Stage

Who Does It

Activity

Application

Laboratory

The laboratory fills out the application form, and sends it to the CAP, along with the requested documentation.

How to Apply?

Note: Once the application is complete, the CAP assigns a lead assessor, who guides the laboratory through the subsequent steps to become accredited to ISO 15189.

Desk Assessment

CAP

The CAP conducts an offsite review of documents the laboratory has submitted.

The purpose is to study the QMS, look for major issues in the documentation, and evaluate the laboratory’s readiness for the accreditation assessment.

Gap Assessment

Laboratory & CAP

The CAP performs a detailed on-site assessment of the QMS and technical competency.

This helps the laboratory scope the work required for accreditation and allows time for corrective actions before the accreditation assessment.

Optional Pre Assessment

Laboratory & CAP

The CAP performs a one-day review of progress after the gap assessment to assess the laboratory’s readiness for the accreditation assessment.

Internal Audit

Laboratory

The laboratory performs an internal audit of its QMS against the15189 standard.

This must be done before the on-site accreditation assessment.

On-site Accreditation Assessment

Laboratory & CAP

The CAP performs a detailed review of the laboratory’s QMS and technical competency, including document control system, records management, and interviews with staff.

The output of the assessment is a report of the level of conformance. Subsequently, the assessors make a recommendation to the accreditation committee.

Accreditation

CAP

The CAP 15189 Accreditation Committee reviews the assessor report, documentation, and corrective action reports. The committee votes on whether to accredit.

Surveillance 1 (Management)

Laboratory & CAP

The CAP performs a review of the laboratory’s QMS from the standpoint of ISO 15189 Section 4, Management Requirements.

Surveillance 2 (Technical)

Laboratory & CAP

The CAP performs a review of the laboratory’s QMS from the standpoint of ISO 15189 Section 5, Technical Requirements.