Background Knowledge on Accreditation & StandardsTuesday, August 10, 2021
On the occasion of the first anniversary of our quality management system, we have started a series of news articles on the topic of quality management & reference materials. This is the second article in the series and it is about ISO Standards and the importance of an accreditation.
In setting up our quality management system, we have not only followed our internal quality standards, but also international guidelines and standards. These standards make it possible to ensure that all reference materials worldwide are manufactured according to uniform and comparable specifications and meet the basic quality requirements. This has enabled us to benefit from the knowledge and experience that various companies and institutions have contributed to the preparation of these standards.
This gives us the opportunity to be accredited as a reference material producer. The confirmation by an independent body can create confidence towards customers and investors. In Germany, the Deutsche Akkreditierungsstelle (DAkkS), the national accreditation body of the Federal Republic of Germany, is responsible for accreditation. In contrast, certification is only carried out by a conformity assessment body which has also previously been accredited by DAkkS. This means that, in addition to conformity, accreditation also demonstrates the competence to carry out certifications oneself. In our case, it is about the competence to certify reference materials. Achieving accreditation is an extensive process that can take several years and, once successful, it is regularly monitored and reviewed by DAkkS.
The demonstration of the scientific and technical competence of reference material producers (RMPs) is a basic requirement for ensuring the quality of RMs. The demand for new RMs of higher quality is increasing as a consequence of both the improved precision of measuring equipment and the requirement for more accurate and reliable data in the scientific and technological disciplines. It is not only necessary for RMPs to provide information about their materials in the form of RM documents, but also to demonstrate their competence in producing RMs of appropriate quality.DIN EN ISO 17034:2017-04, General requirements for the competence of reference material producers
The standard to which reference material manufacturers are accredited is ISO 17034. This document was written by the International Organization for Standardization (ISO), one of the largest and best-known authors of standards and guidelines. This non-governmental organization is an association of national standardization bodies. Germany is represented by Deutsches Institut für Normung (DIN).
As a DIN member, we are part of the DIN Standards Committee for reference materials, represented by Simon Nordstad. This allows us to participate in international standardization work. The committee ensures that the standards are state of the art and in line with scientific findings and corresponds to other German Standards. This also means that we, the myStandards GmbH, are always up to date.
In addition to the revision of ISO 17034, the committee is also responsible for ISO Guides 30 to 35, which complement the ISO Standard. These ISO Guides are documents that provide advice to meet the requirements of the ISO 17034. In general, ISO 17034 outlines the general requirements for reference material producers from contractual matters to technical and production requirements to management system requirements. To fulfill the management system requirements, it is almost inevitable to have a quality management system.
The best-known standard in this area is ISO 9001, which defines the general requirements for a quality management system. More than one million companies worldwide adhere to this standard. The concept of ISO 9001 employs the process approach and incorporates risk-based thinking. By implementing this system, we have standardized our work processes and are now able to maintain our level of performance on a sustained basis, respond to changes and exploit new opportunities.
Since a quality management system based on the guidelines of ISO 9001 can also meet the requirements of ISO 17034, we have used ISO 9001 as a basis to set up our own individual quality management system.
Then we adapted our quality management system even further to meet the more extensive requirements for reference material producers according to ISO 17034. Compliance with the standards thus leads to the highest level of quality. By achieving accreditation, our customers can be even more certain in the future that the product they receive is of excellent quality and manufactured according current standards.
More articles from our series on the quality management system: