ACCREDITATION FOR 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-4/18:2010: Guidance on the level and frequency of proficiency testing participation
- ILAC G17:01/2021: ILAC Guidelines for Measurement Uncertainty in Testing
- ILAC G-24:2007: ILAC Guidelines for the determination of calibration intervals of measuring instruments
ACCREDITATION MESSAGES (ONLY IN DANISH)
1. ACCREDITATION MESSAGES - GENEREL AMF
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