ISO 14064
International standard for GHG quantification, reporting, verification
ISO 13485
International standard for medical device quality management systems
Quick Verdict
ISO 14064 provides GHG quantification and verification for all organizations seeking climate credibility, while ISO 13485 mandates rigorous QMS for medical device safety and regulatory compliance. Companies adopt them for stakeholder trust, market access, and risk mitigation.
ISO 14064
ISO 14064 Greenhouse gases quantification and verification
Key Features
- Three-part modular framework for inventories, projects, assurance
- Five core principles: relevance, completeness, consistency, transparency, accuracy
- Defines Scope 1-3 boundaries and consolidation approaches
- Risk-based validation/verification with materiality assessment
- Aligns with GHG Protocol for global comparability
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based QMS process controls
- Design development and validation requirements
- Medical device file traceability
- Supplier evaluation and outsourcing controls
- Post-market complaint handling CAPA
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 14064 Details
What It Is
ISO 14064 is an international standard family (Parts 1:2018, 2:2019, 3:2019) for greenhouse gas (GHG) quantification, reporting, and verification. It provides a modular framework for organizations to develop credible GHG inventories, project reductions, and independent assurance using principles of relevance, completeness, consistency, transparency, and accuracy.
Key Components
- **Part 1Organizational inventories with Scope 1-3 boundaries.
- **Part 2Project-level baselines, additionality, monitoring.
- **Part 3Risk-based validation/verification processes. Built on GHG Protocol alignment; no fixed controls but principle-driven requirements; voluntary third-party assurance model.
Why Organizations Use It
Supports regulatory compliance (e.g., CSRD, SB-253), investor trust, carbon markets access, and decarbonization strategy. Mitigates greenwashing risks, enables benchmarking, and drives efficiency via data insights.
Implementation Overview
Phased approach: governance, boundary setting, data collection, verification. Applies to all sizes/industries globally; 6-12 months typical; external verification enhances credibility.
ISO 13485 Details
What It Is
ISO 13485:2016, titled Medical devices — Quality management systems — Requirements for regulatory purposes, is an international certification standard for QMS in medical device organizations. It ensures consistent delivery of safe devices meeting customer and regulatory requirements across the lifecycle, using a risk-based process approach.
Key Components
- Clauses 4–8 cover QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
- Emphasizes validation, traceability, risk management (per ISO 14971), supplier controls, post-market surveillance.
- Requires quality manual, medical device files, documented procedures/records.
- Third-party certification via audits.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment 2026), reduces risks/recalls.
- Builds stakeholder trust, supply chain assurance.
- Drives operational excellence, cost savings via CAPA, audits.
Implementation Overview
- Phased: gap analysis, process design, validation, audits (6–36 months).
- Applies to manufacturers/suppliers globally; certification by accredited bodies.
Key Differences
| Aspect | ISO 14064 | ISO 13485 |
|---|---|---|
| Scope | GHG emissions quantification, reporting, verification | Medical device QMS, lifecycle safety, compliance |
| Industry | All organizations, global GHG reporting | Medical devices, healthcare supply chain |
| Nature | Voluntary international standard family | Regulatory-purpose QMS certification standard |
| Testing | Third-party validation/verification optional | Mandatory audits, process validation, CAPA |
| Penalties | Loss of credibility, no legal penalties | Regulatory enforcement, market access denial |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 14064 and ISO 13485
ISO 14064 FAQ
ISO 13485 FAQ
You Might also be Interested in These Articles...
Your Compliance Command Center: How Modern Tools Orchestrate Cross-Departmental Adherence
Unlock your compliance command center with modern tools for real-time monitoring, automation & integrations across IT, HR, Legal & Finance. Slash non-compliance
Using CIS Controls v8.1 as a ‘Compliance On-Ramp’: Map One Security Program to NIST CSF, ISO 27001, PCI DSS, and NIS2
Use CIS Controls v8.1 as your compliance on-ramp. Map one security program to NIST CSF, ISO 27001, PCI DSS, and NIS2 without duplicating work via practical mapp
One Step at a Time - a 6 Month Plan to Live and Breath DORA
Achieve DORA compliance in 6 months with our detailed plan. Learn implementation sequence, starting steps, pitfalls to avoid, and accelerators for success. Toug
Run Maturity Assessments with GRADUM
Transform your compliance journey with our AI-powered assessment platform
Assess your organization's maturity across multiple standards and regulations including ISO 27001, DORA, NIS2, NIST, GDPR, and hundreds more. Get actionable insights and track your progress with collaborative, AI-powered evaluations.
Check out these other Gradum.io Standards Comparison Pages
K-PIPA vs NIST 800-53
Discover K-PIPA vs NIST 800-53: Korea's consent-centric privacy law with CPOs & 72h breaches meets US 20-family controls, baselines & RMF. Align strategies for global compliance today.
IATF 16949 vs ISO 41001
Compare IATF 16949 vs ISO 41001: Automotive QMS rigor—core tools, defect prevention, supplier governance—vs FM's stakeholder alignment, sustainability focus. Uncover key diffs in leadership, risks & ops. Optimize now!
ENERGY STAR vs SAMA CSF
Compare ENERGY STAR vs SAMA CSF: EPA's energy efficiency gold standard meets Saudi's cyber framework. Master compliance, maturity tiers & strategies for peak performance. Dive in now!