Skip to main content

Advertisement

SpringerLink
Log in

A Review of Metrological Supervision: Towards the Common Understanding of Metrological Traceability in Legal and Industrial Metrology

  • Review Paper
  • Published:
MAPAN Aims and scope Submit manuscript

Abstract

Metrology, standardisation, and conformity assessment are used by businesses to optimise production quality, monitoring, and control of production processes. Accreditation, traceability assurance, and metrological supervision are closely related, and all these elements are integral parts of quality infrastructure. Their effective implementation supports sustainable development and social welfare, and facilitates trade. The concept of metrological traceability is also important for fundamental and applied research when results from various systems and obtained in different laboratories are compared. The accredited institutions meet established standards and are competent to carry out different conformity assessment tasks, such as testing, inspection, or certification. These institutions work in the field of ensuring the uniformity of measurements in various industrial areas, and will also perform type approval and verification procedures in legal metrology to confirm the compliance of measuring instruments with metrological requirements. This review paper presents a comprehensive analysis of metrological supervision procedures that enable deeper understanding and highlights the differences in legal and industrial metrology, ensuring reliable results for solving measurement traceability problems.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5

Similar content being viewed by others

References

  1. Three pillars of sustainable development: metrology, standardization and conformity assessment. International Organization for Standardization, (2006) 4.

  2. Sustainable development & the future of quality infrastructure. the United Nations Industrial Development Organization (UNIDO) under the overall supervision and guidance of Mr. Bernardo Calzadilla-Sarmiento, PhD, Director of the Department of Trade, Investment and Innovation (TII) (2019) 68.

  3. Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (recast). Applicable from 20 April 2016. OJ L 96, 29 March 2014.

  4. Commission implementing regulation (EU) 2016/799 of 18 March 2016 implementing Regulation (EU) No 165/2014 of the European Parliament and of the Council laying down the requirements for the construction, testing, installation, operation and repair of tachographs and their components. Official Journal of the European Union, L 139/1 (2016) 506.

  5. Commission regulation (eu) no 601/2012 of 21 June 2012 on the monitoring and reporting of greenhouse gas emissions pursuant to Directive 2003/87/EC of the European Parliament and of the Council. Official Journal of the European Union, L181/30 (2012) 75.

  6. ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories. ISO/CASCO Committee on conformity assessment, (2018) 30.

  7. ISO/IEC 17065:2012 Conformity assessment — Requirements for bodies certifying products, processes and services. ISO/CASCO Committee on conformity assessment, (2014) 27.

  8. ILAC P10:01/2013. ILAC Policy on the Traceability of Measurement Results. International Laboratory Accreditation Cooperation, (2013) 10.

  9. EA 4/07 rev 01:1995 Traceability of measuring and test equipment to national standards. European accreditation, (1995) 16.

  10. P102 – A2LA Policy on Metrological Traceability. American Association for Laboratory Accreditation, p. 26, Document Revised: June 9, 2016.

  11. International vocabulary of metrology- Basic and General Concepts and associated terms (VIM 3rd edition) JCGM 200: 2012.

  12. National Metrological Infrastructure. Joint Guide 1. The edition by APLMF/APMP under the MEDEA project, (2016) 48.

  13. Hubert W. Vesper, Linda M. Thienpont, Traceability in Laboratory Medicine, Clinical Chemistry 55:6 (2009) 1067–1075.

  14. Graham H White, Metrological traceability in clinical biochemistry. Review Article, Ann Clin Biochem; 48 (2011) 393–409,

  15. OIML D9: 2004 (E). Principles of metrological supervision. OIML TC 3/SC 2 Metrological supervision (2004) 17.

  16. OIML D1: 2012(E). Considerations for a Law on Metrology. OIML TC 3 Metrological control, (2012) 54.

  17. EA-1/23: EA policy to speak with “One Voice”. European accreditation, (2019) 8.

  18. Ulrich Harmes-Liedtke. Quality infrastructure for development. Posted on April 19, 2020.

  19. ISO/IEC 17020:2012 Conformity assessment — Requirements for the operation of various types of bodies performing inspection. ISO/CASCO Committee on conformity assessment, (2012) 18.

  20. Joint ILAC-OIML Assessment Procedure in the field of legal metrology. OIML, (2018) 9.

  21. OIML D 30: Guide for the application of ISO/IEC 17025 to the assessment of Testing Laboratories involved in legal metrology, 2008.

  22. Guidelines of the Assessment and Reporting of Compliance with Specification,” ILAC-G8:1996, International Laboratory Accreditation Cooperation, 1996.

  23. Guidelines on the Calibration of Digital Multimeters. Calibration Guide EURAMET/cg-15/v.01, European Association of National Metrology Institutes, July 2007.

  24. S.D. Phillips, W.T. Estler, T. Doiron, K.R. Eberhardt and M.S. Levenson, A Careful Consideration of the Calibration Concept. J. Res. Natl. Inst. Stand. Technol., 106 (2001) 371–379.

    Article  Google Scholar 

  25. Michael C Dobbert, Robert M Stern, Rui Villela Ferreira, A Pragmatic Method for Pass/Fail Conformance Reporting that Complies with ANSI/NCSL Z540.3, ISO/IEC 17025, and ILAC-G8, IMEKO-TC4–2011–054 (2011) 4.

  26. The Accredited Calibration Certificate for Laboratory Balances. Overview, Definitions, Information. Sartorius Lab Instruments GmbH & Co. KG, (2011) 12.

  27. L.R. Pendrill, Using Measurement Uncertainty in Decision-Making and Conformity Assessment. Metrologia, 5 (2014) 206–218.

    Article  Google Scholar 

  28. C. J. van Leeuwen, T. G. Vermeire, Risk Assessment of Chemicals: An Introduction, Springer (2007) 673.

  29. JCGM 106: 2012 Evaluation of measurement data – The role of measurement uncertainty in conformity assessment. JCGM, (2012) 57.

  30. L.R. Pendrill, Optimised Measurement Uncertaint y and Decision-Making in Conformity Assessment. MEASURE NCSLI, 2 (2016) 76–86.

    Article  Google Scholar 

  31. OIMLG19: The role of measurement uncertainty in conformity assessment decisions in legal metrology. OIML TC 3/SC 5, (2017) 72.

  32. K. D. Sommer, S. E. Chappell, M. Kochsiek, Calibration and verification: Two procedures having comparable objectives and results, OIML bulletin, volume XLII Nr.1 (2001) 8.

  33. S. K. Kimothi, The uncertainty of measurements: physical and chemical metrology: impact and analysis, American Society for Quality (2002) 425.

  34. Del Caldwell, Requirements for the Calibration of Measuring and Test Equipment, ANSI/NCSL Z540.3:2006 (2016) 26–30.

  35. EA-4/02 • Evaluationof the Uncertainty of Measurement in Calibration. EA Laboratory Committee, (2013) 75.

  36. Ignacio Lira and Wolfgang Wöger, Evaluation of the Uncertainty Associated with a Measurement Result not Corrected for Systematic Effects. Measurement Science and Technology, 9 (1999) 1010–1011.

    Article  ADS  Google Scholar 

  37. Klaus- Dieter Sommer, Manfred Kochsiek, Uncertainty role of measurement uncertainty in deciding conformance in legal metrology, OIML bulletin, volume XLIII Nr 2, 2002.

  38. Hakan Kallgren, Margreet Lauwaars, Bertil Magnusson, Leslie Pendrill, Phillip Taylor, Role of measurement uncertainty in conformity assessment in legal metrology and trade, Accred Qual Assur, No. 8 (2003) 541–547.

  39. Isabel Taverniers, Erik Van Bockstaele, Marc De Loose, Trends in quality in the analytical laboratory. I. Traceability and measurement uncertainty of analytical results, Trends in Analytical Chemistry, vol. 23, no. 7 (2004) 480–490.

  40. EURACHEM / CITAC Guide. Guide to Quality in Analytical Chemistry. An Aid to Accreditation. Third Edition. QAC, (2016) 59.

  41. ORA-LAB.5.4.5 Food and drug administration office of regulatory affairs ORA Laboratory Manual Volume II. Methods, Method Verification and Validation Sections in This Document, (2020) 1–32.

  42. Serkan Levent, Umut Beskan, Evren Algin Yapar, An Overview of Analytical Method Development in Pharmaceutical Product Analysis, Türk Farmakope Dergisi 4(1) (2019) 44-61.

  43. Elvar Theodorsson, Validation and Verification of Measurement Methods in Clinical Chemistry. Bioanalysis, 4 (2012) 305–320.

    Article  Google Scholar 

  44. Muhammad T. Abdel Ghafar, Muhammad I. El-Masry, Verification of quantitative analytical methods in medical laboratories, J Med Biochem 39 (2020) 1-12.

  45. Panchumarthy Ravisankar, Ch. Naga Navya, D. Pravallika, D. Navya Sri., A Review on Step-by-Step Analytical Method Validation, IOSR Journal Of Pharmacy, vol 5, Issue 10 (2015) 07–19.

  46. How to Meet ISO 17025 Requirements for Method Verification. ALACC Guide. The Scientific Association Dedicated to Analytical Excellence, (2007) 18.

  47. B. Magnusson, U. Örnemark (eds.), Eurachem Guide: The Fitness for Purpose of Analytical Methods – A Laboratory Guide to Method Validation and Related Topics, Second ed. (2014) 62.

  48. Technical Note 17 — June 2012. Guidelines for the validation and verification of quantitative and qualitative test methods. NATA (2012) 32.

  49. Guideline. Comparators & Comparisons: Direct and indirect comparisons. Eunethta, (2014) 34.

  50. Metrology in Industry: The key for quality/ edited by French college of metrology. ISTE Ltd, (2006) 271.

  51. Manuela Schulze. Methods verification. Transfer of validated methods into laboratories working routine. Available: https://docplayer.net/20820796-Methods-verification-transfer-of-validated-methods-into-laboratories-working-routine-dr-manuela-schulze-1.html

Download references

Author information

Authors and Affiliations

  1. Institute of Metrology, Kaunas University of Technology, Studentu str. 50-454, 44029, Kaunas, Lithuania

    Asta Meškuotienė, Justina Dobilienė & Edita Raudienė

  2. Department of Legal Metrology of Lithuanian Metrology Inspectorate, A. Gostauto str. 9, 01101, Vilnius, Lithuania

    Lilijana Gaidamovičiūtė

Authors
  1. Asta Meškuotienė
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Justina Dobilienė
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Edita Raudienė
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Lilijana Gaidamovičiūtė
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Edita Raudienė.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Springer Nature or its licensor holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Meškuotienė, A., Dobilienė, J., Raudienė, E. et al. A Review of Metrological Supervision: Towards the Common Understanding of Metrological Traceability in Legal and Industrial Metrology. MAPAN 37, 693–701 (2022). https://doi.org/10.1007/s12647-022-00594-x

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12647-022-00594-x

Keywords

Search

Navigation