The quality standard for the medical-device sector. We audit your device QMS against ISO 13485 and, on the evidence, issue certification — independently of the audit team.
ISO 13485:2016 sets the requirements for a quality management system specific to medical devices: risk management, design controls, traceability, and regulatory alignment across the device life cycle.
As an independent certification body, Skyeblanc Certification audits your medical-device quality management system against ISO 13485 and, where the evidence supports conformity, issues certification. We do not design, document or improve your system — that separation is a requirement of ISO/IEC 17021-1 and is exactly what gives a ISO 13485 certificate its meaning.
Certification is delivered under ISO/IEC 17021-1, with the certification decision made by an independent decision-maker who did not conduct your audit.
The same defined path for every applicant — the certification decision held independent of the audit team.
A readiness review of your documented QMS, scope and objectives, and audit planning.
On-site or ICT-assisted assessment of the QMS in operation against ISO 13485.
An independent decision-maker reviews the evidence and grants — or declines — certification.
Annual surveillance audits, then a full recertification at year three renews the cycle.
Audit duration for ISO 13485 is determined per IAF MD5 — never a flat rate. The main factors:
The number of people — including shifts and part-time — is the primary driver of audit duration.
How many sites and where. Multi-site sampling follows IAF MD1.
The range of activities and processes within your certified scope.
Operations across multiple shifts can extend on-site audit time.
Transfers from another accredited body are reviewed under IAF MD2.
On-site or ICT-assisted remote auditing per IAF MD4, matched to risk.
Fees are fixed for the defined audit programme. A fixed fee covers the audit; it never buys an outcome — certification is granted only on the evidence, by an independent decision-maker.
ISO 13485 applies across the medical-device supply chain and its regulatory environment. We routinely audit across:
Tell us your scope, sites and employee numbers, and we'll return a fixed-fee audit quotation with the programme and timeline.
Prefer pricing first? Request an audit quotation →
