ISO 17034 requirements explained: video brief

Five clauses, shared with ISO/IEC 17025

ISO 17034 has five requirement clauses, 4 to 8, in the sequence it shares with ISO/IEC 17025, its only normative reference. Clause 7 carries most of the weight, with sub-clauses that follow a material from the production plan to the customer. Requirements for reference materials come first, the additional ones for certified reference materials follow, and Annex A summarises which apply to each. This short film walks through the structure.

Clause 4 covers general requirements: reviewing each request, tender or contract, including subcontracted work; safeguarding impartiality and identifying risks to it on an ongoing basis, with top management commitment; and keeping information confidential. Clause 5 covers structural requirements, and clause 6 covers resources: personnel, subcontracting, provision of equipment, services and supplies, and facilities and environmental conditions.

The production process in clause 7

Clause 7 sets the technical and production requirements, following a material from the production plan to the customer: production planning and the processing and preparation of the material; measurements made in-house or by controlled subcontractors; assessment of homogeneity; assessment and monitoring of stability; characterisation; assignment of property values and their uncertainties; metrological traceability of certified values; the reference material documents and labels that travel with each material; distribution; and the control of nonconforming work and complaints. Clause 8 sets the management system requirements.

ISO 17034 distinguishes two products: a reference material, sufficiently homogeneous and stable for the properties specified, and a certified reference material, whose values come with uncertainties and metrological traceability. ISO 17034:2016 replaced ISO Guide 34:2009. Accreditation is granted by an accreditation body for a defined scope of materials, properties and value ranges, then maintained through surveillance and reassessment.

Processing, homogeneity and stability testing and characterisation can be subcontracted to providers evaluated on evidence of competence, but production planning, the selection of subcontractors, the assignment of property values and their uncertainties, and their authorisation stay with the producer. ISO/IEC 17025 is the only normative reference, so measurements must meet its relevant requirements, although laboratory accreditation is not a condition of producer accreditation.