Strengthen Laboratory Competence and Healthcare Quality Faster
Choose practical laboratory and healthcare toolkits with editable procedures, competence records, quality controls, risk documents, audit resources and implementation guidance for reliable, patient-focused operations.
Choose the Right Laboratory & Healthcare Toolkit
Start with your operating environment: medical laboratories, testing and calibration, healthcare quality, medical devices, sensitive health information, biorisk or continuity of critical services.
ISO 15189 Medical Laboratories Toolkit
For medical laboratories that need a structured quality and competence framework covering personnel, equipment, examination processes, records, risk and accreditation preparation.
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Structured laboratory quality, competence and examination-process documentation
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Support for equipment, traceability, quality assurance, risks and internal audits
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Designed for medical laboratories preparing for accreditation and continual improvement
Laboratory Quality, Competence & Biorisk
Strengthen technical competence, reliable results, laboratory governance and biorisk controls.
ISO 15189 Toolkits
Strengthen laboratory quality, competence, examination processes, traceability and accreditation readiness.
Best for: medical laboratory quality and competence.
Explore ISO 15189 Toolkit →
ISO 17025 Toolkits
Improve technical competence, method control, equipment management and confidence in testing or calibration results.
Best for: testing and calibration laboratory competence.
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ISO 35001 Toolkits
Manage laboratory biorisk using structured governance, containment, competence and operational controls.
Best for: biorisk management in laboratory environments.
Explore ISO 35001 Toolkit →Healthcare Quality & Information Protection
Improve patient-focused healthcare quality, medical-device controls and protection of sensitive health information.
ISO 7101 Toolkits
Strengthen quality governance and patient-focused service delivery in healthcare organizations.
Best for: healthcare quality management and patient-focused governance.
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ISO 13485 Toolkits
Build controlled quality processes for medical-device design, production, suppliers and lifecycle documentation.
Best for: medical-device quality management.
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ISO 27799 Toolkits
Strengthen information-security and privacy controls for sensitive health and clinical information.
Best for: healthcare information security and privacy.
Explore ISO 27799 Toolkit →Medical Device Risk & Assurance
Manage medical-device risk while strengthening audit and enterprise-risk practices across healthcare operations.
ISO 14971 Toolkits
Manage medical-device hazards and lifecycle risk using structured evaluation, control and monitoring records.
Best for: medical-device risk management.
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ISO 19011 Toolkits
Plan, conduct, document and improve management-system audits using a consistent audit-program approach.
Best for: internal audit programs and management-system assurance.
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ISO 31000 Toolkits
Structure enterprise risk identification, assessment, treatment, monitoring and reporting across functions.
Best for: enterprise and operational risk management.
Explore ISO 31000 Toolkit →Operational Resilience & Measurement Support
Support continuity of critical services, organization-wide process control and reliable measurement management.
ISO 22301 Toolkits
Build a business continuity management system covering impact analysis, strategies, plans, exercises and recovery readiness.
Best for: BCMS implementation and resilience readiness.
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ISO 9001 Toolkits
Build a structured quality management system with stronger process control, customer focus and continual improvement.
Best for: organization-wide process consistency and QMS control.
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ISO 10012 Toolkits
Improve control of measurement processes, measuring equipment, calibration and related records.
Best for: measurement management and reliable inspection results.
Explore ISO 10012 Toolkit →Not Sure Which Laboratories & Healthcare Toolkit Fits Your Organization?
Use the ISO Toolkit Selector to compare your objective, industry and implementation priority before choosing a toolkit.
Practical Documentation Built for Implementation Teams
Reduce document-development time while keeping your laboratories & healthcare implementation structured, editable and easier to review across teams, sites and audit activities.
Editable Word, Excel and supporting files designed for practical customization.
Implementation and audit support resources organized around real management-system activities.
Instant digital access so teams can begin reviewing and adapting the toolkit immediately.
100% money-back guarantee supported by the published refund policy.
ISO 15189 Laboratories & Healthcare Toolkit
Everything you need for your medical laboratory quality management project.
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Designed for laboratory managers, quality managers, healthcare teams, consultants and accreditation leaders
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ISO 15189 documentation support for laboratory quality, competence, process control, risk management, and audit readiness
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100% money-back guarantee
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Instant download - sent to your inbox immediately
What ISO 15189 Template Are You Looking For?
ISO 15189 Laboratory Quality Manual
For: Laboratory quality managers refreshing an existing quality manual. Not for first-time implementers.
Includes: Laboratory Quality Manual only
Documentation Toolkit
For: Laboratory professionals who already understand ISO 15189 and want ready-to-customise documents, but will manage implementation themselves.
Includes: Laboratory Quality Manual + Policies + Procedures + Forms
Implementation Toolkit
For: Anyone running a structured ISO 15189 project - first-time implementation, laboratory accreditation preparation, quality system upgrade, or continual improvement.
Includes: Documentation Toolkit + Project Plan + Gap Analysis + Audit Program + Training
Successfully Prepared For Laboratory Audits
Used by organizations in 132 countries, our ISO 15189 templates help laboratories prepare structured quality management documentation for implementation, internal review, competence evaluation, process control, accreditation readiness, and external audit preparation.
ISO 15189 Document Samples - See What You're Buying
Every document is fully editable, professionally formatted, and ready to support laboratory quality management implementation.
- LQMS Document Map
- Laboratory Quality Implementation Project Plan
- Step 1 - Laboratory QMS Implementation Checklist
- Laboratory Gap Analysis
- Laboratory Gap Analysis Action Plan
- Laboratory Gap Analysis Guidance
- Laboratory Quality Management Manual
- Laboratory Quality Policy, Objectives & Indicators Guidance
- Internal Laboratory Audit Procedure
- Laboratory Process Map
- Internal Laboratory Audit Checklist
- Laboratory Audit Results - Automated Charts
- Internal Laboratory Audit Report
- Laboratory Audit Guidance
- Documented Information Procedure
- Documented Information Guidance
- Laboratory Management Review Procedure
- Laboratory Management Review Agenda & Minutes
- Laboratory Management Review Guidance
- Method Verification Checklist
- Equipment Calibration Charts
- Competence Evaluation Checklist
- Nonconformity & Corrective Action Charts
- Laboratory Quality Management System Guidance
100% Money Back Guarantee
Customers: 132 countries
We are 100% confident in the quality and contents of our products. Used by thousands of organizations around the world, our templates have been sold online since 2009.
If our templates don't help you prepare your laboratory quality management documentation, we'll refund your purchase in full.
No questions asked.
Used By Thousands Of Companies In 132 Countries
Bought by small businesses and large corporations, our ISO 15189 templates help laboratories and healthcare organizations build quality management documentation with stronger structure, competence control, and accreditation readiness.
Used by Small Businesses - independent laboratories, diagnostic centers, consultants, clinics, and growing healthcare providers
Used by Large organizations - hospitals, medical laboratory networks, healthcare groups, research laboratories, and multi-site diagnostic services
Suitable for first-timers with step-by-step guidance and experienced Laboratory Quality Managers
Written in International English - practical documentation for global laboratory and healthcare quality programs
Five Reasons To Choose Our Templates
1. Save Time and Money
Our customizable templates offer a streamlined process to create your laboratory quality management documentation.
2. Everything You Need
They include practical documents to support laboratory governance, competence, method control, equipment management, quality assurance, and audit preparation.
3. Proven to Work
Our templates help laboratories organize quality requirements, responsibilities, technical processes, records, risks, and improvement actions in a structured way.
4. Easy to Update
Documents use styles to make reformatting, rebranding, and laboratory quality system updates easier.
5. Works for Any Laboratory
Our templates are adaptable for laboratories and healthcare organizations managing quality, competence, patient safety, technical processes, and continual improvement.
Speed Up ISO Implementation
with Ready Made Documentation
Access editable ISO templates, procedures, forms, registers, and audit checklists to reduce manual work and prepare faster with confidence.
The templates gave us a well-organized management system that is professional, accessible, and easy for process owners to use.
Our teams and auditors responded positively. The toolkit helped us present our processes in a structured and professional way.
The toolkit provides a flexible best-practice framework that keeps our documentation aligned as requirements evolve.
We saved significant time preparing our policies, procedures, forms, and internal audit materials for the implementation project.
The documentation was clear, professional, and easy to adapt. It gave our team a much stronger starting point.
A practical toolkit for consultants who need a repeatable and organized approach to ISO implementation documentation.
The toolkit helped us organize our health and safety documents into a more practical and Audit Ready structure.
The templates were easy to customize and gave us a clear foundation for building a client-ready ISO management system.
The audit checklists were practical and helped our team review gaps before the external audit preparation stage.
We appreciated the clear structure. It made implementation planning easier and helped our department owners understand their role.
The documentation package saved our team time and reduced the need to create ISO forms and registers from the beginning.
The toolkit gave us a professional starting point and helped us improve consistency across procedures, records, and checklists.
Trusted by over 10,000+ Client Organizations
We have provided ISO Implementation Toolkits to over 10,000 businesses and organizations of all sizes, from startups and small businesses to the Fortune 100, in over 130 countries.
