ISO 17034-2016 PDF
Name in English:
St ISO 17034-2016
Name in Russian:
Ст ISO 17034-2016
Original standard ISO 17034-2016 in PDF full version. Additional info + preview on request
Full title and description
ISO 17034:2016 — General requirements for the competence of reference material producers. This International Standard specifies the general requirements that a reference material producer (RMP) must meet to demonstrate competence and ensure consistent production and management of reference materials (including certified reference materials).
Abstract
ISO 17034:2016 establishes requirements for the competence, impartiality and consistent operation of producers of reference materials. It covers planning, production, characterization, value assignment, homogeneity and stability assessment, traceability, quality assurance and documentation necessary for both non‑certified and certified reference materials. The standard aligns requirements with the ISO/IEC 17000 series and replaces ISO Guide 34:2009.
General information
- Status: Published / Current (confirmed at review).
- Publication date: Edition 1 — November 2016 (ISO 17034:2016).
- Publisher: International Organization for Standardization (ISO).
- ICS / categories: 03.120.20 (Reference materials).
- Edition / version: Edition 1, ISO 17034:2016.
- Number of pages: 24 (ISO published version).
Scope
ISO 17034:2016 applies to organizations that produce reference materials (RMs) and sets out requirements for demonstrating their competence to produce RMs with defined properties and stated uncertainty and traceability where applicable. It covers planning and production processes, measurement and characterization activities, statistical assessment of homogeneity and stability, documentation, quality management aspects and additional requirements where RMs are certified. The standard is intended to be used alongside other conformity assessment standards (for example ISO/IEC 17025) and to support accreditation of RMPs.
Key topics and requirements
- Management and organizational requirements to ensure impartiality and competence (policy, control of records, personnel competence).
- Production planning and control for reference material manufacture and handling.
- Procedures for characterization and value assignment, including estimation and reporting of measurement uncertainty.
- Assessment of homogeneity and stability (experimental design, statistical evaluation, acceptance criteria).
- Traceability of property values to SI units or other accepted references where applicable.
- Documentation and metadata for RMs: certificates, instructions for use, and accompanying information.
- Quality assurance, corrective actions, and continuous improvement processes.
- Additional requirements specific to certified reference materials (CRMs) versus non‑certified RMs.
Typical use and users
Used by reference material producers (industrial, academic and governmental laboratories), national metrology institutes, accreditation bodies assessing RMP competence, testing and calibration laboratories that rely on RMs for quality control, and regulators who reference or require accredited RMPs. It is also used by quality managers and technical staff responsible for RM production, characterization and distribution.
Related standards
Commonly used alongside and referenced with: ISO/IEC 17025 (competence of testing and calibration laboratories), ISO/IEC 17043 (proficiency testing), ISO Guide 31 (reference materials — contents of certificates), and other ISO Guides and ILAC/EA accreditation documents. ISO 17034:2016 superseded ISO Guide 34:2009.
Keywords
reference material, certified reference material, CRM, reference material producer, RMP, traceability, homogeneity, stability, characterization, uncertainty, accreditation, ISO 17034.
FAQ
Q: What is this standard?
A: ISO 17034:2016 is an International Standard that specifies general requirements for the competence and consistent operation of reference material producers (RMPs).
Q: What does it cover?
A: It covers organizational and technical requirements for planning and producing reference materials, methods for characterization and value assignment, evaluation of homogeneity and stability, traceability, documentation and quality assurance, and additional requirements for certified reference materials.
Q: Who typically uses it?
A: Reference material producers, national metrology institutes, accreditation bodies, testing and calibration laboratories, regulators and quality managers involved in RM production or use.
Q: Is it current or superseded?
A: ISO 17034:2016 is the published International Standard (Edition 1, 2016). The ISO record notes the publication was reviewed and confirmed (status maintained) in a subsequent review (2022), so the 2016 edition remains current. It superseded ISO Guide 34:2009.
Q: Is it part of a series?
A: It is aligned with the ISO/IEC 17000 family of conformity assessment standards and is commonly used together with ISO/IEC 17025 and ISO/IEC 17043 and relevant ISO Guides concerning reference materials.
Q: What are the key keywords?
A: Reference material, certified reference material (CRM), reference material producer (RMP), traceability, homogeneity, stability, characterization, uncertainty, accreditation, competence.