Lead-Assessor Training for ISO/IEC 17025

Assessing a laboratory is different from auditing a management system. The assessor must judge whether methods are valid, uncertainty is realistic, traceability is secure and staff are competent, and must witness work being done. Many assessors are strong on the quality management clauses but less confident in technical areas, while others are strong technically but have not been taught how to plan an assessment, sample evidence, write findings and lead a team.

This programme combines both skills. It starts with the requirements of ISO/IEC 17025:2017 and the accreditation framework, moves through planning and preparing an assessment, assessing the technical requirements through witnessing and record review, writing and grading findings, and leading the team through reporting, recommendation and follow-up.

Built on recognised practice. The programme references ISO/IEC 17025:2017, ISO/IEC 17011:2017 on requirements for accreditation bodies, ISO 19011 guidelines for auditing, ILAC policies on metrological traceability, measurement uncertainty and proficiency testing participation, the JCGM Guide to the Expression of Uncertainty in Measurement and ISO/IEC 17043 for proficiency testing. It explains how accreditation bodies use these documents, without representing any particular body.

Decisions this programme improves. How to scope and plan an assessment; which tests or calibrations to witness; how much evidence is needed on validation, uncertainty and traceability; whether a finding is a nonconformity and how serious it is; whether corrective actions are adequate; and what recommendation to make on the laboratory's scope.

How it is delivered. Twenty hours across five sessions, built around one running case: a testing laboratory applying for an extended scope. Participants review its documents, plan the assessment, assess a validation file and an uncertainty budget, role-play a witnessing interview, write findings and present conclusions at a closing meeting.

In-house option. For organisations, the programme can be adapted for accreditation bodies, regulators, laboratory networks or groups of laboratories that run internal or peer assessments, using your own procedures and forms.

Who Should Attend

Assessors and prospective assessors working with accreditation bodies or regulators

Laboratory managers, technical managers and quality managers

Internal auditors in testing and calibration laboratories

Consultants supporting laboratories through accreditation

Staff of laboratory networks running peer or group assessments

Objectives

Interpret the requirements of ISO/IEC 17025:2017 from an assessor's perspective

Explain the accreditation process and the requirements that ISO/IEC 17011 places on assessors and accreditation bodies

Plan an assessment, including document review, scope, team and witnessing schedule

Assess method validation and verification evidence

Evaluate measurement uncertainty estimates and metrological traceability

Review quality control and proficiency testing performance

Conduct witnessing and interviews to judge staff competence

Write clear, evidence-based findings and grade their significance

Lead an assessment team and manage opening and closing meetings

Evaluate corrective action responses and prepare a scope recommendation

Course Outline

ISO/IEC 17025 and the Accreditation Framework

Purpose of accreditation and the ILAC arrangement
Structure and intent of ISO/IEC 17025:2017
ISO/IEC 17011 and the role of accreditation bodies
Scopes of accreditation: fixed and flexible
Assessor competence, impartiality and ethics
Differences between assessment and management system audit

Planning and Preparing the Assessment

Types of assessment: initial, surveillance, reassessment and extension
Document review and readiness judgement
Assessment plan, team roles and time allocation
Selecting activities for witnessing
Sampling of records and evidence
Remote assessment techniques

Assessing the Technical Requirements

Personnel competence and authorisation
Equipment, calibration and metrological traceability
Method selection, verification and validation
Measurement uncertainty and decision rules
Assuring the validity of results: quality control and proficiency testing
Sampling, handling of items and reporting of results

Assessing the Management System and Gathering Evidence

Impartiality, confidentiality and risk management
Control of data, records and information management systems
Complaints, nonconforming work and corrective action
Internal audit and management review
Witnessing techniques and interviewing staff
Evaluating evidence objectively

Findings, Reporting and Leading the Team

Writing nonconformity statements that are clear and traceable
Grading findings and deciding on observations
Team meetings and consensus on conclusions
Opening and closing meetings: handling disagreement
Assessment report and scope recommendation
Reviewing corrective action and closing findings
Continuing development as a lead assessor

Competencies

Interpretation of ISO/IEC 17025 for assessment

Accreditation process and assessor roles

Assessment planning and witnessing selection

Evaluation of method validation

Evaluation of measurement uncertainty and traceability

Quality control and proficiency testing review

Finding writing and grading

Assessment team leadership

Corrective action evaluation and scope recommendation

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