PD ISO Guide 34:2009 General requirements for the competence of reference material producers
Accurate measurements are important for a number of reasons. For example, they are needed to detect dangerous amounts of toxins in food, to diagnose diseases, and to check whether a sample of steel is strong enough for safely constructing a building. These measurements can only be done when the measurement instruments being used have been calibrated correctly. Materials that can be used for instrument calibration are needed, and are known as “reference materials”.
Vital decisions often depend on measurements such as those mentioned above, confidence is required in the measurement data. As a result, the measurement procedures must also be controlled by using reference materials similar to the material to be tested, and for which the measured value is already known. This means labs are able to verify their ability to measure accurately.
ISO Guide 34 ensures reference material producers are competent to manufacture their products to a given quality. It covers all the elements of ISO/IEC 17025 and some additional ones for production, storage and distribution (ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling). This is particularly important with complex materials such as seawater, soil, and clay where traceability, homogeneity and stability are not necessarily inherent characteristics of the product.
The United Kingdon Accreditation Service (UKAS) operate an accreditation scheme to ISO Guide 34, and UKAS-accredited testing laboratories should be using either ISO Guide 34 or ISO 17025 accredited certified reference materials wherever possible.
Once UKAS accredit a lab with ISO Guide 34 , the reference material producer has the competency to manufacture CRM’s, and have the authority to self-certify these products. Therefore, more products can be offered under this scheme so long as they are manufactured in accordance with the Guide. In addition newly accredited products require less administration by the accrediting body so can be brought to market in a shorter time-scale.
The use of reference materials enables the transfer of the values of measured or assigned properties between testing and measurement laboratories. Such materials are widely used, e.g. for the calibration of measuring equipment and for the evaluation or validation of measurement procedures.
There are an increasing number of reference material producers, and a demonstration of their scientific and technical competence is nowadays a basic requirement for ensuring the quality of reference materials. The demand for new reference materials of higher quality is increasing because of both the increased precision of measuring equipment and the requirement for more accurate and reliable data in the scientific and technological disciplines. Some previously acceptable reference materials may not meet these more stringent requirements anymore. It is, therefore, not only necessary for reference material producers to provide information about their materials in the form of reports, certificates and statements, but also to demonstrate their competence in producing reference materials of appropriate quality.
PD ISO Guide 34 sets out the management system requirements in accordance with which reference materials shall be produced. It is to be used as part of a reference material producer's general quality assurance (QA) procedures.
PD ISO Guide 34 covers the production of certified and non-certified reference materials. For non-certified reference materials, the production requirements are less stringent than for certified reference materials. The minimum requirements for the production of non-certified reference materials are specified throughout the Guide.
PD ISO Guide 34 is not to be used as the basis for conformity assessment by certification bodies.
Who should use PD ISO Guide 34?
- Reference material producers
- Administrative and technical operators
- Reference material customers
- Regulatory authorities
- Accreditation bodies
This Published Document is the UK implementation of ISO Guide 34:2009. It replaces PD 6532-5:2000, which is now withdrawn.
Contents of PD ISO Guide 34 include:
- Normative references
- Terms and definitions
- Organization and management requirements
- Management system requirements
- Organization and management
- Document and information control
- Request, tender and contract reviews
- Use of subcontractors
- Procurement of services and supplies
- Customer service
- Control of non-conforming work and/or reference materials
- Corrective actions
- Preventive actions
- Internal audits
- Management reviews
- Technical and production requirements
- Production planning
- Production control
- Accommodation and environmental conditions
- Material handling and storage
- Material processing
- Measurement methods
- Measuring equipment
- Data evaluation 5.12 Metrological traceability
- Assessment of homogeneity
- Assessment of stability
- Assignment of property values and their uncertainties
- Certificates or documentation for users
- Distribution service
- Metrological traceability of certified property values of reference materials
- Commutability of reference materials
- ISO/IEC 17025/ISO Guide 34 cross-reference table
Relevant publications in the area include:
ISO Guide 30 Revision of definitions for reference material and certified reference material
BS EN ISO/IEC 17025 Competence of Testing and Calibration Laboratories
ISO 17025 was written to incorporate all the ISO 9001 requirements that are relevant to the scope of testing and calibration services as well as specifying the technical requirements for technical competence.
ISO Guide 34 (in conjunction with ISO/IEC 17025) is the definitive standard for reference material production used by accreditation bodies (such as UKAS) and the CIPM* world-wide. It describes the fundamental quality system and technical requirements to produce reference materials (RMs) and certified reference materials (CRMs) at the highest level. ISO Guide 34 is supported by ISO Guides 30, 31, 33 and 35. These guides are used as references to ISO Guide 34, and these all should be read in conjunction with each other.
UKAS operate an accreditation scheme to ISO Guide 34, and UKAS-accredited testing laboratories should be using either ISO Guide 34 or ISO 17025 accredited certified reference materials wherever possible. Once UKAS accredit a lab with ISO Guide 34, the reference material producer is competent to manufacture CRM’s, and is able self-certify these products. Therefore, more products can be offered under this scheme so long as they are manufactured in accordance with the Guide. In addition newly accredited products require less administration by the accrediting body so can be brought to market in a shorter time-scale.