One of the ways Waters ERA demonstrates a company-wide commitment to quality is through our comprehensive list of internationally recognized quality designations.
Waters ERA achieves registration or accreditation when an outside authority that has been qualified to review our processes and procedures evaluates us against an internationally developed set of strict requirements. These requirements span from making certain we maintain the proper physical facilities to evaluating the calculations we use in our statistical analysis. Waters ERA customers recognize that the products and services we provide are among the very best in the world. Our certifications and accreditations are just one facet of what distinguishes Waters ERA as an elite manufacturer of CRMs and PTs globally.
What Waters ERA's Accreditations Means To You
Few manufacturers can document (through the accreditation process) the same rigorous quality programs we have in place—programs that affirm Waters ERA’s ability to provide customers with the highest quality products possible and allow for international acceptance of Waters ERA products by laboratory accreditation bodies. Your selection of a CRM or PT provider means you are accepting of the provider’s quality levels and programs and are willing to integrate their quality programs into your laboratory processes. If quality is important to you then you should be discriminating in your vendor selection process and diligently consider your vendor’s demonstrated commitment to quality.
‘Our ISO certificates are important because they demonstrate our passion for prioritizing customer expectations. They also represent our commitment to being a trustworthy supplier that consistently delivers high-quality products.’
- Heidi Senft, Sr. Quality Systems EngineerISO 9001
ISO 9001 is a quality management standard that applies to all types of organizations regardless of size or function. This international standard helps both product and service-oriented organizations achieve standards of quality that are recognized and respected throughout the world. This is accomplished mostly through quality management practices that extend into all areas of an organization. ISO 9001 registered companies must have written procedures and training documentation in the areas of customer service, complaint handling, product design, purchasing, manufacturing, product evaluation, packaging, and shipping. Included on our ISO 9001 accreditation scope are Synthetic Reference Materials and Quality Control Standards.ISO 17025
ISO 17025 certification, covering the competence of testing and calibration laboratories, ensures that a company’s laboratory tests are performed correctly, and that attestations of product quality are appropriate and defensible. All aspects of raw material, in-process and final product verification are covered by this accreditation. It certifies the company’s ability to demonstrate the robustness of their quality program through comprehensive and accurate product testing. ISO 17034
ISO 17034 covers the production of all reference materials, including certified reference materials. This was previously addressed in ISO Guide 34. ISO 17034 specifies general requirements for the competence and consistent operation of reference material providers. It also sets out the requirements in accordance with which reference materials are produced and is intended to be used as part of the general quality assurance procedures of the reference material provider.ISO 17043
ISO 17043 is designed specifically for Proficiency Testing providers. ISO 17043 specifies the essential activities that need to be evaluated when conducting inter-laboratory testing comparisons. ISO 17043 defines the criteria related to study design, sample manufacture and the ensuring of homogeneity and stability, which must be considered in the design and execution of proficiency testing schemes.* Waters ERA’s U.S. facility is accredited to ISO 17025, ISO 17034, and ISO 17043 by American Association of Laboratory Accreditation (A2LA) and registered to ISO 9001 by National Quality Assurance (NQA).
Waters ERA’s Ireland facility is accredited to ISO 17025 and ISO 17034 by Irish National Accreditation Board (INAB) and registered to ISO 9001 by BSI Assurance UK Limited (BSI).
How CRMs Add Value To My Quality Assurance Program
Count on ERA for meticulous and accredited quality processes