ISO/IEC 17025 assessments led personally by Roberto L. Rivera — an ACLASS ISO 17025 Lead Assessor with 45 years of cGMP experience. Whether you're a lab preparing for accreditation or a manufacturer qualifying a contract lab, he assesses competence the way an accreditation-body assessor does.
ISO/IEC 17025 is the international benchmark for the competence of testing and calibration laboratories. Accreditation to it isn't a paperwork exercise — it demands demonstrated technical competence, validated methods, measurement traceability, and a management system that holds together clause by clause.
Whether you run a lab chasing accreditation or a manufacturer relying on contract labs for release data, the risk is the same: a gap you can't see until an assessor — or a regulator — finds it. Invalid data from an unqualified lab flows straight into your own quality decisions.
What makes the difference is being assessed by someone who has sat in the assessor's chair and knows exactly how each clause is judged.
"We think we're ready for accreditation — but we don't actually know how an assessor will read our method validation and traceability records."
That's the gap an ACLASS ISO 17025 Lead Assessor closes. Roberto assesses your lab against every clause the way the accreditation body will, so there are no surprises when the real assessment comes.
Scoped to your lab's scope of testing. Roberto assesses personally as an ACLASS Lead Assessor.
Assessment against every clause of ISO/IEC 17025 — management requirements and technical requirements — with a prioritized gap report.
Evaluation of method validation, measurement uncertainty, equipment calibration, and measurement traceability — where labs most often fall short.
Review of the lab's management system, document control, records, and internal audit and management review processes against the standard.
A corrective action roadmap that takes the lab from current state to ready for the accreditation body's assessment, with realistic timelines.
For manufacturers: independent assessment of contract testing labs in your supply chain, with a clear qualification recommendation.
Combined GMP and 17025 assessment of QC and contract laboratories — analytical chemistry, microbiology, and rapid methods.
Roberto reviews your lab's scope of testing, current status, and objective — accreditation readiness or contract-lab qualification — and builds the assessment plan. A mutual NDA can be executed first.
A clause-by-clause assessment of the management system and technical competence, including method validation, traceability, and records, with a daily debrief.
A written report mapping every finding to the specific ISO/IEC 17025 clause, prioritized by risk to accreditation or to data validity.
A concrete, sequenced plan to close each gap — the path from current state to accreditation-ready, or the basis for a qualification decision.
Optional follow-up assessment to confirm the corrective actions hold before the accreditation body's assessment — so you meet it with confidence.
You work directly with Roberto L. Rivera — an ACLASS ISO/IEC 17025 Lead Assessor and former Pfizer Senior Audit Manager with 45 years across the world's most regulated laboratories. He has assessed laboratory competence across analytical chemistry, microbiology, and specialized methods, and he reads your lab against the standard exactly as an accreditation body will.
It's the international standard for the competence of testing and calibration laboratories. Accreditation to it demonstrates that a lab produces valid, reliable results under a sound quality management system, and it's widely required of contract laboratories serving regulated industries.
Two audiences: testing and calibration labs preparing for or maintaining ISO/IEC 17025 accreditation, and manufacturers who need to qualify and audit the contract labs in their supply chain against the standard.
Roberto holds an ACLASS ISO/IEC 17025 Lead Assessor credential and has assessed laboratory competence across analytical chemistry, microbiology, and specialized methods over a 45-year career, most recently as a Pfizer Senior Audit Manager. He assesses labs the way an accreditation-body assessor would.
Roberto assesses the lab's management system, technical competence, method validation, measurement traceability, and records against each clause of the standard, then delivers a prioritized gap report and a corrective action roadmap toward accreditation readiness or a qualification decision.