CEO SUMMARY: Early signs are that the quality management systems (QMS) most likely to find favor with hospitals and clinical laboratories in the United States will be those that meet standards developed by the International Organization for Standardization (ISO). Many hospitals and clinical labs are considering adopting ISO 9001 or ISO 15189, respectively. As they do, it will be important to understand how the terms “accreditation,” “certification,” and “registration” are used in the application of standards published by ISO.
IN RECENT YEARS, THE UNITED STATES has seen the first hospitals and laboratories adopt quality management systems such as ISO 9001 and ISO 15189: Medical Laboratories.
This is notable, because it heralds the arrival of quality management systems (QMS) to healthcare and laboratory medicine in the United States. At this time, many pathologists and laboratory managers in this country do not fully understand QMS and what distinguishes a QMS from, say, quality assurance (QA) and quality control (QC)—two activities which take place daily in every laboratory.
Earlier this fall, THE DARK REPORT provided an intelligence briefing about quality management systems. A definition of QMS was provided. ISO 9001 is the world’s leading QMS. It is used in many industries, including healthcare. The management system requirements in ISO 15189 are derived from the ISO 9001 QMS. ISO 15189 is designed to be a quality management system specific to the management and operation of clinical laboratories. (See TDR, October 12, 2009.)
For those not familiar with ISO QMS, it is common to confuse ISO use of the terms “certification” and “accreditation.” That’s because, for decades, certification and accreditation have been used in a variety of settings to describe how individuals and organizations qualified under a wide spectrum of academic, legal, and professional requirements.
“When it comes to ISO’s quality management standards, the concepts of ‘certification’ and ‘accreditation’ need to be understood as described by the International Organization for Standardization (ISO),” stated Dan Tholen, M.S., an independent consultant in statistical methods who is based in Traverse City, Michigan.
A consultant who has worked for a variety national and international standards development organizations, Tholen is an expert in applying quality management and accreditation standards to testing and calibration labs, proficiency testing providers, and reference material producers in the United States and other countries worldwide.
In an interview with THE DARK REPORT, Tholen explained that most pathologists and lab directors in the United States do not understand the distinctions between accreditation and certification as defined in ISO standards. Additionally, most medical laboratory professionals in the United States don’t yet fully appreciate the benefits of having a functioning quality management system implemented in their laboratory.
“The growing acceptance of QMS in healthcare signals that a profound new paradigm is poised to transform long-standing practices in healthcare and clinical laboratories,” observed Tholen. “Any laboratory organization that truly embraces and implements a well-designed QMS will see everything through a different perspective—and will operate in a fundamentally different manner.
Certification To ISO 9001
“Let’s set that aside for a moment and discuss the difference between certification and accreditation—as used in the context of implementing an ISO quality management system,” said Tholen. “I will also briefly discuss ‘registration.’
“First is certification,” he stated. “ISO 9001 is a QMS standard designed to be universal and useful in almost any industry. However, ISO does not specify a means of recognition of compliance with the requirements. An organization has three ways to comply: it may simply declare compliance (first party declaration), or the organization’s customers may accept compliance (second party recognition), or, the organization can seek recognition by an organization (third party certification).
“Third party certification of compliance is usually done by an organization that is accredited to meet the requirements of ISO 17021 as determined under the procedures developed by the International Accreditation Forum (IAF),” added Tholen.
“A comment about the accrediting bodies which issue certifications of compliance with ISO 9001 and the related ISO QMS standards,” continued Tholen. “IAF has a Memorandum of Understanding with ISO for certifying compliance with the range of ISO management system standards (all of which contain the same basic elements of ISO 9001).
“In the United States, the IAF member is the American National Accreditation Board (ANAB), which is a cooperation between the American National Standards Institute (ANSI) and the American Society for Quality (AQC).
“ANAB currently accredits 46 organizations to offer certificates of compliance with ISO 9001 and other ISO management system standards,” he explained. “In addition, ANAB recognizes accreditation by all other IAF members, so accredited organizations from other countries may provide certification in the United States.
“Next is the term ‘registration’,” continued Tholen. “ISO itself states that, in the context of ISO 9001, there is not much difference in the use of the words ‘certification’ and ‘registration’,” he added. “The words are used interchangeably. Certification is the preferred term globally, while in North America and a few other countries, registration is often used.
“That leaves accreditation,” he commented. “The ISO draws an important distinction for this term. Lab managers and pathologists should understand the precise meaning of accreditation and the role it plays in the relationship between ISO, IAF, and the International Laboratory Accreditation Cooperation (ILAC). ILAC is a separate organization of accreditation bodies, specifically for accreditation of laboratories, including their QMS. Accreditation by members of ILAC signifies a demonstration of competence for specific activities, according to other standards, in addition to complying with ISO 9001 QMS.
“‘Certification’ signifies only that an organization has a QMS in place that conforms to the ISO 9001 standard,” said Tholen. “There are no requirements for technical competence. Accreditation affirms a laboratory’s competence in addition to the QMS. This is why testing laboratories should be recognized as ‘accredited’ and not as ‘certified.”
The objective of this intelligence briefing is to help pathologists and lab managers develop an appropriate road map for their laboratory’s strategy concerning adoption of a quality management system.
Having introduced clients and regular readers of THE DARK REPORT to a description of quality management systems and the basic definitions of certification, registration, and accreditation, an upcoming issue will provide a detailed overview of the accreditation process as it applies to testing labs (including medical laboratories).
Accreditation versus Certification: Understanding The Differences in How ISO Defines the Terms
COPYRIGHT PREVENTS DIRECT QUOTATION of ISO definitions, but they can be rephrased for testing laboratories. The following information was paraphrased by Dan Tholen from “ISO/IEC 17000:2004 Conformity Assessment—Vocabulary and General Principles.”
This standard is the responsibility of the ISO Committee on Conformity Assessment (ISO CASCO), on which Tholen serves as a member. The terms and definitions below all cascade from “conformity assessment,” which was first coined for this purpose by the U.S. National Bureau of Standards (NBS— now the National Institute of Standards and Technology, or NIST). Tholen points out that the extremely delicate distinction between conformity assessment and accreditation is the product of many years of debate and negotiation within ISO.
- “Conformity Assessment” is an activity to demonstrate that a stated need or expectation is met, related to a particular object. Certification and laboratory testing are both considered to be conformity assessment activities, but accreditation is not.
- “Conformity Assessment Body” is any organization conducting conformity assessment activity. The definition specifically excludes accreditation bodies. This includes testing laboratories, inspection bodies, and certification bodies.
- “Object of Conformity Assessment” includes any “material, product, installation, process, system, person or body” that can be assessed for conformity. It can include any organization that is not a conformity assessment body. Laboratory patient samples are objects of conformity assessment, but the laboratory is not.
- “Certification” is a third party statement that an object of conformity assessment meets specified requirements. This has to be the result of a review. The definition notes that this is sometimes called “registration,” but there is no definition for “registration” in ISO/IEC 17000.
- “Accreditation” is a third party statement that a conformity assessment body has demonstrated competence to carry out specific conformity assessment activities.
- “Accreditation Body” is an authoritative body that provides accreditation; with its authority usually coming from government.