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Blood Samples

Medical Lab Accreditation

Medical Lab Accreditation: Projects

CAP (Cap Accreditation Consultant)

The College of American Pathologists (“CAP”), is a medical society leading organization of board-certified pathologists, serves patients, pathologists and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. CAP serving more than 17,000 physician members. 

It is the world’s largest association composed exclusively of pathologists certified by the American Board of Pathology and is widely considered the leader in laboratory quality assurance. The College is an advocate for high-quality and cost-effective medical care. It is also affiliated with the American Medical Association (AMA).CAP does accreditation of laboratories under deemed authority by CMS (Medicare).

The CAP Laboratory Accreditation Program’s goal is to improve patient safety by advancing the quality of pathology and laboratory services through education, standard setting and ensuring laboratories meet or exceed regulatory requirements.

Laboratory Accreditation Program:

The College of American Pathologists (CAP’s) Laboratory Accreditation Program accredits the entire spectrum of laboratory test disciplines with the most scientifically rigorous customized checklist requirements.

The CAP’s peer-based inspector model provides a unique balance of regulatory and educational coaching supported by the most respected worldwide pathology organization.

The Laboratory Accreditation Program inspects a variety of laboratory settings from complex university medical centers to physician office laboratories and covers a complete array of disciplines and testing procedures.

Benefits of Achieving CAP Accreditation program:

            -Meet CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) REGULATORY REQUIREMENTS (specific to laboratories subject to US regulations)

-Ensure compliance through the guidance of the most comprehensive scientifically endorsed laboratory standards

-Maintain accuracy of test results and ensure accurate patient diagnosis.

-Increase the value they bring to organizations, customers, patients.

Program Details 

-Peer-based inspection model uses teams of practicing professionals qualified through a CAP TRAINING PROGRAM.

-On-site inspections occur every two years using CAP ACCREDITATION CHECKLISTS to assess compliance with program requirements.

-Participating laboratories can access the checklists through E-LAB SOLUTIONS; and non-accredited laboratories, may PURCHASE THE CHECKLIST.

Eligibility Requirements

-The CAP accredits laboratories performing testing on specimens from human beings or animals, using methodologies and clinical application within the expertise of the program. Laboratories must be appropriately licensed to perform testing when required by law.

-The laboratory accreditation program is available for laboratories in the United States and for international laboratories.

-Information specific to international laboratories interested in CAP Accreditation is available in (

Our Consultancy Scope of Services:

-Assisting in selection of test menu and guiding for CAP Proficiency testing

-Assisting in Preparation CAP Quality and Answer manual as per CAP checklist

-Interpretation of CAP checklist requirement

-Designing and Development of Quality Management system requirement as per CAP checklist

-Preparation of CAP self-Assessment documentation

-CAP Application filing

-Answering all CAP challenges raised by CAP assessment team.

(See further

ISO 15189 Consultancy (Medical Laboratory Accreditation)

Within the healthcare sector as in most other areas of healthcare sectors, the need for organizations to operate formal Quality Management Systems is fast becoming a Commissioner, Service User, and/or Regulatory Authority prerequisite.

Our ISO consultancy department is offering quality management system implementation services for ISO 15189 accreditation in medical laboratories. Our team of experienced ISO 15189 consultants guides medical laboratories in management system establishment and, documentation and training process, which helps in quick implementation of effective quality management system, and hence, quick ISO 15189:2012 accreditation. Our QMS consultants facilitates the lab compliance to the requirements of standard and-pre-eminently various global and local regulations.

Definition of ISO 15189:2012

It`s standard specifies requirements for quality and competence in medical laboratories.

ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

The following are the basic requirements for ISO 15189 accreditation:

-A well-documented procedures analysis by the laboratories.

-Training manual provided by the laboratories.

-ISO 15189 requires an effective detailed analysis of medical laboratory procedures in a bid to make sure that all weaknesses have been identified.

-Detailed evaluation reports of the existing quality management system as well as other monitoring and evaluation reports.

            -A detail audit of management reviews.

Benefits of Achieving ISO 15189 Accreditation:

 One of unique benefits and the main objective of Accreditation is quality assurance. In addition to the following benefits listed below:

-An ISO 15189 Accreditation promotes development of an international reputable image for your organization through Quality Assurance and Management Systems.

-Promotes a strong degree of consistency in compliance to medical laboratory laws and legislation both from an international and national perspective.

            -Fundamentally critical in promoting laboratory efficiency and responsibility for better results and service delivery.

-The Accreditation also has been very critical in promoting modern laboratory practices that include professionalism and expertise in conduction of medical activities in the labs.

-Ultimately, promote the growth of customer satisfaction in organizations involved in medical laboratory testing.

-Accreditation ensures technical competence of the laboratory.

-Insurance, corporate customer, clinician and patient get confidence on the test results issued by the Accreditation Body.

Who can provide Accreditation:

Accreditation Body

Recognized organization from ILAC provides accreditation based on the internationally standard ISO 15189:2012 Medical Laboratories – requirements for quality and competence. 

List of Accreditation Body can be checked from ILAC Website

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