ISO 17034 General Requirements for the Competence of Reference Material Producers

Scope of ISO 17034 Standard

Reference materials (RMs) are used in all stages of the measurement process, including method validation, calibration, and quality control. They are also used in interlaboratory comparisons for method validation and laboratory competence evaluation.

Demonstrating the scientific and technical competence of reference material producers (CRMs) is a fundamental requirement to ensure the quality of RMs. The growing demand for higher-quality new RMs is a result of both the advanced precision of measuring equipment and the need for more accurate and reliable data in scientific and technological disciplines. RMPs are required not only to provide information on RMs in the form of RM certificates but also to demonstrate their competence in producing RM materials of appropriate quality.

The ISO 17034 standard summarizes the general requirements for RM producers, including certified reference materials (CRMs). It replaces ISO Guide 34:2009 and is in compliance with the relevant requirements of ISO/IEC 17025. Further guidance (e.g., on the content of certificates, characterization, and the design of homogeneity and stability studies) is provided in ISO Guide 31 and ISO Guide 35. While the approaches outlined in ISO Guide 31 and ISO Guide 35 meet the relevant requirements of ISO 17034, they may offer alternative ways to comply with the ISO 17034 standard.

CRMs compliant with this international standard generally operate according to the principles of ISO 9001. For medical testing, ISO 15189 may be used as a reference instead of ISO/IEC 17025.

ISO 17034 Standard Training Scope Information

The ISO 17034 standard is an international standard developed to ensure the competence and consistent operation of reference material producers. Reference materials produced in compliance with this standard are used in various areas, such as calibration of measuring devices, validation of measurement methods, and interlaboratory comparisons.

ISO 17034 standard training aims to transfer all the knowledge and skills required by this standard to participants. The training typically covers the following topics:

• General Structure and Purpose of the Standard: Detailed information is provided on the history, scope, target users, and the relationship with other standards.
• Importance and Types of Reference Materials: The role of reference materials in measurement processes, different types and characteristics of reference materials, production and certification of reference materials.
• Key Requirements of the Standard: Detailed explanations of the general competency requirements set by the standard, quality system, technical requirements, and staff competencies.
• Reference Material Production Process: Focus on the production stages of reference materials, material selection, homogeneity and stability studies, and measurement uncertainty calculations.
• Certificate Preparation and Issuance: Discussion on the content of reference material certificates, calculation and presentation of certificate data, and certificate validity.
• Internal Audits and Management Reviews: Information on internal audits and management review processes required by the standard.
• Accreditation Process: Information on the assessment of compliance with ISO 17034 and the accreditation process.

With ISO 17034 standard training, participants will acquire all the knowledge and skills required by the standard and become more competent in reference material production. This training is of great importance, especially for employees of organizations that are reference material producers or wish to become reference material producers, quality managers, laboratory technicians, and other relevant personnel.

Skills Acquired at the End of the Training:

• Understanding ISO 17034 standard and its terminology
• Managing reference material production processes
• Creating and improving quality systems
• Performing measurement uncertainty calculations
• Preparing and issuing certificates
• Conducting internal audits and management reviews

Types of Training:

ISO 17034 standard training is typically offered in the following formats:

• Open Training: Group training sessions held at specific dates and locations.
• Closed Training: Custom-designed training sessions held on-site for a specific client.
• Online Training: Training sessions that can be attended live or recorded over the internet.

Training Duration:

The training duration typically ranges from 1 to 3 days, depending on the content and scope of the training.

Certificate Issued at the End of the Training:

Participants will receive a certificate of participation or an official certificate issued by the training institution.