The ILAC Arrangement: Promoting Global Acceptance of Test Data

When a food testing laboratory in Mumbai analyzes samples for bacterial contamination, how can a regulator in Germany trust those results? This is where the International Laboratory Accreditation Cooperation comes into play. ILAC operates a global system that allows test data from accredited laboratories to cross borders with confidence, eliminating the costly need for products to be retested in every country they enter.

What is the International Laboratory Accreditation Cooperation? 🔗

ILAC is an international organization that brings together laboratory accreditation bodies from around the world. These accreditation bodies operate according to ISO/IEC 17011 and are responsible for evaluating whether laboratories, inspection bodies, and other conformity assessment organizations meet internationally recognized standards for competence and impartiality.

The organization covers a wide range of conformity assessment bodies. This includes calibration and testing laboratories using ISO/IEC 17025, medical testing laboratories following ISO 15189, inspection bodies adhering to ISO/IEC 17020, proficiency testing providers under ISO/IEC 17043, and reference material producers operating to ISO 17034 standards.

The evolution of global laboratory cooperation 🔗

ILAC started as a conference in 1977 when laboratory accreditation bodies recognized the need for international cooperation to facilitate trade. The goal was straightforward: promote the acceptance of accredited test and calibration results across borders, reducing technical barriers that slowed commerce and increased costs.

In 1996, ILAC took a significant step by becoming a formal cooperation with a charter to establish mutual recognition agreements among accreditation bodies. This formalization laid the groundwork for what would become one of the most important frameworks in global quality infrastructure.

The watershed moment came in 2000 when 36 ILAC Full Members signed the ILAC Mutual Recognition Arrangement in Washington DC. This agreement, which became effective on January 31, 2001, established a system for promoting the acceptance of technical test and calibration data for exported goods. Since then, the arrangement has expanded considerably, extending to inspection bodies in 2012, proficiency testing providers in 2019, and reference material producers in 2020.

Understanding the ILAC Arrangement 🔗

The ILAC Arrangement, formally known as the ILAC Mutual Recognition Arrangement or ILAC MRA, represents a multilateral agreement among accreditation bodies worldwide. The arrangement provides technical underpinning to calibration, testing, medical testing, and inspection results from accredited conformity assessment bodies, delivering confidence in the acceptance of these results globally.

The core principle is simple yet powerful: when laboratories are accredited by ILAC-recognized accreditation bodies, their test results should be accepted everywhere. This concept, often summarized as “accredited once, accepted everywhere,” eliminates the need for products to undergo duplicate testing each time they cross international borders.

How the arrangement operates 🔗

The ILAC Arrangement functions through a system of peer evaluation and mutual recognition. Accreditation bodies that wish to become signatories must undergo rigorous peer evaluation to demonstrate their competence according to international standards. Once they successfully complete this evaluation, they can sign the arrangement and their accredited laboratories gain international recognition.

The arrangement operates through recognized regional cooperation bodies that work in harmony with ILAC. These regional bodies include European Accreditation (EA) in Europe, Asia Pacific Accreditation Cooperation (APAC) in the Asia-Pacific region, Inter American Accreditation Cooperation (IAAC) in the Americas, African Accreditation Cooperation (AFRAC) in Africa, Southern African Development Community Accreditation (SADCA) in Southern Africa, and Arab Accreditation Cooperation (ARAC) in the Arab region.

Breaking down technical barriers to trade 🔗

The ILAC MRA enhances the acceptance of products across national borders by removing the need for additional calibration, testing, medical testing, or inspection of imports and exports. This directly reduces technical barriers to trade, which are often invisible but significant obstacles to international commerce.

Consider the journey of a food product from one country to another. Without the ILAC Arrangement, that product might need to be tested for safety and quality in the country of origin, then tested again upon arrival in the destination country, and potentially tested yet again if it moves to a third country. Each round of testing adds time, cost, and complexity to the supply chain.

With the ILAC Arrangement in place, a single test from an accredited laboratory can suffice. The test report travels with the product, and regulators in the destination country can trust the results because they know the laboratory was accredited by an ILAC-recognized body that has been peer-evaluated for competence.

Supporting food safety and public health 🔗

The ILAC Arrangement plays a critical role in supporting food safety systems worldwide. The arrangement helps ensure the provision of safe food and clean drinking water, along with other essential services like energy delivery, healthcare, and environmental protection.

In 2022, the US Food and Drug Administration established a program requiring food testing laboratories to be accredited by ILAC MRA signatories. This Laboratory Accreditation for Analyses of Foods program aims to improve the safety of the US food supply by ensuring that food testing of importance to public health is conducted with appropriate oversight and produces reliable, valid results.

This regulatory requirement demonstrates how governments increasingly rely on the ILAC framework to protect consumers. By specifying ILAC-accredited laboratories, regulators can have confidence in test results without needing to individually evaluate every laboratory that might test products entering their markets.

Real-world impact on businesses 🔗

For food businesses engaged in international trade, working with ILAC-accredited laboratories provides a clear pathway to market access. When a company exports food products, test reports from an accredited laboratory carry weight with foreign regulators because those regulators recognize the ILAC Arrangement.

This recognition translates into tangible benefits. Companies avoid the expense and delay of duplicate testing. Products move through customs more smoothly. Market access becomes more predictable, allowing businesses to plan their export strategies with greater confidence.

The scope of international recognition 🔗

Today, the ILAC Arrangement includes numerous accreditation bodies representing a significant portion of the global economy. The ILAC MRA signatories represent approximately 95% of global GDP, demonstrating the widespread acceptance and economic significance of this framework.

The arrangement covers multiple types of conformity assessment activities. Testing laboratories use the arrangement for chemical analysis, microbiological testing, physical testing, and other analytical work. Calibration laboratories rely on it for measurement traceability. Inspection bodies use it for conformity verification. Medical laboratories depend on it for clinical testing that informs patient care.

Supporting developing economies 🔗

ILAC provides advice and assistance to organizations from developing economies that are establishing their own accreditation systems. This support helps ensure that countries at all levels of economic development can participate in the global quality infrastructure.

By helping developing economies build competent accreditation bodies, ILAC enables laboratories in those countries to gain international recognition. This, in turn, helps businesses in developing economies access international markets, supporting economic development and trade integration.

The peer evaluation process 🔗

The credibility of the ILAC Arrangement rests on rigorous peer evaluation. Accreditation bodies that wish to join the arrangement must demonstrate their competence through a comprehensive evaluation conducted by peers from other accreditation bodies.

This evaluation examines whether the accreditation body operates according to ISO/IEC 17011, the international standard for accreditation bodies. Evaluators review the body’s procedures, witness assessments of laboratories, examine records, and verify that the accreditation body maintains impartiality and competence in its operations.

Once an accreditation body becomes a signatory, it undergoes regular surveillance and periodic re-evaluation to ensure continued compliance. This ongoing oversight maintains confidence in the arrangement and ensures that signatory accreditation bodies continue to meet international standards.

Practical implications for food safety professionals 🔗

Food safety professionals should understand how to leverage the ILAC Arrangement in their work. When selecting a testing laboratory, choosing one accredited by an ILAC-recognized accreditation body provides assurance that test results will be accepted internationally.

For companies developing food safety management systems, incorporating requirements for ILAC-accredited laboratories into specifications and procedures demonstrates commitment to internationally recognized quality standards. This can strengthen relationships with customers and facilitate regulatory compliance.

Regulators and auditors increasingly expect organizations to use accredited laboratories for critical testing. Understanding the ILAC framework helps food safety professionals explain why they choose particular laboratories and how those choices support overall food safety objectives.

Looking at the broader quality infrastructure 🔗

The ILAC Arrangement works alongside other elements of the global quality infrastructure. ILAC collaborates closely with the International Accreditation Forum, which manages similar arrangements for management system certification, product certification, and personnel certification.

Together, these organizations create an interconnected system that supports international trade and protects consumers. The system operates on principles of peer evaluation, mutual trust, and technical competence, providing a foundation for confidence in conformity assessment results worldwide.

What do you think? How might increased use of ILAC-accredited laboratories in your organization improve your international market access? What challenges do you see in implementing requirements for accredited testing in your food safety programs?

References

1. https://ilac.org/about-ilac/
2. https://en.wikipedia.org/wiki/International_Laboratory_Accreditation_Cooperation
3. https://ilac.org/ilac-mra-and-signatories/
4. https://www.apac-accreditation.org/apac-mra/
5. https://ilac.org/latest_ilac_news/laboratory-accreditation-specified-for-food-analyses/
6. https://iaf.nu/partner_organization/ilac-international-laboratory-accreditation/
7. https://ilac.org/about-ilac/role/