1. The CAP is focused on medical laboratory testing
The CAP 15189 program is embedded within the CAP, the largest association composed exclusively of board-certified pathologists, serving more than 17,000 physician members and the laboratory community throughout the world.
The CAP has a large staff of registered medical technologists to add to the pool of expertise. These medical technologists serve as subject matter experts in different types of testing.
CAP 15189 has dedicated full time staff consisting of lead and technical assessors experienced in both QMS and medical laboratory systems.
2. CAP 15189 rests on the foundation of the CAP’s Laboratory Accreditation Program
Laboratories applying to CAP 15189 must be accredited by the CAP’s Laboratory Accreditation Program.
The CAP has 50 years of accreditation experience, and 7,000 laboratories in its accreditation programs in nearly 50 countries.
3. The CAP has deemed status for medical testing under CLIA
The CAP’s Laboratory Accreditation Program has Centers for Medicare and Medicaid Services (CMS) deeming authority.
This program exceeds US federal regulatory requirements with more stringent general and discipline-specific requirements. CAP member experts, focusing on technical and procedural aspects in the laboratory, developed these requirements.
4. The CAP has member pathologist representation on TC 212
CAP members made significant contributions in the development of the ISO 15189 standard originally released in 2003, Medical Laboratories-Particular Requirements for Quality and Competence, and continue to do so through participation in ISO TC 212 Committee (Clinical laboratory testing and in vitro diagnostics test systems) membership.
5. CAP 15189 has an accrediting committee composed of board-certified pathologists
The CAP created a separate accrediting committee composed of board certified pathologists (including liaison members of TC 212). The committee is involved in every accreditation decision.
6. CAP 15189 assessors have depth in quality management
Our assessors understand not only the language of the ISO requirements but the intent behind them.
They can help you create a system that provides your laboratory with tangible results.
CAP can help you eliminate the non-value-added work that many organizations perform in order to satisfy ISO assessors. This saves your laboratory time and money.
7. CAP provides superior quality management education programs
Many education programs tell you what to do, but not how to do it. CAP’s QMEd modules provide clear guidance with the tasks and requirements that laboratories find most difficult to implement.
CAP’s QMEd modules provide:
- Engaging educational experiences based on sound instructional principles
- Examples tailored to medical laboratories
- Templates you can follow in creating your own QMS
- Online, self-paced, affordable education
- Access to perspectives from medical quality experts
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