Review Article

General Laboratory Medicine

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Ann Lab Med 2017;37:365-370

https://doi.org/10.3343/alm.2017.37.5.365
ISSN 2234-3806 • eISSN 2234-3814
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International Organization for Standardization (ISO)

15189
Frank Schneider, M.D.1, Caroline Maurer, M.T.2, and Richard C. Friedberg, M.D.3
College of American Pathologists 15189 Committee1; College of American Pathologists 15189 Program2; College of American Pathologists3, Northfield, IL, USA

The College of American Pathologists (CAP) offers a suite of laboratory accreditation pro- Received: March 6, 2017
Revision received: May 10, 2017
grams, including one specific to accreditation to the international organization for stan-
Accepted: June 8, 2017
dardization (ISO) 15189 standard for quality management specific to medical laboratories.
CAP leaders offer an overview of ISO 15189 including its components, internal audits, oc- Corresponding author: Caroline Maurer
College of American Pathologists, 325
currence management, document control, and risk management. The authors provide a Waukegan Road, Northfield, IL 60093,
comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accredita- USA
tion Program. The authors conclude with why laboratories should use ISO 15189. Tel: +1-847-832-7451
Fax: +1- 847-832-8451
E-mail: cmaurer@cap.org

© Korean Society for Laboratory Medicine

This is an Open Access article distributed under
the terms of the Creative Commons Attribution
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mons.org/licenses/by-nc/4.0) which permits
Key Words: ISO 15189, Quality management, Laboratory accreditation, College of Ameri- unrestricted non-commercial use, distribution,
and reproduction in any medium, provided the
can Pathologists original work is properly cited.

INTRODUCTION accreditation to the international organization for standardization

(ISO) 15189 standard, building on the longstanding CAP LAP
Drawing on the collective knowledge of more than 650 experts program. As such, the laboratory must first be accredited in the
in laboratory medicine, the College of American Pathologists CAP LAP before seeking accreditation to the ISO 15189 stan-
(CAP) helps laboratories navigate the accelerating changes in dard with CAP 15189. Accreditation to the ISO 15189 standard
laboratory medicine and health care through our integrated lab- does not meet US Clinical Laboratory Improvement Amendments
oratory improvement programs. These programs focus on ac- (CLIA) requirements and cannot replace a CLIA-based accredi-
creditation and proficiency testing (PT) to ensure the highest tation for laboratories in the United States. The CAP offers the
quality of patient care and mitigate risk of noncompliance where following overview of ISO 15189 from the chair of the CAP 15189
applicable. The CAP is proud of its accreditation programs, with Committee, Frank Schneider, MD, FCAP, a pathologist at the
the core CAP Laboratory Accreditation Program (LAP) launched Kaiser Foundation Hospital in Oakland, California, and Caroline
more half a century ago. Today, the CAP accredits more than Maurer, MT (ASCP), PMP, director of the CAP 15189 Program
8,000 laboratories in all of its accreditation programs, including in Northfield, Illinois. The overview is adapted from the original
approximately 437 international laboratories in more than 50 chapter in Schneider F., Maurer C. (2017). ISO 15189 In Qihui
countries. Other CAP accreditation programs include Forensic Z., Siegal G.P. (Eds.), Quality Management in Anatomic Pathol-
Drug Testing, Reproductive, Biorepository, and CAP 15189. CAP ogy: Strategies for Assessment, Improvement, and Assurance
15189 is a quality management program the CAP designed for (pp. 185-193). Northfield, IL: College of American Pathologists [1].

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 Schneider F, et al.
International Organization for Standardization (ISO) 15189

ISO 15189: An Overview from the College of Components of the ISO 15189 quality
American Pathologists management system

ISO 15189 standard, Medical laboratories - Requirements for The ISO 15189 requirements, or clauses, fill merely 31 pages
quality and competence, hereafter referred to as ISO 15189 , was (plus a few pages of definitions and appendices). ISO 15189 is
first published in 2003 and revised in 2007 and again in 2012. divided into management requirements (Part 4, focusing on the
ISO 15189 is not a tool merely to meet accreditation requirements quality management system [QMS] structure, function, and ef-
or provide quick fixes for individual mistakes. Instead, laborato- fective management of laboratory operations, its quality system,
ries implementing ISO 15189 strive to: guiding policies, and processes) and technical requirements
• Create systems that are as failure resistant as possible, will (Part 5, focusing on the technical competency and related pro-
catch mistakes before they become a problem, and reduce cedures and processes). Table 1 summarizes the content of the
errors by getting things right the first time ISO 15189 standard, Parts 4 and Part 5 [2, 3].
• Identify opportunities for improvement at all times ISO 15189 is a comprehensive standard, offering an overarch-
• Involve and empower their staff by involving them in the solv- ing structure to laboratory operations. It applies to all divisions of
ing of problems and the implementation of solutions a medical laboratory, regardless of the services it provides or the
ISO 15189 encourages full involvement and utilization of the way it is organized; the standard is as relevant in a full-service
abilities of all employees at all levels to improve the organization. medical laboratory as it is in a laboratory providing services ex-
In a laboratory accredited to ISO 15189, the goal is continual clusively for either clinical or anatomic pathology. It is not pre-
improvement, and for staff members to know exactly what to do, scriptive in the sense that it does not specify how to address a
how to do it, who is in charge of a process, and where to find all particular requirement or clause. Its focus and importance lies
information necessary to perform their jobs. in encouraging users to maintain an effective quality manage-
By 2015, about 60 countries had made ISO 15189 part of ment system integrated across all parts of their operation, with a
their mandatory medical laboratory accreditation requirements. goal of continual improvement.
In the United States, accreditation to ISO 15189 is voluntary, as The management requirements demand regular management
no governmental or regulatory agency requires laboratories or reviews and internal audits to assure that the laboratory’s activi-
health care providers to conform to ISO 15189. ties adhere to the QMS, are effective, and continually meet cli-

Table 1. Content of the ISO 15189 standard, divided into management requirements (Part 4) and technical requirements (Part 5), was in-
fluenced by the Clinical and Laboratory Standards Institute’s Quality System Essentials [2, 3]
ISO 15189 Management requirements (Part 4) Technical requirements (Part 5) Quality System Essentials
Organization and management responsibility Personnel Organization
Quality management system Accommodation and environmental conditions Customer focus
Document control Laboratory equipment, reagents, and consumables Facilities and safety
Service agreements Preexamination processes Personnel
Examination by referral laboratories Examination processes Purchasing and inventory
External services and supplies Ensuring quality of examination results Equipment
Advisory services Postexamination processes Process management
Resolution of complaints Reporting of results Documents and records
Identification and control of nonconformities Release of results Information management
Corrective action Laboratory information management Nonconforming event
Preventive action management
Continual improvement Assessments
Control of records Continual improvement
Evaluation and audits
Management review

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International Organization for Standardization (ISO) 15189

ents’ needs, and to identify opportunities for improvement be- testing?”)

fore issues arise. Laboratory management has to take a step back ISO 15189-accredited laboratories usually perform internal
and view its operation holistically, including appropriateness, suit- audits by section, with an entire cycle completed within one year.
ability, and performance of testing; relations to suppliers, clini- Increased frequency of audits may be required depending on
cians, patients, and consultants; and detecting nonconformities, risk and occurrence management outcomes.
finding their causes, and implementing effective solutions. Internal audit results are one of several inputs for the regular,
The technical requirements reflect many elements from the high-level management review required of ISO 15189-accred-
CAP LAP accreditation checklists, but in a more generic format. ited laboratories. Management review meetings offer the oppor-
The focus of the standard here, just as in the management sec- tunity to review issues that impact the laboratory’s processes,
tion, is implementation and effectiveness. To those trying to im- including, but not limited to, internal audit results, quality met-
plement ISO 15189 in their laboratory, it will soon become clear rics, ongoing quality improvement projects, opportunities for im-
that nonconformance to technical requirements can often be provement, complaints, and forthcoming new technologies or
traced back to nonconformance in the laboratory’s QMS and regulatory changes.
potentially highlights broader process issues than the incidental Quality management decisions in an ISO 15189 system are
transaction. based on facts and data. This prevents personal preferences or
It would be counter to the idea of ISO 15189 to consider some a top-down management style from inhibiting process and qual-
components of the standard more important than others. For ity improvement.
the purpose of this article, we chose to highlight the following Continual improvement is a permanent objective of ISO 15189
four elements of ISO 15189 because we find that their effective quality management. This does not mean, for example in ana-
implementation is often the most novel and challenging, while tomic pathology that every conceivable effort should be made to
also the most rewarding aspect of ISO 15189. reduce the frozen section turnaround time by 1 min. The labo-
ratory should find meaningful metrics that are aligned with the
Internal audits laboratory’s mission. Improvements may affect any aspect of the
quality management system and its processes. They may in-
ISO 15189 is a systems- and process-oriented QMS. It encour- volve issues such as saving control tissue for immunohisto-
ages systematic identification of processes and their interrelat- chemical stains, making the work instructions for lymphoma
edness. Proper documentation of core processes helps reveal workups more succinct and accessible, or automating frozen
the structure of the operation. The understanding of the interac- section versus final diagnosis correlations using the laboratory
tions of processes enhances effectiveness and efficiency be- information system.
cause it uncovers gaps and unnecessary activities. Assessing Similarly, in clinical chemistry, continual improvement does
implementation and effectiveness of process is a major, if not not mean making every conceivable effort to reduce hemoglo-
the most important, element of a thorough ISO 15189 accredi- bin turnaround time by 10 sec. However, it may mean making
tation assessment. efforts to drive down variation and risk, which can help a core
ISO 15189-accredited laboratories have to perform internal laboratory avoid repeating testing, incorrect results, physician
audits of their QMS on a regular basis. Such audits need to in- complaints, or even possibly having to add a satellite lab with its
clude the managerial and technical components, as well as pre- associated overhead costs.
examination, examination, and postexamination processes. More importantly, continual improvement also refers to the
These serve to: improvement of the quality management system, for example
• Ascertain that all activities of the QMS are covered (“Are we (1) performing better, more thorough internal audits; (2) increas-
adhering to our own quality system?”) ing the use of personal protective equipment (and thus better
• Assure that processes are effective (“Does every consulta- implementation of safety procedures) in the gross room to pre-
tion report requested by a pathologist always end up being vent eye splashes or scalpel injuries; or (3) sending staff mem-
reported in an addendum?”) bers to training courses for performing root cause analysis, an
• Identify opportunities for improvement (“Can we establish integral part of the standard for occurrence management.
criteria with our oncologists when to perform reflex molecu-
lar testing rather than having to wait for a request to initiate

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 Schneider F, et al.
International Organization for Standardization (ISO) 15189

Occurrence management ing mistakes, and cost. For example, a laboratory scientist re-
ceiving an unexpected flow cytometry sample on a Saturday af-
Occurrence management refers to the resolution of nonconfor- ternoon should be able to find the information on how to submit
mities. Nonconformities are routinely identified through a pleth- the material in the correct medium with the right form to the
ora of sources, the most important of which include internal and right section in the shortest amount of time required for suc-
external audits as well as errors made. The central theme of oc- cessful acquisition.
currence management in an ISO 15189 QMS is root cause anal-
ysis (RCA) [4]. RCA is often thought of as one step in the inves- Risk management
tigation of a major, potentially life-threatening, patient safety event.
RCA in the context of ISO 15189 has a very different connota- ISO 15189 states, “The laboratory shall evaluate the impact of
tion. In an ISO 15189-accredited laboratory, RCA is a commonly work processes and potential failures on examination results as
and regularly used tool addressing a wide variety of problems, they affect patient safety, and shall modify processes to reduce
ranging from the most minor (usually recurring) to the most com- or eliminate the identified risks and document decisions and
plex (usually rare). ISO 15189-accredited laboratories view RCA actions taken” [1].
as an opportunity to brainstorm, think of solutions “outside the Insights into existing or potential risks come from several sources.
box,” and make improvements. In general, the scope and mag- • When a new process is developed, the laboratory will iden-
nitude of any corrective action should be appropriate to the non- tify the process owner, map the process, and identify its risk
conformity and its effects. points.
RCA also provides an opportunity to engage staff in the pro- • In most cases, risks will be identified during internal or ex-
cess of quality improvement. Staff is viewed as a most valuable ternal audits (eg, inspections or PT events).
asset and should always be considered part of the solution, rather • Review of the occurrence management data will allow iden-
than part of a problem. As a corollary, errors in an ISO 15189-ac- tification of future risks based on past errors.
credited laboratory are not attributed to individuals, but to pro- • If the environment and culture of the organization support
cess failures. By definition, removing the root cause(s) of a non- it, staff at all levels will feel comfortable and find it worthwhile
conformity should prevent its recurrence. Blaming and retrain- to bring up potential risks identified during routine events
ing staff following an error usually does not eliminate the risk of and everyday observation (eg, near-misses that may other-
recurrence in the long term. In an ISO 15189 QMS, an RCA is a wise get no follow-up, or unofficial “water-cooler talk” about
component of corrective action that serves to redesign and an upcoming change in another department that may affect
“mistake-proof” a process, implement those process changes, the laboratory).
and assure through effectiveness checks that the changes actu- No matter how risks are identified, in an ISO 15189 QMS, each
ally solved the problem. The universal and liberal use of RCA is risk will be assessed on the basis of its probability, severity, and
a strong point of ISO 15189. impact on patient care. The laboratory should then discuss and
agree upon the level of risk it is willing to accept. In the vast ma-
Document control jority of instances, risk cannot be eliminated. The ISO 15189-ac-
credited laboratory will take appropriate steps to control risks.
Most laboratories are struggling with document control, evidenced This may require mistake-proofing of an existing process or com-
by its being a common deficiency cited in CAP LAP inspections. plete redesign of a process if risk is severe. Care must be taken
Work aids (or “cheat sheets”), if necessary, must be included that process changes do not introduce new, unanticipated risks.
under document control and reference the complete procedure.
They also become subject of internal and external audits. Docu- Relationship of CLIA and ISO 15189
ment control is more than having procedures signed on time, accreditation
eliminating cheat sheets with outdated information, and finding
a document during an accreditation visit. Document control means Accreditation to the ISO 15189 standard does not meet US CLIA
that pathologists and other staff have the correct information requirements and cannot replace a CLIA-based accreditation.
needed for a task readily available when needed. This reduces ISO 15189 could be chosen as the QMS of a CLIA laboratory,
risk of error, need to rework, incorrect results, time spent on fix- but it needs to be supplemented with the specific CLIA require-

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Table 2. Features of the College of American Pathologists (CAP) 15189 program and the CAP Laboratory Accreditation Program (LAP)
CAP 15189 CAP LAP
Voluntary (in United States) Based on CLIA law (required in United States)
International expert consensus Federal regulatory requirement
Focus on process: Focus on procedure:
Laboratory needs to sustain integrated QMS across all parts of organization Stringent criteria by CAP member experts
Full-time ISO assessors with background in ISO and laboratory Volunteer peer inspectors who work in medical laboratories
Internal audit every year Self-inspection every year
3-yr accreditation cycle with 2 interim on-site surveillance visits 2-yr accreditation cycle
Abbreviations: CLIA, Clinical Laboratory Improvement Amendments; ISO, International Organization for Standardization; QMS, quality management system.

ments. Because elements of CLIA were incorporated into the Justifying ISO 15189 with return on investment
ISO 15189 standard, many laboratories considering implement-
ing ISO 15189 can readily meet many of the technical require- The value of implementing and sustaining an ISO 15189 QMS
ments. We find that the management requirements are often is not easy to quantify. The literature is sparse. Firstly, variability
more difficult to implement, but we cannot stress enough that in the medical laboratory industry is high. Secondly, it would be
their implementation, driving effective outcomes and improved difficult to show statistically significant differences in outcome
patient care, are the most rewarding aspect of an ISO 15189 measures because of this complexity. Furthermore, what consti-
QMS. Table 2 compares features of the CAP 15189 program tutes appropriate outcome measures is controversial in itself.
with the CAP LAP. Over the last nine years in which we have been involved with
A laboratory must first be accredited in the CAP LAP before laboratories that implemented ISO 15189 quality management
seeking accreditation to the ISO 15189 standard with the CAP. systems, we have found the following elements to be of value to
When a laboratory applies to the CAP 15189 accreditation pro- laboratories.
gram, the assessment team first conducts an off-site review of Engaging in ISO 15189 is a journey that requires many years
the laboratory’s documents in order to evaluate the components of commitment. We often hear that “things” become easier the
of the QMS and the laboratory’s readiness for accreditation. The longer the laboratory pursues this course. The culture of the
laboratory also performs an internal audit in order to assess read- laboratory changes gradually to enable a mindset of “seeing”
iness on its own. problems as, or before, they occur, therefore evolving to a cul-
Prior to the on-site accreditation assessment, the laboratory ture of prevention. Staff engagement improves and morale im-
has the option to undergo a gap assessment. A gap assessment proves, as there is no blame and staff members are part of the
is a detailed on-site assessment against the ISO 15189 standard solution. Reductions in LAP inspection deficiencies have been
and adherence to the laboratory’s QMS that reveals holes in the demonstrated as a result of investing in ISO 15189 [5].
system and issues that need to be addressed before accredita- Financial reward is a desirable and most-often-sought argu-
tion could be granted. ment in favor of ISO 15189. Although the literature of money-
During the actual on-site accreditation assessment, the CAP savings in an ISO 15189 system is sparse, cost-of-quality mod-
examines in detail the QMS and its implementation. Nonconfor- els have demonstrated potential cost savings [6-8]. Such mod-
mities have to be addressed before accreditation can be granted, els consider the cost of trying to be the best you can be (cost of
requiring an RCA, a plan on how to fix the problem, and a plan pathologists’ continuing medical education or money spent on
to check whether the fix was effective. A committee, comprised process design), the cost of maintaining a quality operation (eg,
mostly of practicing pathologists, renders an accreditation deci- accreditation program expenses or enrollment of pathologists in
sion after review of the laboratory’s corrective actions. If accredi- PT programs), the cost of correcting process failures before the
tation is granted, the laboratory is ISO 15189 accredited for three result is reported (eg, cost of histology having to recut skin biop-
years. sies to obtain a full face), and the cost of resolving problems af-
ter reporting results (eg, cost of pathologist’s time to amend a
report because operating room staff indicated the wrong site on

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 Schneider F, et al.
International Organization for Standardization (ISO) 15189

a requisition form). Using ISO 15189 methods to reduce the gists, 2017:185-93.
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day November 13, 2013:50. http://www.captodayonline.com/at-henry-
Authors’ Disclosures of Potential Conflicts of ford-36-lab-sites-now-under-iso-umbrella-111350/
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No potential conflicts of interest relevant to this article were re-
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ported. ity for improvement of laboratory and pathology specimen processes.
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