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Completion of ISO 9001 Certification and ISO 17025 Accreditation
Douglas Laboratories is proud to announce that we have completed our in-house laboratory certification and accreditation program to meet both the ISO 9001 and ISO 17025 standards, ensuring that we are compliant with one of the highest and most recognized standards of quality in the world. To the best of our knowledge, we are the only company manufacturing dietary supplements for physicians to have its laboratories ISO 9001 certified and ISO 17025 accredited. While the term "ISO" may be familiar as displayed by various companies (including Federal Express, Boeing, and Proctor and Gamble to name a few), it is important to understand what this certification and accreditation truly represents. The International Organization for Standardization (ISO) is a worldwide federation of 111 national standards bodies who's primary objective is to promote the development of manufacturing, trade and communication among business organizations worldwide through the development of standards. The term "ISO 9001" refers to a detailed set of quality management standards that a company must adhere to in order to meet the conditions of certification. The more rigorous ISO 17025 provides a third-party accreditation of our laboratories, which serves to demonstrate that our laboratory has the technical and managerial capabilities to perform specific tests and measurements using correct, validated procedures and equipment. This accreditation demonstrates a number of important factors including:
- Personnel are competent and have the applicable theoretical and practical backgrounds to properly perform their work
- Written procedures are used for the sampling, handling, transport, storage, and preparation of items to be tested
- When applicable, testing methods are those published as international or national standards
- Testing methodology is validated to confirm that it is appropriate for each particular test
The emphasis that ISO 17025 accreditation places on method validation is of particular interest. Anyone can develop a method by which they analyze one or more compounds, but it is the validation of the method and the adherence to a set of tightly controlled procedures that is the key to being assured of accuracy and reproducibility. Of course, even a validated method will give you poor results if the instruments being used are not properly calibrated. Consequently, strict maintenance and calibration schedules are in place for analytical instruments. We also have a dedicated Quality Control Manager to monitor and supervise the daily progress of our quality systems, as well as an experienced Ph.D. in pharmaceutics who monitors and oversees the entire Quality Control department. Our staff of highly skilled Chemists, Microbiologists and other scientists have the combined experience and dedication to ensure that you receive the best possible product. Their hard work, knowledge and determination was invaluable to our successful ISO certification and accreditation. We are proud to offer yet another level of assurance that our products and procedures are unsurpassed in the industry.Figure 1 shows our dedicated Quality Control team members.
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