ISO 13485 vs EN 1090
ISO 13485
International standard for medical device quality management systems
EN 1090
EU harmonized standard for steel and aluminium structural execution
Quick Verdict
ISO 13485 provides risk-based QMS for global medical device makers to ensure regulatory compliance and patient safety. EN 1090 mandates CE marking via FPC for EU structural steel/aluminium fabricators. Companies adopt them for market access, liability reduction, and operational excellence.
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based controls across device lifecycle stages
- Mandatory medical device files for traceability
- Explicit post-market surveillance and complaints handling
- Process, software, and sterilization validation requirements
- Outsourced processes with written quality agreements
EN 1090
EN 1090 Execution of steel and aluminium structures
Key Features
- Factory Production Control (FPC) certification by Notified Body
- Risk-based Execution Classes (EXC1-EXC4) scaling requirements
- CE marking and Declaration of Performance under CPR
- Welding quality management aligned with ISO 3834
- Material traceability and geometrical tolerance controls
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 13485 Details
What It Is
ISO 13485:2016 is an international certification standard titled "Medical devices – Quality management systems – Requirements for regulatory purposes." It provides a risk-based framework for organizations in the medical device lifecycle, from design to post-market surveillance, ensuring consistent conformity to customer and regulatory requirements.
Key Components
- Organized into Clauses 4–8: QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
- Emphasizes documented procedures, medical device files, validation, traceability, and CAPA.
- Built on process approach with regulatory integration; certification via accredited bodies with stage 1/2 audits.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment effective February 2026).
- Reduces risks like recalls via supplier controls and post-market obligations.
- Builds stakeholder trust, operational efficiency, and competitive edge in global supply chains.
Implementation Overview
- Phased: gap analysis, process design, validation, audits (9–18 months typical).
- Applies to manufacturers, suppliers, distributors; requires eQMS, training, continual improvement.
EN 1090 Details
What It Is
EN 1090 is a family of European harmonized standards (EN 1090-1, -2, -3) for the execution and conformity assessment of steel and aluminium structural components and kits. It implements the EU Construction Products Regulation (CPR), enabling CE marking through a risk-based approach via Execution Classes (EXC1-EXC4).
Key Components
- **EN 1090-1Conformity assessment, Factory Production Control (FPC) certification, Declaration of Performance (DoP).
- **EN 1090-2/-3Technical rules for steel/aluminium execution (materials, welding, tolerances, inspection, corrosion protection).
- Core principles: Risk-scaled controls linking consequence class, service category, production category.
- Notified Body certification with ongoing surveillance.
Why Organizations Use It
- Mandatory for EU market access via CE marking.
- Reduces liability, ensures traceability, improves weld quality.
- Builds trust with stakeholders, enables high-risk projects.
Implementation Overview
- Phased: Gap analysis, FPC design, personnel training, NB audits.
- Applies to fabricators in construction; scales by size/EXC.
- Requires FPC certification, welding coordinator, ISO 3834 alignment. (178 words)
Key Differences
| Aspect | ISO 13485 | EN 1090 |
|---|---|---|
| Scope | Medical device QMS lifecycle from design to post-market | Structural steel/aluminium execution and conformity assessment |
| Industry | Medical devices, global manufacturers and suppliers | Construction, EU steel/aluminium structural fabricators |
| Nature | Voluntary certification standard for regulatory alignment | Harmonized standard mandatory for EU CE marking |
| Testing | Internal audits, process validation, certification body audits | FPC certification, ITT/ITC, notified body surveillance |
| Penalties | Loss of certification, market access barriers | Market exclusion, legal enforcement under CPR |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 13485 and EN 1090
ISO 13485 FAQ
EN 1090 FAQ
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