Why should your Reference Materials come from an accredited supplier?
In order to demonstrate regulatory compliance, laboratories are required to qualify their instruments against internationally recognised reference materials. These test samples must be prepared to exacting standards and often involve the use of toxic, flammable or otherwise hazardous materials. Pre-calibrated and certified commercially available Certified Reference Materials (CRMs) therefore offer by far the most convenient route to regulatory compliance. In order to demonstrate compliance, however, prospective users of these materials must ensure that they are sourced from an accredited supplier and therefore have been produced and calibrated in a controlled environment
What International Standards must be met to achieve accreditation?
Historically, producers of CRMs have used either ISO/IEC 17025 or ISO 17034 (formerly ISO Guide 34) to control their production processes. There is considerable overlap between the two standards, but essentially ISO/IEC 17025 is mainly concerned with the technical competence and procedures of the supplier’s calibration laboratory, whereas ISO 17034 is more concerned with organisational and production control systems. Today, however, accreditation to ISO 17034:2016 alone is accepted as this standard includes normative references to ISO/IEC 17025, so that certification measurements must still be performed in an ISO 17025 controlled environment.
Does my supplier have the right accreditation?
Users are advised to always check that the scope of a supplier’s accreditation includes the references they intend to purchase. Suppliers can claim accreditation to the above standards on the basis of a single product, and references not included in the published scope of their accreditation may not be recognized for instrument qualification purposes by regulatory bodies. Accreditation is granted by the appropriate national body: in the case of Starna this is the United Kingdom Accreditation Service (UKAS). The accreditation covers not only the products, but also the value range over which a given parameter (e.g. absorbance) may be certified and the degree of uncertainty to be expected in the certified values.
What is the scope of Starna’s accreditations?
Starna Scientific was accredited to ISO/IEC 17025 in 2001 and to ISO 17034 (formerly ISO Guide 34) in 2006. Added to this, over forty five years’ experience in the production of both glass filters and heat sealed liquid reference materials give Starna unrivalled expertise in the production of spectroscopy CRMs covering wavelengths from the Deep UV to the Mid-infrared.
ISO 17025 Accreditation Certificate 0659 (UKAS) ISO 17025 Accreditation Schedule 0659 (UKAS)
ISO 17034 Accreditation Certificate 4001 (UKAS) ISO 17034 Accreditation Schedule 4001 (UKAS)
Certified Quality Management System
Starna's Quality Management System (QMS) holds accredited certification to the International Standard ISO 9001:2015 Quality management systems, and is audited and certified by the British Standards Institution (BSI).
ISO 9001 Accredited Certificate FM 39003 (BSI)