What It Is

Scaled Agile Framework (SAFe) 6.0 is a comprehensive framework for scaling Lean-Agile practices across enterprises. It enables Business Agility by aligning strategy, execution, and operations in large-scale software and IT environments. SAFe uses systems thinking, integrating Agile, Lean, and DevOps principles.

Key Components

• **Agile Release Trains (ARTs)50-125 people delivering value.
• **Program Increments (PIs)8-12 week cycles with PI Planning.
• 10 immutable Lean-Agile principles (e.g., economic view, decentralize decisions).
• 7 core competencies (e.g., Lean-Agile Leadership, Continuous Learning Culture).
• Configurations: Essential, Large Solution, Portfolio, Full. Individual certifications like SAFe Agilist; no org certification.

Why Organizations Use It

Accelerates time-to-market (20-50%), boosts productivity (30-75%), improves quality. Voluntary for competitive edge in IT/software; manages risks via ROAM; builds trust through transparency and flow metrics.

Implementation Overview

**Implementation RoadmapTraining, value stream mapping, phased ART launches via SPCs. For large enterprises globally; key activities include PI events, role definitions. Tailored, ongoing via Inspect & Adapt.

What It Is

ISO 13485:2016 is the international standard titled Medical devices — Quality management systems — Requirements for regulatory purposes. It provides a certifiable framework for organizations to demonstrate consistent provision of safe medical devices meeting customer and regulatory needs across the device lifecycle. It employs a risk-based process approach emphasizing documentation, validation, and traceability.

Key Components

• Organized into Clauses 4–8 covering QMS, management responsibility, resources, product realization, and measurement/improvement.
• Requires documented procedures, medical device files, risk management (linked to ISO 14971), design controls, supplier oversight, process validation, and post-market surveillance.
• Built on process interactions, objective evidence, and continual improvement; certification via accredited bodies with stage audits.

Why Organizations Use It

• Enables market access (e.g., EU MDR, FDA QMSR alignment by 2026), reduces recalls, and ensures supply chain control.
• Mitigates regulatory risks, builds stakeholder trust, and drives operational efficiency/cost savings.

Implementation Overview

• Phased approach: gap analysis, documentation, training, validation, audits.
• Applies to manufacturers, suppliers globally; 9–18 months typical for mid-size firms, with ongoing surveillance.