ISO/IEC 17025 clause 5.7: communicate and protect planned changes
Clause 5.7 gives laboratory management two connected responsibilities: ensure communication about management-system effectiveness and the importance of meeting customer and other requirements, and maintain the system's integrity when changes are planned and implemented. People need both useful information and controlled changes to keep work reliable.
What clause 5.7 requires in practice
Clause 5.7 places two duties on laboratory management. The first is to ensure communication takes place about how effective the management system is and why meeting customer and other requirements matters. The second is to maintain the integrity of the management system when changes to it are planned and carried out.
On the first duty, the standard names the topics but not the method, so a briefing, a controlled notice or a team meeting can all work provided people actually receive and understand the message. On the second, integrity means that controls stay in place during a transition: competence, authorisation, documents, equipment status and reporting must not have a gap while the change is under way.
The outputs are evidence that staff understand how well the system is working and why requirements matter, and evidence that planned changes were assessed and managed so that results stayed valid throughout.
Communicate what affects laboratory decisions
Explain significant performance issues, changed requirements and the actions expected from relevant personnel. Choose communication methods appropriate to the workforce, including remote or customer-site teams. A meeting, controlled notice or briefing can work; the clause does not prescribe a fixed meeting schedule or communication platform.
Communication about effectiveness should help staff understand whether arrangements are working. For example, recurring report corrections may indicate a review weakness rather than individual carelessness. Explain the decision and the revised responsibility, not just the number of errors. Connect messages with customer and other requirements so the reason for the change is clear.
Examine the system before changing one part
A method, facility, instrument, supplier or software change can affect several controls at once. Consider competence, authorisation, documents, equipment status, data handling and reporting. Plan responsibilities, verification and release so the revised arrangement does not leave a period in which necessary controls are absent.
A change log or impact checklist can help, but clause 5.7 does not demand a particular form. The requirement is maintaining system integrity during planning and implementation. Apply the detailed requirements of the relevant technical clauses as well; calling a project “approved” does not establish that its method or software is technically ready.
Why controlled change matters to the business
Changes are when laboratories are most exposed. A relocation, a new software release or a supplier switch can disturb several controls at once, and the errors that follow tend to surface in customer reports weeks later.
Communication matters just as much. Staff who understand why a requirement exists apply it with judgement, while staff who only receive a revised form may apply it mechanically or ignore it. Managing both well supports steady output, lowers the cost of rework and reassures customers who depend on continuity of service.
How to implement clause 5.7
Aim for proportionate arrangements that can be run by a small team as easily as by a large one.
- Decide how management will share information on system effectiveness, using channels that reach remote and customer-site staff.
- Explain performance information in terms of decisions, for example why recurring report corrections point to a review weakness.
- Create a simple impact check for changes covering competence, authorisation, documents, equipment, data handling and reporting.
- Assign an owner for each change who confirms that necessary technical checks are complete before the new arrangement is used.
- Plan how work in progress is handled during the switch and when the old process is retired.
- After the change, ask staff to explain the current process and check that forms, training and software agree.
- Look back at a completed change after a suitable interval and ask whether results, complaints or corrections suggest that any control was missed. Share what was learned with the people who will plan the next change.
Two illustrative change situations
A calibration laboratory moves to new premises. Management coordinates environmental suitability, equipment handling, verification before return to service, staff access to instructions and recognition-body requirements. It communicates when activities may resume instead of allowing the relocation timetable alone to determine technical readiness.
A testing laboratory changes its report-generation software. Technical staff review calculation and transfer risks, authorised personnel approve the change, and users receive clear instructions on the release date. The old and new systems are handled so results cannot be issued from an unapproved configuration. Relevant software controls under clause 7.11 still apply.
Evidence and common mistakes
Useful evidence may include change decisions, impact reviews, briefings and the technical checks required by affected clauses. Records should show that the transition worked, not merely that an announcement was sent. Check whether staff can explain the current process and what happened to work already in progress.
Avoid treating management-system integrity as an IT-only concept, excluding support departments from changes that affect them, or communicating after the new process is already in use. A procedure update that leaves forms, training and software inconsistent can create fresh errors while appearing administratively complete.
Frequently asked questions
Does clause 5.7 require a formal change board?
No. Use a proportionate arrangement that evaluates relevant effects, assigns responsibility and maintains effective controls through the change. The clause does not prescribe a board.
Is sending a revised procedure by email sufficient?
It may be one communication step, but consider whether recipients understand the change, have necessary competence and are using the correct version when work proceeds.
Does this apply only to major reorganisations?
No. Even a small change can affect result validity or control. Evaluate the effect of the change rather than using project size alone to decide whether attention is needed.
Turn this requirement into reliable laboratory practice
Sterling can help review a planned laboratory change before it disrupts technical controls. Bring the proposed change and affected workflow to a free consultation to define responsibilities, evidence and preparation needs.
Build the team's understanding through Documented Information Management. Discuss the relevant scope, employee learning and agreed access to Effivity ISO & GRC automation software with Sterling; laboratory technical decisions remain with competent, authorised personnel.
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