Independent ISO/IEC 17025:2017 laboratory assessments led personally by Roberto L. Rivera — an ACLASS ISO 17025 Lead Assessor with four decades in cGMP, 24 years of GMP auditing, and a former Pfizer Senior Audit Manager II. Whether you are preparing your own laboratory for accreditation or qualifying a contract testing lab, the assessment tells you whether the competence is genuinely there — before the accreditation body or a regulator decides for you.
ISO/IEC 17025:2017 is the international benchmark for the competence of testing and calibration laboratories. A laboratory that meets it can demonstrate — to an accreditation body, a client, or a regulator — that its results are technically valid and defensible. A laboratory that only believes it meets the standard is carrying risk it cannot see.
Two situations bring that risk to the surface. A laboratory pursuing or maintaining accreditation needs to know where the gaps are before the accreditation body's assessors arrive — because findings discovered then are far more expensive to close. And a manufacturer qualifying a contract testing laboratory needs an independent read on whether that lab's method validation, traceability, and records will actually hold up when its data lands in a regulatory submission.
"Our contract lab says it's ready for ISO 17025 accreditation. I need an assessor's read on whether the method validation and traceability records will actually hold up."
That is the assessment. Roberto works clause-by-clause through the standard's management and technical requirements, witnesses the work where it matters, and tells you exactly where the laboratory stands — and what it will take to close the distance.
Scoped to your situation, whether you are seeking accreditation or qualifying a laboratory you rely on. Roberto is your Lead Assessor throughout.
A pre-assessment against ISO/IEC 17025:2017 for laboratories pursuing accreditation — so the gaps are found and closed on your timeline, not discovered during the accreditation body's assessment.
Systematic review of both the management requirements (impartiality, document and record control, corrective action, internal audit, management review) and the technical requirements against the current standard.
Evaluation of whether analytical and microbiological methods are appropriately validated or verified for their intended use, with documentation that will withstand scrutiny.
Review of metrological traceability of calibrations and the estimation of measurement uncertainty — two of the technical areas where laboratories most often fall short of the standard.
For manufacturers: an independent competence assessment of a third-party testing laboratory before you rely on its data, combining ISO/IEC 17025 expectations with GMP data-integrity requirements.
A single engagement covering both cGMP laboratory controls under 21 CFR Part 211 and ISO/IEC 17025 competence — efficient for QC laboratories that must satisfy both.
Roberto reviews your scope of testing or accreditation, the quality manual, and key procedures, then builds a targeted assessment plan. A mutual NDA can be executed first.
Assessment against ISO/IEC 17025:2017 — witnessing testing where it matters, reviewing records and calibrations, interviewing analysts, and examining equipment, with real-time observations and a daily debrief.
A written report with prioritized nonconformities mapped clause-by-clause to the standard, plus a clear readiness or qualification recommendation your laboratory can act on directly.
Review of corrective action responses and supporting evidence, confirming the gaps are genuinely closed rather than documented and left open.
Confirmation of readiness ahead of the accreditation body's assessment, or a documented qualification decision for a contract laboratory you intend to rely on.
You work directly with Roberto L. Rivera — an ACLASS ISO/IEC 17025 Lead Assessor who has not only assessed laboratories but built and run them. Early in his career he supervised microbiology, chemistry, pyrogen, and particle-testing laboratories and established a fermentation laboratory from start-up. Across four decades in cGMP, including 24 years of GMP auditing, he has assessed analytical chemistry, microbiology, and rapid-method laboratories on five continents.
That combination matters: he reads a laboratory the way an experienced analyst does, not from a checklist. He knows the difference between a finding that will fail an accreditation assessment and a note that will not — and he tells you which is which, in English or Spanish.
ISO/IEC 17025:2017 is the international standard for the competence of testing and calibration laboratories. An assessment reviews a laboratory against the standard's management and technical requirements — impartiality, personnel competence, equipment and calibration, method validation and verification, measurement traceability and uncertainty, handling of test items, and ensuring the validity of results — to confirm the laboratory can produce technically valid, defensible results.
A GMP audit evaluates manufacturing and laboratory controls against regulations such as 21 CFR Part 211. An ISO/IEC 17025 assessment evaluates a laboratory's technical competence — its methods, traceability, measurement uncertainty, and impartiality. The two overlap in the QC laboratory and can be run as a single combined engagement.
The assessment is performed against ISO/IEC 17025:2017 itself, so it prepares a laboratory for accreditation by any recognized body, including A2LA and ANAB in the United States. Roberto assesses readiness against the standard regardless of the body you ultimately choose.
A written report with prioritized findings mapped clause-by-clause to ISO/IEC 17025:2017, a readiness or qualification recommendation, and review of the laboratory's corrective action responses. Assessments can be scoped for a laboratory pursuing its own accreditation or for a manufacturer qualifying a contract testing laboratory.
Roberto responds personally within one business day. A mutual NDA can be executed before any detail is shared.
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