COBIT
Framework for enterprise IT governance and management
ISO 13485
International standard for medical device quality management systems
Quick Verdict
COBIT provides flexible IT governance frameworks for enterprises optimizing value and risk, while ISO 13485 mandates rigorous QMS for medical device makers ensuring safety, traceability, and regulatory compliance. Organizations adopt COBIT for strategic alignment, ISO 13485 for market access.
COBIT
COBIT 2019 Governance and Management Objectives
Key Features
- Tailors governance system using 11 design factors
- 40 objectives across 5 domains (EDM, APO, BAI, DSS, MEA)
- CMMI-based performance management with 0-5 capability levels
- Separates governance (EDM) from management responsibilities
- Goals cascade links stakeholder needs to metrics
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based QMS processes and controls
- Design and development controls with validation
- Medical device files for traceability
- Post-market surveillance and complaint handling
- Supplier evaluation and outsourcing management
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
COBIT Details
What It Is
COBIT 2019 is a comprehensive framework for enterprise governance and management of information and technology (EGIT), developed by ISACA. It helps organizations create value from IT, manage risk, and optimize resources through a tailored governance system. Its risk-based, customizable approach uses design factors to align with enterprise context.
Key Components
- 40 governance and management objectives grouped into 5 domains: EDM (governance), APO (align/plan), BAI (build/implement), DSS (deliver/support), MEA (monitor/assess).
- 6 governance system principles and 7 components (processes, structures, policies, information, culture, skills, infrastructure).
- CMMI-based performance management (levels 0-5); no formal certification, but capability assessments and ISACA training (Foundation, Design & Implementation).
Why Organizations Use It
- Aligns IT with business goals via goals cascade.
- Supports compliance (SOX, GDPR) and risk optimization.
- Enhances assurance, reduces incidents, improves ROI.
- Builds board trust through measurable outcomes.
Implementation Overview
Phased approach: assess maturity, design via toolkit, pilot objectives, monitor with MEA. Suited for large/regulated enterprises; scalable for mid-size. Involves training, RACI, integration with ISO 27001/ITIL.
ISO 13485 Details
What It Is
ISO 13485:2016 is an international standard specifying requirements for quality management systems (QMS) in medical devices, designed for regulatory purposes. It applies to organizations across the device lifecycle, from design to post-market activities, using a risk-based process approach.
Key Components
- Clauses 4–8 cover QMS, management responsibility, resources, product realization, and measurement/improvement.
- Emphasizes documented procedures, medical device files, validation, traceability, and risk management per ISO 14971.
- Built on process interactions, with certification via accredited bodies through staged audits.
Why Organizations Use It
- Ensures compliance with regulations like EU MDR and upcoming FDA QMSR.
- Mitigates risks, enables market access, reduces recalls, and builds stakeholder trust.
- Provides competitive edge through operational excellence and supply chain assurance.
Implementation Overview
- Phased approach: gap analysis, process design, documentation, validation, audits.
- Suited for manufacturers, suppliers, all sizes; global applicability.
- Requires certification audits, ongoing surveillance. (178 words)
Key Differences
| Aspect | COBIT | ISO 13485 |
|---|---|---|
| Scope | Enterprise IT governance and management | Medical device quality management lifecycle |
| Industry | All industries, enterprise-wide IT | Medical devices and related services |
| Nature | Voluntary governance framework | Certification standard for regulatory compliance |
| Testing | Capability assessments (0-5 levels) | Internal audits and certification audits |
| Penalties | No legal penalties, loss of maturity | Certification loss, regulatory actions |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about COBIT and ISO 13485
COBIT FAQ
ISO 13485 FAQ
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