Market access
A foundation for EU, US and other regulatory submissions and audits.
Certification support
ISO 13485 Medical Device Quality Management
Current edition: ISO 13485:2016 (reconfirmed)
The quality management standard for organisations across the medical device life cycle. Regulators use it as the basis for quality system requirements, so a working system supports both certification and market access.
2016Current edition
ISO 13485:2016 remains current
ISO 13485:2016 was reconfirmed at its systematic review, and the US FDA Quality Management System Regulation incorporates it by reference from February 2026. A system built to ISO 13485:2016 now supports both certification and US regulatory compliance.
What the standard covers
Requirements, clause by clause
ISO 13485 keeps a structure close to ISO 9001:2008 and adds requirements driven by medical device regulation.
4
Quality management system
Documentation, medical device files, validation of QMS software, control of records.
5
Management responsibility
Commitment, quality policy, objectives, management review.
6
Resource management
Competence, infrastructure, work environment and contamination control.
7
Product realisation
Risk management, design and development, purchasing, production, sterilisation, traceability.
8
Measurement and improvement
Feedback, complaints, regulatory reporting, internal audit, CAPA.
Risk management across product realisation is applied in line with ISO 14971.
Why organisations implement it
What ISO 13485 delivers
Supplier approval
Device manufacturers commonly require certified suppliers of components and services.
Controlled design
Design and development controls produce the evidence regulators expect.
Traceability
Product and component traceability that supports recalls and field actions.
Effective CAPA
Complaints, nonconformities and trends turned into corrective action.
Inspection readiness
A system that holds up to notified body and regulator inspections.
How we work
Path to certification
One AEC methodology from first assessment to certificate, delivered by registered lead auditors.
- AssessGap assessment against ISO 13485, scope and roadmap
- DesignProcesses, risk register, policy and documented information
- ImplementProcesses embedded with coaching for process owners
- TrainAwareness for all staff and internal auditor development
- VerifyInternal audit, management review and mock certification audit
- Certify & sustainStage 1 and Stage 2 support, then surveillance readiness
Full implementation
No existing system. We design and implement from the ground up.
Typically 9 to 12 monthsGap remediation
Some documentation in place. We close the gaps and prove effectiveness.
Typically 6 to 9 monthsUpgrade & integration
We extend your ISO 9001 system with device-specific requirements.
Typically 4 to 6 months
Who certifies
Independent certification and regulatory assessment
ISO 13485 certificates are issued by accredited certification bodies. Where EU MDR or IVDR requires notified body involvement, the quality system is assessed as part of the notified body's conformity assessment. AEC prepares you for these audits; the decisions are theirs.
CB-neutral
We help you select a certification body or notified body suited to your devices and markets.
Audit-ready
Mock audit, technical records review and closed CAPAs before the certification audit.
No guarantees
We prepare you thoroughly and never promise an outcome only an independent assessor can decide.
Case study
ISO 13485 in practice
Healthcare & packaging · USA
DuPont Spectrum
ISO 13485:2016 · 2021 · 12 months · 13 sites in 10 states
1stAttempt
0Major NCs
13Sites
The challenge
Bringing 13 sites under one medical-device quality system: controlling design files, purchasing, complaints and CAPA records, qualifying suppliers across a complex supply chain, and keeping practice consistent site to site.
What AEC did
Multi-site gap assessment, harmonised QMS documentation and records, design, purchasing, complaints and CAPA processes, supplier qualification, risk management, site training, multi-site internal audits and management review, and certification audit support.
Certified at first attempt, no major nonconformities. ISO 13485 opened access to medical device makers that require certified suppliers.
Where it applies
ISO 13485 by industry
Healthcare · device manufacturers and contract manufacturers
Manufacturing · components, packaging and sterilisation services
Transport & logistics · medical device distribution and storage
Related standards
Training Academy
View ISO 13485 courses
ISO 13485 training
Delivered by practising, registered lead auditors. In-house, public, virtual or hybrid.
- Awareness (half day) for all staff
- Implementer (2 to 3 days) for system owners
- Internal Auditor (2 to 3 days) in line with ISO 19011
Questions
ISO 13485 FAQ
Does AEC issue the ISO 13485 certificate?
No. Certificates are issued by accredited certification bodies, and EU MDR or IVDR assessments are carried out by notified bodies. AEC prepares your organisation for those audits.
Is ISO 13485 being revised?
ISO 13485:2016 was reconfirmed at its systematic review and remains the current edition. The US FDA Quality Management System Regulation incorporates it by reference from February 2026.
We hold ISO 9001. Is that enough for medical devices?
Usually not. ISO 13485 adds requirements for risk management, design controls, sterile and implantable devices, traceability and regulatory reporting that ISO 9001 does not cover. Your ISO 9001 system is a good base for the upgrade.
Do suppliers to device manufacturers need ISO 13485?
Often, yes. Many device manufacturers require certified suppliers for critical components, packaging and services. We scope the system to the activities your customers rely on.
Start your ISO 13485 programme
Tell us your devices, sites and markets. We reply with a proposal covering gap assessment, implementation, training and certification support.
Certification decisions are made by independent, accredited certification bodies. AEC prepares organisations for certification and does not guarantee certification outcomes.