ISO compliance
ISO 15189 quality manual template for modern laboratories.
Capture your laboratory identity, quality policy, and operational commitments in a single, inspector-ready blueprint. LabsVerified keeps every clause connected to evidence, ownership, and continual improvement.
Clauses mapped
120+
ISO clauses linked
Sites supported
300+
laboratories onboarded
Audit findings prevented
98%
first-pass success rate
How the platform helps
Build, execute, and evidence ISO 15189 programs with live dashboards and automation.
• Pre-built manual templates aligned to every clause and sub-clause.
• Linked risk registers, document control, and competency tracking.
• Task automation with owner reminders, escalations, and audit trails.
• Export-ready reports for inspectors, executives, and customers.
1. Laboratory identity
Clarify who you are, where you operate, and the services your quality manual governs.
Laboratory identity
Laboratory name
LabsVerified Central Diagnostics Laboratory
Locations / sites covered
Primary campus in Austin and Phoenix AZ, TX with satellite PCR suites in Phoenix, AZ and Raleigh, NC.
Tests / services provided
Clinical chemistry, hematology, immunoassay, molecular diagnostics, and reference testing for affiliate hospitals.
2. Quality policy
Share the pledges leadership makes to patients, customers, and regulators.
Deliver accurate, timely, and traceable patient results that safeguard clinical decisions.
Operate every process in accordance with ISO 15189, CAP, CLIA, and regional regulatory requirements.
Continuously improve through data-driven reviews, corrective actions, and staff empowerment.
Bring policies to life
Assign each policy to measurable programs and evidence packs maintained in LabsVerified.
• Map statements to KPIs, audits, and SOP acknowledgments.
• Capture leadership sign-off with digital signatures.
• Distribute updates automatically to all personnel.
3. Objectives and success measures
Translate your policy into measurable outcomes with clear accountability.
Objectives dashboard
| Objective | How we measure it | Target | Owner |
|---|---|---|---|
| Protect patient safety through verified diagnostic reporting. | Critical result notification compliance | 100% communicated within 30 minutes | Laboratory Director |
| Sustain ISO 15189 accreditation readiness across all sites. | Internal audit action closure time | ≤ 10 business days | Quality Manager |
| Maximize instrumentation reliability and lifecycle control. | Preventive maintenance completion rate | ≥ 98% on-time | Technical Supervisors |
4. Roles and responsibilities
Define leadership, ownership, and support expectations across the laboratory.
Team roles
Laboratory Director
Sets strategic direction, approves the quality manual, ensures resources are adequate, and serves as final authority for accreditation decisions.
Quality Manager
Maintains the quality management system, coordinates audits, oversees risk registers, and stewards corrective and preventive actions.
Technical Supervisors
Lead discipline-specific operations, validate methods, manage competency assessments, and monitor analytical performance.
Support Teams (IT, Facilities, Procurement)
Provide secure data infrastructure, controlled environments, dependable supply chains, and document traceability services.
5. Key processes
Summaries ensure every team can see the flow from specimen to certified report.
Process map
Sample reception and identification
Barcoded intake, chain-of-custody verification, and LIS reconciliation ensure every specimen enters the system with traceable metadata.
Examination / testing workflow
Validated methods, real-time QC rules, and dual verification checkpoints drive analytical accuracy from setup to release.
Result verification and release
Automated delta checks, clinical correlation reviews, and electronic sign-off protect result integrity before provider delivery.
Equipment maintenance and calibration
Lifecycle schedules combine vendor SLAs, service logs, and tolerance tracking to keep instruments within specification.
Handling of nonconformances and CAPA
Deviation reports trigger root-cause analysis, documented corrective actions, and effectiveness checks with executive oversight.
Document control and change management
Digitized SOP workflows route drafts for review, approval, staff acknowledgment, and archival with version retention policies.
6. Risk and improvement
Keep continuous improvement loops visible and accountable.
Risk register
How we log risks or ideas
Centralized ISO risk register in LabsVerified with linked CAPA workspace and ideation board for continuous improvement.
How often we review them
Standing review each month with ad-hoc escalations for high-severity entries and quarterly trend analysis.
How we track completion
Action owners update status, due dates, and evidence; dashboards highlight overdue items until closure is verified.
7. Resources and support
Document the infrastructure that keeps your laboratory compliant and resilient.
Resource readiness
Staffing levels and backup plan
Competency matrix covers primary and secondary operators per bench with cross-trained float pool for surge coverage.
Critical suppliers / service contracts
Strategic agreements in place with instrument OEMs, reagent vendors, external reference labs, and validated courier partners.
Environmental controls
Continuous monitoring of temperature, humidity, and differential pressure with alert thresholds and documented excursions.
8. Management review summary
Capture the cadence, inputs, and outputs the standard expects.
Review cadence
Frequency
Formal management review convenes quarterly with interim focus sessions when major risks emerge.
Inputs reviewed
Key performance indicators, proficiency testing trends, quality control data, customer feedback, complaints, resource sufficiency, and supplier performance.
Outputs recorded
Documented decisions, assigned improvement actions, responsible owners, due dates, and follow-up checkpoints.
9. Document control
Keep every revision, approval, and distribution traceable.
Document lifecycle
Version numbering method
Semantic format (major.minor.revision) aligned to change magnitude and effective dates.
Where the master copy lives
LabsVerified document library with read-only master access and controlled distribution copies.
Who approves new or revised versions
Quality Manager initiates review, Laboratory Director grants final approval, and impacted supervisors acknowledge implementation.
10. Approval
Capture signatures and review cadence to finalize your manual.
Sign-off
Prepared by
Reviewed by
Approved by
Effective date
Next review date
Turn your manual into a living ISO program
Sync this template with LabsVerified to automate audits, evidence packs, and continual improvement across every site.
ISO 15189 • CAP • CLIA • NABL • LabsVerified