Last Updated on September 24, 2025 by Melissa Lazaro

Who Accredits ISO 15189 2022 Laboratories? Global Bodies You Can Trust

Let’s be honest—navigating ISO 15189:2022 accreditation can feel overwhelming, especially when you’re trying to figure out which bodies are actually legitimate. I’ve worked with dozens of medical laboratories over the years—from small diagnostics labs to national health agencies—and this is one of the first questions they always ask: Who can we really trust to accredit us?

It’s a fair concern. Not all accreditation bodies are created equal, and choosing the wrong one can cost you time, money, and credibility. I’ve seen labs invest months into preparing for audits, only to realize later that their accreditor wasn’t even internationally recognized. Trust me, that’s a mistake you don’t want to make.

In this guide, I’ll walk you through exactly who accredits ISO 15189:2022 laboratories—and more importantly, how to spot the global bodies you can actually rely on. You’ll come away knowing which names carry real weight, how international recognition works, and what to double-check before you sign anything. Whether you’re just starting out or reassessing your current accreditation path, this will help you move forward with confidence.

What Is ISO 15189:2022 and Why Does Accreditation Matter?

Before we explore who accredits laboratories under ISO 15189:2022, it’s important to understand why this accreditation holds such weight in the medical and diagnostic industry.

What ISO 15189:2022 Covers

ISO 15189:2022 is an international standard designed specifically for medical laboratories. It integrates requirements for both quality management systems and technical competence, making it more than just a procedural checklist. The standard ensures that laboratories operate under a framework that supports reliable, consistent, and clinically valid results. This includes everything from sample handling and test methods to equipment calibration, staff qualifications, and result reporting.

Unlike general quality standards such as ISO 9001, ISO 15189 is tailored to the specific workflows and risks inherent to medical testing environments. This specialization is why its accreditation is often mandated by health ministries, hospital networks, and international regulatory bodies.

Why Accreditation Is Critical

Accreditation confirms that a laboratory meets all the stringent requirements of ISO 15189:2022 and that its processes have been independently assessed by a qualified third-party body. This matters because:

• It ensures technical competence, not just procedural compliance.

• It builds trust with clinicians, patients, and regulatory agencies.

• It facilitates international acceptance of test results.

• It improves operational efficiency through structured quality management.

In short, ISO 15189 accreditation is both a mark of excellence and a practical tool for reducing diagnostic errors, improving patient safety, and meeting national or global regulatory demands.

Next, let’s look at what it really means to be accredited—and why not all accreditors are equal.

What Does It Mean to Be an Accredited Laboratory?

When a laboratory says it is “accredited to ISO 15189:2022,” it means more than just compliance with a checklist. Accreditation is a formal recognition that the laboratory operates competently and generates valid results, as confirmed by a recognized third-party accreditation body.

Accreditation vs. Certification

One of the most common misconceptions is confusing accreditation with certification. While both involve external assessments, their scope and meaning differ significantly:

• Certification usually applies to management systems (such as ISO 9001) and confirms that a process meets defined requirements.

• Accreditation, on the other hand, specifically verifies a laboratory’s technical competence in performing specific types of testing.

ISO 15189 accreditation involves detailed evaluations of laboratory methods, staff qualifications, equipment, internal audits, and quality control measures. The focus is not just on whether procedures exist—but whether they produce reliable and defensible results.

The Role of Third-Party Accreditation Bodies

Only independent, impartial, and technically competent accreditation bodies are authorized to assess and grant ISO 15189:2022 accreditation. These organizations must follow international standards themselves, such as ISO/IEC 17011, which governs how accreditation bodies operate.

This is where choosing the right accreditor becomes vital. An accreditation body without international recognition may offer you a certificate, but it could lack credibility—especially when dealing with cross-border stakeholders or regulatory authorities.

Why Global Recognition Matters

Accreditation by a reputable body recognized through international agreements (like the ILAC MRA) ensures that your lab’s status is accepted across borders. This is especially crucial for:

• Reference laboratories conducting testing for international clients

• Hospitals participating in global clinical trials

• Laboratories exporting test results or working with overseas partners

In the next section, we’ll explore the global system that oversees legitimate accreditation—starting with ILAC and the Mutual Recognition Arrangement.

The Global Oversight Framework: ILAC and the MRA

To understand who accredits ISO 15189:2022 laboratories, we must first examine the system that ensures global credibility and mutual trust in accreditation—led by ILAC and its Mutual Recognition Arrangement.

What Is ILAC?

The International Laboratory Accreditation Cooperation (ILAC) is a global organization that oversees and coordinates accreditation activities for laboratories and inspection bodies. ILAC does not accredit laboratories directly. Instead, it recognizes accreditation bodies that meet rigorous international standards and operate with technical and procedural integrity.

These accreditation bodies must demonstrate compliance with ISO/IEC 17011, the standard that defines how accreditation bodies themselves must function. Once accepted, they become signatories to the ILAC Mutual Recognition Arrangement (ILAC MRA).

What Is the ILAC MRA?

The ILAC Mutual Recognition Arrangement (MRA) is an agreement among accreditation bodies around the world to recognize and accept each other’s accredited test results. This is vital for international consistency and trust. A laboratory accredited by a body that is an ILAC MRA signatory gains international recognition for its results—removing barriers to cross-border acceptance.

For example, if a laboratory in France is accredited by COFRAC (an ILAC MRA signatory), its test results may be accepted by regulatory bodies, hospitals, or clients in Canada, Australia, or Japan without the need for additional validation.

How ILAC Safeguards Trust

ILAC performs regular peer evaluations of its signatories to ensure continued compliance. These assessments are thorough and focus on both the management system of the accreditation body and its technical assessments of laboratories.

Without ILAC’s oversight, the global consistency of laboratory accreditation would erode, leading to duplicated audits, skepticism in test data, and loss of public trust.

Why This Matters to Your Laboratory

• Global recognition: Accreditation by an ILAC MRA body enables your results to be accepted internationally.

• Credibility with regulators: Ministries of health, WHO, and national agencies often require ILAC-recognized accreditation.

• Avoidance of non-recognized accreditors: If your accreditation body is not ILAC-recognized, your lab may not qualify for public tenders, insurance reimbursements, or cross-border contracts.

Next, we’ll explore which national and regional accreditation bodies you can rely on—and how to find the right one for your laboratory.

Trusted National and Regional Accreditation Bodies You Can Rely On

Once you understand the importance of ILAC and its Mutual Recognition Arrangement, the next step is identifying which accreditation bodies are trustworthy, recognized, and appropriate for your specific region or sector.

How to Identify a Reputable Accreditor

A credible accreditation body will:

• Be a signatory to the ILAC MRA

• Follow ISO/IEC 17011 standards

• Have clearly published scopes of accreditation

• Be listed on the official ILAC website or regional cooperation group sites (such as APAC, EA, IAAC, or AFRAC)

These organizations assess medical laboratories for ISO 15189:2022 compliance with full transparency, technical rigor, and international oversight.

Examples of Recognized Accreditation Bodies by Region

Below are some of the most well-established ILAC MRA signatories that offer ISO 15189 accreditation:

North America

• A2LA (American Association for Laboratory Accreditation) – United States

• ANAB (ANSI National Accreditation Board) – United States

• SCC (Standards Council of Canada) – Canada

Europe

• UKAS (United Kingdom Accreditation Service) – United Kingdom

• DAkkS (Deutsche Akkreditierungsstelle) – Germany

• COFRAC (Comité Français d’Accréditation) – France

• ENAC (Entidad Nacional de Acreditación) – Spain

Asia-Pacific

• NABL (National Accreditation Board for Testing and Calibration Laboratories) – India

• JAB (Japan Accreditation Board) – Japan

• NATA (National Association of Testing Authorities) – Australia

• CNAS (China National Accreditation Service) – China

Africa

• SANAS (South African National Accreditation System) – South Africa

• EGAC (Egyptian Accreditation Council) – Egypt

Latin America

• EMA (Entidad Mexicana de Acreditación) – Mexico

• OAA (Organismo Argentino de Acreditación) – Argentina

• INMETRO (National Institute of Metrology, Quality and Technology) – Brazil

How to Match an Accreditor to Your Laboratory

When selecting an accrediting body, consider:

• Geographical relevance: Some ministries or health authorities mandate accreditation by a national or regional body.

• Language and documentation: Working in your native language streamlines communication and document submission.

• Technical scope: Ensure the body has experience in your specific testing area (clinical chemistry, microbiology, pathology, etc.).

• Processing time and audit availability: Regional bodies may offer quicker on-site audits than international ones, depending on your location.

How to Verify If an Accreditation Body Is Legitimate

Not all accreditation bodies are created equal. Some operate without international oversight, while others may misrepresent their credentials. To protect your laboratory’s reputation and ensure the widest possible recognition of your results, it’s critical to verify that any accreditation body you engage with is both authentic and globally recognized.

Step-by-Step: How to Verify an Accreditor’s Legitimacy

1. Check ILAC’s Official Website
Visit the ILAC MRA Signatory List and search by country or name. If the body is not listed here, it is not recognized under the ILAC Mutual Recognition Arrangement. Only MRA signatories provide accreditation that is widely accepted across borders.

2. Review Regional Cooperation Bodies
Some regional groups, like EA (Europe), APAC (Asia-Pacific), AFRAC (Africa), and IAAC (Americas) also publish their own databases of accredited bodies. These regional cooperations coordinate directly with ILAC and follow the same standards.

3. Confirm Their Scope of Accreditation
Once you find the accreditor, verify that they actually accredit medical laboratories under ISO 15189:2022. Some accreditors may cover only testing/calibration labs under ISO/IEC 17025, which is not applicable for clinical labs.

4. Look for ISO/IEC 17011 Compliance
Reputable accreditation bodies must comply with ISO/IEC 17011. This ensures their processes are impartial, transparent, and technically sound. Most legitimate bodies publish this compliance openly on their websites.

Red Flags to Watch For

• Fast-track promises without any mention of assessment or audit

• No online listing with ILAC, IAF, or regional groups

• Certificates that reference ISO 15189 but are issued by non-accreditation companies

• No documented scope of accreditation on their website

• Accreditors with no published office address or contact information

Why This Matters

Accreditation by a non-legitimate body can have serious consequences:

• Your lab’s results may be rejected by regulatory authorities or global clients.

• You may be barred from participating in international programs or partnerships.

• Corrective re-accreditation can be costly and time-consuming.

Verifying legitimacy ensures your investment in accreditation yields real benefits and international recognition.

Next, we’ll explore how to choose the right accrediting body for your specific laboratory and needs.

Choosing the Right Accrediting Body for Your Laboratory

Once you’ve confirmed that an accreditation body is legitimate and ILAC-recognized, the next step is finding the one that best fits your laboratory’s operational, technical, and strategic needs. Not all accrediting bodies offer the same services, responsiveness, or domain expertise, so this decision deserves careful evaluation.

Factors to Consider When Selecting an Accrediting Body

1. Regional Acceptance and Regulatory Alignment
Many countries have health ministry regulations or reimbursement frameworks that prefer or require accreditation from specific national bodies. For instance, in South Africa, SANAS is the only officially recognized ISO 15189 accreditor. In the UK, it’s UKAS. Choosing a nationally endorsed body helps avoid future compliance conflicts.

2. Technical Specialization and Scope
Each accreditation body maintains a scope of accreditation that details what types of laboratories and testing disciplines it covers. If your lab specializes in advanced diagnostics, molecular biology, or rare testing categories, ensure your chosen body has prior experience and technical expertise in that domain.

3. Responsiveness and Accessibility
Some global accreditation bodies may have long waiting lists, especially in high-demand regions. Others may lack sufficient auditors fluent in your local language or familiar with regional health protocols. A more responsive, regionally embedded body can often provide faster audit scheduling, clearer communication, and ongoing support.

4. Language, Documentation, and Logistics
ISO 15189 audits require the submission of policies, SOPs, training records, and more. If your team operates primarily in a local language, ensure the accrediting body accepts documentation in that language or provides translation support. Miscommunication during assessment can delay the process or lead to misunderstandings in nonconformity reports.

5. Fee Structure and Long-Term Value
Accreditation involves not only an initial assessment fee but also surveillance and re-assessment audits. Compare pricing structures across reputable bodies, and factor in whether they offer additional value—like technical workshops, pre-assessment consultations, or digital submission tools.

Lessons from the Field

In our consultancy experience, we’ve found that laboratories choosing a body based solely on cost or timeline often face challenges during reassessment or international result acceptance. Conversely, labs that prioritize strategic fit—such as compatibility with their national health policy or international client expectations—tend to maintain smoother long-term accreditation.

In the final sections, we’ll share expert tips, flag common mistakes, and answer key questions that frequently arise during the ISO 15189 accreditation journey.

Pro Tips and Expert Insights: How to Navigate ISO 15189 Accreditation Like a Professional

Drawing from years of direct consulting with medical laboratories across regions, here are practical insights and tested strategies to help you avoid delays, reduce risk, and increase the long-term value of your accreditation journey.

Pro Tip 1: Always Start with a Gap Assessment

Before engaging an accrediting body, conduct a thorough internal gap assessment against the ISO 15189:2022 standard. This will:

• Identify technical or documentation weaknesses

• Save time during the pre-assessment or initial audit

• Help you choose an accreditor that understands your lab’s complexity and scope

Experienced labs typically use a structured checklist or hire external consultants to ensure nothing is missed.

Pro Tip 2: Prioritize ILAC MRA Signatories from the Start

Engaging a non-ILAC body may seem faster or cheaper initially, but often leads to:

• Limited recognition of your lab’s reports

• Rejection from national health procurement frameworks

• The need to redo accreditation with a recognized body later

Accreditation is an investment—make sure it’s recognized internationally from day one.

Pro Tip 3: Ask for Their Scope of Accreditation in Writing

Before committing, request a documented scope from the accrediting body that confirms they handle:

• Medical laboratories (not just testing or calibration labs)

• Your specific field of testing (e.g., hematology, microbiology, pathology)

This ensures your application isn’t delayed due to scope mismatches or administrative rejections.

Pro Tip 4: Prepare Your Team, Not Just Your Documents

One of the biggest causes of nonconformities during audits isn’t missing SOPs—it’s untrained or underinformed staff. Make sure:

• All key personnel understand ISO 15189:2022 requirements

• Staff are familiar with your lab’s quality manual and procedures

• Technical leads can explain competency assessments, validations, and internal QC methods

Auditors often focus heavily on interviews and staff understanding—preparation pays off

Common Mistakes to Avoid and Frequently Asked Questions

Even well-intentioned laboratories can stumble during the ISO 15189 accreditation journey. Below are the most frequent missteps we’ve observed, followed by expert answers to questions that often come up during the planning or selection phase.

Common Mistakes Laboratories Should Avoid

1. Choosing a Non-Recognized Accreditor Based on Cost or Speed
Some organizations offer “ISO 15189 certificates” with little more than a paperwork review. These are not legitimate accreditations. Without ILAC recognition, such certificates often hold no value with regulators, insurance systems, or international partners.

2. Submitting Incomplete or Generic Documentation
Many labs use borrowed templates or outdated procedures. Accreditation bodies assess how well your documentation reflects your lab’s actual practices—not just whether it exists.

3. Ignoring Staff Training and Competency Requirements
Auditors look beyond documentation. If staff are unaware of standard operating procedures, internal QC methods, or their roles in the QMS, this can result in major nonconformities—even with strong paperwork.

4. Overlooking the Importance of Internal Audits and Management Reviews
Some labs focus entirely on technical accuracy and neglect internal QMS elements. Regular audits and documented management reviews are essential for ISO 15189:2022 compliance.

Frequently Asked Questions (FAQs)

Q1: Is ISO 15189 accreditation valid worldwide if it comes from any body?
A: No. Only accreditation from bodies that are signatories to the ILAC Mutual Recognition Arrangement is recognized globally. Always verify the body’s status before starting the process.

Q2: How long does it take to get accredited?
A: It typically takes three to nine months, depending on your lab’s readiness, the accrediting body’s schedule, and the complexity of your testing scope. Pre-assessment and corrective actions can extend this timeline.

Q3: Can we switch accreditation bodies later?
A: Yes, but it’s not always simple. You’ll need to go through a new application, potentially undergo a full assessment, and ensure there’s no disruption in recognition or reporting during the transition. It’s better to choose the right accreditor from the beginning.

Q4: What happens if we receive a nonconformity during the audit?
A: Nonconformities are common and expected. You’ll be given time to implement corrective actions and submit evidence. Minor issues typically do not prevent accreditation if properly addressed.

Your Path to Trustworthy ISO 15189:2022 Accreditation

Selecting the right accrediting body is not just a technical requirement—it’s a strategic decision that defines how your laboratory is perceived by regulators, clients, and the broader healthcare community. With the 2022 revision of ISO 15189, the bar for competence and quality is higher than ever. That makes choosing a globally recognized, ILAC MRA-endorsed accreditor absolutely essential.

Throughout this article, you’ve learned:

• The critical differences between accreditation and certification

• How ILAC and its Mutual Recognition Arrangement ensure global trust

• Which national and regional bodies are legitimate and recognized

• How to verify an accrediting body’s credentials with confidence

• Insider tips for preparing your team and avoiding common pitfalls

As consultants who’ve worked closely with laboratories across continents, we’ve seen the long-term value that comes from doing this right the first time. Accreditation is not just about compliance—it’s about building a system that inspires confidence in your results and resilience in your operations.

Ready to begin or optimize your accreditation process?
Our team at QSE Academy offers hands-on support to help you select the right accreditor, prepare for assessment, and align your quality system with ISO 15189:2022. We invite you to connect with us for tailored guidance, document toolkits, or a full roadmap to successful accreditation.

Visit www.qseacademy.com to take the first step toward global recognition and lasting laboratory excellence.