WELL
Certification standard for building occupant health
ISO 13485
International standard for medical device quality management systems
Quick Verdict
WELL certifies healthy buildings via performance testing for occupant well-being across sectors, while ISO 13485 mandates QMS rigor for medical device safety and regulatory compliance. Companies adopt WELL for ESG appeal and talent attraction; ISO 13485 for market access and liability reduction.
WELL
WELL v2 Building Standard
Key Features
- Mandates on-site performance verification testing
- 10 core concepts for occupant health
- Preconditions mandatory plus optimizations for points
- Bronze-Silver-Gold-Platinum certification tiers
- Supports continuous monitoring pathways
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based QMS controls for device lifecycle
- Design and development validation requirements
- Post-market surveillance and CAPA processes
- Supplier evaluation and outsourcing controls
- Traceability and medical device file mandates
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
WELL Details
What It Is
WELL Building Standard v2 is a performance-based certification framework administered by the International WELL Building Institute (IWBI). It focuses on designing, operating, and verifying buildings to advance human health and well-being. Scope covers new/existing buildings across types like offices, residential, hospitality. Key approach: evidence-based preconditions (mandatory) and optimizations (points-based) across 10 concepts.
Key Components
- **10 core conceptsAir, Water, Nourishment, Light, Movement, Thermal Comfort, Sound, Materials, Mind, Community (+ Innovation).
- 24 Preconditions, 102 Optimizations; total ~110 points max.
- Built on public health/building science research.
- Certification model: tiers (Bronze 40pts, Silver 50, Gold 60, Platinum 80) with concept minimums; requires documentation review + on-site testing.
Why Organizations Use It
Drives occupant productivity, retention, ESG reporting; complements LEED. Mitigates health risks (IAQ, water); boosts rents/values. Builds stakeholder trust via verified outcomes; voluntary but tenant-demanded.
Implementation Overview
Phased: gap analysis, scorecard, design/ops integration, verification, recertification (3yrs). Cross-functional teams; applies globally to all sizes. Involves pre-testing, continuous monitoring, third-party audits.
ISO 13485 Details
What It Is
ISO 13485:2016 is the international standard titled Medical devices — Quality management systems — Requirements for regulatory purposes. It provides a risk-based framework for QMS tailored to medical devices across their lifecycle, from design to post-market surveillance.
Key Components
- Organized into Clauses 4-8 covering QMS, management responsibility, resources, product realization, and measurement/improvement.
- Emphasizes documented procedures, validation, traceability, and risk management per ISO 14971.
- Requires quality manual, medical device files, and certification via accredited bodies.
Why Organizations Use It
- Enables market access in regulated markets like EU MDR and upcoming FDA QMSR.
- Reduces risks of recalls and non-conformities through robust controls.
- Builds stakeholder trust and competitive edge via demonstrated compliance.
Implementation Overview
- Phased approach: gap analysis, process design, documentation, validation, audits.
- Applies to manufacturers, suppliers, distributors globally; scales by organization size.
- Culminates in Stage 1/2 certification audits with ongoing surveillance.
Key Differences
| Aspect | WELL | ISO 13485 |
|---|---|---|
| Scope | Occupant health, 10 concepts (Air, Water, etc.) | Medical device QMS lifecycle (design to post-market) |
| Industry | Buildings, real estate, all sectors globally | Medical devices, healthcare supply chain globally |
| Nature | Voluntary performance-based certification | Regulatory-purpose QMS certification standard |
| Testing | On-site performance verification, continuous monitoring | Internal audits, process validation, certification audits |
| Penalties | Loss of certification, no legal penalties | Regulatory enforcement, market access denial |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about WELL and ISO 13485
WELL FAQ
ISO 13485 FAQ
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