What It Is

Six Sigma is a de facto industry framework for process improvement, anchored by ISO 13053:2011 defining quantitative methods. It focuses on reducing variation and defects to achieve near-perfect quality (3.4 DPMO benchmark), using data-driven, statistical approaches like DMAIC (Define-Measure-Analyze-Improve-Control) for existing processes and DMADV for new designs.

Key Components

• DMAIC/DMADV structured phases with mandatory deliverables (charters, SIPOC, FMEA, control plans)
• **Belt hierarchyChampions, Master Black Belts, Black/Green Belts
• Statistical tools: MSA (Gage R&R), hypothesis testing, DOE, SPC
• Governance: tollgates, project selection tied to strategy Certification via bodies like ASQ (experience + projects required).

Why Organizations Use It

Drives financial savings (e.g., GE $1B+), customer satisfaction, risk reduction. Voluntary but strategic for competitiveness; integrates with Lean/ISO 9001. Builds data culture, stakeholder trust via proven ROI.

Implementation Overview

Enterprise deployment: executive sponsorship, training, project portfolio. Applies to all sizes/industries (manufacturing to services). Phased rollout (readiness, pilots, scale); audits/sustainment ongoing. No universal certification but ASQ/IASSC benchmarks competence.

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 to ensure consistent safety, performance, and compliance.

Key Components

• Organized into Clauses 4–8 covering QMS, management responsibility, resources, product realization, and measurement/improvement.
• Emphasizes documented procedures, records, validation, traceability, and risk management (linked to ISO 14971).
• Requires quality manual, medical device files, and controls for outsourcing, software validation.
• Certification via accredited bodies through staged audits.

Why Organizations Use It

• Enables market access (e.g., EU MDR, FDA QMSR alignment by 2026).
• Mitigates risks like recalls via robust CAPA, complaints handling.
• Builds stakeholder trust, reduces costs through process efficiency.
• Provides competitive edge in supply chains and partnerships.

Implementation Overview

• Phased: gap analysis, documentation, training, validation, audits.
• Suits all sizes in medical devices globally.
• Involves cross-functional teams, eQMS tools; 9–18 months typical.