviewer who was not part of the audit team evaluates the findings and makes the certification decision — the impartiality safeguard behind every certificate we issue.
Your certificate is issued with a QR code for instant online verification, valid for three years subject to annual surveillance audits.
Indicative, not exhaustive — your auditor confirms the exact list for your scope during Stage 1.
A ISO 13485:2016 certificate is valid for three years from the date of issue, subject to annual surveillance audits that confirm the management system is still being maintained — not a one-time snapshot. Recertification before the three-year expiry keeps the certificate (and the QR-code verification behind it) current.