ISO 15189 Accreditation for Medical Labs: Requirements and Process

 Accurate laboratory testing is an essential part of modern healthcare. Physicians depend on laboratory findings when diagnosing illnesses, selecting treatments, monitoring patients, and making important clinical decisions. Because of this, medical laboratories need reliable systems that support accuracy, competence, consistency, and patient-focused quality.

ISO 15189 accreditation gives medical laboratories an internationally recognized framework for demonstrating the quality and competence of their services. In India, laboratories preparing for accreditation can evaluate different accreditation organizations according to their scope, operational requirements, and long-term objectives. FDASIndia provides an India-based accreditation route for eligible medical laboratories seeking accreditation against ISO 15189:2022.

Understanding ISO 15189 for Medical Laboratories

ISO 15189 is specifically designed for medical laboratories. Unlike standards that focus only on management systems, it combines quality management requirements with requirements for technical competence.

The standard applies across different stages of laboratory operations. These include patient-related activities, sample collection, transportation, examination processes, result evaluation, reporting, personnel competency, equipment management, reagent control, risk management, and continual improvement.

An ISO 15189 accreditation assessment therefore looks beyond paperwork. The laboratory needs to demonstrate that its systems are properly implemented and that it has the technical competence required for the activities included in its accreditation scope.

This provides healthcare organizations and other stakeholders with greater confidence in the laboratory's ability to deliver consistent and technically reliable results.

How ISO 15189 Can Improve Laboratory Performance

Quality in a medical laboratory depends on many interconnected activities. A laboratory may have qualified professionals, but without effective equipment controls, sample management, quality monitoring, and documented procedures, maintaining consistent performance can be difficult.

ISO 15189 helps laboratories establish structured controls for important areas such as:

• Personnel qualifications, training, and competency

• Equipment selection, maintenance, and monitoring

• Reagent and consumable management

• Patient and sample identification

• Pre-examination activities

• Examination procedures

• Post-examination processes

• Result validation and reporting

• Quality indicators

• Risk management

• Nonconforming work

• Corrective actions

• Internal audits

• Management reviews

• Continual improvement

When these elements operate together, they can support a stronger quality culture and more consistent laboratory performance.

For this reason, clinical lab accreditation should not be viewed merely as a regulatory formality. It can become part of a laboratory's broader approach to quality improvement and operational control.

Preparing for the Laboratory Accreditation Process

The laboratory accreditation process involves preparation at both management and technical levels.

A laboratory should first identify the examinations and services it wants to include within its proposed accreditation scope. Once the scope is established, appropriate procedures, technical methods, quality controls, documentation, records, and competency requirements need to be developed and implemented.

Internal audits can help the laboratory identify areas that require improvement before the external assessment. Management reviews can further support evaluation of system performance and help leadership address identified risks and weaknesses.

During the formal assessment, the laboratory needs to demonstrate that its documented systems are implemented effectively. Assessors may evaluate personnel competence, equipment, technical procedures, records, quality control activities, reporting processes, and other applicable areas within the defined scope.

Since requirements and assessment procedures can vary between accreditation organizations, laboratories should carefully review the applicable policies and documentation of their selected accreditation body.

FDASIndia provides medical laboratory accreditation documentation, including application-related information and assessment requirements based on ISO 15189:2022.

Medical Laboratory Accreditation Around the World

ISO 15189 is internationally used, but accreditation arrangements differ between countries and regions.

In India, NABL is a major accreditation organization providing accreditation to medical laboratories against ISO 15189. It also provides accreditation services for testing and calibration laboratories under ISO/IEC 17025.

In the United States, the College of American Pathologists (CAP) operates an ISO 15189 accreditation program. CAP indicates that its ISO 15189 program works alongside CLIA requirements rather than replacing them.

In the United Kingdom, UKAS provides accreditation for medical laboratories against ISO 15189 and evaluates areas related to quality management, technical competence, impartiality, and laboratory activities.

Singapore's Singapore Accreditation Council (SAC) operates accreditation schemes covering medical laboratories under ISO 15189 and testing and calibration laboratories under ISO/IEC 17025.

In the Middle East, laboratories may consider organizations such as the Emirates International Accreditation Centre (EIAC) in the UAE and the Saudi Accreditation Center (SAAC) in Saudi Arabia, which provide accreditation programs covering medical laboratories.

These organizations operate within their respective accreditation environments. Therefore, laboratories should compare accreditation options based on scope, applicable regulations, recognition arrangements, assessment requirements, and organizational needs.

What Makes FDASIndia an Option for Indian Laboratories?

FDASIndia provides an additional accreditation option for eligible laboratories in India.

The Federation for Development of Accreditation Services (FDAS) is a non-government and non-profit organization registered in Haryana. Its accreditation management system operates in accordance with ISO/IEC 17011:2017, which provides requirements for accreditation bodies.

FDAS offers accreditation programs covering medical laboratories, testing laboratories, and calibration laboratories. Medical laboratories can apply for accreditation against ISO 15189:2022, subject to the applicable scope and requirements.

For Indian laboratories, an India-based accreditation organization can offer practical accessibility while operating within an internationally aligned accreditation framework.

FDAS states that it became an APAC MRA Signatory/Full Member on 16 June 2023 and an ILAC MRA Signatory/Full Member on 28 August 2023 for testing and calibration scopes.

These international arrangements form part of FDASIndia's stated international accreditation orientation.

Accreditation Support for Different Laboratory Activities

Some healthcare organizations and laboratory groups manage multiple technical activities. A medical laboratory may operate alongside testing or calibration facilities, creating a need to understand different accreditation standards.

FDASIndia's programs cover medical laboratories under ISO 15189 and testing and calibration laboratories under ISO/IEC 17025, subject to applicable accreditation scopes.

The organization also provides supporting documentation, including application forms, assessment checklists, supplementary criteria, policies, and procedures.

Having access to defined requirements can help laboratories organize their preparation and understand the areas that need attention before an accreditation assessment.

Selecting an Appropriate Accreditation Organization

Choosing an accreditation body is an important decision in the accreditation journey. Laboratories should not base this decision only on location or familiarity.

Important considerations can include:

• Availability of the required accreditation scope

• Applicable national and regulatory requirements

• Accreditation framework and policies

• Recognition arrangements

• Assessment procedures

• Technical requirements

• Geographic and operational considerations

• Long-term organizational objectives

NABL, CAP, UKAS, SAC, EIAC, SAAC, and FDASIndia represent different accreditation options within their respective environments. The most appropriate choice depends on the laboratory's individual requirements.

For Indian medical laboratories considering an alternative accreditation pathway, FDASIndia offers an India-based framework for ISO 15189:2022 accreditation.

Building a Sustainable Quality Culture

Obtaining accreditation is only one stage of a laboratory's quality journey. Maintaining the system effectively requires ongoing attention from laboratory management and personnel.

Competency should be monitored, equipment should remain under appropriate control, quality indicators should be reviewed, risks should be assessed, internal audits should be conducted, and identified problems should be addressed through suitable corrective actions.

A laboratory that treats ISO 15189 as an ongoing management and technical framework can build quality into everyday operations rather than treating accreditation as a one-time project.

Also read: FDASIndia: Your Trusted Partner for ISO 15189 Accreditation for Medical Laboratories

FDASIndia and ISO 15189 Accreditation

For medical laboratories in India, selecting the right accreditation pathway requires an understanding of both technical requirements and organizational objectives.

FDASIndia provides an India-based option for eligible medical laboratories seeking ISO 15189 accreditation, supported by documented requirements and an accreditation management system aligned with ISO/IEC 17011:2017. Its programs also include applicable testing and calibration laboratory accreditation under ISO/IEC 17025.

Laboratories considering clinical lab accreditation can compare FDASIndia with other laboratory accreditation agencies and determine which organization best fits their required scope and operational needs.

Is your medical laboratory preparing for ISO 15189:2022 accreditation? Contact FDASIndia to discuss your applicable scope, requirements, and accreditation process.

New Medical Laboratory? Everything You Need to Know Before Applying for ISO 15189 Accreditation

Starting a medical laboratory means juggling equipment procurement, staffing, and compliance — often all at once. If accreditation feels like the most confusing part of that list, this guide breaks down exactly what ISO 15189 requires and how to prepare before you apply.

This article walks new lab owners and quality managers through the essentials of ISO 15189, what accreditation bodies expect, and how to avoid the delays that trip up first-time applicants.

What Is ISO 15189 and Why It Matters for New Labs

ISO 15189 is the international standard specifically written for medical laboratories, covering both technical competence and quality management systems. Unlike general-purpose standards, it addresses the realities of clinical testing — sample handling, result accuracy, and patient safety.

For a new lab, accreditation under ISO 15189 signals to hospitals, physicians, and patients that your results can be trusted. It's often a prerequisite for contracts with insurers, hospital networks, or government health programs, not just a nice-to-have credential.

ISO 15189 vs ISO 17025: Clearing Up the Confusion

New lab owners frequently ask whether they need ISO 15189 or ISO/IEC 17025. Here's the distinction:

• ISO 15189 applies specifically to medical/clinical testing laboratories, covering pre-examination, examination, and post-examination processes tied to patient care.

• ISO 17025 is the broader standard for testing and calibration labs generally used by industrial, environmental, and calibration lab accreditation programs.

If your lab handles patient specimens and reports diagnostic results, ISO 15189 is the relevant path. Labs that also run calibration services alongside diagnostics sometimes pursue both standards, but that's the exception rather than the rule for a new facility.

Also read: Facing ISO 15189 Non-Conformities? Here's How Medical Laboratories Can Get Back on Track

What Accreditation Bodies Look For

ISO 15189 accreditation bodies evaluate labs against two broad categories: management requirements and technical requirements.

Management Requirements

This covers your quality management system — document control, internal audits, corrective action processes, and staff competency records. Assessors want to see that your lab has a functioning system, not just a policy binder that looks good on paper.

Technical Requirements

This is where equipment calibration, method validation, reference intervals, and result reporting accuracy come under scrutiny. A common early-stage gap is incomplete calibration records. Assessors will ask for traceable calibration history, not just a certificate on the wall.

The Laboratory Accreditation Process, Step by Step

Before submitting an application, most new labs move through these stages:

1. Gap analysis — Compare current lab operations against ISO 15189 clauses to identify missing documentation or procedures.

2. Quality manual development — Draft your quality policy, SOPs, and document control system aligned to the standard.

3. Staff training — Ensure technical staff understand both the testing methods and the documentation requirements tied to them.

4. Internal audit and management review — Run a mock audit internally before inviting an external assessor.

5. Application submission — Submit to your chosen accreditation body with supporting documentation.

6. On-site assessment — Assessors review records, interview staff, and observe testing procedures.

7. Corrective actions (if needed) — Address any non-conformities raised during assessment.

8. Accreditation granted — Certification is issued, typically followed by periodic surveillance audits.

Skipping the gap analysis is the most common reason new labs face delays; assessors find gaps during the actual audit that could have been caught earlier internally.

Common Pitfalls New Labs Should Avoid

• Underestimating documentation timelines — Building a compliant quality management system from scratch usually takes longer than lab owners initially expect.

• Treating accreditation as a one-time event — ISO 15189 requires ongoing surveillance audits, so systems need to stay current, not just be ready for launch day.

• Inconsistent staff training records — Assessors frequently flag missing or outdated competency assessments for lab personnel.

• Confusing calibration lab accreditation with medical lab accreditation  If your lab also calibrates equipment for external clients, that activity may need separate consideration under ISO 17025.

Getting Ready Before You Apply

New labs benefit from starting the documentation and internal audit process well before contacting an accreditation body. A structured pre-assessment review can help identify gaps in your quality management system before they become findings during the formal audit,  saving both time and cost in the long run.

Also read: Don't Let Your Lab's Accreditation Lapse: How FDASINDIA Simplifies ISO 17025 Renewal

A Practical Next Step

ISO 15189 accreditation isn't just a compliance checkbox; it's the framework that protects your lab's credibility from day one. Labs that invest in a solid gap analysis and internal audit process before applying tend to move through the laboratory accreditation process with fewer surprises and shorter timelines.

If your lab is preparing for its first ISO 15189 application, reach out to FDASIndia's accreditation consulting team to walk through your current readiness and next steps.

FDASINDIA – Federation for Development of Accreditation Services
📍 118-119, First Floor, Sushant Tower, Sector 56, Gurgaon – 122011, Haryana, India
📞 +91 8448278215
📧 fdasindia@hotmail.com 

5 Signs Your Lab's ISO 17025 Accreditation Needs Expert Attention Before It's Too Late

A laboratory may appear to be operating smoothly, yet small compliance gaps can grow into major accreditation issues if they go unnoticed. Delayed corrective actions, inconsistent documentation, or outdated procedures often become visible only during an assessment—when fixing them is far more difficult.

This article explains five common warning signs that indicate a laboratory may need professional guidance to maintain or achieve ISO 17025 compliance. It also highlights practical steps laboratories can take to strengthen their quality management system before minor issues become costly setbacks.

Why Early Attention Matters for ISO 17025

Maintaining ISO 17025 accreditation is not a one-time achievement. Laboratories are expected to demonstrate continual compliance with the ISO/IEC 17025:2017 requirements through effective quality management, technical competence, and documented processes.

Whether the laboratory performs testing, calibration, or analytical services, ignoring early warning signs can increase the likelihood of nonconformities during assessments. Timely expert guidance helps laboratories identify weaknesses before they affect accreditation status.

1. Internal Audits Keep Identifying the Same Nonconformities

One of the strongest indicators that a laboratory requires expert support is the repeated occurrence of the same audit findings.

For example, an internal audit identifies incomplete equipment records. The issue is corrected temporarily, but the next audit uncovers the same problem. This usually indicates that the corrective action addressed the symptom rather than the root cause.

An experienced testing lab accreditation or accreditation consultant encourages laboratories to perform proper root cause analysis instead of implementing short-term fixes. Strong corrective actions reduce recurring findings and improve long-term compliance with the ISO 17025 standard.

Common examples include:

• Incomplete calibration records

• Missing document revisions

• Unclosed corrective actions

• Repeated staff competency observations

2. Laboratory Documentation Is No Longer Up to Date

Documentation is the backbone of the ISO/IEC 17025 certification process.

As laboratories grow, procedures often change faster than documents are updated. Staff may unknowingly follow outdated work instructions while newer versions remain unpublished or uncontrolled.

Typical warning signs include:

• Old SOPs still in circulation

• Obsolete quality manuals

• Missing document approval records

• Inconsistent forms across departments

Expert reviewers typically conduct a comprehensive documentation review to ensure every controlled document aligns with the latest ISO/IEC 17025:2017 requirements.

Also read : ISO/IEC 17025 Renewal Due? Here's Why FDASINDIA Should Be Your First Call

3. Staff Are Uncertain About ISO/IEC 17025 Requirements

Even well-qualified technical personnel can struggle with accreditation requirements if regular competency evaluations and refresher training are missing.

During assessments, assessors frequently ask personnel about:

• Test methods

• Measurement uncertainty

• Equipment verification

• Quality control procedures

• Handling of nonconforming work

If responses vary significantly between team members, it may indicate that competency management requires attention.

Regular awareness sessions help laboratories ensure that every employee understands both technical procedures and the expectations of IEC 17025.

Example

A laboratory technician follows the correct testing method but cannot explain how measurement uncertainty affects the reported result. Although the testing itself may be technically correct, inadequate understanding may still become an assessment observation.

4. Equipment Management Has Become Difficult to Control

Equipment management is one of the most closely reviewed areas during ISO 17025 certification assessments.

As laboratories expand, equipment inventories also increase. Without an effective tracking system, laboratories may experience:

• Missed calibration schedules

• Expired reference standards

• Missing maintenance records

• Incomplete equipment histories

Professional reviews often identify these gaps long before an external assessment.

Good equipment management should clearly demonstrate:

• Calibration status

• Maintenance history

• Verification records

• Equipment identification

• Traceability documentation

Maintaining accurate records supports confidence in laboratory results and demonstrates ongoing compliance with the ISO 17025 standard.

5. Preparing for an Assessment Feels Stressful Every Time

Assessment preparation should never depend on last-minute document collection.

If laboratory personnel spend several weeks searching for records, updating documents, or resolving outstanding issues immediately before an assessment, the management system may not be functioning effectively throughout the year.

Healthy management systems are assessment-ready every day—not just before an external visit.

Professional gap assessments often identify process weaknesses that laboratories may overlook internally, making future assessments significantly more organized and efficient.

How Expert Guidance Helps Laboratories

Seeking expert attention does not necessarily mean a laboratory has failed. In many cases, external reviews simply provide an independent perspective on areas that internal teams may miss after working with the same system for years.

Professional support may include:

• Complete gap assessment against ISO/IEC 17025:2017

• Documentation review

• Internal audit assistance

• Corrective action guidance

• Staff awareness training

• Assessment readiness evaluation

These activities help laboratories improve consistency while reducing the risk of avoidable nonconformities.

Choosing the Right Accreditation Support

When selecting an Indian accreditation body or accreditation partner, laboratories should consider factors such as:

• Compliance with international accreditation requirements

• Transparent assessment processes

• Technical expertise

• Industry experience

• Ongoing support throughout the accreditation lifecycle

Selecting the right partner contributes to smoother accreditation management and continual improvement rather than treating accreditation as a one-time project.

Also read : Which Organizations Offer ISO/IEC 17025 Accreditation in India?

Final Takeaway

Most accreditation challenges do not appear suddenly—they develop gradually through recurring audit findings, outdated documentation, inconsistent staff knowledge, and weak equipment management. Recognizing these warning signs early gives laboratories time to strengthen their quality management system before formal assessments.

If your laboratory is preparing for ISO 17025 certification, renewal, or expanding its scope, FDAS India can support your accreditation journey with assessments aligned to ISO/IEC 17025:2017 requirements.

Contact Federation for Development of Accreditation Services (FDAS) at +91 124 495 9882, +91 8448278215, email fdasindia@hotmail.com, or visit 118-119, First Floor, Sushant Tower, Sector 56, Gurugram, Haryana – 122011 to learn more about laboratory accreditation services.