26
and ISO/IEC 17025 for ‘the related laboratory activities’ in 2006, the first UK reference material supplier to be accredited to both standards. In November 2016 the standard was revised again, by the ISO Committee on Conformity Assessment (CASCO), in collaboration with the ISO Committee on Reference Materials (REMCO) to become ISO 17034 [13]. One of the reasons for this transition was to allow a Mutual Recognition Agreement (MRA) to be signed, whereby laboratory inspections and assessments made by the regulatory authorities in one country will be recognised by another.
ISO 9001 [14] – This family of standards is a general quality management tool. While producers accredited to ISO/IEC 17025 will also satisfy the requirements of ISO 9001, conformity to ISO 9001 does not of itself demonstrate the competence of the laboratory to produce technically valid data and results.
Conclusions
ISO Guide 25 or ISO/IEC 17025 – ISO Guide 25 was first published in 1990 [10] and describes “General requirements for the competence of calibration and testing laboratories”. It replaced EN 45001:1989, “General criteria for the operation of testing laboratories”. In 1999 it was revised to become ISO 17025 [11], which was again revised in 2005 and at the time of writing is being revised again. It is the gold standard against which any calibration laboratory is judged, so accreditation to this standard is a prerequisite for a reference material producer. Accreditation is granted and periodically re-assessed by a competent third party, normally the national accreditation body, in the case of the UK the UK Accreditation Service, UKAS. A very important aspect of a Calibration Laboratory’s accreditation is its Scope. This defines the types of material and the measurements that the laboratory is entitled to perform. A laboratory could claim to be ‘accredited to ISO 17025’ on the strength of just one measurement process, so users should check the proposed supplier’s Schedule of Accreditation to satisfy themselves that it includes the reference materials they propose to purchase. Recently, is has become possible for laboratories to extend their accreditation to allow calibrations to be performed that are not specifically listed in the existing Scope, providing that:
• The method, procedure or standard does not introduce new principles of measurement.
• The method, procedure or standard does not require measurements to be made outside the parametric boundaries defined in the Schedule.
This flexibility allows laboratories to calibrate references to customer requirements, giving them, within their sphere of competence, virtually the same authority as an NMI. Starna Scientific was accredited to ISO/IEC 17025 in 2001 and the associated Scope extended to cover the above protocol in May 2017.
ISO Guide 34 or ISO/IEC 17034. ‘General requirements for the competence of reference material producers’. Like ISO/IEC 17025, this standard, first published in 1999 [12], has undergone revisions, in 2000 and 2009. In 2004 the International Laboratory Accreditation Cooperation (ILAC) resolved that reference material producers should be accredited to this standard, in combination with ISO/IEC 17025, and ISO/ REMCO, the ISO Committee on Reference Materials, decided in 2005 to revise ISO Guide 34 to align it more closely with ISO/IEC 17025. This has caused some confusion, as it is sometimes thought that accreditation to ISO Guide 34 or ISO 17034 alone is sufficient for a producer to claim CRM status for its products, but as the standard states that “the reference material producer shall meet the requirements of ISO/IEC 17025 with respect to tests, calibrations and measurements…...” CRM producers should therefore be accredited to both standards. Starna Scientific was accredited to ISO Guide 34
Commercial suppliers, working closely with regulatory authorities and NMIs, have greatly expanded the range of reference materials available for the qualification of UV/Visible & NIR spectro(photo) meters, among the most widely used tools in analytical chemistry. An evolving system of accreditation gives users confidence in the CRMs they purchase provided care is exercised in the choice of supplier. The continuing evolution of these ISO 17xxx (where xxx = 025, 034, and 043) series standards now allows suitably accredited suppliers to extend their calibration services to include a wide range of additional reference materials not within their normal catalogue, and to expand the function, and format of these materials to cover the ever- expanding range of instrumentation which fundamentally has optical spectroscopy as its primary analytical measurement technique.
References
1. “Good Laboratory Practices (GLP) for Non-Clinical Laboratory Studies” Code of Federal Regulations, 21 CFR Part 58, USA. 2. “OECD Principles of Good Laboratory Practice” – (1998), OECD Environmental Health and Safety Publications. OECD. 1.
3. “ Harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances.” (2004) EC Directive 2004/10/EC 11. 4. ‘The development and application of guidance on Equipment Qualification of analytical instruments’ – (1996)
P.Bedson
et.al., Accred Qual Assur 1:265-274. 5. “<857> Ultraviolet-Visible Spectroscopy”, (2015), USP 38, United States Pharmacopeia, Rockville, USA. 6. “Technical Specifications for Certification of Spectrophotometric NTRMs”, (2000), NIST SP260-140, National Institute of Standards and Technology, Gaithersburg, MD. USA.
7. “International vocabulary of metrology - Basic and general concepts and associated terms (VIM)” (2007), ISO/IEC Guide 99.
8. “Reference materials - Selected terms and definitions” (2015), International Organization for Standardization (ISO), Geneva, Switzerland. 9. “Challenges in providing standard reference materials for chemical and pharmaceutical process analysis”, (1999), J. C. Travis, et. al., Anal. Chem. Acta 380, p.115 – 126.
10. ISO Guide 25 “General requirements for the competence of calibration and testing laboratories”, (1990), International Organization for Standardization (ISO), Geneva, Switzerland.
11. ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories”, (2005), International Organization for Standardization (ISO), Geneva, Switzerland.
12. ISO Guide 34, “General requirements for the competence of reference material producers”, (1999), International Organization for Standardization (ISO) Geneva, Switzerland.
13. ISO 17034, “General requirements for the competence of reference material producers”, (2016), International Organization for Standardization (ISO), Geneva, Switzerland.
14. ISO 9001, “Quality Management” (2015), International Organization for Standardization (ISO), Geneva, Switzerland.
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120 |
Page 121 |
Page 122 |
Page 123 |
Page 124 |
Page 125 |
Page 126 |
Page 127 |
Page 128
