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:
Does the proposed medical testing scope fall within the currently applicable accreditation scheme?
Which application checklist and management system documents are required?
What are the current personnel and technical evidence requirements?
How are medical laboratory examinations evaluated during assessment?
What is the procedure for responding to non-conformities?
What are the current application and assessment charges?
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:
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
