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Next year, a new version of ISO/IEC 17025 will be published, which is going to mean changes for all those involved in quality systems. Peter Jenks investigates.
Peter Jenks looks back to the BERM 14 conference on biological and environmental reference materials in the Quality Matters Column. The next conference in the series returns to Europe: Berlin in June 2018.
In the Quality Matters Column, Peter Jenks, Paul Boother and Annette Marshall are concerned about “The proper use of certified reference materials for analytical instrumentation qualification”. There are many aspects to consider in ensuring the validity of an analytical system, from before any instrumentation is installed, before it is used and during its use. Readers interested in the chemicals and reference material field may be interested in the news that, as this issue was being prepared, Merck completed its $17-billion acquisition of Sigma-Aldrich.
John Hammond updates us on “Reference materials: what’s new?”. The 2015 meeting of the ISO Committee on Reference Materials (ISO/REMCO) was held in June and significant developments in a number of standards that will ultimately affect all users of reference materials have taken place.
John Hammond and Chris Burgess are also in the middle of a multi-part contribution to the Quality Matters column. “…that’s what I thought you said?” looks at further misundertandings in terminologies surrounding Reference Materials, and sets the record straight.
In the Quality Matters Column, Peter Jenks wants to clarify “What is a ‘Primary Standard’?”.
John Hammond reports on important developments at the ISO Committee on Reference Materials (ISO/REMCO) annual meeting.
Peter Jenks and John Hammond describe how the important ISO 17025 standard has developed, and point out that a review for the third edition of the standard will start soon. All those with an interest in quality standads—an increasing number of us—should make sure their voice is heard at their local standards body.
Peter Jenks and John Hammond continue their series on “CRMs and PT in an ISO 17025 accredited laboratory” with instructions on how you can prepare your own in-house certified reference materials.
Certified reference materials and proficiency testing in an ISO 17025 accredited laboratory. Part one: Defining the role
Peter Jenks looks at some current trends in the supply of CRMs and proficiency testing and highlights difficulties labs may have been when no commercial CRM is available. This will be followed with a second part looking at the production of in-house reference materials.
A new product line of analytical standards and reagents consisting of an initial portfolio of more than 200 pre-formulated reference materials and reagents for the scientific laboratory, the hallmark of which is absolute traceability.
Solvent-less standards used for calibration of GC retention indices, MS ion masses and target compound concentrations. The standards contain 13 compounds specifically customised for calibration and performance validation of the TRIDION GC-TMS.
Designed for use with US Pharmacopeia 232 testing for elemental impurities in pharmaceutical and nutraceutical compounds, the kit contains two USP standards, UPS-TXM1A and TXM1B which are not available separately.
An extension of their metal-on-quartz neutral density filters for the NIR produced under ISO/IEC 17025 and ISO Guide 34. This CRM is protected from oxidation, physical degradation and contamination by the use of a novel cover plate optically bonded to the surface providing extended lifetimes. Starna now also offer a range of solid state glass filters between 1% and 92% T in compliance with USP 〈1119〉 NIR protocols.
A range of neutral density filter certified reference materials which have been manufactured and produced within the Starna ISO/IEC 1702 and ISO Guide accreditation. In a format as per SRM 2013a, which is no longer available from NIST, the filter’s metallic surface, used to define the transmission characteristics, is overlaid by an optically bonded coverplate, protecting the reactive optical surface from oxidation, contamination or physical degradation.
Peter Jenks gains new respect for microbiologists and learns that the way they approach analytical quality control is different from chemists.
Chris Burgess and John Hammond respond to Peter Jenks' thoughts in the last issue's Quality Matters Column. Please join in the debate and add your comments at the end of the article.
The reasoning behind strict compliance to an ISO Standard is logical, but the consequences can be commercially questionable, if not unsound. Peter Jenks, and many other scientists, are starting to question the commercial viability of all this regulation. What is your opinion?
Peter Jenks is concerned at the lack of mutual help available on the Internet within the field of analytical chemistry. Other fields, outside science, have strong communities where enthusiasts give freely of their advice and time; why not in analytical chemistry? Please tell us your views by adding a comment to this column article.
Sigma-Aldrich has acquired the assets of Resource Technology Corporation (RTC) of Laramie, Wyoming, USA, manufacturer of analytical standards and certified reference materials. The acquisition of RTC's business complements Sigma-Aldrich's recently completed acquisition of Cerilliant.