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 by 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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