According to ILAC (International Laboratory Accreditation Cooperation), as of 2025, over 114,600 laboratories are accredited under ISO 17025 worldwide.

Notably, section 8.8 of the ISO 17025 Standard mandates an internal audit before every accreditation assessment.

The reality that most labs are reluctant to admit is that the internal audit is the most important step that nobody does well themselves. You need the outside expert’s expertise and perspectives.


Why External Experts are Key to Internal Audit Success

Here is a scenario that plays out in laboratories more often than anyone in the industry likes to acknowledge.  An accreditation assessment is scheduled.  The quality manager pulls the team together, everyone works late for three weeks, dozens of procedures get hastily approved, and when the assessor walks in the door, it is painfully obvious that most of the preparation happened in the final month.  The assessor has seen it hundreds of times.  The volume of recently dated approvals tells its own story.

The uncomfortable truth is that the internal audit, which is the single most powerful tool a laboratory has for preparing for accreditation, is routinely underused, rushed, or performed so narrowly that it misses the very areas where the external assessor will find problems.

Lab Manager magazine put it plainly in a January 2025 analysis of ISO 17025 assessment preparation stating that the internal audit is "rarely given the attention needed to improve the laboratory's compliance." The article added that “many laboratories tend to exclude areas in their internal audits or quickly perform an overview, which results in findings in their external assessment.”

It is not that laboratory managers are careless.  In fact, most are deeply competent scientists and technical professionals who simply did not train as quality auditors. Conducting a rigorous internal audit against every clause of ISO/IEC 17025:2017 requires a specific set of skills, objectivity, and time that most laboratories simply cannot produce internally. Clause 8.8 of the ISO 17025 standard requires the audit to be performed by someone independent of the activities being assessed.  In a small or mid-sized laboratory, that creates an immediate structural problem. If everyone is too close to the work, nobody can audit it impartially.

This is exactly why so many laboratories, from independent calibration labs in the Midwest to pharmaceutical testing facilities on the East Coast, bring in IBEC to conduct their ISO 17025 internal audits.  They do this not because they cannot read the standard, but because an outside set of eyes, with no stake in the outcome and years of pattern recognition from auditing laboratories across dozens of industries, finds things that insiders miss every time.

When you have IBEC conduct your internal audit service for ISO 17025, you ensure that your nonconformities are identified on your schedule. This gives you an opportunity to fix those nonconformities before they cost you your accreditation. Don’t let the accreditation body find the problems first.

What IBEC Provides

IBEC offers a complete suite of internal audit services, from standalone annual audits to full pre-assessment readiness programs. Every engagement is scoped to your laboratory's specific accreditation scope, size, and industry sector.

One of the most frequent criticisms we hear from laboratory directors who have tried to manage internal audits in-house is that they end up being desk audits, meaning a review of whether documents exist, rather than a genuine assessment of whether the laboratory is actually operating in compliance with those documents. The accreditation body does not make the same mistake.

When IBEC conducts an internal audit, we do what external assessors do: we interview the analysts who actually perform the work, observe procedures being carried out, check that calibration records match what equipment is actually in use, and trace results end-to-end from the initial customer request through to the final report. If there is a gap between your documented procedures and your actual laboratory practice, we will find it.

Section 8.8 of ISO 17025:2017 requires the internal audit to cover both management system requirements and technical requirements.  Many laboratories cover one reasonably well and let the other slide. We audit both, in full.

What We Include in the ISO 17025 Internal Audit

Full-Scope Internal Audit (Clause 8.8) – A comprehensive audit covering all management and technical requirements of ISO/IEC 17025:2017. This includes the clauses that laboratories most commonly skip, such as contract review, nonconforming work, risk management, as well as purchasing.  We review documentation, interview personnel, and observe technical activities to produce a complete picture of where you stand.

Pre-Assessment Readiness Review – Scheduled 60–90 days before your accreditation body assessment, this service simulates the external audit experience as closely as possible.  We identify nonconformities, help you prioritize corrective actions, and verify that your quality system will hold up under scrutiny. This is done to ensure that there are no surprises when the accreditation body arrives.

Annual Surveillance Audit Support – Already accredited and preparing for your annual surveillance visit?  IBEC can conduct a targeted pre-surveillance internal audit to confirm your quality system has remained compliant since your last assessment and that any previously identified nonconformities have been properly closed out and are not recurring.

Corrective Action Follow-Up – Finding a nonconformity is only half the work. Closing it effectively, with documented root cause analysis, corrective action evidence, and verification of effectiveness, is where many labs stumble.  IBEC helps you develop corrective action responses that will satisfy your accreditation body's requirements.

Internal Auditor Training & Mentoring – Want to build internal audit capability within your own team?  IBEC can train your staff to conduct effective ISO 17025 internal audits independently, providing coaching, audit checklists, and practical guidance.  This is particularly valuable for multi-site laboratories wanting to reduce reliance on external auditors over time.

Emergency Audit Triage – If you have received a notice of nonconformity from your accreditation body and need help fast, IBEC provides expedited audit support for laboratories in immediate need of corrective action guidance, helping you respond within required timelines and avoid suspension or withdrawal of accreditation.

It’s noteworthy that by the time IBEC has completed an internal audit, your team knows exactly where you stand. This refers to not just your standing in terms of clause-by-clause compliance, but in terms of the underlying health of your quality system. That knowledge has value well beyond the accreditation cycle.


Be Proactive, Reach out to IBEC Experts to Schedule Your Internal Audit.