ISO 17025 gap analysis: what Sterling examines in your laboratory, what you receive and what happens next

Readiness check, gap analysis and pre-assessment: three different exercises

The readiness check is Sterling's free online tool that returns a score and first priorities from your own answers. In the gap analysis, Sterling's consultants examine the evidence themselves. The pre-assessment, where offered, is the accreditation body's informal visit before its initial assessment.

What the gap analysis examines

Findings are organised under the five requirement clauses of ISO/IEC 17025:2017 and then broken down by method, because accreditation is granted for a defined list of tests or calibrations, not for the laboratory as a whole.

Governance and structure (clauses 4 and 5)

Whether risks to impartiality have been identified and acted on; how customer information is kept confidential; and whether the range of laboratory activities you intend to claim is written down and matches what you actually do.

Resources (clause 6)

Competence requirements and authorisations for each person on each method; the environmental conditions the methods need and whether they are monitored; the equipment register, calibration programmes and intermediate checks; the chain of calibration certificates that links each result to the SI; and how providers of calibration, reference materials and proficiency testing are selected and evaluated.

Processes (clause 7)

This is usually the longest part. For each method we look at contract review and any decision rule for statements of conformity, whether a standard method has been verified or a laboratory-developed or modified method validated, sampling where you sample, item handling, technical records, uncertainty evaluation, the monitoring that ensures valid results, proficiency testing, report content, complaints, nonconforming work and control of data in spreadsheets and information systems.

Management system (clause 8)

Whether you intend Option A or Option B, and then document and record control, risks and opportunities, improvement, corrective action, internal audit and management review.

How the evidence is gathered

The approach is an audit, with one addition that management system reviews lack: we watch the work.

1. Desk review. You send the draft scope, the method list, the equipment register, a few calibration certificates, any validation files and recent reports.
2. Opening meeting. Management confirms the intended scope, who needs the accredited results and any date driving the project.
3. Observing tests or calibrations. Analysts perform selected methods as they normally would. We compare what they do with the written method and ask how they know the result is right.
4. Tracing results back. We take issued reports and follow each back through the technical record: sample receipt, the analyst, the equipment and its calibration status, the environmental conditions, the raw data and any calculation.
5. Sampling of records. Samples are small and deliberate, spread across methods, analysts, shifts and sites, and include the difficult cases: a failed quality control run, a complaint, a retest.
6. Closing meeting. Preliminary findings are discussed before the report is written, so nothing in it comes as a surprise.

Findings describe the system and the methods, never individual analysts, so people talk openly about how the bench really works.

What you receive

A gap report, by clause and by method

For each requirement area, the report states what is in place and working, what exists but is incomplete or not followed, and what is missing, with the evidence we saw. A method matrix sets every method in the intended scope against the technical requirements: verification or validation, uncertainty, traceability, competence and authorisation, quality control and proficiency testing.

A prioritised action plan

Every gap becomes an action with an owner, a due date and the resources it needs. The items whose evidence takes longest to accumulate come first: calibrations from accredited providers, validation work, uncertainty budgets and enrolment in proficiency testing rounds, whose dates the provider sets. Decisions only management can take, such as dropping a weak method from the first application or buying a reference standard, are listed separately.

An effort and timeline estimate

The time your technical and quality staff will need, the share of the work Sterling carries under each route, the technical spend to plan for without figures attached, and a realistic month for application. A first accreditation typically takes six to twelve months; the ISO/IEC 17025 timeline guide explains what moves that range, and the cost guide explains what moves the investment.

Who needs to be in the room, and for how long

Times are typical for a single-site laboratory with a focused scope.

Fieldwork length depends mainly on the number of methods in scope and the disciplines they span; each further site adds time. Gap analyses that underestimate the work usually discussed methods in an office instead of watching them at the bench.

What happens next: Design™ or Drive™

Once the plan is agreed, the route is chosen. Both routes follow Sterling OS™ and differ in how much of the build Sterling carries.

• Design™, guided implementation. Your staff do the work with Sterling's templates, workshops and coaching. It suits laboratories with a capable quality manager and time for validation work.
• Drive™, fully managed implementation. Sterling's consultants carry the agreed work alongside your technical managers, who keep ownership of their methods and of the experimental data. It suits a heavy workload or a fixed deadline.

Management system records and plan milestones run in Effivity, included with the engagement at no additional cost; technical records stay in the laboratory's own systems and are linked as evidence. The ISO/IEC 17025 implementation plan follows the project from here.

What a gap analysis is not

• Not an assessment. There is no grant, no refusal and no schedule of accreditation; only the accreditation body decides, after document review, on-site assessment and witnessing.
• Not the readiness check. The online tool reflects your answers; the gap analysis reflects the evidence.
• Not method validation. It identifies which methods need verification or validation and what is missing; the work itself is covered in the method verification and validation guide.
• Not your internal audit. ISO/IEC 17025 requires your own audits of a running system, set out in the internal audit guide.
• Not a document-writing exercise. It tells you which procedures and records each method genuinely needs; the documentation guide lists what is required.

ISO 17025 gap analysis: questions buyers ask