ISO 17034

ISO 17034 General requirements for the qualification 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 evaluation of laboratory proficiency.

Demonstration of scientific and technical competence of reference material producers (CRMs) is a fundamental requirement to ensure the quality of  RMs. The demand for new higher quality RMs is increasing as a result of both the improved precision of measurement equipment and the need for more accurate and reliable data in scientific and technological disciplines. RMPs are required not only to provide information about their materials in the form of RM documentation, but also to demonstrate their competence in producing RMs of appropriate quality.

The ISO 17034 standard outlines general requirements for RM manufacturers, including certified reference materials (CRMs). It supersedes ISO Guide 34:2009 and complies with the relevant requirements of ISO/IEC 17025. Further guidance (for example, regarding the content of certificates and the design of characterization, homogeneity and stability studies) is given in ISO Guide 31 and ISO Guide 35. Although the approaches outlined in ISO Guide 31 and ISO Guide 35 meet the relevant requirements of the ISO 17034 Standard, there may be alternative ways to comply with the ISO 17034 Standard.

CRMs that comply with this International Standard will also generally operate in accordance with ISO 9001 principles. For tests performed in the medical field, ISO 15189 can be used as a reference instead of ISO/IEC 17025.

Information about the Scope of ISO 17034 Standard Training

ISO 17034 The standard is an international standard developed to ensure the competence and consistent work of reference material manufacturers. Reference materials produced in accordance with this standard are used in many areas such as calibration of measuring devices, verification of measurement methods and interlaboratory comparisons.

ISO 17034 standard trainingaims to convey to participants all the knowledge and skills required by this standard. The following topics are generally included in the training:

• General structure and purpose of the standard: Detailed information is given about the history of the standard, its scope, intended users and its relationship with other standards.
• Importance and types of reference materials: Topics such as the role of reference materials in measurement processes, different types of reference materials and their properties, production and certification of reference materials are discussed.
• Basic requirements of the standard: Detailed explanations are made about the general qualification requirements, quality system, technical requirements and personnel qualifications determined by the standard.
• Reference material production process: Issues such as production stages of reference materials, material selection, homogeneity and stability studies, and measurement uncertainty calculations are emphasized.
• Certificate preparation and publication: Topics such as the content of reference material certificates, calculation and presentation of certificate data, and certificate validity are addressed.
• Internal audits and management reviews: Information is given about the internal audits and management review processes required by the standard.
• Accreditation process: Information is given about the conformity assessment and accreditation process to the ISO 17034 standard.

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

Skills to be Gained at the End of Training:

• Understanding the ISO 17034 standard and terminology
• Managing reference material production processes
• Creating and developing a quality system
• Making measurement uncertainty calculations
• Certificate preparation and publication
• Conducting internal audits and management reviews

Training Types:

ISO 17034 standard training is generally provided in the following formats:

• Open trainings: These are mass trainings held on certain dates and places.
• Closed trainings: These are trainings prepared specifically for the customer and given within the company.
• Online trainings: These are trainings that can be followed live or recorded over the internet.

Training Duration:

Although the training duration varies depending on the content and scope of the training, it generally lasts between 1-3 days.

Document Given at the End of Training:

Participants in the training are given a certificate of participation or certificate by the educational institution.