To develop each of the above listed statistics, data is averaged from several batches. Number of production batches used to create the certificate of quality.
Confidence interval with 95 percent probability.It offers the user a quick overview of all relevant quality data and can be downloaded on each product page. Your Document for Consistently High Product QualityĮach Spectroquant® test kit comes with our quality certificate. For this purpose, Merck supplies Spectroquant® CombiCheck products for many of the test kits.Quality Certificates in Spectroquant® Test Kits Occasionally it is also useful to check the data quality for critical samples. This saves users of Merck´s Spectroquant® test kits time and money while still providing maximum safety.Īltogether using the lot certificates provided with Merck´s Spectroquant® test kits, it is sufficient for the customer to focus on the review of their performance using standard solutions – as part of their own quality assurance.
Millipore sigma certificate of analysis iso#
Users do not need to do a receiving inspection, as required by ISO 9001, because Merck already proves the outgoing quality of its test kits in the lot certificates. By comparing Merck´s supplied data with their own quality data, it is easy for the laboratory to provide the auditor with results proving their compliance with regulatory standards: It is sufficient for the user of our test kits to provide the corresponding Merck lot certificates to the auditor, since Merck is a certified supplier of test kits and maintains an ISO 9001 documented quality management system. Accepted Document for AuditionĪt least annually, these labs must verify the quality of data such as calibration accuracy, lower limit of detection and the detection limit of the method for their laboratory.
This information, such as slope, is especially important for laboratories that need to create a regular review of results and analysis of relevant laboratory quality data. Although a standard 5-point calibration method can be used, Merck employs a more rigorous 10-point calibration system ensuring that the user obtains the highest accuracy and reliability.īy expanding the batch certificate to a second page, the customer not only has the important actual/nominal value comparison for the Spectroquant® test kit, but also reference values used to calibrate the photometer. Merck adheres strictly to the requirements of ISO 8466-1. Each lot certificate shows the defined standard value and the value obtained in quality testing with the specific lot. Compliance is evidenced by review of quality data produced by the control laboratory. Self-evidently when creating the lot certificate Merck has defined the tolerances for all relevant measured values.
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