According the the CDC Vaccine Guideline, pages 38 – 41, http://www.cdc.gov/vaccines/recs/storage/toolkit/storage-handling-toolkit.pdf:
Thermometer calibration must be tested annually or according to the manufacturer’s recommendation by a laboratory with accreditation from an International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) signatory body. Laboratories that have attained this accreditation meet the requirements for traceability.
Often this is confusing for those requiring NIST certification in the realmn of biopharmaceuticals and vaccine storage. Metrology labs say ISO17025 but not ILAC MRA usually, so what does that mean? A quick history lesson is useful to understand the importance of ISO17025 and ILAC on your NIST Certification.
The introduction of ‘interchangeable parts’ was a logic-based manufacturing technique and concept in the dawn of the Industrial Revolution. The main goal: Coordination of production techniques to make all ‘pieces’ fit together equally, wherein any assortment of parts (given the parts form a complete set) from any production line can be fitted together to create/repair the product or device. This development, along with the assembly line, jumpstarted the idea of streamlining massive distribution networks for consumer and industrial products in the United States.
Still, interchangeable parts were the precursor to the concept of trade globalization. In today’s world, we still struggle with standardization in the pursuit of a true “globalized marketplace”. For this purpose, a large number of committees and governing bodies exist to promote the “one size fits all” approach for a variety of standards, qualifications and certifications worldwide. The difficulty in ‘global standardization’ is obvious (much less national standardization), but there are a number of excellent examples in today’s market that represent progressive steps in worldwide adoption of technical qualifications and scientific standards.
One of these governing bodies, the ILAC (International Laboratory Accreditation Cooperation) is tasked with developing “international cooperation for facilitating trade by promotion of the acceptance of accredited test and calibration results”. A number of international organizations are under the ILAC umbrella with the same standardization goals for laboratory accreditation. These include, but are not limited to, the European Accreditation Cooperation (EA), the Inter-AmericanAccreditation Cooperation (IAAC), and the Asia Pacific Laboratory Accreditation Cooperation. All of these organizations, under the ILAC initiative, attempt to push standardization of laboratory accreditation techniques and practices for global markets. Without these initiatives, for example, laboratory certifications in Japan may not be accepted, applicable, or recognized in a different country such as South Africa. ILAC attempts to solve the globalization standardization problem, as “An essential pre-requisite of trade is that any product or service is accepted formally in one economy, must also be free to circulate in other economies without having to undergo extensive re-testing”.
More specifically, ISO 17025 defined as “General requirements for the competence of testing and calibration laboratories” is the main ISO standard used by testing and calibration laboratories. There are two main requirements for ISO 17025 certification. The first is management requirements, which can be defined as the operation and effectiveness of a quality management system in a laboratory. The second requirement is defined as “technical”, and includes:
-Competence of Staff
-Equipment and Measurement Tracability
-Reporting of Test and Calibration Results
These two requirements are fundamental for ISO 17025 certification, and represent the building blocks for the globalization of this standard. ILAC’s umbrella organizations are, by definition, tasked with maintaining this accreditation standard in their respective locations. This makes the communication between the organizations and ILAC crucial in defining a globalized standard for laboratory accreditation. Products that are ISO17025 certified can be accepted in areas that have an ILAC-coordinated network of accreditation, and prevent the “extensive re-testing” problem that occurs with globalized trade. These accreditation partners are aiding the “interchangeability” of laboratory certified products worldwide, wherein a US-made ISO17025 certified product can carry the badge of certification overseas and beyond. By patching together a global framework for ISO 17025 laboratory certification, consumer and industrial products can be ultimately be distributed with a holistic adoption philosophy. Whether the idea is “interchangeable parts” or “accreditation standards”, the task of homogeneity across national and global markets is no easy task. As ILAC expands its reach to new regions and laboratories, ISO17025 certification will soon become a recognized laboratory custom for all countries.
For more information on ILAC & ISO17025, please visit the ILAC website: https://www.ilac.org/ilacarrangement.html.