ISO 15189 - Διαπίστευση Ικανότητας Ιατρικού Εργαστηρίου
post-analytical controls
post-analytical controls ISO 15189 - Readiness & Accreditation Support (Med Labs) Quality, technical competence and confidence in laboratory results. Copy: In healthcare, quality is not only about processes. It is primarily about the validity and reliability of results. ISO 15189:2022 is the international accreditation standard for medical laboratories, defining requirements for both Quality Management Systems and demonstrated technical competence. Accreditation covers the entire laboratory lifecycle: pre-analytical processes analytical activities post-analytical controls equipment and traceability risk management personnel competence patient safety and confidentiality ISO 15189 is not a documentation project, but a framework for organized reliability.
Management Challenge
Accreditation is not based solely on scientific expertise. It requires evidence of a structured and controlled operating model. Organizations must demonstrate: documented and repeatable procedures
- 01 Diagnostic and clinical laboratories
- 02 Microbiology, biochemistry and hematology laboratories
- 03 Private and hospital laboratories
- 04 Organizations seeking accreditation
- 05 Laboratories aiming to strengthen trust and service quality
Implementation phases
Implementation & Scope
A structured implementation path covering analysis, documentation, accountability, and audit readiness.
Gap Analysis & Process Mapping
Baseline current operations, identify gaps, and map critical processes to standard requirements.
Policy & Documentation Framework
Design policies, procedures, and records that management can actually use and audit.
Roles, Responsibilities & KPIs
Clarify accountability, assign owners, and define measurable performance indicators.
Internal Audit & Certification Readiness
Build audit routines, corrective actions, and certification preparation with management oversight.
Management Gains
ISO 15189 brings together quality, risk management, technical competence and patient safety within a single governance framework, enabling laboratories to operate with greater reliability, regulatory confidence and long-term resilience.