SOX
U.S. federal law mandating financial reporting controls
ISO 13485
International standard for medical device quality management systems
Quick Verdict
SOX mandates financial controls for US public firms via CEO certifications and audits, while ISO 13485 certifies medical device QMS for safety. Companies adopt SOX for legal compliance, ISO 13485 for market access and quality.
SOX
Sarbanes-Oxley Act of 2002
Key Features
- Mandates CEO/CFO certification of financial accuracy
- Requires ICFR assessment and auditor attestation
- Establishes PCAOB for audit firm oversight
- Enforces auditor independence and rotation rules
- Imposes criminal penalties for false certifications
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based controls for device lifecycle processes
- Design development verification and validation
- Post-market surveillance and complaint handling
- Supplier evaluation and outsourcing management
- Traceability and medical device file requirements
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
SOX Details
What It Is
Sarbanes-Oxley Act of 2002 (SOX) is a U.S. federal regulation enacted post-Enron scandals. It mandates internal controls over financial reporting (ICFR) for public companies, using a risk-based approach via frameworks like COSO. Primary purpose: enhance disclosure accuracy, auditor independence, and executive accountability.
Key Components
- 11 Titles covering PCAOB creation (Title I), auditor independence (Title II), certifications (Sections 302/906), ICFR assessments (Section 404), governance (Section 301), and penalties (Sections 802/806).
- Core on **key controlsentity-level, ITGC, financial close, access controls.
- Built on COSO principles; compliance via annual management reports and auditor attestations for accelerated filers.
Why Organizations Use It
Legal mandate for U.S. public firms; reduces fraud risk, builds investor trust, lowers capital costs. Strategic benefits: operational efficiency, M&A readiness, governance maturity. Exemptions for smaller/EGC filers retain management duties.
Implementation Overview
Top-down risk scoping, documentation, testing, remediation cycles. Applies to public issuers; phased (scoping, design, testing); requires PCAOB audits for Section 404(b). (178 words)
ISO 13485 Details
What It Is
ISO 13485:2016 is the international standard titled Medical devices — Quality management systems — Requirements for regulatory purposes. It is a certifiable QMS framework specifically for medical device organizations, emphasizing risk-based controls to ensure consistent safety, performance, and regulatory compliance across the device lifecycle—from design to post-market surveillance.
Key Components
- Organized into Clauses 4–8: QMS foundation, management responsibility, resources, product realization, measurement/improvement.
- Over 20 documented procedures/records required, including medical device files, risk management, validation, CAPA, and supplier controls.
- Built on process approach, ISO 9001 compatibility, and ISO 14971 risk integration.
- Third-party certification via accredited bodies with stage 1/2 audits and surveillance.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment by 2026), reduces recalls, cuts quality costs.
- Meets regulatory expectations, builds stakeholder trust, differentiates in supply chains.
- Manages lifecycle risks, ensures traceability for audits/inspections.
Implementation Overview
- Phased: gap analysis, process design, documentation, validation, audits.
- Applies to manufacturers, suppliers, SMEs to multinationals globally.
- Requires eQMS tools, training, internal audits; certification every 3 years. (178 words)
Key Differences
| Aspect | SOX | ISO 13485 |
|---|---|---|
| Scope | Financial reporting internal controls | Medical device quality lifecycle |
| Industry | Public companies (finance) | Medical device manufacturers |
| Nature | US federal law, mandatory | Voluntary certification standard |
| Testing | Annual ICFR audits by PCAOB | Process validation, internal audits |
| Penalties | Criminal fines, imprisonment | Certification loss, no legal penalties |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about SOX and ISO 13485
SOX FAQ
ISO 13485 FAQ
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