PECB ISO/IEC 17025 Lead Assessor flashcards

33 cards. Read the term and the definition here. The deck at the top of this page is optional.

Objective evidence

Verifiable data, records or statements of fact that support the existence or truth of something. In assessment it is the basis for every finding and must be traceable to its source.

Audit criteria

The set of policies, procedures, requirements or standards against which audit evidence is compared. In an ISO/IEC 17025 assessment the criteria include the standard and the laboratory's own documented system.

Major nonconformity

A nonconformity that significantly affects the validity of results or the integrity of the management system, or that shows a systemic failure of a requirement. It usually requires correction before accreditation is granted.

Minor nonconformity

An isolated or limited lapse in fulfilling a requirement that does not by itself invalidate results or indicate a systemic breakdown. It still requires root cause analysis and corrective action.

Metrological traceability

The property of a measurement result whereby it can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty.

Measurement uncertainty

A non-negative parameter characterizing the dispersion of quantity values attributed to a measurand, based on the measurement model and the information used. It must be evaluated and reported as required.

Decision rule

A documented rule that describes how measurement uncertainty is accounted for when stating conformity or nonconformity with a specification limit. It must be agreed with the customer and stated in the report.

Method validation

Confirmation by examination and provision of objective evidence that a method meets the requirements for its intended use. Required for non-standard, laboratory-developed or modified methods.

Proficiency testing

Evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons. Results are evidence of competence and must be reviewed within the assessment.

Impartiality

The presence of objectivity, meaning the laboratory is free from commercial, financial or other pressures that could adversely influence technical judgement. It is a structural and management requirement.

Confidentiality

The laboratory's obligation to protect information obtained or created during its activities. It must be managed by legally enforceable commitments and documented procedures.

Scope of accreditation

The specific tests, calibrations, methods and locations for which accreditation is granted. It is stated on the certificate schedule and must match the assessed competence.

Assessment plan

A description of the activities and arrangements for an assessment, including objectives, scope, criteria, dates, locations, team roles and schedule. It is communicated to the applicant in advance.

Opening meeting

A meeting at the start of the on-site assessment that confirms the plan, scope, criteria, team roles, confidentiality, safety arrangements and the process for reporting findings.

Closing meeting

A meeting at the end of the assessment where findings, the assessment conclusion and the corrective action timeline are presented, and the laboratory may ask questions.

Corrective action

Action taken to eliminate the cause of a nonconformity and prevent recurrence. It requires root cause analysis and evidence of implementation and effectiveness, not merely a stated intention.

Root cause analysis

A structured method for identifying the underlying reason a nonconformity occurred, distinguishing it from the immediate symptom. Its output drives the corrective action plan.

Internal audit programme

A documented set of planned internal audits covering all management system elements and laboratory activities over a defined cycle, with frequency based on risk and prior results.

Auditor independence

The principle that an auditor must not audit their own work or have a conflict of interest in the activity being assessed. Where full independence is impossible, cross-auditing or external auditors are used.

Management review

A formal review by top management of the management system's continuing suitability, adequacy and effectiveness, considering internal audit results, risks, complaints and improvement actions.

Document review

The pre-assessment examination of the applicant's manual, procedures, scope, method lists and records to confirm the management system is documented and ready for on-site assessment.

Witnessed activity

Direct observation by the assessor of a test, calibration or sampling activity in progress. It provides real-time evidence of conformity with methods and procedures.

Risk-based assessment

Allocation of assessment time and attention according to the likelihood and impact of failure, concentrating on new methods, new personnel, complex equipment and prior nonconformities.

Accreditation decision

The formal determination to grant, maintain, extend or withdraw accreditation, made by an independent decision-maker or committee based on the assessment report and corrective action evidence.

Surveillance assessment

A periodic assessment conducted between full reassessments to confirm continuing conformity with the accreditation criteria and to review changes since the last assessment.

Nonconforming work

Work that does not conform to the laboratory's procedures or the agreed customer requirements. It requires a documented procedure for stopping work, evaluating significance and authorizing resumption.

Equipment calibration programme

A planned schedule for calibrating and verifying equipment that affects results, with records of dates, results, uncertainty and maintenance, ensuring fitness for intended use.

Sampling plan

A documented plan describing how samples are taken, including the sampling method, quantities, locations and acceptance criteria, where sampling is part of the laboratory's activity.

Technical expert role

A specialist who provides technical knowledge to the assessment team but does not independently assess conformity or make findings; the assessor remains responsible for the finding.

Audit sampling

The risk-based selection of a subset of activities, records or locations for examination. It supports conclusions about the sampled evidence but does not guarantee full conformity.

Statement of conformity

A report statement that a result conforms or does not conform to a specification or standard. It requires a stated decision rule and consideration of measurement uncertainty.

Audit trail

The documented sequence linking a finding to its objective evidence, the requirement it violates, and the corrective action taken. It provides traceability for the accreditation decision.

Structural requirements

ISO/IEC 17025 clauses covering legal entity status, defined responsibility, documented scope of activities and arrangements for permanent, site and mobile locations.