CEO SUMMARY: This intelligence briefing is the third in an ongoing series about quality management systems (QMS) and their role in advancing the performance of clinical laboratories and improving the quality of the testing services they provide. ISO 15189 is a set of standards for medical laboratories based on the ISO 9001 quality management system. It provides a way for medical laboratories to demonstrate to outside examiners both conformance to the QMS and competence in the performance of laboratory testing services.
IN THE UNITED STATES, ISO 15189 is making inroads with those clinical laboratories wanting to implement a quality management system (QMS).
One factor contributing to this new interest in QMS is the fact that many of the nation’s clinical laboratories and anatomic pathology groups are harvesting ongoing benefits from their use of Lean, Six Sigma, and similar methods. Adoption of a quality management system is a natural progression for these laboratories.
For its part, THE DARK REPORT was the first lab industry publication to call attention to these developments and write about the experiences of the nation’s earliest laboratories to certify under ISO 9001 (1998— see TDR, July 6, 1998); to implement Lean Six Sigma (2003—See TDR, September 8, 2003); and, to become accredited under the requirements of ISO 15189 (2008—See TDR, September 8, 2008).
The world’s biggest player in QMS is ISO, which stands for the International Organization for Standardization (Organisation Internationale de Normalisation). The organization’s headquarters is in Geneva, Switzerland. From here, it coordinates development of technical standards in virtually every area of international trade and professional activity.
It supports the development of specific quality management systems for every relevant activity, including all areas related to laboratory testing and calibration.
Terminology Used By ISO
In response to the growing interest in QMS by pathologists and lab managers, THE DARK REPORT interviewed QMS expert Lucie Berte of Laboratories Made Better!, based in Broomfield, Colorado, about the definition of a quality management system. Berte explained how laboratory quality control (QC) and lab quality assurance (QA) functions differ from a true QMS. (See TDR, October 12, 2009.)
In its next installment about QMS, THEDARK REPORT interviewed Daniel Tholen, M.S., founder and owner of Dan Tholen Statistical Consulting, based in Traverse City, Michigan. Tholen has extensive experience with QMS. He serves in various roles with a number of national and international standards development organizations, including the group that recently developed the standard for laboratory proficiency testing, ISO/IEC 17043.
Terminology Used By ISO
Tholen provided information about ISO 9001, ISO 15189, and ISO 17025. He also explained the importance of understanding the terminology relating to certification to ISO 9001 requirements and accreditation to ISO 15189 requirements. (See TDR, November 23, 2009.)
This third installment about QMS deals with the practical steps a clinical laboratory or pathology group should take as it prepares to implement a quality management system. Globally, the QMS most widely used by clinical laboratories is ISO 15189: Medical Laboratories—Particular Requirements for Quality and Competence, which was first introduced in 2003 and updated in 2007.
Since 2003, many countries passed laws requiring laboratories to meet the requirements of ISO 15189 in fulfillment of their national scheme of accreditation or licensing. For example, Australia has used ISO 15189 since July, 2005, administered by its National Association of Testing Authorities (NATA). In Canada, Ontario Province similarly mandates ISO 15189 as the requirement medical laboratories must use to meet accreditation laws.
In the United States, a medical laboratory that wants to implement a QMS like that contained in ISO 15189 will still need to comply with the statutory requirements of federal and state laws. For example, U.S. medical laboratories must meet the accreditation requirements of the Centers for Medicare and Medicaid Services (CMS) in order to provide services to most government health programs. Medical laboratories in the U.S. must also meet licensing requirements as defined by the federal Clinical Laboratory Improvement Act (CLIA).
QMS Starts With ISO 9001
Internationally, the quality management system represented by ISO 9001 forms the basis for the other ISO standards, including ISO 15189. “ISO 15189 includes the QMS requirements in ISO 9001, but it also includes technical requirements for competence that are general for all medical laboratory testing situations,” stated Tholen.
“In most countries where ISO 15189 is applied, there are specific requirements from the medical or health regulatory authority, as there is in the United States under the CLIA regulations,” he noted. “Every application of ISO 15189 requires consideration of the specific program requirements in the laboratory’s country.”
“It is important to understand that in the ISO system, ‘certification’ means that the company’s QMS meets the requirements of ISO 9001, while ‘accreditation’ means that the testing laboratory not only meets the QMS requirements, but also meets the requirements for competence of specific technical activities,” explained Tholen. These points were discussed in detail in THE DARK REPORT’S second installment on quality management systems.
“For that reason, certification is actually a very limited designation,” he continued. “To avoid confusion about certification and accreditation, ISO and the two main players in the application of QMS— the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC)—have all agreed that testing laboratories should be accredited and not certified.”
“There is unanimity on this principle within ISO and any organization holding an agreement with ISO,” added Tholen. “I should also point out that, in the medical community here in the United States, the terms ‘certification’ and ‘accreditation’ are often used interchangeably, generally in reference to long-standing state and federal laws for licensing of health providers.
“That is why readers should be aware that my statements here use the terms ‘certification’ and ‘accreditation’ according to international usage as it relates to quality management systems, and specifically to the numerous ISO standards,” he noted.
“Clinical laboratories in the United States take note,” continued Tholen. “This difference in certification versus accreditation is why the testing laboratory accreditation process for ISO standards—including ISO 15189—are more rigorous than for an ISO 9001 certification.
Safeguarding The Public
“Any type of testing laboratory delivers a service that may directly affect public health and safety,” he added. “This is why ISO and ILAC develop and refine standards so that accreditation of a testing laboratory is a meaningful measure of competence.”
“The second fundamental involved in the ISO accreditation process is integral to the goal of conducting a meaningful assessment of a testing laboratory,” he added. “In practical terms, if a clinical laboratory wants to achieve accreditation under ISO 15189, the clinical lab needs to utilize a third-party organization which has itself met the standard of ISO 17011: Conformity Assessment—General Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies.”
Tholen stresses the importance of understanding this requirement . “Memoranda of Understanding between ISO, ILAC, and IAF state that a testing laboratory—such as a clinical laboratory seeking accreditation to ISO 15189— should be accredited by a body which is itself recognized to ISO 17011, the standard for accreditation bodies,” he said. (See sidebars on pages 13 and 15.)
“ISO 17011 is a well-established requirements document,” added Tholen. “It is the cornerstone of the accreditation process for those countries which use ISO standards for conformity assessment. It applies to organizations that accredit conformity assessment bodies. That includes testing, calibration, and medical laboratories. It also includes inspection bodies, reference material producers, proficiency testing providers, and organizations that certify QMS.”
“Let’s stop for a moment and review,” stated Tholen. “Accreditation is more rigorous than certification because accreditation indicates the testing laboratory has a management system which conforms and the testing laboratory is competent in its performance.
“Accreditation is more rigorous than certification because accreditation indicates the testing laboratory has a management system which conforms and
the testing laboratory is competent in its performance. ”
“Further, because the testing laboratory has been audited by a registrar or body that is, itself, recognized by its peers as meeting the requirements of the ISO 17011 QMS, the examiners possessed the technical competence to evaluate both the testing laboratory’s management systems and the competence with which it operates,” he noted.
“Remember, the examiners are assessing both conformity to the QMS requirements and competence in the performance of testing services,” observed Tholen. “This requires the examiners to have extensive training, including knowledge of the science and technology involved in the testing activities taking place within the candidate testing laboratory.”
Tholen notes that the body offering accreditation must itself meet a high standard. “When an organization wants to offer accreditation services to laboratories, it must meet key (and very difficult to achieve) provisions of ISO/IEC 17011,” he explained. “Included are requirements for impartiality (such as separation of accreditation and proficiency testing); training assessors and monitoring assessor competence; and operation of a QMS in their own organization.
Accrediting Your Lab
“Think about it. Shouldn’t an organization that accredits your clinical laboratory’s QMS, also operate under an ISO-compliant QMS?” asked Tholen. “Shouldn’t an organization that assesses the competence of your laboratory, demonstrate that it has documented the competence of its assessors in the areas of technical knowledge, experience, and competence in the skill of assessing? After all, this accreditation process must have teeth so that consumer and patient safety can be assured.
“In the United States, there are no accreditation bodies that offer ‘full service’ to clinical laboratories seeking the dual goals of approval by CMS for CLIA activities and accreditation to ISO 15189 by an organization that complies with 17011,” he commented. “For example, the American Association for Laboratory Accreditation (A2LA) is a full member of ILAC and is recognized to be compliant with ISO/IEC 17011. But, at this time, A2LA is not approved by CMS. It has an application pending with CMS for this authority.
“By contrast, the College of American Pathologists (CAP) is a CMS-approved accreditation body. And CAP does offer ‘CAP ISO 15189’. But it is not itself recognized as being compliant with ISO/IEC 17011,” said Tholen. “CAP is an affiliate member of ILAC and has not applied for recognition by other members. “There are other CMS-approved laboratory accreditation bodies here in the United States,” he added. “However, none of these bodies offer accreditation to ISO 15189 and none of these bodies are members of ILAC. There are also other accreditation bodies in the U.S. recognized to comply with 17011, but they do not offer 15189.
“It should be of interest to medical laboratories in the United States that several important U.S. federal agencies fully recognize the integrity of the ILAC system involving accreditation of testing laboratories,” he continued. “For example, A2LA accredits all of the FDA’s laboratories in the Food Safety Inspection Service (FSIA).
U.S. Federal Agencies
“Similarly, the U.S. Department of Defense Environmental Laboratory System consists of 260 laboratories which are accredited by four different U.S. members of ILAC,” added Tholen. “The same is true of testing laboratories involved in the U.S. Consumer Product Safety System(CPSS).
“The area of consumer product safety shows how ISO creates a uniform international standard,” offered Tholen. “In the United States, hundreds of ISO-accredited testing laboratories are involved in this field. These labs are accredited by six different U.S. accreditation bodies.
“The accreditation of these U.S. laboratories to ISO 17025 is recognized by any ILAC Full Member anywhere in the world,” he emphasized. “That works in reverse. For test methods of interest to the U.S. Consumer Product Safety Commission, test results from accredited consumer safety testing laboratories in other countries are recognized in the United States.”
ISO 15189 Goes Global
Growing global acceptance of ISO 15189 is one example of the internationalization of clinical laboratory testing. This may be one factor that encourages more clinical labs in the United States to pursue accreditation under ISO15189.
Who Accredits the Bodies Doing the Accrediting? It’s Complex, But Important to Understand
SINCE ITS INCEPTION, the ISO system has evolved steadily to support the concept of a single, internationally-accepted process for assessing the adherence to standards by companies, organizations, and recognition bodies.
“The role of ISO is very specific. It develops, publishes, and maintains the range of standards applicable to different industries, services, and products,” observed Daniel Tholen, owner of Dan Tholen Statistical Consulting. “Implementation of ISO standards is independent of ISO itself.
Who Accredits Accreditors?
“To the question ‘who accredits the accrediting bodies?’, there is a fascinating answer: no one and everyone,” said Tholen.“The International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC) arrangement calls for each accreditation body within a country to be recognized by its peers as being in compliance with ISO 17011.
“Thus, an accrediting body will undergo a rigorous assessment by its peers to demonstrate that it operates in compliance with ISO/IEC 17011: Conformity Assessment— General Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies,” he explained. (Editor’s note: IEC is the International Electrotechnical Commission—a sister organization to ISO that has a scope of obvious importance, and is directly involved in the ILAC/IAF agreements, but is not concerned with medical laboratories.)
“For a body that wants to provide accreditation services, the process of recognition by peers is extremely rigorous within ILAC and IAF,” noted Tholen. “It involves an on-site assessment by a team of peers from at least two other regions (Asia Pacific, InterAmerican, Europe). The assessment requires observation of the candidate body as it conducts accreditation assessments of testing laboratories and other organizations in its country.
“These on-site assessments involve a team of three to five individuals and typically take at least a week,” he added. “The process includes citations of non-conformances and a resolution process before recognition of that body’s compliance to ISO 17011 is extended by peers. This process is repeated every four years. Members are admitted to the IAF and ILAC Mutual Recognition Arrangement (MRA) upon a 75% majority vote of peers.
“Of course, an agency of that nation’s government can recognize or designate a body to determine the competence of medical or other testing laboratories in its country,” he added. “The key point here is that, within the ILAC and IAF systems, accrediting bodies are recognized by their peers to be competent and to operate in compliance with ISO/IEC 17011.
“Also, both IAF and ILAC have Mutual Recognition Arrangements (MRAs) that require every full member to recognize—as equivalent—accreditations by other members, even in different nations,” stated Tholen. “Under this system, any testing lab- oratory accredited by one nation’s ILAC member body will have that accreditation recognized by the ILAC member organizations of any other country.
Compliance With ISO 17011
ILAC members are also obliged to promote the ILAC system within their countries, especially among ‘specifiers’—usually, government agencies for trade or health,” concluded Tholen. “Although there is no accreditation body for ISO 17011, IAF and ILAC have formal Memoranda of Understanding with each other and with all authoritative international organizations. These include the United Nations, World Health Organization, ISO, and IEC, and many others.”
Understanding the Hierarchy of the ISO System and Accreditation of Testing Laboratories
THERE IS A DEFINED HIERARCHY within the international conformity assessment system. It includes not just laboratory accreditation, but also quality management systems, personal certification, inspection services, and product certification.
There are three levels in this hierarchy. It is important that companies and clinical labs understand the structure of this hierarchy when considering whether to seek certification to ISO 9001 or accreditation to ISO 15189.
“What underpins this hierarchy are standards developed by the International Organization for Standardization (ISO),” stated Daniel Tholen, founder and owner of Dan Tholen Statistical Consulting. “ISO writes the requirements for the different ISO systems. The top level of the hierarchy are the members of ILAC and IAF. These are the accreditation bodies that accredit conformity assessment bodies. These organizations must operate in conformance with ISO 17011 and be recognized by their peers in this regard.
“The second level in the hierarchy is made up of the conformity assessment bodies that are accredited to be competent,” he continued. “On the ILAC International Laboratory Accreditation Cooperation side, this includes laboratories involved in testing and calibration, (including medical/clinical testing). On the IAF (International Accreditation Forum) side, included are organizations that certify quality management systems.
“Included are: 1) organizations that certify QMS (accredited to ISO 17021); 2) inspection bodies (ISO 17024); 3) reference material producers (ISO Guide 34); 4) proficiency testing providers (ISO/IEC 17043); 5) testing and calibration laboratories (ISO/IEC 17025); and, 6) medical laboratories (ISO 15189),” said Tholen.
“In the third level of the hierarchy are found: 1) certified organizations or companies (as under ISO 9001); 2) people or products— including manufacturing and service organizations—that have a QMS; and, 3) professionals or products that are tested or inspected for compliance with specifications,” noted Tholen. “For medical laboratories the third level of the hierarchy are the patients, since their specimens were inspected, tested, or measured in some way, for conformance with some expectation, or inquiry.
“We can see how this hierarchy works by looking at our country,” continued Tholen. “The sole IAF member for the United States, is the American National Accreditation Board (ANAB), which is a cooperation between the American National Standards Institute (ANSI) and the American Society for Quality (ASQ). ANAB is the entity in the U.S. which represents IAF at the first level. On the ILAC side of the first level in the hierarchy, there are seven accreditation bodies recognized as full members of ILAC.
“At the second level in the hierarchy, ANAB accredits 46 organizations to offer certificates of compliance with ISO 9001 and other ISO management system standards here in the United States,” stated Tholen. “At the same level in the hierarchy, ILAC members accredit over 5,000 testing and calibration laboratories, inspection bodies, proficiency testing providers, and reference material producers. Clinical laboratories are included, although the number is very small (only two clinical labs in the U.S. are accredited to ISO 15189 by an ILAC-recognized body, and a growing number are accredited by CAP under their proprietary system, which is not recognized by ILAC or IAF).
“The third level in the hierarchy is very diffuse for medical laboratories—they are the patients whose specimens have been sampled, inspected, and measured,” explained Tholen. “Or, more broadly in ILAC, the products that have been tested, measured for acceptability, and products that have been inspected. On the IAF side, the third level is filled by the thousands of organizations with certified quality management systems as well as certification of products and personal competence.”
How Ontario Province Uses ISO 15189 for Accreditation
LOOKING NORTH TO CANADA, the laboratory licensing program in the Province of Ontario shows how ISO 15189 functions as an internationally-accepted standard for medical laboratory accreditation.
The Ontario Medical Association (OMA), as an agent of the Ministry of Health and Long-Term Care (MOHLTC), created a quality management program for licensed medical laboratories in Ontario. It is called QMP-LS, for Quality Management Program-Laboratory Services.
The Ontario Laboratory Accreditation (OLA) is one component of QMP-LS. With the publication of ISO 15189:2003 Medical Laboratories, OLA adopted those standards as the way for clinical laboratories in Ontario to meet licensing requirements.
OLA’s web site (http://www.qmpls.org) describes meets ISO/IAF/ILAC requirements:
QMP–LS identifies, designs and delivers external quality assessment (EQA), accreditation and education services and related products that meet its regulatory mandate, relevant international standards and client and stakeholder requirements. QMP–LS has been issuing accreditation certificates since 2003.
Clients from other jurisdictions in Canada or other countries may voluntarily apply for accreditation and/or participate in EQA surveys.
Accreditation processes are aligned with ISO 17011:2004 Conformity Assessment—General requirements for accreditation bodies accrediting conformity assessment bodies and International Laboratory Accreditation Cooperation (ILAC) guidelines for assessor qualifications, training and competence.
EQA surveys are conducted in accordance with ISO standards and ILAC guidelines for competent proficiency testing schemes. For more information on EQA surveys, see “Program Information” at http://www.qmpls.org/eqa/eqa.html.