PMBOK
Global standard for project management practices
ISO 13485
International standard for medical device quality management systems
Quick Verdict
PMBOK provides flexible project governance for all industries, while ISO 13485 mandates rigorous QMS for medical devices. Companies adopt PMBOK for delivery success, ISO 13485 for regulatory compliance and patient safety.
PMBOK
Project Management Body of Knowledge Guide
Key Features
- Matrix of 5 Process Groups and 10 Knowledge Areas
- ITTO framework for 49 traceable project processes
- Tailoring to predictive, adaptive, hybrid lifecycles
- 12 principles guiding value-focused outcomes
- Planning-dominant for proactive baselines and controls
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based QMS for medical device lifecycle
- Design and development controls with validation
- Supplier evaluation and outsourcing controls
- Post-market surveillance and complaint handling
- Traceability and record retention requirements
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
PMBOK Details
What It Is
PMBOK® Guide, published by Project Management Institute (PMI), is a global standard and guide for project management. It codifies generally accepted practices applicable across industries, evolving from process-based (6th edition) to principle- and outcome-based (7th/8th editions) with tailoring emphasis.
Key Components
- **5 Process GroupsInitiating, Planning, Executing, Monitoring/Controlling, Closing.
- **10 Knowledge AreasIntegration, Scope, Schedule, Cost, Quality, Resources, Communications, Risk, Procurement, Stakeholders.
- ITTOs for processes; 12 principles and 7-8 performance domains (governance, stakeholders, etc.). No formal certification for standard; aligns with PMP® credentialing.
Why Organizations Use It
Enhances predictability, reduces risks via baselines/change control; strategic benefits include 3x better performance per PMI research. Builds governance baseline, stakeholder trust; voluntary but contractual in regulated sectors.
Implementation Overview
Phased rollout: assess gaps, tailor processes, pilot, train, deploy tools/PMO. Suits all sizes/industries; 12-24 months typical, focusing OCM, OPM3 maturity.
ISO 13485 Details
What It Is
ISO 13485:2016, titled Medical devices — Quality management systems — Requirements for regulatory purposes, is an international certifiable standard establishing a risk-based QMS framework. It ensures organizations consistently meet customer and regulatory requirements across the medical device lifecycle, from design to post-market surveillance.
Key Components
- Structured into Clauses 4–8: QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
- Over 20 key requirements emphasizing validation, traceability, design controls, supplier management, and CAPA.
- Integrates ISO 14971 risk management and process approach.
- Third-party certification via accredited bodies with Stage 1/2 audits and surveillance.
Why Organizations Use It
- Facilitates market access (EU MDR, FDA QMSR by 2026).
- Mitigates recalls, compliance risks, and liabilities.
- Enhances operational efficiency, supplier control, and continual improvement.
- Builds regulator, customer, and partner trust.
Implementation Overview
- Phased: gap analysis, documentation, training, validation, internal audits, certification.
- Suited for manufacturers, suppliers, distributors globally, any size.
- Requires documented processes, evidence, and management review.
Key Differences
| Aspect | PMBOK | ISO 13485 |
|---|---|---|
| Scope | Project lifecycle governance, processes, principles | Medical device QMS, lifecycle, regulatory compliance |
| Industry | All industries worldwide, any project type | Medical devices, healthcare supply chain |
| Nature | Voluntary guide/standard, PMI certification | Regulatory QMS standard, certification required |
| Testing | Tailored audits, internal reviews, no mandatory cert | Mandatory audits, validation, certification bodies |
| Penalties | No legal penalties, loss of certification | Regulatory actions, market bans, fines |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about PMBOK and ISO 13485
PMBOK FAQ
ISO 13485 FAQ
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