2019

STANDARDS OUTLOOK

Common Ground

Ensuring proper assessment of standards compliance globally

by Dale K. Gordon

I recently returned from the International Accreditation Forum (IAF) annual meeting in Seoul, South Korea. There, IAF members coordinate activities, agree on cooperation methods and work in subcommittees and technical committees to establish requirements, policies and rules of operation for the global accreditation of just about anything.

The IAF is defined as:

"… the world association of conformity assessment accreditation bodies and other bodies interested in conformity assessment in the fields of management systems, products, services, personnel and other similar programs of conformity assessment. Its primary function is to develop a single worldwide program of conformity assessment which reduces risk for business and its customers by assuring them that accredited certificates may be relied upon. Accreditation assures users of the competence and impartiality of the body accredited."1

Most of us in the standards writing, compliance and implementation process recognize the fairly well-established schemes that are used across various standards, such as ISO 9001 or similar systems for aerospace, automotive, the environment, forestry, food safety, healthcare, medical devices, security and telecommunications.

Additionally, we recognize the certification processes that are in place for these standards to allow for global recognition of compliance. These processes are facilitated through the use of certification bodies (CB) that are accredited by accreditation bodies (AB). The role of the ABs, for the most part, is to assess and accredit CBs, ensuring they demonstrate competence to audit and certify organizations conforming to recognized standards.

Accreditation by a recognized AB ensures the impartiality and competence of the CB, and fosters confidence and acceptance of the CB’s certifications by end users in public and private sectors. This is essential so an organization can be confident in the certification it obtains to demonstrate compliance to a standard.

Accreditation ensures the CB is competent and has procedures, processes and personnel in place to manage the certification process under consistent and agreed on rules from the ABs.

Auditing the auditors

Where, however, is the assurance that there is agreement across ABs on what these rules, processes and procedures should be so certifications can cross borders and be accepted globally? This is important in facilitating commerce and assuring customers the organizations and personnel they do business with—as well as the products they use—comply with standards as intended.

In simple terms, who is auditing the auditors? Beyond the accreditation of the CBs, who is overseeing the ABs? This is where the IAF comes in. The IAF consists of ABs who agree to abide by a certain set of requirements for themselves and the CBs they oversee.

Participation in the IAF acts as an agreement and facilitates a peer-review process to ensure the ABs follow the established rules. This is accomplished through the multilateral agreement (MLA), which each of the member ABs signs.

There are 63 countries and 70 ABs that sign the MLA. Some ABs are government entities that have the sole authority to accredit CBs for the issuance of certifications. In other cases, such as in the United States, ABs are independent organizations that collect fees for the accreditation service but follow all of the MLA requirements.

This is not to say that there are no requirements for the issuance of certifications and the determination of the competency of personnel and the processes to be performed. In fact, there are existing International Organization for Standardization (ISO) standards that serve this purpose, many of which have been promulgated by IAF in cooperation with the ISO Committee on Conformity Assessment (CASCO), which works on standards such as the ISO 17000 series.2

CASCO is comprised of 75 countries that vote and publish the current standards. These standards include requirements for ABs’ accreditation of CBs (ISO 17011), requirements for CBs’ certification of management systems (ISO 17021), requirements for the duration of management systems audits (ISO 17023) and requirements for CBs’ certification of products, processes and services (ISO 17065).

Some of these standards replace what were known originally in the certification process as Guides 62 and 65, as well as other ISO guidance on conformity assessment.

IAF, however, is the glue that holds the system together. There are implementation issues and variables in these standards that require clarification for consistency across the globe. For this reason, IAF issues various mandatory documents (MD) for its member organizations to assist in filling in gaps or addressing implementation issues.

The MDs are put forward by technical committees and voted on by IAF members. These MDs include interpretative requirements. Examples include:

  • IAF MD 1:2007—Certification of multiple sites based on sampling, which states that all clauses of ISO/IEC 17021:2006 continue to apply and do not supersede any of the requirements in that standard.3
  • IAF MD 2:2007—Transfer of accredited certification of management systems, which is for the consistent application of clause 9.1.1 of ISO/IEC 17021. All clauses of ISO/IEC 17021 continue to apply. This document does not supersede any of the requirements in that standard.4
  • IAF MD 3:2008—Advanced surveillance and recertification procedures, which provides normative criteria for advanced surveillance and recertification procedures for consistent application of clause 9.1.1 of ISO/IEC 17021 for determining subsequent adjustments to the audit program.5
  • IAF MD 5:2013—Duration of quality management system (QMS) and environmental management system audits, which provides mandatory provisions and guidance for conformity assessment bodies to determine the audit duration for stage one and stage two initial audits, surveillance audits and recertification audits.6
  • IAF MD 8:2011—Application of ISO/IEC 17011 in medical device quality management systems, which enables ABs to harmonize their application of ISO/IEC 17011 for the accreditation of bodies providing audit and certification to ISO 13485.7
  • IAF MD 10:2013—Assessment of certification body management of competence in accordance with ISO 17021, which provides a harmonized approach on how ABs assess a CB’s management of competence per ISO 17021.8

These are just examples of the outputs of IAF. There are also policy documents, procedures and informative documents.

IAF brings together—on a worldwide basis—partner ABs and representatives of stakeholder groups that seek to facilitate global trade through the acceptance of accredited certificates of conformity. It also supports developing countries in implementing ABs and certification programs to enable free trade with other developed economies by assuring confidence in the organizations that hold those approvals.

Crossing borders

In this day and age of interlinked global sourcing of food, pharmaceuticals and equipment for products such as aircrafts, automotives, medical devices and telecommunications devices, it becomes prohibitively expensive for all organizations or users of the global supply chain to independently monitor capability and compliance.

Think about some recent headlines about improper manufacture of pharmaceuticals, or food issues from foreign or domestic sources of food. Even the recent tragedies related to working conditions in places such as Bangladesh are the types of matters that could ultimately fall under the purview of an accreditation program for standards on workplace safety and working conditions.

The goal is to provide users and stakeholders a level of confidence in certification processes—a guarantee that organizations with certificates from accredited CBs have been through specified audits conducted by competent personnel and have demonstrated compliance to the standards to which they’re certified.

Accreditation does not replace regulatory or governmental powers, but it can, in fact, help reduce the regulations or laws by implementing a self-governance approach by like-minded organizations in similar types of industries or service groups. This will benefit all the stakeholders and consumers of the products or services.

While ISO 9001, the current QMS standard, is the most widely used approach for accredited certification-type programs, certification to specific management system standards that directly apply to certain types of products are gaining much attention and interest as global supply chains get longer and requirements for safe and quality products become more demanding.

The value provided by auditing the auditors is needed and welcome to ensure confidence in the certificates organizations obtain to show compliance to standards. It’s important for consumers to be able to easily differentiate accredited certificates from something an organization may have bought off the internet or was issued in exchange for a simple payment—which has no value to the consumer or user at all.


References

  1. International Accreditation Forum (IAF), www.iaf.nu.
  2. International Organization for Standardization, CASCO, www.iso.org/iso/home/about/conformity-assessment/casco.htm.
  3. IAF, IAF Mandatory Document for the Certification of Multiple Sites Based on Sampling, 2007, www.compad.com.au/cms/iaf/workstation/upFiles/351519.IAF-MD1-2007_Certification_of_Multiple_Sites_Pub2.pdf (case sensitive).
  4. IAF, IAF Mandatory Document for the Transfer of Accredited Certification of Management Systems, 2007, www.compad.com.au/cms/iafnu/workstation/upFiles/127162.IAF-MD2-2007_Transfer_of_Certification_Pub2.pdf (case sensitive).
  5. IAF, IAF Mandatory Document for Advanced Surveillance and Recertification Procedures, 2008, www.compad.com.au/cms/iafnu/workstation/upFiles/847722.IAF-MD3-2008_ASRP_Pub.pdf (case sensitive).
  6. IAF, IAF Mandatory Document for Duration of Quality Management Systems and Environmental Management Systems Audits, 2013, www.compad.com.au/cms/iafnu/
    workstation/upFiles/IAFMD52013QMSEMS_Audit_DurationPub.pdf
    (case sensitive).
  7. IAF, IAF Mandatory Document for the Application of ISO/IEC 17011 in Medical Device Quality Management Systems (ISO 13485), 2011, www.compad.com.au/cms/
    iafnu/workstation/upFiles/IAFMD82011ApplicationofISO17011inMDQMSPub.pdf
    (case sensitive).
  8. IAF, IAF Mandatory Document for Assessment of Certification Body Management of Competence in Accordance with ISO/IEC 17021:2011, 2013, www.compad.com.au/cms/iafnu/workstation/upFiles/IAFMD102013CB_Competence.pdf (case sensitive).

Dale K. Gordon is director of supplier quality for Aerojet Rocketdyne/Gen Corp., in Sacramento, CA. He is an ASQ fellow, chair of the SAE Americas Aerospace Quality Standards Committee (G-14) and has served on many writing teams for the aerospace series of standards. Gordon earned a bachelor’s degree in industrial engineering from General Motors Institute (now Kettering University) in Flint, MI, and an MBA from Butler University in Indianapolis.


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