ISO and the International Organization for Standardization
ISO is a word chosen by the International Organization for Standardization to refer to a set of standards that apply to all users equally. “ISO” is taken from the Greek word “isos,” meaning equal, which is found in the English word “isosceles” (triangle).
In English, ISO has the same letters as the organization, but ISO is not an acronym.
The International Organization for Standardization is a worldwide federation of national standards bodies from more than 140 countries, one from each country. It is a non-governmental organization established in 1947. The organization’s mission is to promote the development of standardization to facilitate the international exchange of goods and services, and to develop cooperation in the spheres of intellectual, scientific, technological, and economic activity. Its work results in international agreements, which are published as international standards.
A standard is a guidance document to the state of art in a specific discipline or technical area developed through expert consensus. It can be thought of as a set of best practices that an organization agrees to adopt and live by. Standards set forth requirements that an organization must meet. Standards do not have the force of law except in those countries that incorporate the requirements into national law.
ISO 15189
It is an international standard, based on ISO/IEC 17025 and ISO 9001, that specifies requirements for competency and quality that are particular to medical laboratories.
ISO 15189 focuses on the continuum of care directly connected with improved patient safety, risk mitigation and operational efficiency.
The International Organization for Standardization has released three versions of the standard. The first two were released in 2003 and 2007. In 2012, the organization released a revised and updated version of the standard, ISO 15189:2012 (Medical laboratories—Requirements for quality and competence). The standard is often referred to without the version, simply as “ISO 15189.”
It is a set of interacting parts, functions and activities designed to insure quality in an organization’s products and services. These parts, functions, and activities typically include:
- A well-planned set of processes for providing a good or service
- Continual analysis and improvement of processes
- Identifying and tracking metrics to monitor quality
- Infrastructure (eg, quality manager, management review committee, internal auditors) and ongoing
Currently ISO 15189 is an internationally recognized standard, with accreditation organizations offering ISO 15189 in over 50 countries. In some countries it is the standard by which laboratories are reimbursed. Although it is not currently a standard in the US, the CAP believes that it will further support the goals of a laboratory that is working to achieve best practices in quality management systems.
ISO 9001 is a certification/registration of a quality management system and is intentionally very generic.
ISO 15189 incorporates the essential elements of ISO 9001 and adds technical competency factors relevant to medical laboratories. Its primary application is to improve the structure and function of medical laboratories. The accreditation (as opposed to a registration) includes both the certification of the QMS and the evaluation of the competency of the laboratory functions.
If a potential CAP 15189 client already has an ISO 9001 registration, the decision to keep both the 9001 and 15189 is one that each individual laboratory must make based at a minimum on the value added of each standard, customer requirements, industry requirements, and any applicable regulatory requirements.
| ISO 9001 Standard | ISO 15189 Standard |
| Best fits generic client/provider arrangements Commonly used in manufacturing industry and commercial services |
Designed specifically for clinical and medical laboratories |
| Provides confidence about the organization’s QMS | Includes QMS elements, but also assesses a laboratory’s technical competence and its ability to provide reliable and accurate test data |
If a potential CAP 15189 client already has an ISO 9001 registration, the decision to keep both the 9001 and 15189 is one that each individual laboratory must make based at a minimum on the value added of each standard, customer requirements, industry requirements, and any applicable regulatory requirements.
ISO 15189 is the medical laboratory version of ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories).
The CAP’s ISO 15189 Accreditation Program
Since the fall of 2008. At that time, the CAP launched the program based on the ISO 15189:2007 standard.
The CAP’s program was developed to help reinforce the ISO goals and standards while supporting CAP’s mission of advocating excellence in the practice of pathology and laboratory medicine. The CAP was also a significant contributor to the development of the ISO 15189 standard.
The CAP assigns assessors with complimentary backgrounds—typically a lead assessor, who focuses on QMS issues, and a technical assessor with extensive knowledge of the medical laboratory environment, who focuses on technical issues.
CAP assessors will conduct a thorough evaluation of all factors in a laboratory that affect the production of patient testing results. These include the following:
- Management of technical areas
- Effectiveness of process and interactions/handoffs
- Effectiveness of integration and continual improvement activities in technical areas
- Organization’s ability to sustain an integrated standardized quality management systems approach across all areas of patient testing
- Laboratory’s ability to ensure quality of patient care by influencing areas beyond traditional boundaries of the laboratory
- Integrity of technical processes, both documented and deployed
The stages are as follows:
| Stage | Who Does It | Activity |
| Get Started | Laboratory | Purchase the ISO 15189 standard, obtain educational resources from the CAP, and gain stakeholder commitment for the project. |
| Application Submission | Laboratory | The laboratory fills out the application form, and sends it to the CAP, along with the requested documentation.
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 Review | 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. |
| Internal Audit | Laboratory | The laboratory performs at least one internal audit of its QMS against the ISO 15189 standard. This must be done before the on-site accreditation assessment. |
| Gap Assessment (On-site) |
Laboratory & CAP | The CAP performs a detailed on-site assessment of the QMS and technical competency. This helps the laboratory identify holes in the system and scope the work required for accreditation. |
| Pre Assessment (On-site) |
Laboratory & CAP | The CAP performs a one-day on-site review of progress after the gap assessment to assess the laboratory’s readiness for the accreditation assessment. |
| Accreditation Assessment (On-site) |
Laboratory & CAP | The CAP performs a detailed review of the laboratory’s QMS and technical competency. The output of the assessment is a report of the level of conformance. Subsequently, the assessors make a recommendation to the accreditation committee. |
| Accreditation Decision | 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. |
The CAP assigns assessors with complimentary backgrounds—typically a lead assessor, who focuses on QMS issues, and a technical assessor with extensive knowledge of the medical laboratory environment, who focuses on technical issues.
CAP assessors will conduct a thorough evaluation of all factors in a laboratory that affect the production of patient testing results. These include the following:
- Management of technical areas
- Effectiveness of process and interactions/handoffs
- Effectiveness of integration and continual improvement activities in technical areas
- Organization’s ability to sustain an integrated standardized quality management systems approach across all areas of patient testing
- Laboratory’s ability to ensure quality of patient care by influencing areas beyond traditional boundaries of the laboratory
- Integrity of technical processes, both documented and deployed
CAP’s ISO 15189 Accreditation Program and the CAP Laboratory Accreditation Program
The ISO 15189 program compliments the Laboratory Accreditation Program by increased focus on the management system, whereas the Laboratory Accreditation Program inspection focuses on technical procedures.
Part of the difference is based on the ISO 15189 standard:
| ISO 15189 Standard | CAP Laboratory Accreditation Program |
| Voluntary in US | Based on CLIA (required in US) |
| Developed through international expert consensus on medical laboratory best practices | Exceeds US federal regulatory requirements |
| Focus is on process—the overarching QMS, and the organization’s ability to sustain an integrated QMS approach across all parts of an organization with which the laboratory interacts | Focus is on procedures—by integrating more stringent general and discipline specific requirements developed by our member experts with an emphasis on technical and procedural aspects in the laboratory |
The ISO 15189 program also differs from the CAP Laboratory Accreditation Program in terms of the accreditation staffing:
| ISO 15189 | CAP Laboratory Accreditation Program |
| Full time ISO 15189 assessors, with backgrounds in quality management and medical laboratory work | Volunteer peer assessors who currently work in medical laboratories |
No. The programs are distinctly separate but complementary; ISO 15189 does not fulfill US federal regulatory requirements. A laboratory that chooses to become accredited to ISO will experience a separate Laboratory Accreditation Program inspection from the ISO assessment.
The key differences are as follows:
| ISO 15189 Accreditation Program | CAP Laboratory Accreditation Program Inspection |
Initial accreditation depends upon:
|
From date of application, laboratory has 12 months to be inspected. |
Once the laboratory is accredited, the re-accreditation cycle is a three-year cycle.
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Once laboratory is accredited, the re-accreditation cycle is a two-year cycle.
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No. The accreditation to ISO 15189 is in addition to CLIA‘88 accreditation and does not replace it.
There is no tie to CMS for reimbursement.
Any laboratory conducting medical testing is eligible to apply for the accreditation program.
Please call 800-323-4040 option 1 or consult the CAP 15189 Accreditation Program page for additional information.