ISO 15189:2022 · Section 5 · Structural and governance requirements
Clause 5.3: Laboratory activities and scope
Check the exact requirement in your licensed copy of the standard.
Last reviewed
What this clause is about
A clear scope describes the laboratory activities for which the organisation accepts responsibility. It should let staff and users understand what is provided, where it is performed and which boundaries apply. Scope is broader than a list of instruments: examination disciplines, sample types, advisory work and relevant collection or near patient activities may all affect how the service is defined.
Develop the description from actual operations, not an aspirational catalogue. Identify locations, examination groups and interfaces with external providers. Distinguish work performed by the laboratory from referred examinations and explain who manages the associated communication. If an accreditation claim is made, its wording must match the formally recognised scope rather than imply that every advertised activity is included.
Changes need deliberate review. Before adding an examination, moving a service or changing who performs it, consider competence, facilities, equipment, verification or validation, reporting and clinical advice. Record who approves the change and how users will receive revised information. Removing an activity also needs planning so that existing requests and urgent needs are handled safely.
Keep internal scope descriptions consistent with service directories, user agreements and public information. Check the practical boundaries during audits by following real requests through collection, examination, referral and reporting. Where the laboratory supports point of care testing, describe the governance relationship and responsibilities rather than assuming that an offsite location removes the activity from consideration. A well maintained scope helps management identify resource needs and prevents users from relying on services the laboratory cannot reliably deliver.
What assessors typically ask to see
- Which controlled document defines activities, locations and service boundaries for the laboratory’s current operations?
- How are performed examinations distinguished from referred work in information supplied to users?
- How are new activities reviewed for resources, competence and technical readiness before requests are accepted?
- How do public statements about accreditation remain consistent with the scope formally recognised by the accrediting body?
- How are users informed when an examination is withdrawn, moved or temporarily unavailable?
Documents and records that usually provide evidence
- Laboratory scope and service directory
- Service introduction and withdrawal change control forms
- User service agreements and referral information sheets
- Examination menu review and approval records
- Site and point of care responsibility agreements
- Public scope statement review and approval records
Common findings to avoid
- The published examination menu includes discontinued activities or gives an outdated performing location.
- Referred examinations are presented without explaining the external provider’s role and reporting pathway.
- A new activity begins before competence, equipment readiness and reporting arrangements have been approved.
- Public wording suggests broader accredited coverage than the laboratory’s formally recognised scope supports.
How LabToolkit Pro maps documents to this clause
Each SOP, form and record in LabToolkit Pro can carry clause tags. When a document tagged 5.3 becomes effective, it counts as direct evidence on the readiness dashboard for ISO 15189:2022; links from other standards through the crosswalk are shown separately as indicative coverage. Gaps appear clause by clause, so you can see which parts of 5.3 still need a controlled document or a current record. Readiness is a planning aid — only an accreditation body confirms conformity.
Frequently asked questions
Is a service directory the same as an accreditation scope?
No. A service directory can describe the full service available to users, including referred work and activities outside accredited coverage. The accreditation scope is the formally recognised boundary. Keep these distinctions visible and check claims carefully whenever the directory, website or referral arrangements change.
Does moving an examination require a scope review?
Yes. Even if the examination name stays the same, a new location may change environmental conditions, transport, equipment, staffing and supervision. Assess the consequences before transfer, complete necessary technical checks and obtain required approvals. Consider any notification obligations associated with the accreditation arrangement.
How detailed should the scope description be?
Provide enough detail to establish responsibility and prevent misunderstanding about activities and locations. Link to controlled examination lists where a single document would become unwieldy. The description should be usable by staff and users, not merely a broad statement that the organisation performs medical laboratory work.
Check the exact requirement in your licensed copy of the standard.
Put it into practice
Draft, approve and e-sign your SOPs with version control, or get the complete template pack.