Where ISO 15189 Accreditation: Avoidable Gaps

Author : fdasindia fdasindia | Published On : 29 Oct 2026

Your medical laboratory may have qualified professionals, advanced diagnostic equipment and established quality procedures. Yet an accreditation assessment can still expose weaknesses that were not obvious during routine operations.

The problem is often not a complete absence of procedures. Instead, it is a difference between what your laboratory documents say and what your daily technical records demonstrate.

Understanding common ISO 15189 accreditation mistakes helps you recognize these differences before they affect assessment readiness.

If you manage laboratory quality, a practical review of scope, personnel competence, equipment records, and examination processes can help you prioritize corrective action and prepare evidence more effectively.

What ISO 15189 Accreditation Covers

ISO 15189:2022 establishes requirements for quality and competence in medical laboratories.

The standard addresses management-system arrangements and the technical processes necessary to provide reliable medical laboratory services.

Its application extends beyond maintaining laboratory equipment or preparing administrative files. You also need to demonstrate that your laboratory controls the activities involved in producing and communicating examination results.

These activities may include sample collection arrangements, specimen handling, examination methods, result verification, and reporting.

ISO 15189:2022 also addresses point-of-care testing, where applicable.

However, the precise activities assessed depend on your proposed accreditation scope and any additional applicable requirements.

For example, accreditation body  for a defined clinical biochemistry examination does not automatically establish accreditation for unrelated microbiology or molecular diagnostic examinations.

Your laboratory must be able to demonstrate competence for every activity it includes in its requested scope.

This distinction is essential when planning resources and deciding which services are ready for assessment.

Who Needs It?

ISO 15189 accreditation is relevant to medical laboratories seeking formal recognition of their quality and technical competence.

You may need to examine its requirements if you operate or manage:

• A clinical biochemistry laboratory.

• A hematology laboratory.

• A clinical microbiology laboratory.

• A molecular diagnostic laboratory.

• A pathology laboratory.

• A multidisciplinary diagnostic facility.

The first step is confirming that the particular examinations your laboratory performs fall within the accreditation programme you intend to pursue.

Not every laboratory should use the same accreditation standard.

For example, if your organization primarily performs instrument calibration rather than medical examinations, ISO/IEC 17025 or another applicable standard may be more appropriate.

A clear distinction at the beginning prevents unnecessary effort and incorrect applications.

Gaps That Delay Laboratory Readiness

Many accreditation problems become visible when your team compares written procedures against actual working records.

The following gaps deserve particular attention.

1. An accreditation scope that is too broad

Your laboratory may provide several diagnostic services but have established complete technical evidence for only some of them.

Applying for every available examination without evaluating readiness creates avoidable difficulties.

Suppose your laboratory performs clinical chemistry, haematology and microbiology examinations.

Your team may have reliable equipment records and established quality-control arrangements for chemistry testing but incomplete method-verification evidence for selected microbiology examinations.

In that situation, you should not assume that both disciplines are equally ready.

Instead, examine each activity separately.

Your scope review should identify:

• The examination or test.

• The method used.

• The relevant specimen type.

• Responsible personnel.

• Required equipment.

• Available technical evidence.

• Applicable supplementary requirements.

Once these details are clear, your team can distinguish ready activities from those requiring further work.

2. Incomplete personnel competence evidence

Employing qualified professionals does not automatically demonstrate competence for every assigned examination.

You need records showing how personnel are trained, evaluated and authorized for relevant responsibilities.

For example, a recently recruited technician may have extensive previous laboratory experience.

However, your laboratory should still establish that the technician understands its specific instruments, procedures, quality controls and reporting arrangements before authorizing independent work.

A useful competence review examines initial training, observed performance, periodic reassessment and authorization records.

Where gaps exist, document the action taken and the evidence used to confirm readiness.

3. Weak control of examination methods

A written procedure is not sufficient if the laboratory cannot demonstrate that its method is appropriate for the intended clinical use.

Your team should review the requirements for method verification or validation, depending on the nature of the examination.

Records may need to address analytical performance, acceptance criteria, limitations and changes to methods.

A common problem arises when laboratories adopt a manufacturer's examination procedure without adequately documenting the verification necessary under the applicable requirements.

The solution is to create a method inventory and connect each examination with its corresponding performance evidence.

This also helps identify procedures that have changed without appropriate technical review.

4. Fragmented equipment records

Medical laboratories often maintain equipment information across paper registers, digital files, service reports and instrument software.

This may work for day-to-day operations but become difficult during assessment.

Your laboratory should be able to retrieve relevant equipment records without lengthy searches.

Review:

• Equipment identification.

• Installation and acceptance information.

• Calibration and maintenance requirements.

• Performance verification.

• Service history.

• Equipment failures and corrective actions.

• Authorization for return to use.

Where equipment performance affects examination reliability, relevant acceptance criteria and follow-up actions should also be documented.

A central equipment register can make these relationships easier to manage.

5. Inconsistent internal quality control

Your laboratory may perform internal quality control regularly but fail to document how staff respond to unacceptable results.

This creates an important difference between recording data and demonstrating process control.

You should evaluate whether quality-control results are reviewed against defined criteria and whether appropriate action follows unacceptable performance.

The review should also establish whether affected patient results were evaluated when a significant problem occurred.

Where relevant, external quality assessment or other suitable performance comparison arrangements should be reviewed as part of readiness planning.

6. Weak sample-management procedures

An examination result can be affected before the analytical process begins.

Incorrect identification, unsuitable transport conditions or incomplete acceptance criteria can compromise specimen suitability.

Your review should cover the pre-examination process, including instructions, sample identification, collection, transport, receipt and rejection where applicable.

For example, if a specimen arrives outside your defined acceptance criteria, personnel should know how to document and manage the situation.

A procedure is effective only when employees understand it and apply it consistently.

7. Outdated management-system records

Your laboratory may have written quality procedures several years ago and updated operational practices without revising the documents.

During an ISO 15189 Accreditation document review, this inconsistency can create confusion.

Ensure that current versions are available where needed and that obsolete documents are controlled.

Your internal audit programme should also evaluate actual implementation rather than simply confirming that documents exist.

8. Corrective actions without evidence of effectiveness

Recording a nonconformity and implementing a correction are not always enough.

Your laboratory should consider why the problem occurred, whether similar problems exist and whether the chosen action was effective.

For example, repeatedly reminding staff to complete an equipment register may not resolve an underlying problem with an impractical recording system.

A stronger response examines the process, revises it where necessary and verifies whether the weakness recurs.

Evidence to Prepare

Once you identify the gaps, organize your ISO 15189 Accreditation assessment evidence by process.

Your objective should be to demonstrate that the laboratory system operates consistently.

Avoid preparing documentation solely for an assessment visit. The same records should support routine laboratory quality and patient-related decision-making.

Also read: -  ISO 15189 Internal Audit Checklist for Medical Laboratories 

Practical Application Checklist

Before proceeding, ask whether your team can answer the following questions with evidence.

• Is the requested medical laboratory scope clearly defined?

• Are personnel authorized for the activities they perform?

• Are all required equipment records available?

• Have examination methods been appropriately verified or validated?

• Can the laboratory demonstrate sample identification and traceability?

• Are quality-control results evaluated and acted upon?

• Have relevant internal audits and management reviews been performed?

• Are corrective actions documented and evaluated?

• Are current application and supplementary requirements understood?

If several answers remain uncertain, address those weaknesses before proceeding.

A readiness checklist should identify work still required, not simply produce a positive score.

Questions to Confirm With FDAS

After your internal review, contact your intended accreditation body to clarify the applicable application requirements.

FDASindia publishes medical laboratory application information and an accreditation information brochure.

Its published medical application form identifies supporting documents and describes aspects of the application process. However, the form also contains historical transition language concerning ISO 15189:2012. You should therefore confirm that you are using the latest forms and current ISO 15189:2022 requirements.

Questions worth raising include:

1. Which medical examination disciplines and scopes are currently available for application?

2. How should individual examinations be described?

3. Which current application forms and supplementary criteria apply?

4. What supporting documents are mandatory?

5. What process applies to laboratories operating at multiple locations?

6. What are the assessment stages and relevant applicant responsibilities?

7. How should the laboratory address examinations involving external referral arrangements?

It is also useful to confirm how the accreditation body's current recognition arrangements apply to your specific requirements.

Recognition must be checked for the appropriate accreditation body, scheme, and scope rather than assumed from a general statement.

You can also check: - medical lab accreditation | calibration lab accreditation | laboratory accreditation agencies 

Next Steps

The most effective preparation begins with a realistic assessment of your laboratory's existing system.

Start by selecting your proposed examinations, confirming the applicable requirements, and assigning responsibility for a structured evidence review.

Then examine the gaps affecting competence, technical reliability, and management-system implementation.

Prioritize weaknesses that could affect examination validity or patient safety, and document appropriate corrective actions.

Once your laboratory can demonstrate consistent implementation, review the current application requirements and clarify remaining questions with the accreditation body.

ISO 15189 Accreditation readiness is not measured by the quantity of documents you prepare. It depends on whether your laboratory can consistently demonstrate quality and competence across its defined activities.

For further application guidance, consult the FDAS medical laboratory application guidance and verify its current applicability before submission.

Get in touch today

Ask FDAS about the applicable ISO 15189 Accreditation scope and the evidence required for your laboratory's application.

Email: [email protected]
Phone: +91 8448278215