What It Is

TOGAF® Standard, 10th Edition (The Open Group Architecture Framework) is a vendor-neutral enterprise architecture framework. It enables designing, planning, implementing, and governing enterprise-wide change. Primary methodology is the iterative Architecture Development Method (ADM) spanning business, data, application, and technology domains.

Key Components

• **ADM10 phases from Preliminary to Change Management, with ongoing Requirements Management.
• **Content FrameworkDeliverables, artifacts (catalogs, matrices, diagrams), building blocks, and Metamodel.
• **Enterprise ContinuumClassifies reusable assets in Architecture Repository.
• **Reference ModelsTRM, SIB, III-RM for standards and interoperability.
• **Capability FrameworkGovernance via Architecture Board, compliance, skills. Practitioner certification available, no organizational certification.

Why Organizations Use It

• Aligns strategy with IT for efficiency and ROI.
• Enables reuse, reducing duplication and costs.
• Strengthens governance, risk management, agility.
• Avoids vendor lock-in, supports Boundaryless Information Flow.
• Builds trust through standardized practices and certification.

Implementation Overview

Phased tailoring: maturity assessment, Preliminary setup, iterative ADM cycles, pilots scaling to enterprise. Key activities: governance establishment, repository tooling, stakeholder engagement. Ideal for large enterprises across industries; voluntary adoption.

What It Is

ISO 13485:2016, officially Medical devices — Quality management systems — Requirements for regulatory purposes, is an international certification standard for QMS in medical device organizations. It covers the full device lifecycle from design to post-market, employing a risk-based approach for consistent safety, performance, and regulatory compliance.

Key Components

• Clauses 4–8: QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
• Emphasizes validation, traceability, risk management (ISO 14971), medical device files.
• Built on process approach; certification via accredited bodies with stage 1/2 audits.

Why Organizations Use It

• Enables market access (EU MDR, FDA QMSR 2026).
• Reduces risks, costs of quality; builds stakeholder trust.
• Strategic for suppliers, manufacturers; competitive edge in partnerships.

Implementation Overview

• Phased: gap analysis, documentation, training, validation, internal audits.
• Applies to all sizes in medtech; 9–18 months typical; requires certification audits.