Laboratorio Aclimu
ITAES accredited 2026–2029

Quality and accreditations

Every result we deliver is backed by a quality management system with internal and external controls, standardized procedures and a team in continuous training. It isn't a tagline — it's how we work every day.

Accredited by ITAES

The Technical Institute for the Accreditation of Health Establishments (ITAES)evaluates whether a laboratory meets quality standards across processes, personnel, facilities and results. Accreditation isn't permanent: it's renewed through periodic evaluations.

Our current certificate covers the period 2026–2029. We're also associate members of ITAES, reinforcing our commitment to continuous improvement of the quality system.

Laboratorio Aclimu — instrumentation and quality control

External assessment programs

We participate regularly in national and international intercomparison programs. Each program sends "blind" samples that we process as if they were from patients, and our results are compared with those of hundreds of participating laboratories.

PEEC — Argentine Biochemistry Foundation

PEEC — Argentine Biochemistry Foundation

Nationwide External Quality Assessment Program.

ProgBA — CEMIC

ProgBA — CEMIC

International intercomparison program based in Buenos Aires.

EMQN — European Molecular Genetics Quality Network

EMQN — European Molecular Genetics Quality Network

International quality control for genomics and molecular biology.

GenQA — Genomics Quality Assessment

GenQA — Genomics Quality Assessment

BRCA1, BRCA2 and HRR gene variant classification assessment, run together with EMQN within the UK NEQAS consortium. We took part in Run 15 (2025).

SmartSpot Q

SmartSpot Q

Targeted assessment for SARS-CoV-2 RT-PCR.

If you need a certificate of participation or accreditation, write to administracion@aclimu.com.ar and we will send it to you.

Our commitment to quality

Aclimu's quality policy rests on eight pillars that guide every step of the process, from sample collection to report delivery.

High-quality analyses

We work to national and international standards and continuously update our procedures to deliver accurate, reliable results.

Continuous improvement

Our Quality Management System (QMS) is reviewed regularly with the active participation of the entire team.

Care and confidentiality

We protect your personal data in accordance with the law and communicate results clearly, promptly and confidentially.

Patient satisfaction

We listen to your experience, collect your feedback and use it to improve every step of how we care for you.

Qualified personnel

The team trains continuously through programs that ensure up-to-date technical competence.

Quality controls

We participate in internal (IQC) and external (EQA) assessment programs to verify the accuracy of every result.

Traceable equipment

State-of-the-art instruments, regularly calibrated and sourced from qualified suppliers.

Full traceability

Every sample is logged and traced from receipt to report issuance, ensuring auditable results.

How we work

Beyond accreditations, these are the practices behind every result: a licensed laboratory, a documented and audited quality system, daily controls and data you can trace.

Health authority licensing

Licensed by the national Ministry of Health (Disposition DI-2025-1309-APN-DNHFYSF#MS, 2025) and by the City of Buenos Aires (DI-2025-9386-GCABA-DGHP, 2025) as a clinical analysis laboratory: chemistry, hematology, immunoassays, hemostasis, molecular biology and bacteriology.

Daily internal QC

Every analytical run is checked against Westgard rules and assessed with Six Sigma metrics, complemented by the PEEC, ProgBA and GenQA (BRCA and HRR variant classification) external programs.

ISO 15189 as reference

Our quality management system is designed with ISO 15189 and ISO 9001 as reference standards, plus ISO 15190 for laboratory safety.

Controlled documentation

A Quality Manual with around 90 standards and a Procedures Manual with around 40 standard operating procedures, under version control and digitally signed.

Audits

An annual internal audit program and an annual accreditation audit, with recorded findings and a report signed by management.

Nonconformities

Every deviation is recorded, its cause is analyzed and it is closed with a corrective action.

Data integrity

Every result is versioned with user and timestamp, as is every status change (entered, validated, reported). Critical results are flagged automatically at validation and trigger the notification protocol.

Biosafety

Universal biosafety precautions, personal protective equipment, hepatitis B vaccination for staff, and pathogenic waste removed by a licensed operator with manifests, under Argentine Law 24,051.

What we measure

An indicator program reviewed at management meetings. Among others:

  • Report turnaround time and delayed protocols
  • Critical result notification time
  • Sample rejection for pre-analytical criteria
  • Formal complaints and patient satisfaction
  • WhatsApp response time
  • Incidents and nonconformities
  • Reagent utilization
  • Temperature excursions
  • Hand hygiene compliance
Jonatan Garcia, Technical Director of Laboratorio Aclimu

Technical direction

Jonatan Garcia, Biochemist

National license MN 12,541 · Argentine Ministry of Health

Technical director named in the laboratory's national license and responsible for quality management system assurance.

Meet the team

Team training

The whole team follows an annual training program, and each personnel file records the requirements of the role. For clinical trials, our biochemistry and technical staff are trained in:

  • Good Clinical Practice ICH E6 (R2)

    The Global Health Network · TransCelerate-recognized

  • Good Clinical Practice refresher for site personnel (ICH E6 R2)

    Syneos Health

  • J-GCP based on ICH-GCP

    Syneos Health

  • IATA Dangerous Goods Regulations, 62nd edition

    Syneos Health

  • Transporting dangerous goods (P.A.C.E.)

    Mayo Clinic Laboratories

Clinical trials laboratory services