A Personalized, Flexible Accreditation Process
Each laboratory’s quality improvement program is unique, so we offer a flexible preparation experience to help guide you through your initial accreditation journey. Your dedicated lead assessor supports you with Quality Management System (QMS) educational resources and unique tools developed by the College of American Pathologists (CAP).—where and when you need them.
The CAP Laboratory Accreditation Program provides the foundation for our ISO 15189 program; therefore your laboratory must first be accredited by the CAP Laboratory Accreditation Program.
CAP 15189 Accreditation Process
CAP 15189 Accreditation Steps and Activities
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The laboratory completes the online application, includes requested documentation, and submits it to the CAP. After receiving the application, the CAP assigns a dedicated lead assessor who guides the laboratory through the subsequent steps to earn accreditation to ISO 15189.
The CAP lead assessor conducts an off-site review of the documents submitted by the laboratory. The purpose is to learn your QMS, look for major issues with the documentation, and evaluate the laboratory’s readiness for the accreditation assessment. Based on this review, the lead assessor may recommend CAP online courses, such as Internal Auditing and Root Cause Analysis.
The laboratory performs at least one internal audit of its QMS against the ISO 15189 standard. This must be done prior to the on-site accreditation assessment.
The CAP assessment team performs a detailed on-site assessment of the QMS and technical competency. This helps the laboratory identify gaps in the system and scope of work required for accreditation. The lead assessor discusses readiness for the accreditation assessment.
The laboratory updates QMS gaps as needed, including development or revision of policies and procedures and redesign of processes.
The CAP performs a detailed review of the laboratory’s QMS and technical competency. The output of the assessment is a report on the level of conformance, listing specific nonconformances, strengths, opportunities for improvement, and any vulnerabilities.
The laboratory performs root cause analysis on all nonconformances and submits corrective action responses to the CAP. The CAP reviews these responses, evaluating the root cause analysis conducted for each. Subsequently, the assessors make a recommendation to the CAP 15189 Accreditation Committee.
The CAP 15189 Accreditation Committee, which is comprised of pathologists and quality experts, reviews the assessors’ report, documentation, and corrective action reports prior to voting on whether or not to grant accreditation.
The CAP performs a review of the laboratory’s QMS focusing on ISO 15189 Section 4, Management Requirements. Progress on corrective action from prior assessments will be reviewed.
The CAP performs a review of the laboratory’s QMS focusing on ISO 15189 Section 5, Technical Requirements. Progress on corrective action from prior assessments will be reviewed.
The timeline for the initial accreditation cycle varies depending on the laboratory’s readiness, resources, and level of commitment. Gain further insight into each step in the accreditation process, then assess your readiness to apply.
Before You Apply, Make Sure that You Are Fully Prepared
ISO 15189:2022 Medical Laboratories – Requirements for quality and competence was published on December 6, 2022.
Through its CAP 15189 Accreditation Program, the CAP is planning for a three-year transition period. By the end of this period, laboratories currently accredited to ISO 15189:2012 3rd edition worldwide are to be assessed and accredited to ISO 15189:2022 4th edition.
- Purchase and review the ISO 15189:2022 standard
- Purchase and review the ISO 15189:2012 standard - applies to the CAP 15189 Accreditation Program participants; proposed transition to ISO 15189:2022 starting June 2024 for gap assessments and new accreditations.
Key updates to the standard include a greater focus on risk management more clearly linked to impact of services on patients; less prescription, eg, fewer documented procedures required and more flexibility in leadership structure; and a structural reorganization to bring the standard in line with ISO 17000-series standards (the “parent” standards of ISO 15189).
More details will follow in the weeks ahead from the CAP on notable changes and for transitioning customers currently accredited under ISO 15189:2012
- Complete the CAP 15189 Walkthrough and QMS Implementation Roadmap QMEd courses
- If you are a CAP-accredited laboratory, complementary access to these courses is available. Go to eStore, log in, specify the laboratory on whose behalf you are purchasing, add the courses to your shopping cart, and the system will zero out the cost for these courses.
- Purchase and complete the QMEd courses:
- Quality Manual Development
- Internal Auditing
The cost to obtain accreditation will vary depending on the size and scope of the organization seeking accreditation, and the organization’s readiness for assessment. Since each laboratory’s journey to accreditation is unique, the pre-accreditation fee schedule will include an application fee, annual base fee, and fees to reflect the assessors time for remote and on-site assessments plus travel expenses for on-site assessments.
Once accredited, over the three-year accreditation cycle, the fee schedule will include an annual base fee, and fees to reflect the assessors time for remote and on-site assessments plus travel expenses for on-site assessments.
Learn about the accreditation journey from CAP 15189 accredited laboratories.