Lab Teams and iso 15189 2022: Accreditation Applicant Questions

Medical laboratories handling clinical investigations need reliable procedures, competent personnel, and documented evidence to support the quality of their results. When considering ISO 15189:2022 accreditation, laboratory owners should understand the applicable requirements, proposed scope, and assessment expectations before submitting an application.

This ISO 15189:2022 buyer guide explains the questions Indian medical laboratories should ask before applying, the documentation they should organize, and the points worth confirming with an accreditation body.

What Does ISO 15189:2022 Cover?

ISO 15189:2022 is an international standard specifying requirements for quality and competence in medical laboratories.

It provides a framework for laboratories to establish management systems and demonstrate their competence in medical laboratory activities. The standard also applies to point-of-care testing (POCT).

Its scope is relevant to medical laboratories involved in activities such as:

• Clinical biochemistry.

• Haematology and immunohaematology.

• Clinical pathology.

• Medical microbiology.

• Serology.

• Histopathology.

• Cytopathology.

• Medical genetics.

The standard focuses on the quality and competence of medical laboratory activities. It should not be confused with ISO/IEC 17025, which addresses testing and calibration laboratories more broadly.

Laboratories should also distinguish between implementing a standard and obtaining accreditation. Accreditation involves an independent evaluation against applicable requirements and the laboratory's defined scope.

Who Should Consider ISO 15189:2022 Accreditation?

ISO 15189:2022 is particularly relevant to medical laboratories that want to demonstrate the competence of their clinical testing activities.

Potential applicants include:

• Independent diagnostic laboratories.

• Hospital-based medical laboratories.

• Clinical pathology laboratories.

• Biochemistry testing facilities.

• Microbiology and serology laboratories.

• Histopathology laboratories.

• Medical laboratories providing point-of-care testing.

For example, a diagnostic laboratory may provide biochemistry, hematology, and microbiology services. However, the laboratory should define the activities and tests for which it intends to seek accreditation.

A general statement that the laboratory performs diagnostic testing is not sufficient to describe its technical scope.

Questions to Ask Before Applying for ISO 15189:2022

Before starting the application process, laboratory management should clarify the following areas.

1. Is the proposed medical laboratory scope clearly defined?

Scope definition is one of the most important preparation activities.

Laboratories should identify:

• Medical testing disciplines.

• Specific examinations and parameters.

• Testing methods.

• Equipment and instruments.

• Available technical personnel.

• Relevant laboratory facilities.

For example, a laboratory performing clinical biochemistry should identify the examinations it intends to include rather than applying for a broad scope that does not reflect its available resources.

2. Which edition of the standard applies?

Applicants should confirm that their preparation follows ISO 15189:2022 and the applicable accreditation-body requirements.

ISO published the 2022 edition in December 2022, replacing the earlier ISO 15189:2012 edition.

Laboratories should avoid relying exclusively on older manuals, checklists or procedures without checking whether they remain applicable.

3. What does the document review involve?

An ISO 15189:2022 document review helps determine whether the laboratory has appropriate documented processes and supporting records.

The laboratory should ask which documents must accompany the application and which records will be examined during assessment.

These may include the management system manual, quality procedures, examination procedures, personnel records and technical documentation.

4. What are the ISO 15189:2022 readiness criteria?

Readiness requires evidence that laboratory procedures are implemented consistently.

Laboratory management should evaluate:

• Personnel competence and authorisation.

• Equipment suitability and maintenance.

• Examination procedures.

• Sample collection and handling.

• Internal quality control.

• External quality assessment, as applicable.

• Result reporting procedures.

• Risk management.

• Internal audits and management reviews.

• Corrective action processes.

A laboratory may have written procedures but still have gaps in implementation. Actual records are therefore important when evaluating readiness.

5. How are assessment findings addressed?

Laboratories should understand how the accreditation body communicates non-conformities and what evidence is required to demonstrate corrective action.

They should clarify applicable deadlines, submission procedures and the review process before beginning the assessment.

Evidence to Prepare Before Applying

A systematic document review can help identify missing or inconsistent records.

The following checklist provides a practical starting point.

ISO 15189:2022 application readiness checklist

• Medical laboratory management system manual.

• Defined medical testing scope.

• Examination procedures and work instructions.

• Personnel qualifications and competency records.

• Equipment inventory and maintenance documentation.

• Calibration and verification records, where applicable.

• Sample collection and handling procedures.

• Internal quality control records.

• External quality assessment or proficiency testing records, as applicable.

• Examination result validation and reporting procedures.

• Records of non-conformities and corrective actions.

• Internal audit documentation.

• Management review records.

• Risk assessment and relevant monitoring records.

For example, a laboratory performing haematology examinations should maintain appropriate records relating to equipment, personnel competency, quality-control activities and examination procedures.

The records should demonstrate how the laboratory manages its activities in routine practice.

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

Questions to Confirm with FDAS

The Federation for Development of Accreditation Services (FDAS) publishes information about laboratory accreditation, application requirements and assessment procedures.

Its FDAS 100 information brochure identifies ISO 15189:2022 as the applicable standard for medical laboratory accreditation.

Before applying, laboratory owners should confirm the following:

1. Does the proposed medical testing scope fall within the currently applicable accreditation scheme?

2. Which application checklist and management system documents are required?

3. What are the current personnel and technical evidence requirements?

4. How are medical laboratory examinations evaluated during assessment?

5. What is the procedure for responding to non-conformities?

6. What are the current application and assessment charges?

7. What conditions apply to maintaining accreditation and expanding the scope?

FDAS also publishes information about medical laboratory activities, including clinical biochemistry, clinical pathology, haematology, microbiology, histopathology and other medical testing fields.

Laboratories should review the published requirements and ask for clarification where their proposed activities need further interpretation.

For additional information, applicants can refer to the ISO 15189:2022 buyer guide information and accreditation application guidance published by FDAS.

Understanding Assessment Evidence and Accreditation Scope

A medical laboratory assessment involves more than reviewing its quality manual.

The accreditation body may examine the documented management system, laboratory records, personnel competence and technical activities relevant to the applied scope.

For this reason, applicants should organise their evidence so that records can be traced to actual examinations and laboratory operations.

A useful preparation method is to create a document register containing:

Evidence category	Records to organise
Management system	Manuals, policies and procedures
Personnel	Qualifications, training and authorisation
Equipment	Maintenance and calibration records
Examination activities	Methods and technical records
Quality assurance	Internal and external quality records
Governance	Audits, reviews and corrective actions

The laboratory should also check that its records are consistent and that responsibilities are clearly assigned.

Accreditation is granted only after the applicable assessment and decision-making requirements have been satisfied. Preparing documentation does not guarantee approval.

Next Steps: Discuss Your Medical Laboratory Scope

Medical laboratory owners should approach accreditation preparation with a clear understanding of their examination activities, available resources and applicable standard requirements.

A practical first step is to review the proposed scope, identify documentation gaps and prepare specific questions before contacting the accreditation body.

FDAS provides published information about medical laboratory accreditation and application procedures. Laboratory management can seek clarification about the applicable scope, current documentation requirements and assessment arrangements.

Contact FDAS for application-related information:

Federation for Development of Accreditation Services (FDAS)
Phone: +91-124-2570004
Email: fdasindia@hotmail.com

ISO 15189 Internal Audit Checklist for Medical Laboratories

If your lab is preparing for an assessment, the internal audit is your last chance to find problems on your own terms. A missed calibration record or an unsigned competency form is far cheaper to fix in an internal audit than as a nonconformity raised on assessment day. This guide gives you a practical ISO 15189 Internal Audit Checklist you can adapt for your Medical Laboratories, aligned with ISO 15189: 2022, and shows how to run Audits for Laboratories that improve both quality processes and technical activities.

Why Internal Audits Matter for ISO 15189 Accreditation

An internal audit is a planned, documented review of whether your lab does what its own system says it does, and whether that system meets the standard. For ISO 15189 Accreditation, it is also direct evidence that your management system is working, not just written down.

Many accreditation bodies for medical laboratories expect to see a complete audit cycle, findings with corrective actions, and proof that results reached management review. Labs that treat the audit as a paperwork exercise usually discover the weakness during the external assessment.

What Changed in ISO 15189:2022 That Auditors Should Know

The 2022 edition reorganized the requirements and brought in a few shifts that directly affect how you audit:

• Point-of-care testing requirements are now part of the main standard instead of a separate document.

• Risk management runs through the whole system, not just a single clause.

• Patient-centred language is stronger, covering impartiality, confidentiality and patient care.

• Structure is regrouped into general, structural and governance, resource, process, and management system requirements.

If your checklist still follows the 2012 clause order, rebuild it. Auditing against the old structure creates gaps the assessor will notice quickly.

Planning the Audit Programme

Good audits start before anyone opens a file. Cover these points first:

• Scope and frequency. Plan to cover every process and location across the accreditation cycle, giving higher-risk areas more frequent attention.

• Auditor independence. Auditors should not review their own work. In a small lab, this may mean borrowing a trained auditor from another department or an external consultant.

• Auditor competence. Train and record the qualifications of your internal auditors, covering both the standard and the technical discipline.

• Criteria and sampling. Define what you are auditing against (the standard, your manual, SOPs, regulatory requirements) and how many records you will sample.

The ISO 15189 Internal Audit Checklist

Use the sections below as a working structure. Each question should be answered with a record, an observation or an interview, not an assumption.

1. General, Structural and Governance Requirements

• Is the lab’s legal identity clear, with defined responsibilities for its director and management?

• Are impartiality risks identified and reviewed regularly?

• Is patient and client confidentiality protected in practice, including in reports, sample handling and data storage?

• Are the lab’s scope of services and the services being delivered consistent?

2. Resource Requirements

• Does each staff member have a current job description, documented competence assessment and training record?

• Is the facility suitable for the testing performed, with environmental conditions monitored where they affect results?

• Is every piece of equipment identified, maintained, verified or calibrated at defined intervals, and traceable to its records?

• Are reagents and consumables checked on receipt, stored correctly and used within expiry?

• Are external suppliers and referral labs evaluated, and are their performance records on file?

3. Process Requirements

This is the largest section for most labs, and where technical findings tend to appear.

• Pre-examination: Are test request forms complete, and are sample collection, labelling, transport and rejection criteria followed and recorded?

• Examination: Are methods verified or validated before use? Is measurement uncertainty considered where it applies?

• Quality assurance: Is internal quality control run and reviewed? Are results from proficiency testing or inter-laboratory comparison evaluated and acted on?

• Post-examination: Are results reviewed and authorized by qualified staff? Are critical values communicated and documented?

• Reporting: Do reports contain the information the standard requires, and are amended reports traceable?

• Complaints and nonconforming work: Are they logged, investigated and closed with evidence?

4. Management System Requirements

• Are documents controlled, current and available at the point of use?

• Are records legible, retained for the defined period and protected from loss?

• Are risks and opportunities for improvement identified and tracked?

• Are quality indicators defined, monitored and reviewed?

• Are corrective actions addressing root causes, with checks on effectiveness?

• Is management review held at planned intervals, using the audit results as an input?

A Mini-Scenario: How One Small Finding Grows

Consider a lab where an auditor traces a haematology analyser. The calibration certificate is on file, but the verification after a service visit was never recorded. Patient results were released in the meantime.

The auditor’s note is short, but the implications are not. The lab now has to assess whether results are affected, document the investigation and close the process gap. Found internally, this is a manageable corrective action. Found by an assessor, it becomes a formal nonconformity with more scrutiny of the rest of your equipment records.

Also read : ISO 17025 Renewal Checklist: How FDASINDIA Makes Compliance Simple

Running the Audit and Writing Findings

During the audit, follow a simple rhythm:

1. Hold an opening meeting to confirm scope, schedule and criteria.

2. Collect evidence through record review, observation and staff interviews.

3. Trace at least one patient sample from request to report.

4. Grade findings clearly as nonconformities, observations or opportunities for improvement.

5. Close with a meeting to confirm that findings are understood.

Write each finding with three parts: the requirement, the evidence and the gap. Vague statements such as “records incomplete” slow down corrective action. Precise ones such as “calibration verification missing for analyser ID X after service on a given date” speed it up.

Closing the Loop With Corrective Actions

An audit has value only when findings lead to change. Assign an owner and a deadline for each finding, ask for root cause analysis instead of quick fixes, and verify that the action worked. Feed the trends into management review so recurring problems get resources and not just reminders.

Beyond Medical Labs: Related Accreditation Routes

The audit discipline here applies across other lab types, though each follows its own standard. Organizations exploring clinical laboratory accreditation in india typically work with NABL, and the same preparation habits support clinical lab accreditation and medical lab accreditation more broadly. Facilities that serve manufacturers may also look at testing lab accreditation, medical device testing lab accreditation and calibration lab accreditation, which are generally assessed against ISO/IEC 17025 rather than ISO 15189. Understanding the full laboratory accreditation process, from application and document review to assessment and surveillance, helps you time your internal audits sensibly.

Practical Takeaway

A strong internal audit is specific, evidence-based and tied to action. Use the checklist above to build your own version, map it to ISO 15189:2022 clauses, train independent auditors, and make sure every finding is closed with proof. Do this once a cycle and your external assessment becomes a confirmation of what you already know about your lab.

If your lab needs expert guidance on gap analysis, audit preparation or accreditation support, Contact FDASIndia today to plan your accreditation journey with fewer surprises and a faster path to approval. 
Call Us : +91 8448278215 / +91 8448278215
Email : fdasindia@hotmail.com

ISO 15189 Accreditation: A Complete Guide for First-Time Medical Laboratories

For a medical laboratory, maintaining accurate testing, consistent processes, and dependable patient results is essential. ISO 15189 Accreditation provides an internationally recognized framework for demonstrating a medical laboratory’s technical competence and quality management practices.

For laboratories approaching accreditation for the first time, the requirements can appear extensive. A clear understanding of the laboratory accreditation process, documentation, technical requirements, and assessment stages can make preparation more systematic.

This guide covers the major aspects of ISO 15189 accreditation, the importance of ISO 15189:2022, and the practical steps a medical laboratory can take before applying for accreditation.

What Is ISO 15189 Accreditation?

ISO 15189 is an international standard developed specifically for medical laboratories. It combines quality management requirements with technical competence requirements applicable to medical laboratory activities.

ISO 15189:2022, the current edition of the standard, addresses several important areas, including:

• Quality management and laboratory operations

• Competence of laboratory personnel

• Equipment and infrastructure

• Examination procedures

• Sample collection, identification, and handling

• Verification and validation of examination methods

• Internal quality control

• Risk management

• Reporting of laboratory results

• Management of nonconformities

• Continual improvement

Accreditation against ISO 15189 demonstrates that a laboratory has established controlled processes and systems intended to support technically valid and reliable examination results.

Why Is ISO 15189:2022 Important for Medical Laboratories?

Laboratory test results can have a direct role in diagnosis, treatment decisions, and patient management. For this reason, an effective laboratory quality system needs to address both documentation and actual day-to-day practices.

ISO 15189:2022 gives significant attention to risk-based thinking, patient-focused services, personnel competence, and consistent examination processes. Proper implementation can help laboratories strengthen traceability, reduce process-related errors, improve documentation, and increase confidence in laboratory results.

For this reason, medical lab accreditation can support both compliance and the continuous improvement of laboratory operations.

Who Needs Clinical Lab Accreditation?

Clinical lab accreditation applies to laboratories involved in medical examinations and diagnostic testing. Depending on their scope of activities, these may include:

• Pathology laboratories

• Clinical chemistry laboratories

• Hematology laboratories

• Microbiology laboratories

• Molecular diagnostic laboratories

• Immunology laboratories

• Histopathology laboratories

• Hospital-based medical laboratories

• Independent diagnostic laboratories

Laboratories seeking clinical laboratory accreditation in India should first understand the requirements applicable to their activities. They should then establish the necessary management and technical systems before undergoing an assessment.

ISO 15189 Accreditation vs Other Laboratory Accreditation

A common issue for first-time applicants is assuming that the same accreditation standard applies to every type of laboratory.

The applicable standard generally depends on the laboratory activity and the scope for which accreditation is being sought.

Laboratory Activity	Common Standard
Medical laboratory examinations	ISO 15189
Testing laboratories	ISO/IEC 17025
Calibration laboratories	ISO/IEC 17025
Medical device testing	ISO/IEC 17025, where applicable
Inspection activities	ISO/IEC 17020

Therefore, testing lab accreditation, medical device testing lab accreditation, and calibration lab accreditation should not be considered the same as medical laboratory accreditation.

The appropriate standard should be determined according to the laboratory's activities and proposed accreditation scope.

Understanding Accreditation Bodies for Medical Laboratories

An accreditation body assesses whether a laboratory meets the relevant standard and demonstrates the competence required for its defined scope.

When evaluating accreditation bodies for medical laboratories, organizations may consider several factors, such as:

• Applicable accreditation standard

• Proposed accreditation scope

• Assessment procedures

• Recognition arrangements

• Competence of assessors

• Application and accreditation procedures

• Surveillance and reassessment requirements

• Transparency of the accreditation process

Choosing an appropriate accreditation body is an important part of the initial planning stage because it determines how the application and assessment process will be handled.

The Laboratory Accreditation Process: Step by Step

For a first-time applicant, the laboratory accreditation process can be approached through a series of practical steps.

1. Understand the Standard

The first step is to study ISO 15189:2022 and determine which requirements apply to the laboratory's activities and proposed scope.

The standard should not be treated simply as a documentation requirement. Its requirements need to be reflected in the laboratory's actual working processes.

2. Define the Scope

The laboratory should clearly identify the examinations and activities for which accreditation is being requested.

A well-defined scope helps the laboratory determine its requirements for personnel, equipment, examination methods, quality controls, facilities, and technical records.

3. Conduct a Gap Assessment

The laboratory should compare its current practices with the applicable requirements of ISO 15189:2022.

A gap assessment can highlight areas that need attention, including:

• Missing or incomplete procedures

• Inadequate records

• Personnel competency gaps

• Equipment management issues

• Quality-control weaknesses

• Method verification or validation requirements

• Risk management deficiencies

• Document-control issues

Resolving these gaps before the formal assessment can improve the laboratory's level of preparedness.

4. Establish the Quality Management System

The laboratory should develop and implement a quality management system that reflects its real operations.

Depending on the laboratory's activities, this may include procedures and records related to document control, personnel management, equipment, purchasing, sample handling, examination processes, quality indicators, nonconformities, corrective actions, internal audits, management reviews, and continual improvement.

The objective should be an effective working system rather than documentation created only for the assessment.

5. Demonstrate Technical Competence

Documentation by itself does not demonstrate laboratory competence.

The laboratory should be able to demonstrate that its personnel are competent, equipment is properly managed, examination methods are appropriate, and technical processes are supported by suitable quality-control evidence.

Where applicable, the laboratory should also address method verification or validation, measurement uncertainty, reference materials, proficiency testing, and traceability.

6. Implement Internal Audits

Internal audits help determine whether the laboratory's management and technical processes are being implemented as intended.

Relevant requirements and laboratory activities should be covered. Audit findings should be recorded, investigated, and addressed through suitable corrective actions.

7. Conduct Management Review

Management review allows laboratory leadership to evaluate the performance and effectiveness of the quality management system.

The review may include:

• Internal audit findings

• Complaints

• Quality indicators

• Nonconformities

• Corrective actions

• Risks and opportunities

• Resource requirements

• Personnel performance

• Opportunities for improvement

This process can help management identify areas that require further attention before or after accreditation.

8. Apply for Accreditation

After the required management and technical systems have been implemented, the laboratory can submit its application and supporting information to the selected accreditation body.

The accreditation body reviews the submitted information and proceeds with the assessment according to its established procedures.

9. Prepare for Assessment

Assessment involves more than reviewing laboratory documents.

Assessors may examine records, interview personnel, observe laboratory activities, review equipment and facilities, and evaluate technical processes included within the proposed scope.

The laboratory should therefore ensure that documented procedures correspond with actual practices.

10. Address Nonconformities

If nonconformities are identified during assessment, the laboratory needs to investigate the underlying causes and implement appropriate corrective actions.

Addressing only the immediate error may not be sufficient. The laboratory should also determine why the issue occurred and identify measures that can reduce the possibility of recurrence.

11. Accreditation Decision

After the assessment process and satisfactory resolution of applicable findings, the accreditation body follows its established decision-making procedure.

Once accreditation is granted, the laboratory remains responsible for maintaining its management system, technical competence, and conformity with applicable requirements.

Also read: ISO 15189 Accreditation for Medical Laboratories: Why the Right Accreditation Partner Matters

Common Challenges for First-Time Applicants

First-time applicants may face difficulties when documentation receives more attention than actual implementation.

Some commonly encountered areas include:

• Procedures that differ from actual laboratory practices

• Incomplete personnel competency records

• Insufficient equipment maintenance documentation

• Missing or incomplete quality-control records

• Weak internal audit processes

• Inadequate corrective-action investigations

• Unclear accreditation scope

• Incomplete method verification or validation

• Gaps in risk management

• Limited management involvement

An effective medical lab accreditation program requires coordination between laboratory management, technical personnel, and other relevant staff.

How FDASIndia Can Support Your Accreditation Journey

For laboratories preparing for ISO 15189 accreditation, a structured implementation approach can make the accreditation journey more organized.

FDASIndia operates as an accreditation body for laboratories and maintains a management system aligned with ISO/IEC 17011:2017. Its accreditation activities include relevant laboratory accreditation requirements, including medical laboratories under ISO 15189 and testing and calibration laboratories under applicable standards.

FDASIndia became an APAC MRA Signatory in June 2023 and an ILAC MRA Signatory in August 2023 for testing and calibration laboratory accreditation.

For organizations evaluating accreditation bodies for medical laboratories, understanding the applicable standard, scope, assessment requirements, and accreditation pathway is an important part of the initial planning process.

Final Thoughts

Beginning the ISO 15189 accreditation journey becomes more manageable when the laboratory approaches each requirement systematically.

Understanding ISO 15189:2022, defining an appropriate scope, implementing a practical quality management system, demonstrating technical competence, conducting internal audits, and preparing for assessment are all important parts of the process.

Whether a laboratory is planning clinical laboratory accreditation in India, strengthening an existing quality system, or applying for ISO 15189 accreditation for the first time, proper preparation can help identify gaps and create a more structured accreditation process.

Ready to begin your ISO 15189 journey? Contact FDASIndia for information about medical laboratory accreditation and the accreditation process.