Quality Assurance, Compliance & International Standards that Impact Companies

Last Updated: 04/02/2024

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Overview

While higher education institutions and other third-party providers typically understand the role of accreditation as a quality assurance mechanism in credentialing, companies more often work with standards and compliance as quality assurance mechanisms related to their products, materials, and processes. Furthermore, while accreditation in credentialing tends to be regional or national in the United States, standards’ compliance for companies are often national and international.

A main international standards organization is the International Organization for Standardization (ISO), an independent, non-governmental international organization that was founded in 1947. Headquartered in Geneva, Switzerland, the ISO has a membership of 168 national standards bodies. Membership is open only to national standards institutes or similar organizations that represent standardization in their country (one member in each country). Individuals or businesses cannot join ISO. (ISO website)

The ISO develops and publishes standards for a vast range of proprietary, industrial and commercial standards related to products, materials, and processes. Currently, the organization has over 24,362 standards, which are included in the ISO Standards catalog, which is broken down into various segments, such as healthcare technology, railway engineering, jewelry, clothing, metallurgy, weapons, paint, civil engineering, agriculture, and aircraft. (Investopedia)

The ISO facilitates world trade by providing common standards among different countries. These standards are intended to ensure that products and services are safe, reliable, and of good quality – and that certified products conform to the minimum standards that are set internationally.

The ISO standards are internationally agreed upon by experts in the relevant. Examples of ISO Standards:

  • the calibration of thermometers
  • food safety regulations
  • manufacturing of wine glasses
  • shoe sizes
  • security management
  • environmental management

Standards may be viewed as a formula that describes the best ways of doing something. For example, standards may be about “making a product, managing a process, delivering a service or supplying materials.” Standards are “the distilled wisdom of people with expertise in their subject matter and who know the needs of the organizations they represent – people such as manufacturers, sellers, buyers, customers, trade associations, users or regulators.” (QSE Academy)

In addition to producing standards, ISO also publishes technical reports, frameworks, guidelines, and various types of specifications. It has published more than 24,500 international standards covering almost all aspects of technology and manufacturing. It has more than 800 Technical committees and subcommittees working on  standards development. (Investopedia)

A related organization is the European Committee for Standardization (CEN/CENELEC), which publishes some standards in parallel with ISO. Standards with the designation EN are mandatory for CEN members. An agreement is in place (Vienna Agreement) between ISO and CEN to share information, attend each other's meetings,  and collaborate on standards at international and European levels.

The United States is represented in the ISO by the American National Standards Institute (ANSI), headquartered in Washington, DC. Since creation in 1918, ANSI has coordinated the development of voluntary consensus standards in the U.S. and represented U.S. stakeholders in standardization forums around the globe. ANSI does not write standards; rather, it accredits standards developers that establish consensus among qualified groups, specifically 220 entities (e.g., businesses and industrial organizations, standards setting and conformity assessment bodies, trade associations, labor unions, professional societies, consumer groups, academia, and government organizations) that are accredited to develop and maintain nearly 10 000 American National Standards (ANS). Though all ANS are developed as voluntary documents, federal, state, and local bodies often refer to ANS for regulatory and procurement purposes. Many ANS are also national adoptions of globally relevant international standards. (ANSI website)Relationship to the Learn-and-Work EcosystemCredential providers like colleges and universities and third-party credential providers face a number of challenges around quality assurance and compliance with state and federal regulations.  Companies also  face quality assurance and compliance challenges — which may be industry-specific, local, state, federal, and international.  For companies that operate within a global marketplace, international standards typically guide the development of proprietary, industrial, and commercial standards that are relevant to their products and processes. All of these quality assurance and compliance issues are part of the learn-and-work ecosystem.

Confusion of Terms - Accreditation, Registration/Registrars, Certificates, Certification

Common terms in the quality assurance and compliance arena include accreditation, registration and registrars, certification, licensing, and certificates. These terms mean different things to different stakeholders; i.e., companies often understand and use these terms differently than credential providers like colleges and universities. This can and does lead to confusion in the learn-and-work ecosystem.

As explained by Advisera (Kosutic), when a company has implemented a standard (for example, an ISO standard), has successfully completed a certification audit, and the certification body has issued the certificate, this is typically called a registration or a certification. In North America, registration is more often used while certification is the predominant term elsewhere.

A certification occurs when a certification body issues the certificate to prove that a company is compliant with a standard. Registration is when this certificate is registered with the certification body.  A company that received a certificate is formally recognized, whatever the term used.

According to the QSE Academy, ISO certification means securing a written assurance from a third party. This is after proving the conformity of a process, product, or service to specified requirements. Also, it is the third-party endorsement of the products or systems of an organization. ISO certification includes evaluating organizations that are offering calibration, inspection, and testing, inspection services against internationally recognized standards. Likewise, it means proving that an organization certainly complies with the relevant standard(s). However, it does not involve implementing extra controls or requirements. Although ISO certification includes an independent organization or a certification body to conduct an audit.

Kosutic explains that the companies that perform the certification audits and issue the certificates are also known by different terms. People in North America typically call them registrars while most other nations call them certification bodies. ISO recommends using the term certification body.

Accreditation is used to describe the license that results when certification bodies perform certification audits and issue the certificates that are needed to get a license. The certification bodies get accredited and companies get certified.  A certification body must be compliant with the relevant ISO Standard if it wants to get accredited to certify specific certificates.

There is typically only one accreditation body for each country while there are several certification bodies operating in each country. These range from small local certification bodies to large multinational corporations.

Accreditation bodies usually publish a list of accredited certification bodies in their countries. Also,   accreditation bodies must be compliant with a standard (for example, ISO 17011 is a standard which defines the process of accreditation).

Kosutic notes that “in order to implement a standard in a company, or to audit it, someone needs to be trained to do it. This is why many trainings for ISO standards have been developed, and there are also certifications and accreditations related to that training industry.”

There is a similar process for accreditation. If institution wants to provide training certificates, it should be accredited by an accreditation body, and the institution then needs to be compliant with ISO 17024. (Advisera)

The accredited training institutions are not typically delivering the courses directly to students. Rather, they have a network of partners (training providers) who deliver the courses under their license and supervision. Training providers use courses developed by accredited institutions. Then the accredited institution issues certificates directly to students. In some cases, the training organization develops its own course and an accredited institution certifies the course. It is common in such a case for the training organization to issue the certificate to students with the approval of the accredited institution. (Advisera)

Numerous training organizations operate worldwide. They include certification bodies that also offer the certification of organizations, and small, specialized providers of online courses.

To summarize the difference between ISO accreditation and ISO certification, Kosutic notes that:

  • ISO accreditation is an independent third-party assessment of an organization’s ability to meet specific standards. An organization might be accredited by ISO to show it has the necessary capabilities to perform ISO audits.
  • ISO certification is granted by an accredited certification body after an organization has been assessed and found in compliance with a specific standard.  An organization might be certified to ISO 9001, for example, meaning it has met the requirements of the ISO 9001 quality management system standard. An ISO certification is conferred for three years if an organization fulfills the requirements and is recommended for certification.
  • Accreditation is needed to certify but certification is not necessarily dependent on accreditation. Many organizations seek both accreditation and certification to demonstrate their commitment to quality and continuous improvement.

References

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