ISO 13485:2016 · Medical device quality management
ISO 13485:2016 certification
ISO 13485 is written for the medical device sector and is referenced by regulators and notified bodies worldwide. It requires a quality management system with documented design controls, risk management and traceability.
Who ISO 13485 suits
- Medical device manufacturers and contract manufacturers.
- Suppliers of components, packaging or services to device makers.
- Organizations preparing for regulatory registration or notified body assessment.
What the standard requires
Quality management system
Documented system, medical device file and control of documents and records.
Management responsibility
Quality policy, management review and defined authority for regulatory matters.
Design controls
Design inputs, outputs, review, verification, validation and transfer.
Purchasing and production
Supplier evaluation, process validation, cleanliness and installation activity.
Risk management
Risk management applied across the product lifecycle, linked to ISO 14971.
Post-market
Complaint handling, adverse event reporting, CAPA and advisory notices.
At a glance
Standard
ISO 13485:2016
Category
Medical device quality management
Indicative fee
From $6,500 for coordination support. Certification body audit fees are quoted separately.
Certification cycle
Three years, with surveillance audits at approximately 12 and 24 months.
Issued by
An authorized certification body. Northbridge coordinates the programme and maintains the register.
Need this standard?
Send the contract clause or questionnaire item that triggered the requirement. We will confirm fit before you commit.
What we prepare with you
Device file and design history
Design controls and the medical device file assembled to the level a notified body expects.
Process validation
Validation protocols and reports for special processes, plus cleanroom and environmental monitoring where applicable.
CAPA and complaints
A functioning corrective action system with evidence of effectiveness checks.
Audit sequence
Stage 1 readiness review
The certification body reviews documentation and readiness, and agrees the Stage 2 plan.
Stage 2 audit
On-site or hybrid assessment of implementation and evidence against the standard.
Findings and correction
Nonconformities are closed with root-cause analysis and evidence of correction.
Decision and registration
On a positive decision the certificate is issued and published in our public register.
ISO 13485 questions
Does ISO 13485 replace regulatory approval?
No. ISO 13485 certification is a quality system certification. Market access still depends on the applicable regulatory pathway, such as FDA clearance or an EU MDR certificate.
Is ISO 13485 accepted by notified bodies?
It is widely used as the quality system basis for regulatory submissions, but the notified body issues its own certificate under the applicable regulation.
Do distributors need certification?
Some distributors and importers do maintain ISO 13485 systems where they take on storage, labelling or repackaging responsibilities. Scope determines applicability.
How does ISO 14971 fit?
ISO 14971 is the risk management standard referenced by ISO 13485. Your risk management file is part of the evidence assessed.
Scope ISO 13485 for your organization
Tell us your sites, headcount and target date. You will receive a written scope, audit-day estimate and fee within one business day.
Related standards: ISO 9001:2015 · ISO/IEC 27001:2022