ISO 15189:2022 · Section 6 · Resource requirements
Clause 6.7: Service agreements
Check the exact requirement in your licensed copy of the standard.
Last reviewed
What this clause is about
A service agreement establishes what the laboratory and its users can reasonably expect from one another. It turns a general promise to provide testing into practical arrangements for requests, specimen requirements, examination availability, reporting, consultation, and communication. The agreement should reflect actual capacity and patient needs rather than describe an ideal service that the laboratory cannot consistently deliver.
Before accepting an arrangement, review whether the laboratory has the people, methods, equipment, referral access, and reporting arrangements needed. Clarify responsibilities for collecting and transporting specimens, supplying clinical information, contacting responsible clinicians, and responding to urgent situations. Where point of care testing is part of the service, define how the laboratory and the operating organization share responsibilities for oversight and support.
Agreements may take different documented forms depending on the relationship and local legal context. A contract, agreed service schedule, or controlled user information package can communicate different parts of the arrangement. What matters is that relevant parties understand the applicable commitments and can access current information. Avoid contradictory statements across a handbook, website, and signed schedule.
Review arrangements when clinical needs, examination availability, referral providers, or turnaround expectations change. Communicate material changes before implementation when feasible, and keep a record of the decision and notification. Complaints, delayed reporting, and recurring unsuitable specimens can reveal that an agreement needs revision. LabToolkit Pro can help control agreement versions and record approvals, while service owners remain accountable for agreeing realistic and clinically appropriate commitments.
What assessors typically ask to see
- How does the laboratory confirm that requested services are achievable before agreeing to provide them to a new user?
- Where are responsibilities for specimen collection, transportation, urgent communication, and clinical advice clearly described and accessible?
- How do relevant users learn about changes to examination availability, referral arrangements, or expected reporting times?
- How are shared responsibilities established when the laboratory supports examinations performed at the point of care?
- What triggers review of an existing agreement when complaints, capacity problems, or clinical requirements change?
- How do staff resolve differences between a signed agreement, the user handbook, and information published elsewhere?
Documents and records that usually provide evidence
- Service review checklist recording requested examinations, available resources, referral needs, limitations, and the decision to accept work.
- Current agreements or service schedules identifying the parties, scope of service, responsibilities, and authorized approval.
- Controlled user information covering requesting, specimen handling, reporting arrangements, urgent contacts, and access to professional advice.
- Change records showing the revised commitment, affected users, communication method, effective date, and responsible service owner.
- Point of care responsibility agreements describing operational support, oversight, escalation, and access to appropriate laboratory expertise.
- Review minutes connecting user feedback and service performance to decisions about continuing or revising the arrangement.
Ready-made forms mapped to clause 6.7: Service Agreement Review Form.
Common findings to avoid
- Turnaround commitments are copied from a generic template without checking transport times, staffing, referral schedules, or clinical urgency.
- An agreement is signed once but no one owns review when the service scope or available resources change.
- Users receive conflicting specimen instructions because the service schedule and controlled handbook are maintained independently.
- Point of care arrangements describe equipment supply but leave responsibilities for oversight and escalation unclear.
How LabToolkit Pro maps documents to this clause
Each SOP, form and record in LabToolkit Pro can carry clause tags. When a document tagged 6.7 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 6.7 still need a controlled document or a current record. Readiness is a planning aid — only an accreditation body confirms conformity.
Frequently asked questions
Does every user need a separate signed contract?
Not necessarily. The appropriate form depends on the service relationship and applicable obligations. Routine services may use documented arrangements shared with a defined user group, while complex partnerships may need formal contracts. Ensure the relevant requirements are understood and that acceptance, changes, and responsibilities can be demonstrated.
How often should agreements be reviewed?
Set a review approach proportionate to the relationship and risk, with additional review when important circumstances change. A scheduled review alone is insufficient if an examination is withdrawn or urgent reporting arrangements change between review dates. Assign an owner who can identify these triggers and coordinate communication.
What if an urgent request falls outside the agreement?
Assess the clinical need and actual capability before accepting the request. Involve an authorized person, explain limitations to the user, and document any exceptional arrangements. An emergency does not justify promising unavailable performance; referral or another safe route may be more appropriate, with clear communication and follow-up.
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.