Biolab: an assessor with a prior training role and a major finding built on three records
An accreditation body is conducting a surveillance assessment of Biolab, a medical laboratory performing haematology, clinical chemistry and microbiology. The lead assessor has one and a half days on site with one technical assessor, Marco, who six months earlier delivered a two-day paid training course on ISO/IEC 17025:2017 to Biolab's quality team; the course included a gap analysis of Biolab's draft documentation. The plan is to cover clauses 6, 7 and 8 using a checklist, to interview one senior technician, and to review three technical records from the chemistry bench. In all three records the raw instrument traces and the analyst worksheet are missing; only the final result is in the laboratory information system. The lead assessor drafts a major nonconformity against 7.5 and is preparing to close the assessment. The quality manager objects: the microbiology bench keeps complete paper worksheets and she can produce them on the spot, and she says one and a half days was too short for the assessment to be representative.
1. How should the lead assessor deal with Marco's prior involvement, and what distinguishes acceptable training from disqualifying consultancy?
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The judgment turns on what Marco actually did, not on how the event was invoiced. ISO/IEC 17011 requires assessment personnel to be independent of the activity assessed and free from undue pressure, and accreditation bodies treat consultancy - designing, implementing or advising on a management system - as disqualifying for a defined period set in their own procedures, commonly two years. Purely informational training may be acceptable if the body's rules allow it, because it does not create an adviser relationship with the specific system under assessment.
Here the course was not purely informational: the gap analysis of Biolab's draft documentation is advice on how to close compliance gaps. That is functionally consultancy, and it also gave Marco detailed prior knowledge of the laboratory's weaknesses, which creates both a self-review threat (he may assess his own advice) and a familiarity threat.
Action: the lead assessor should not simply proceed. The decision on whether Marco can remain belongs to the accreditation body's impartiality function, based on its documented rules, not to the laboratory and not to the lead assessor alone. Depending on those rules, either Marco is replaced, or his role is restricted to clauses he did not advise on with a second assessor covering the rest, and the risk assessment and justification are recorded in the assessment file. The lead assessor's non-delegable duty is to identify the situation, escalate it in writing, and check for other relationships such as prospective work for Biolab. Proceeding silently creates a challengeable assessment regardless of how good the findings are.
2. Is a major nonconformity against 7.5 supportable on three chemistry records when the laboratory can immediately produce complete microbiology worksheets? Explain the reasoning and what the assessor should do before closing.
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Two separate questions must be kept apart: whether a requirement has been breached, and how far the failure extends and how serious it is. Only the second determines major versus minor.
On breach: 7.5 requires technical records for each laboratory activity to contain the results, the report and sufficient information to identify factors affecting the measurement and to permit re-testing or re-calculation, including original observations, data and calculations. If only final values exist in the information system, that is prima facie a breach.
On extent: three records show that a practice exists on that bench. They do not establish that the practice is systemic across the laboratory. The quality manager's microbiology worksheets are precisely the sample that must be examined - refusing them while grading the finding as systemic would be indefensible. The assessor should widen the sample across benches, shifts, analysts and analysers; check whether raw traces exist elsewhere (instrument PCs, middleware, audit trails); read the laboratory's own record-control procedure to establish the criterion the laboratory set for itself; and ask whether results can be reconstructed or verified.
Major is defensible where the failure is systemic, where the validity of reported results is in doubt, or where the management system has failed in a way that defeats its intended purpose. Minor is appropriate for an isolated lapse within a system that otherwise controls records. On the available evidence neither conclusion is safe.
Before closing, the lead assessor should verify, then grade, then write the finding to reflect the verified scope. Closing on three records, with contrary evidence offered and unexamined, invites a successful appeal and discredits the assessment as a whole.
3. How should the lead assessor handle the objection at the closing meeting, including the claim that the assessment was too short?
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Factually and on the record. The assessor presents the requirement, the evidence (which records, which bench, which people, when), and the finding as written. The laboratory presents counter-evidence. If the counter-evidence changes the facts, the finding is amended - that is accuracy, not weakness. What must not happen is that the finding is bargained down to preserve the relationship.
The report should state the sampling basis so the reader can see what the finding rests on. The complaint about duration should be recorded verbatim. Separately, the lead assessor should review internally whether the time allocation was adequate, because ISO/IEC 17011 expects the accreditation body to allocate sufficient time and resources for an effective assessment, and a legitimate time shortfall is the body's problem, not the laboratory's.
After the closing meeting: the laboratory's right to complain about the assessment and to appeal the decision, with the body's appeal mechanism described; and the separation between the assessment team and the accreditation decision-maker. If the laboratory alleges bias or incompetence, that is a matter for the body's impartiality arrangements, not a matter to be argued by the lead assessor.
The one thing the assessor must not accept is a verbal assurance that resolves a finding without evidence. If the quality manager says complete worksheets exist, the assessor asks to see them, examines them, records what was seen, and adjusts the finding wording accordingly.