ISO 15189 - Medical Laboratories Full Implementation Toolkit

This toolkit is designed for medical laboratories, clinical laboratory networks, laboratory directors, quality managers, technical managers, section supervisors, accreditation coordinators, internal auditors, consultants, and trainers who need structured documentation for ISO 15189 quality and competence implementation.

The package includes easy to use Word, Excel, and PowerPoint resources covering laboratory governance, impartiality, confidentiality, personnel competence, facilities, equipment, suppliers, metrological traceability, pre-examination activities, examination methods, quality control, reporting, information management, risk management, CAPA, internal audit, POCT, document control, and continual improvement.

This ISO 15189 package includes 185 files organized into 16 folders, covering the full laboratory quality management and technical competence lifecycle from governance launch through continuous improvement and accreditation evidence control.

Yes. The product page includes a complete document index and an index file download button so you can review the folder structure, document names, and included materials before purchasing.

Yes. Smaller laboratories can use the templates to establish a practical ISO 15189 framework, while larger and multi-site laboratories can adapt them to standardize records, responsibilities, competency evidence, method controls, audit programs, and accreditation readiness across departments or locations.

The toolkit is supplied in standard editable office formats such as Word, Excel, and PowerPoint, with supporting file references shown as docx, xlsx, pptx and related office formats. The templates can be customized using Microsoft Office or compatible software.

Yes. All templates are fully editable. You can add your laboratory name, logo, scope, examination areas, method identifiers, responsibilities, approval workflow, quality indicators, document codes, and accreditation-specific references.

Yes. It includes a laboratory quality program charter, governance framework, ISO 15189 scope definition, quality policy, quality objectives framework, roles and responsibilities, communication plan, readiness roadmap, stakeholder register, RACI matrix, KPI register, governance schedule, and kickoff slides.

Yes. The package includes personnel competence procedures, training and authorization policy, competency assessment procedure, continuing education procedure, job descriptions and competence criteria, competence matrices, training registers, authorization logs, annual competency reviews, and awareness slides.

Yes. It includes facilities and environmental control, equipment management, calibration and maintenance, equipment downtime, supplier and external services control, reagent and consumable management, referral laboratory control, purchasing and receiving inspection, supplier evaluation, and performance monitoring records.

Yes. It includes method selection, method validation, method verification, method change control, analytical performance criteria, validation plans, protocols, summary reports, performance study registers, IQC procedures, EQA/PT participation tools, QC logs, Westgard worksheets, and result validity decision rules.

Yes. The toolkit includes request review, patient preparation, sample collection, specimen acceptance and rejection, sample transport, chain of custody, result reporting, authorization, amended reports, critical result notification, turnaround time monitoring, communication logs, and reporting controls.

Yes. It includes laboratory information management policy, LIS and middleware change control, data integrity and electronic records procedures, user access authorization, backup and recovery, interface validation guidance, access registers, system change logs, backup logs, and data integrity incident logs.

Yes. It includes risk and opportunity management, change control, patient safety escalation, nonconformity and corrective action, complaint handling, occurrence management, root cause analysis, CAPA tracking, effectiveness review, and related dashboards and logs.

Yes. It includes internal audit policy, audit planning and execution procedure, quality indicator monitoring, management review procedure, quality performance reporting, internal audit program, audit checklist, findings register, quality indicators dashboard, action logs, and review slides.

Yes. The package includes POCT governance policy, operator training and authorization procedure, POCT quality control, device management, result review and escalation, POCT device inventory, operator competency register, QC logs, site review checklist, incident log, and governance slides.

After payment is completed, the download process is designed for quick access. Please allow redirects after checkout and check your confirmation information. If you have any issue accessing the download, contact support@iso-toolkits.org with your purchase code and payment reference.

If you have trouble opening files, locating a template, or downloading the package, contact support with your purchase reference, the file name or issue description, and a screenshot where possible so the support team can assist promptly.