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

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 
  • 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

ACCREDITATION MESSAGES - AMF