ISO 15189:2022 · Section 8 · Management system requirements
Clause 8.6: Improvement
Check the exact requirement in your licensed copy of the standard.
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What this clause is about
Improvement is the deliberate effort to make laboratory services more effective and better suited to patient and user needs. It goes beyond fixing individual errors. Useful ideas may come from staff observations, complaints, clinical discussions, audit findings, quality indicators and changes in available technology. Create a route for people to propose changes and explain how suggestions will be assessed, prioritized and followed through.
Choose projects with a clear problem or opportunity, an accountable owner and an intended benefit. Describe the starting position using trustworthy information. If clinicians report difficulty obtaining advice, investigate the actual contact pathway rather than assuming that another leaflet will solve the problem. Agree measures that show whether the intended experience improves and check for effects elsewhere. Faster reporting, for example, should not be achieved by weakening authorization or increasing avoidable repeat work.
Seek feedback from patients, laboratory personnel and service users through methods appropriate to the service. Surveys can help, but direct discussions, focused interviews and recurring themes from complaints may reveal issues that a general satisfaction score misses. Communicate what was learned and what the laboratory decided to do. Staff are more likely to contribute when suggestions receive a response rather than disappearing into a register.
Test changes on a manageable scale when appropriate, assess results and decide whether to adopt, adapt or stop. Embed successful changes into controlled instructions, training and routine monitoring so benefits survive staff turnover. Not every experiment succeeds, and a well-documented decision to stop an ineffective change is useful learning. LabToolkit Pro can support improvement plans, forms and revised SOPs; the laboratory must select meaningful aims, evaluate outcomes and demonstrate sustained benefits in practice.
What assessors typically ask to see
- How does the laboratory identify improvement opportunities from staff experience, patient needs, user feedback and operational evidence?
- Can a selected project demonstrate a clear starting problem, intended benefit, responsible owner and suitable outcome measures?
- How are patients and service users invited to provide feedback through routes appropriate to the laboratory service?
- How are proposed changes assessed for unintended consequences, particularly effects on safety, access and other parts of the pathway?
- What demonstrates that a successful change has been embedded into routine work and that its benefits remain evident?
Documents and records that usually provide evidence
- Improvement register describing opportunities, prioritization decisions, project owners and connections to laboratory objectives.
- Project plans with baseline information, intended outcomes, measures, implementation steps and dates for reviewing results.
- Patient, staff and service-user feedback records showing how information was gathered, reviewed and acted upon.
- Trial evaluations comparing relevant outcomes before and after a change while considering unintended effects and other influences.
- Updated procedures, staff briefings and training records supporting adoption of improvements into normal working arrangements.
- Follow-up monitoring demonstrating whether benefits persisted and identifying further adjustment when performance began to drift.
Ready-made forms mapped to clause 8.6: Customer Satisfaction Survey Form, Customer Survey Report, Personnel Feedback Form, Personnel Feedback Report, Staff Suggestion Form, Staff Suggestion Log, Opportunities Identification Form, Quality Improvement Plan.
Common findings to avoid
- Calling any new equipment purchase an improvement without identifying the service problem or evaluating the intended benefit.
- Collecting satisfaction responses repeatedly without reviewing themes, communicating decisions or taking proportionate practical action.
- Reporting an activity as completed because training occurred while leaving the original service outcome unmeasured.
- Introducing a faster workflow without checking whether identification errors, staff workload or downstream delays have increased.
How LabToolkit Pro maps documents to this clause
Each SOP, form and record in LabToolkit Pro can carry clause tags. When a document tagged 8.6 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 8.6 still need a controlled document or a current record. Readiness is a planning aid — only an accreditation body confirms conformity.
Frequently asked questions
Must improvement always involve a major project?
No. A small change to specimen instructions or contact arrangements can be valuable. Use planning and evaluation proportionate to the change, but still identify the intended benefit and check that it actually occurred.
How can a laboratory obtain useful patient feedback?
Choose accessible methods relevant to patient contact, such as focused questions after collection or discussions with representative groups. Protect confidentiality and consider people who face language, disability or digital-access barriers when selecting the feedback route.
What if an improvement trial does not work?
Record the result and investigate why the expected benefit was absent. Adapt or stop the change as appropriate, share the learning and avoid embedding an ineffective process merely because resources have already been invested.
Check the exact requirement in your licensed copy of the standard.
Put it into practice
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