What is ISO 15189?
A practical introduction to the international standard for quality and competence in medical laboratories — what it covers, who needs it, and what the accreditation process actually looks like.
CAPA in Medical Laboratories
How corrective and preventive action systems work in regulated clinical environments — the CAPA lifecycle, root cause analysis methods, and what accreditation bodies look for at assessment.
QMS vs LIMS: Understanding the Difference
Two categories of software every accredited lab needs — but that are frequently confused. Here is what each one does, where they overlap, and why combining them changes the picture.
Preparing for Accreditation: A Lab Director's Guide
Practical steps for building inspection-ready systems before your next accreditation assessment — gap analysis, document readiness, training records, and what assessors actually look for.
Document Control Best Practices in Clinical Labs
Controlled documents are the backbone of any accredited laboratory. Here is how leading labs manage version control, approval workflows, controlled distribution, and the training linkages that make it all work.
Competency Assessment in Clinical Laboratories
Regulatory expectations, assessment methods, documentation requirements, and what to do when an assessment result is unsatisfactory — a practical guide for quality managers and section leads.
What is a LIMS?
A clear explanation of laboratory information management systems — what they do, who uses them, how they differ from a clinical LIS, and what to look for when evaluating options.
Secure Result Delivery in Clinical Laboratories
How accredited labs deliver results to ordering providers and patients without compromising PHI — authentication requirements, multi-site access controls, audit trails, and direct patient access considerations.
Non-Conformance Events: From Detection to Closure
A structured approach to identifying, classifying, investigating, and closing non-conformances in accredited laboratories — including why NCE culture matters as much as NCE process.
Reagent and Inventory Management in Accredited Labs
Lot-to-lot traceability, expiry management, open-vial stability, storage condition monitoring, and specimen retention — the inventory disciplines that protect test validity and satisfy accreditation requirements.
ISO 17025 vs ISO 15189: Which Applies to Your Lab?
The two most common laboratory accreditation standards share significant structural overlap but serve different environments. Here is how to determine which one — or both — applies to your operation.
Proficiency Testing: Requirements and Best Practices
External quality assessment requirements under ISO 15189, CAP, and CBAHI — selecting appropriate PT programs, responding to unsatisfactory results, and using PT data proactively for performance monitoring.
The Case for a Unified Laboratory Technology Platform
When QMS, LIS, inventory, and client portal software operate in silos, quality suffers in ways that are difficult to measure. Here is what integration actually changes — and what it requires.
Proficiency Testing Providers for Clinical Laboratories
A practical survey of major PT providers — CAP, IQMH, CMPT, UK NEQAS, RCPAQAP, and others — and how to build a well-managed PT cycle that satisfies accreditation requirements across jurisdictions.
CAP and CLIA: The Regulatory Framework for North American Clinical Laboratories
An overview of CLIA — the US federal statute governing clinical laboratories — and CAP accreditation, the dominant voluntary quality program that provides CLIA deemed status. Includes the Canadian context and how these frameworks interact.
Clinical Laboratory Accreditation in Canada: A Provincial Landscape
Canada has no federal equivalent to CLIA — laboratory regulation is a provincial responsibility. This article surveys the major frameworks: CPSA in Alberta, DAP in BC, IQMH and OLA in Ontario, and the federal considerations that apply nationally.
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