Internal Auditing to ISO/IEC 17025

Testing and calibration laboratories often treat internal audit as a documentation check before the accreditation assessment. The audit confirms that procedures and records exist, but does not witness testing, trace a result back to its calibration and reference materials, or challenge how measurement uncertainty and decision rules were applied. Auditors may be colleagues from the same section, which weakens independence, and findings are closed without evidence that the cause was removed.

This programme builds competence in both the standard and the audit process. It starts with the structure and intent of ISO/IEC 17025:2017, moves to planning an audit programme across the laboratory's activities, then to vertical, horizontal and witness audits, recording evidence, and managing nonconformities, risks and corrective action. The focus is on the technical requirements that decide whether results are valid, as well as the management system around them.

Built on recognised practice. The programme references ISO/IEC 17025:2017, the auditing guidance in ISO 19011, ILAC policy on metrological traceability (ILAC P10) and ILAC guidance on decision rules and statements of conformity (ILAC G8), and the JCGM Guide to the Expression of Uncertainty in Measurement (GUM). Participants should also refer to the specific requirements of their own national accreditation body.

What this changes in practice. Which tests, methods and sections to audit and how often; when to witness an activity rather than review records; whether a method has been validated or verified adequately; whether a nonconforming result requires recall of reports to customers; and what the laboratory manager should take into management review.

How it is delivered. Twenty hours across five sessions, built around one running case: a laboratory that performs both testing and calibration and has received a customer complaint about a reported result. Participants plan a vertical audit, trace the result through records, review uncertainty and decision rule evidence, write findings and assess corrective actions.

In-house option. For organisations, the programme can be tailored to your own methods, quality manual and audit forms, and to the requirements of your accreditation body, with a supervised practice audit in your laboratory where possible.

Who Should Attend

Quality staff: laboratory quality managers and quality officers

Internal auditor candidates from testing and calibration laboratories

Laboratory managers and technical managers responsible for results and methods

Senior analysts and technicians who maintain methods, equipment and records

Second-party auditors who assess external or subcontracted laboratories

Objectives

Explain the structure and key requirements of ISO/IEC 17025:2017, including general, structural, resource, process and management system requirements

Apply the principles of auditing and plan an internal audit programme that covers all laboratory activities

Conduct vertical, horizontal and witness audits and choose between them

Audit impartiality, confidentiality and the management of risks and opportunities

Assess personnel competence records, equipment calibration and metrological traceability

Evaluate evidence of method selection, validation and verification

Review how measurement uncertainty is evaluated and how decision rules are applied to statements of conformity

Audit the assurance of validity of results, including quality control data and proficiency testing

Write clear nonconformity statements and evaluate corrective actions for effectiveness

Report audit results in a form that supports management review

Course Outline

ISO/IEC 17025: Structure, Intent and Laboratory Risk

Purpose of the standard and its relationship with ISO 9001
General requirements: impartiality and confidentiality
Structural requirements and laboratory scope
Risk-based thinking and management system options A and B
The role of accreditation bodies and their specific requirements

Planning and Preparing Laboratory Audits

Auditing principles, auditor competence and independence
Building an audit programme across methods, sections and sites
Vertical, horizontal and witness audits
Reviewing documents, records and previous findings before the audit
Audit plans and technical checklists
Remote review of electronic records and LIMS data

Auditing Resources: People, Equipment and Traceability

Competence, training, supervision and authorisation of personnel
Facilities and environmental conditions
Equipment calibration, intermediate checks and reference materials
Metrological traceability and ILAC P10
Externally provided products and services, including subcontracted tests

Auditing Technical Processes and Validity of Results

Review of requests, tenders and contracts
Method selection, verification and validation
Sampling and handling of test or calibration items
Evaluation of measurement uncertainty
Decision rules and statements of conformity (ILAC G8)
Quality control, proficiency testing and interlaboratory comparisons
Reporting of results and control of data and information management

Findings, Nonconforming Work and Improvement

Objective evidence and writing nonconformity statements
Nonconforming work and its impact on reported results
Complaints and their use as audit input
Root cause analysis and corrective action effectiveness
Audit reports and closing meetings
Internal audit results in management review
Action plan: improving the internal audit process in your laboratory

Competencies

ISO/IEC 17025:2017 requirements and their interpretation

Laboratory audit programme planning

Vertical, horizontal and witness audit techniques

Metrological traceability and calibration review

Method validation and verification review

Measurement uncertainty and decision rule evaluation

Assurance of validity of results

Nonconforming work and corrective action review

Laboratory audit reporting

Kuwait

Train in Kuwait City with access to Elite Academy’s full portfolio of professional programs. In a city known as a key Gulf business and government center with an established professional environment, organizations and professionals can join upcoming courses or request any program to be arranged locally. Professional training in Kuwait City is not limited to a specific group of subjects. Elite Academy makes its complete portfolio available in the city across management, business, technical and industry-focused disciplines. With a key Gulf business and government center with an established professional environment, Kuwait City provides an effective setting for international learning. Use the schedule below to view courses already planned for the destination, or contact our team to request another program and preferred dates in Kuwait City, subject to scheduling and delivery requirements.