ISO 15189 Internal Auditor Training in USA

A two-day course that teaches you to plan, conduct, report and follow up internal audits of a medical laboratory’s management system and technical processes.

The international standard setting requirements for quality and competence in medical laboratories.

Yes. It is the fourth edition, published in December 2022.

No.

The 2022 edition was restructured into Clauses 4–8, puts more weight on risk to patients, and brings point-of-care testing into Annex A.

The current guidelines for auditing management systems.

Recognition by an accreditation body that a laboratory is competent for a defined scope of examinations.

Laboratories are normally accredited to ISO 15189 by an accreditation body. It is not an ordinary management system certification.

No. CLIA is a separate US regulatory requirement.

The College of American Pathologists’ program that accredits laboratories to ISO 15189:2022. CAP says laboratories must first be accredited under its Laboratory Accreditation Program.

Laboratory quality managers, directors, supervisors, scientists, QA officers, technical managers, internal auditors, POCT and accreditation coordinators.

None are mandatory. IAS says basic ISO 15189 and quality management knowledge is helpful.

Yes, though an awareness course first can help newcomers.

Not required, but it helps you audit technical processes.

No.

Two days.

Yes, as advertised by IAS.

Yes, as advertised by IAS.

ISO 15189 requirements, technical processes and audit planning.

Conducting audits, laboratory process auditing, findings and corrective action.

4 general, 5 structural and governance, 6 resources, 7 processes and 8 management system requirements.

The internal audit requirement of ISO 15189:2022.

Planning audits so that higher-risk activities, especially those affecting patients, get more attention.

Activities with greater potential for patient harm, incidents, complaints or changes are audited sooner or more often.

Having the education, training, skills and experience to perform assigned work, assessed and authorized by the laboratory.

Internally by the laboratory for its staff; externally by accreditation bodies for the laboratory.

Confirming that a validated method performs as claimed in your laboratory.

Establishing that a method is fit for its intended use, needed for example for laboratory-developed or modified methods.

Running control materials to monitor the validity of examination results.

External quality assessment: comparing your results with others through an external scheme.

A form of EQA in which a provider sends samples and evaluates laboratories’ results.

Linking a result to a reference through an unbroken chain of calibrations.

A parameter describing the spread of values reasonably attributable to a measured quantity.

Requests, patient preparation, collection, identification, transport and receipt.

Performing the examination, with verified or validated methods and quality control.

Result review, authorization, reporting, critical result communication and retention.

Being able to trace a sample from the patient and request to the report.

Under the laboratory’s procedure, which defines communication, timing and records. This page sets no thresholds.

Point-of-care testing performed near the patient, often outside the laboratory.

Yes, in normative Annex A.

No. ISO 22870:2016 was withdrawn in December 2022.

Clause 4.2 requires patient information to be protected.

An audit of validation, access, data transfer, audit trails, backup and confidentiality.

Verifiable records, observations or statements supporting audit conclusions.

By setting objectives, scope and criteria, prioritizing by risk and selecting competent, independent auditors.

From the requirements, the laboratory’s procedures and the risks of the area audited.

At planned intervals set by the laboratory, considering risk. No single frequency applies to every laboratory.

ISO 15189:2022 expects auditors to be independent of the activity audited wherever resources permit.

Being trained, qualified and authorized by the laboratory to audit.

The IAS page lists audit scenario exercises; this page adds a fictional mock audit.

Failure to meet a requirement.

With the requirement, the objective evidence and a clear statement, in the audit report.

Action to remove the cause of a nonconformity and prevent recurrence.

Checking that corrective action worked.

Top management’s review of the management system using defined inputs, including audits and indicators.

Not confirmed. The IAS accreditation page lists ISO 15189 Lead Auditor as EAS certified but does not list this Internal Auditor course.

No CQI-IRCA approval is claimed.

Internal auditor training is two days for first-party audits. Lead Auditor is a separate five-day course on audit leadership.

No. Accreditation bodies authorize their own assessors.

No.

EAS, IAS’s technical partner, as advertised.

Not named yet; we confirm before you enrol.

No.

EAS offers a certificate search; we confirm it covers this course.

Confirmed with the certificate wording.

No.

Advertised by IAS; no public venue is published.

Yes. The IAS schedule lists December 26–27, 2026.

Yes, as advertised.

IAS advertises 30-day online self-learning.

For self-learning, as advertised. It is access to materials, not live instruction.

Not confirmed.

IAS lists quizzes; the final assessment rules are to be confirmed.

Not published.

Not published; we confirm.

A virtual session on December 26–27, 2026 is listed. Confirm before registering.

The schedule lists 9:00–18:00 without a time zone. We confirm it.

Request a fee. No price is published.

Yes.

Usually for virtual sessions; confirm the time zone.

None is published; request a group quotation.

See the refund policy and your quotation.

Use the registration form. A coordinator confirms dates, fees and availability.

You receive confirmation and joining instructions once your place is confirmed in writing.