ISO 17034 Certification

Clause 1 outlines the overall objective and application of the ISO 17034:2016 standard. This clause specifies the general requirements for organisations involved in the production of reference materials, ensuring these materials are created impartially and maintain high quality. Effectively, clause 1 sets the foundation for the standard, indicating its relevance to all reference material producers regardless of their sector or size.

Clause 2 lists essential documents that are critical for implementing the ISO 17034 standard. These normative references provide additional guidelines and standards that are integral to the proper application of ISO 17034, ensuring consistency and reliability in the production of reference materials.

Clause 3 provides clear definitions of key terms used throughout the standard. This ensures that all users have a uniform understanding of these terms, which is crucial for the consistent application of the standard’s requirements. Definitions include terms related to reference materials, production processes, and quality assurance.

Clause 4 focuses on maintaining impartiality and confidentiality during the production of reference materials, ultimately emphasising the importance of managing conflicts of interest and protecting sensitive information. This clause also addresses other fundamental ISO 17034 requirements such as legal status and liability, which are essential for upholding the integrity and trustworthiness of the reference material production process.

Clause 5 specifies the organisational structure necessary for producing reference materials. This clause details the roles, responsibilities, and authorities of personnel involved in the production process. The primary objective at this stage is to ensure that the organisation has a clear and effective structure that supports the competent production of reference materials, with defined responsibilities and communication channels.

Clause 6 of ISO 17034 outlines the requirements for personnel, facilities, equipment, and subcontracting needed to produce high-quality reference materials. This clause specifies the qualifications and training necessary for personnel, as well as the standards for facilities and equipment. Additionally, it addresses the crucial aspect of subcontracting, detailing the requirements for selecting, evaluating, and monitoring subcontractors involved in the production process. Clause 6 ensures that the organisation has the appropriate resources and partnerships to produce reliable and accurate reference materials.

Clause 7 outlines the detailed processes required for producing reference materials. This includes planning, production, characterisation, and documentation, all of which must be carried out under controlled conditions with clear, documented procedures. The clause specifies the methods for characterising reference materials, assessing their homogeneity and stability, and ensuring thorough documentation and traceability. It also covers the important requirements for assigning property values and their associated uncertainties, a key element in producing high-quality reference materials. Meeting these requirements is essential for achieving ISO 17034 accreditation.

Clause 8 details the management system practices necessary for controlling and improving the processes involved in producing reference materials. It includes requirements for quality management systems, internal audits, management reviews, and corrective actions. This clause ensures that the organisation implements a systematic approach to managing its processes, fostering continual improvement and compliance with the ISO 17034 standard requirements.