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.
Risk-based thinking, referred to in ISO 15189 as risk management, continues to be a foundational aspect of the management system in ISO 15189:2022. In the 2022 edition, there is a greater emphasis on risk throughout the document and, more specifically, risk to the patient, including how laboratories should be developing and improving systems to the benefit of the patient.
Other key changes include:
- Better organized. The clauses are organized to better match the structure of a laboratory’s QMS. The new standard eliminates the division of QMS clauses in section 4 and technical clauses in section 5, and follows the general structure of ISO 17025 – a "parent" standard of ISO 15189 that applies to testing and calibration laboratories.
- Less prescriptive. It requires fewer documented procedures and provides more flexibility in leadership structure.
- More focused on processes. There is a greater focus on processes and demonstrating the effectiveness of a laboratory’s processes.
The CAP 15189 program continues to use the ISO 15189:2012 standard for existing customers. It will transition to the ISO 15189:2022 standard starting June 2024 for gap assessments and new accreditations.
- Purchase and review the ISO 15189:2012 standard
- Purchase and review the ISO 15189:2022 standard (New)
- If you are a CAP-accredited laboratory, these courses are complimentary.
- Note: The January 2024 release of 15189 Walkthrough (QMEDWALK.2024) will be based on the 2022 version of the ISO 15189 standard. If you wish to be accredited to the 2022 version, we recommend that you purchase this course.
- 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.
- Quality Manual Development
- Internal Auditing
ISO 15189:2022 Update Frequently Asked Questions
Given the changes to data protection laws since 2012, the updated standard has honed the requirements surrounding information management. This edition features an expanded focus on laboratory information management systems (LIMS), impartiality, confidentiality, and data protection, as well as contingency planning. Laboratories will need to demonstrate procedures for the how, when, and why any information will be stored or released. There are also specific requirements around patient well-being, safety, and rights relating to their data.
There is no longer a requirement for a quality manual nor a quality manager. In addition, there are other modifications related to requirements for request forms, sample labels, and quality control.
Quality manual. While ISO 15189:2022 doesn’t require a quality manual, it remains a requirement for CAP 15189 participation to ensure alignment across CAP accreditation programs.
Quality manager. There is no longer a requirement for a “quality manager.” The quality management system features more flexibility in the structure and design as defined by the organization. For CAP 15189, ISO 15189 must be used in the design of the quality management system. If currently adhering to ISO 9001:2015, it is accepted that ISO 9001 covers many, though not necessarily all, of the quality requirements of ISO 15189. Participants will need to meet the requirements of ISO 15189 prior to CAP 15189 accreditation.
Request forms. The revised standard recognizes that the request can be in any format, agreed by both the laboratory and user.
While not required by ISO 15189 2022, the following procedures are still required for CAP 15189:
- Equipment Requirement and Reagents and Consumables (clauses 6.4.2, 6.6.1)
- Internal audits (clause 8.8.3)
- Management review (clause 8.9)
- Document control (clause 8.3)
- Resolution of complaints (clause 7.7)
- Nonconforming Work (clause 7.5)
- Risk Management, Opportunities for Improvement, and Corrective Action (clauses 5.6, 8.5 and 8.7)
Point-of-care is not in the scope of CAP 15189 accreditation, as it is included in the CAP Accreditation Checklist requirements. These checklists are developed by pathologists and laboratory experts and are a foundation of the CAP accreditation process. As the checklists are updated annually, laboratories stay current with rapidly evolving advances in point-of-care testing and all other areas of laboratory medicine, technology, and regulatory compliance.
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.