Services for Laboratories
In the in vitro diagnostics environment, manufacturers must not only demonstrate the innovation of their assays and instruments, but also ensure that users implement robust, traceable, and defensible quality control practices.
APEX helps manufacturers integrate the vision of quality control into their value proposition, offering services that strengthen adoption, generate scientific evidence, document performance, and project educational leadership.
Our approach turns Quality Control into a key differentiator: a value argument that provides confidence and competitiveness.
At APEX, we understand that clinical laboratories face constant challenges to ensure the reliability of their results, the efficiency of their processes, and compliance with international standards.
Pressure comes not only from auditors or regulators, but also from doctors and patients who rely on every report issued.
After a thorough analysis of laboratory needs, we have designed services that integrate independent quality control, risk-based methodologies, and advanced IT solutions, always aligned with ISO 15189, ISO 22367, and CLSI guidelines.
Our approach seeks to ensure that quality control is not viewed as an isolated requirement, but as the heart of analytical reliability and patient safety.

Today's labs require more than products: they need comprehensive support systems that combine science, strategy, and data.
With these services, APEX helps every clinical laboratory transform its control programs into a competitive advantage, ensuring trust with auditors, credibility with physicians, and peace of mind for patients.
Within this framework, APEX offers services that allow:
- Design robust internal and external control programs, with independent control materials and statistical rules that detect errors early.
- Optimize resources and justify budgets by quantifying the cost of quality and demonstrating the return on investment of well-implemented QC strategies.
- Respond effectively to out-of-control events with documented protocols and CAPAs that reduce clinical risks and strengthen patient safety.
- Integrate IT solutions and interlaboratory comparisons, which convert data into actionable information and strengthen traceability.

Key Needs of a Clinical Laboratory in Quality Control
- Daily reliability: optimal rules/frequencies, independent monitoring materials, clear limits and objectives.
- Evidence and compliance: method verification, metrological traceability, audit-ready documentation.
- Comparability: interlaboratory comparison programs in internal and external control.
- Incident response: risk management, OoC protocols, and CAPAs that reduce clinical risk and recurrence.
- Actionable data: monitoring software, real-time alerts, dashboards, and data governance.
- Economic value: cost of quality, process optimization and ROI of strategies.
In the following sections, you'll discover how each service is designed to address the critical needs of clinical laboratories.
Basic Services Group:
Design and Evidence
This group is the scientific backbone of the laboratory.
A robust control program not only detects errors, but also prevents them before they affect clinical decisions.
This block turns the laboratory into a benchmark of reliability, capable of demonstrating with facts that its results are consistent and defensible.
- Analytical performance: Transform routine analysis into proven accuracy; each result is statistically supported and traceable.
- Operation and management: Simplifies accreditations and audits, avoiding rework and reducing the administrative burden.
- End customers: Physicians and patients receive diagnoses that inspire confidence and support critical decisions with verifiable evidence.
1. Risk-based internal control architecture
We designed and implemented a risk-based Internal Quality Control (IQC) program, integrating independent materials, statistical rules, and optimal frequencies in accordance with ISO and CLSI, to ensure reliable and traceable results every day.
Features:
- Selection of rules and frequencies according to performance and criticality.
- Documented quality objectives, limits and action plans.
- Integration of independent controls with metrological traceability.
Value for the distributor:
- Reduces false rejections/acceptances and improves early detection of problems.
- Ensures consistency and confidence in audits and clinical decisions.
2. Management of data from intercomparison
Integration of data from External Control and Internal Control, from program selection to performance interpretation, converting reports into improvement actions with real impact and evidence.
Features:
- EQA/PT selection and schedule by analytical area.
- Z-score, bias and Sigma analysis with corrective plans.
- Peer groups and benchmarking with executive reports.
- Value for the distributor:
- Quickly detects and corrects biases, increasing external comparability.
- Strengthens compliance and reputation with agencies and clients.
3. Verification of methods and design of basal strategies
We structure the verification of analytical methods by analyte and technology, covering precision, bias, linearity, and limits; we define quality objectives and internal goals. We deliver auditable reports that accelerate accreditation and support clinical decisions with robust and traceable data.
Features:
- Protocols by matrix/technology and sample size.
- Precision, bias, linearity and LoD/LoQ calculations.
- Audit-ready reports and templates (ISO 15189).
Value for the distributor:
- Accelerates accreditation and reduces rework on implementations.
- Support clinical decisions with solid statistical evidence.
Service Group B:
Operation and Response
This group transforms a laboratory into a reliable and agile institution, capable of maintaining quality even in critical situations.
This is where operational resilience is defined. A laboratory may have good systems, but what sets it apart is its ability to react quickly and intelligently when something goes wrong.
- Analytical performance: OoC protocols ensure continuity and reduce clinical risks, avoiding misdiagnoses.
- Operation and management: Real-time dashboards and alerts enable agile decision-making with less manual input and greater efficiency.
- End customers: Physicians receive reliable results without delays, and patients benefit from a safe experience, with fewer risks associated with analytical errors.
4. Response to out-of-control (OoC) events and CAPA
We create and train out-of-control event (OoC) response protocols and CAPAs, using scalable algorithms, checklists, and documentation aligned with ISO 15189 and EP23. We reduce recovery times, clinical risks, and recurrence through root cause analysis.
Features:
- Decision and scaling algorithms with target times.
- CAPA checklists, forms and traceability.
- Use of independent control as an objective reference.
- Value for the distributor:
- Shortens recovery time and protects operational continuity.
- Reduces recurrences, strengthening patient safety.
5. QC IT and real-time automation
We implement and optimize QC software solutions (dashboards, alerts, peer groups) for real-time monitoring, integration with LIS/LIMS, and report automation. We ensure team adoptability, data governance, and agile decisions based on objective and comparable evidence.
Features:
- Centralized dashboards, alerts, and peer analytics.
- Integration with LIS/LIMS and secure connectivity.
- Roles, permissions and data governance.
Value for the distributor:
- Faster and more accurate decisions with early signals.
- Less manual loading and errors, greater team efficiency.
Service Group C:
Value, Governance and Education.
This unique service gives the laboratory a strategic view of its quality in concrete figures.
The cost of quality is not an expense, it is a reflection of risk and operational efficiency.
This service turns quality into a financial and clinical asset, helping the laboratory compete with a long-term vision.
- Analytical performance: Enables intelligent investment in QC strategies that reduce errors and increase accuracy.
- Operation and management: provides clear financial data to justify resources and optimize consumption of inputs.
- End customers: Ensures that the laboratory's investment translates into more reliable and accessible diagnoses for the community.
6. Risk Economics and Cost of Quality
We quantify the cost of quality according to QMS20-R and ISO 22367: prevention, evaluation, and failures. We model the ROI of QC strategies, optimal inspection frequency, and input consumption to justify investments and prioritize actions with technical and financial impact.
Features:
- PAF model and risk map by process.
- Frequency/consumption optimization and “what-if” scenarios.
- Financial KPIs and executive dashboards.
Value for the distributor:
- Maintains budgets with clear ROI and loss reduction.
- Prioritize decisions with the greatest clinical and economic impact.
7. Training Program in QC Fundamentals and Operation
We develop structured training programs to educate staff on the fundamentals, processes, and operational tools of quality control. From basic theory to daily practice, we strengthen competencies that guarantee reliable results and efficient management.
Features:
- Modules adapted to different levels: basic, intermediate and advanced.
- Coverage of ISO 15189, ISO 22367 standards and CLSI guides (C24-A4, EP23).
- Hands-on training in independent control management, chart interpretation, and responding to out-of-control results.
Value for the distributor:
- Ensures a competent and consistent team, reducing variability due to human error and strengthening the culture of quality.
- It facilitates long-term quality sustainability by training professionals capable of maintaining and improving the system beyond initial accreditation.