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ISO 15189:2022 Laboratory Checklist

by Daud Sibanda, from the Community

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Use this ISO 15189:2022 laboratory checklist to assess compliance across governance, risk management, personnel competence, facilities, equipment calibration and traceability, reagents and consumables, service agreements, and information management. Cover pre examination, examination, and post examination processes, quality control and EQA, result reporting, nonconforming work, complaints, emergency preparedness, and management system requirements including internal audits and management review. Support accreditation readiness, continuous improvement, and patient safety.

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Digitize any process, procedure or policy

Eliminate mistakes made by paper-based processes

Create and share professional reports instantly

Confirm accountability and compliance with a digital log

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This community page makes available free workplace checklists and templates created by other users within the SafetyCulture community. SafetyCulture has re-published this content and where possible, has credited the original author. SafetyCulture has not verified the accuracy, reliability or suitability of any community content. You agree that your use of any of this content is in accordance with SafetyCulture’s Terms and Conditions.

Template
ISO 15189:2022 Internal Audit Checklist
Assess your medical laboratory against ISO 15189:2022 with this internal audit checklist. Cover impartiality, confidentiality, patient-focused requirements, governance, quality management, risk management, personnel competence, facility controls, equipment lifecycle, calibration and traceability, reagents and consumables, service agreements, referral laboratories, pre-examination, examination and post-examination processes, IQC and EQA, measurement uncertainty, reporting and critical results, nonconforming work, information management, complaints, emergency preparedness, continual improvement, internal audits, and management reviews. Use it to capture findings, evidence, and corrective actions for accreditation readiness.
by Madan Kalagara, from the Community
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ISO/IEC 17025:2017 Compliance Checklist
Use this ISO/IEC 17025:2017 checklist to evaluate a laboratory’s competence in testing and calibration and to prepare for accreditation. The template guides internal assessments across general and structural requirements, resources (personnel, facilities, equipment, metrological traceability, externally provided services), process controls (method selection and validation, sampling, handling of items, technical records, measurement uncertainty, ensuring validity of results), and reporting obligations. It also covers complaint handling, nonconforming work, data and information management, and management system requirements including risk, improvement, internal audits, and management review.
by sudhir Rajasekaran, from the Community
Downloads: 20+
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Template
ISO 17025 2017 Compliance Assessment Checklist
This ISO 17025 2017 compliance checklist helps testing and calibration laboratories review readiness for accreditation. It covers impartiality, confidentiality, structure and leadership, personnel competence, facilities and environmental conditions, equipment control and calibration, metrological traceability, selection and validation of methods, sampling, handling of items, technical records, measurement uncertainty, quality control and proficiency checks, reporting of results, complaints and nonconforming work, data and information management, internal audits, corrective actions, and management review.
by Muhammad Irshad, from the Community
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Template
ISO 9001:2015 Audit Checklist (Sample)
Use this comprehensive ISO 9001:2015 audit checklist to evaluate your Quality Management System for compliance. The checklist guides internal auditors through key ISO clauses, covering organizational context, leadership and policy, planning and risk, support and resources, competence and awareness, documented information control, operational planning and control, design and development, external provider management, production and service provision, identification and traceability, preservation and post‑delivery, change control, release of products and services, and control of nonconforming outputs. It also includes performance evaluation requirements such as monitoring and measurement, internal audits, and management review, as well as improvement through corrective action and continual improvement. Attach evidence where required and complete sign‑off to finalize the assessment.
by Sifiso Selelane, from the Community
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ISO 15189:2022 Laboratory Checklist

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