The Roadmap to ISO 15189: Understanding the Accreditation Journey

One of the biggest concerns laboratories face is where to begin in their ISO 15189 accreditation journey. The process may appear complex, but with structured planning, it becomes a smooth pathway to quality excellence. Various NABL documents like NABL 112 emphasizes that accreditation assesses both technical competence and compliance with ISO 15189. The roadmap typically includes: Understanding requirements — Reviewing management and technical clauses, including internal audits, record control, and equipment calibration. Gap assessment — Identifying areas needing improvement compared to standards, recognising gaps between available resources and NABL requirements. Documentation development — Quality Manual, QSP, SOPs, forms, calibration plans and process workflows. Training & competence building — ISO 15189 requires personnel competence and defined authorization responsibilities. Participation in External Quality Assurance (EQA / PT) — Mandatory for all disciplines seeking accreditation. Internal audit & management review — covering pre-analytical, analytical and post-analytical phases. Application & on-site assessment — NABL assesses facility compliance and technical performance. At eNABLe, we provide gap analysis, structured implementation support, training, and readiness evaluation so that laboratories confidently approach assessment day with evidence-based compliance. Accreditation is a continuous improvement cycle—not a one-time milestone. Start with clarity, plan with precision, and achieve with expert guidance.