ACCREDITATION FOR PRODUCTION OF REFERENCE MATERIALS
Laboratories in the chemical and microbiological areas use reference materials to ensure the traceability of the analyses.
A reference material is a material, which is sufficiently homogenous and stable with regards to one or more properties. It is a certified reference material if the reference material is characterized by having one or more properties are determined with associated uncertainty described in a concomitant certificate.
By analyzing the reference material, the laboratories can ensure that the model of analysis gives correct results.
DANAK accredits to production of referencematerials in accordance with DS/EN IS 17034:2016, General requirements for the competence of reference material producers.
Accreditation to production of reference materials is not yet included in mutual agreements in EA or ILAC, but the basis for a future MLA has been worked out and the final decision will be made at the EA MLA council meeting in april 2019.
If a laboratory which certifies reference materials also acts as accredited testing or calibration laboratory, assessment of these activities can be done jointly.
DANAK establishes the accreditation area by specifying the matrices/systems and/or parameters/components/quantities that the reference material consists of and/or is attributed to.
RULES AND REGULATIONS:
Below are links or references to documents for the specific scheme.
EXECUTIVE ORDERS
ACCREDITATION STANDARD
- DS/EN ISO/IEC 17025, 2nd edition. 2005-06-10 General requirements for the competence of testing and calibration laboratories in combination with
- ISO Guide 34:2009, General requirements for the competence of reference material producers.
ACCREDITATION REGULATIONS
- AB 1: General regulations for accreditation of companies
- AB 2: DANAK’s accreditation mark and reference to accreditation
- AB 5: Accreditation of companies to production of reference materials
- AB 11: Uncertainty of measurement in calibration
- AB 12: Estimation and reporting of uncertainty of measurement in testing in the mechanical, physical and electric area
- AB 13: Evaluation and reporting of uncertainty of measurement by quantitative chemical and microbiological testing
GUIDELINES
In addition to the requirement documents listed above testing laboratories must comply with, a large number of international guidelines relevant for accredited laboratories are implemented through the accreditation regulations:
- EA-4/02:2013: Evaluation of the Uncertainty of Measurement in Calibration
- EA-4/14:2003: The Selection and Use of Reference Materials.
- EA-4/18:2021: Guidance on the level and frequency of proficiency testing participation
- ILAC G17:01/2021: ILAC Guidelines for Measurement Uncertainty in Testing
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ILAC G24:2022: Guidelines for the determination of recalibration intervals of measuring equipment
Various accreditation messages (AML) have been published to guide and describe the assessment practice and issues relevant to laboratories certifying reference materials.
2. ACCREDITATION MESSAGES - LABORATORIES AML
- AML 02: Extend of accreditation scope
- AML 03: Use of computer systems in accredited laboratories
- AML 04: Processing non-conformities
- AML 07: Securing independence and impartiality
- AML 10: Surveillance of the general management system of multiple accreditations
- AML 17: Internal audit and management evaluation
- AML 18: Formulation of scope of accreditation
- AML 22: Submitting electronic management systems
- AML 23: Reference to DANAK and accreditation and specification of traceability
- AML 28: Calibration and control of measuring equipment
- AML 29: Change of location
ACCREDITATION MESSAGES - AMF
- AMF 04: Management of Non-compliances