Laboratory Technical Management to ISO/IEC 17025

Most difficulties in ISO/IEC 17025 laboratories are technical, not administrative. Methods are verified once and never revisited, uncertainty budgets omit the largest contributors, calibration intervals are set by habit, proficiency testing results are filed rather than analysed, and decision rules for statements of conformity are not agreed with customers. Technical managers are often promoted specialists who have not been shown how to manage these risks across a whole laboratory.

This programme looks at the laboratory through the eyes of the person responsible for the validity of its results. It moves from the structure and risk-based logic of the standard and the roles of technical and quality management, through competence, equipment and traceability, method selection and validation, measurement uncertainty and decision rules, to assuring the validity of results and using data to improve.

Built on recognised practice. The programme references ISO/IEC 17025:2017, ILAC policies on metrological traceability and on measurement uncertainty in testing, the ILAC G8 guidelines on decision rules and statements of conformity, the Guide to the Expression of Uncertainty in Measurement (JCGM 100), the International Vocabulary of Metrology (VIM), Eurachem guidance on method validation and measurement uncertainty, and ISO/IEC 17043 for proficiency testing. Participants apply them to real laboratory situations.

Decisions this programme improves. Whether a method is fit for its intended use; how much validation or verification is enough; which uncertainty contributions matter; how calibration intervals should be set; which decision rule to agree with a customer; how to respond to an unsatisfactory proficiency test result; and when nonconforming work should stop reporting.

How it is delivered. Twenty hours across five sessions, built around one running case: a testing laboratory preparing to extend its scope with a new method. Participants plan the validation, build a simple uncertainty budget in a spreadsheet, set a decision rule, review quality control and proficiency data, and handle a nonconforming result.

In-house option. For organisations, the programme can use your own methods, uncertainty budgets, quality control data and recent assessment findings, and can be delivered to technical and quality staff together.

Who Should Attend

Technical managers and deputies in testing and calibration laboratories

Quality managers responsible for ISO/IEC 17025 management systems

Laboratory heads and section supervisors responsible for methods and results

Senior analysts and metrologists preparing to take on technical management roles

Laboratories seeking accreditation or scope extension in industry, utilities, health, environment and government

Objectives

Explain the structure and risk-based approach of ISO/IEC 17025:2017 and the responsibilities of technical and quality management

Define competence requirements, authorisation and monitoring for laboratory staff

Manage equipment, calibration and intermediate checks to secure metrological traceability

Select, verify and validate methods and document fitness for intended use

Build and review a measurement uncertainty budget for a test or calibration

Agree and apply decision rules for statements of conformity

Design a programme to monitor the validity of results using quality control and proficiency testing data

Investigate nonconforming work and complaints and apply root cause analysis

Use technical records, audits and management review to drive technical improvement

Prepare the laboratory technically for assessment and scope extension

Course Outline

Technical Management in the ISO/IEC 17025 Framework

Structure of ISO/IEC 17025:2017 and its process approach
Impartiality, confidentiality and risk-based thinking
Roles of technical management and quality management
Management system options and links with ISO 9001
Customer requirements and review of requests, tenders and contracts
What assessors look for in technical areas

People, Equipment and Metrological Traceability

Competence criteria, training, authorisation and monitoring
Facilities and environmental conditions
Equipment selection, calibration programmes and intermediate checks
Setting and reviewing calibration intervals
Metrological traceability and reference materials
Externally provided products and services

Methods: Selection, Verification and Validation

Standard, non-standard and laboratory-developed methods
Verification versus validation: when each applies
Performance characteristics: selectivity, precision, trueness, limits and range
Planning and reporting a validation study
Method changes and revalidation
Sampling and handling of test items

Measurement Uncertainty and Decision Rules

GUM principles and the VIM vocabulary
Identifying and quantifying uncertainty contributions
Top-down approaches using validation and quality control data
Building and reviewing an uncertainty budget
Decision rules, guard bands and statements of conformity
Reporting results, opinions and interpretations

Assuring Valid Results and Improving the Laboratory

Monitoring validity: control charts, replicates, blanks and reference materials
Proficiency testing and interlaboratory comparisons: evaluating z-scores and acting on results
Nonconforming work, complaints and corrective action
Control of data, technical records and information management systems
Internal audit and management review of technical performance
Preparing for assessment and scope extension
Technical improvement plan for your laboratory

Competencies

Technical management under ISO/IEC 17025

Staff competence and authorisation

Calibration management and metrological traceability

Method verification and validation

Measurement uncertainty estimation

Decision rules and statements of conformity

Quality control and proficiency testing evaluation

Nonconforming work and corrective action

Assessment readiness and scope extension

Roma

Elite Academy can deliver its complete portfolio of professional training programs in Rome. With a major European capital combining government, business and international institutions, the destination suits both scheduled learning and tailored arrangements for organizations or individual professionals. As an Elite Academy training destination, Rome provides access to our full portfolio rather than a city-specific set of specializations. The city is a major European capital combining government, business and international institutions, creating a suitable environment for organizations developing their teams and for professionals attending independently. Upcoming scheduled courses are listed on this page, while any other Elite Academy program can also be requested for delivery in Rome, subject to scheduling and delivery requirements. Explore the schedule or browse our training areas to find the right option.