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Quality certificates and lot certificates for all Spectroquant® tests

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Lot Certificate

The lot certificate of the Spectroquant® test kits contains all the quality indicators for the specific lot: such as article number, batch number, measurement range and the results of the lot specific quality data.
They can be downloaded on each product page or here.

 

These are listed below:
  • Slope
  • Ordinate segment
  • Reagent blank
  • Confidence Interval with 95% probability
  • Standard Deviation of the Method
  • Variation Coefficient of the Method
 

When creating the lot certificate, it’s clear that Merck has defined the tolerances for all relevant measured values and compliance is evidenced by review of quality data produced by the control laboratory. The lot certificate shows the defined standard value and the value obtained in quality testing with the specific lot. This allows users to compare results.
Merck adheres strictly to the requirements of ISO 8466-1. 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.

By 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. 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.
At 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. 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.

Because Merck is a certified supplier of test kits and maintains an ISO 9001 documented quality management system, it is sufficient for the user of our test kits to provide the corresponding Merck lot certificates to the auditor. 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 using the lot certificates. This saves users of Merck’s Spectroquant® test kits time and money while still providing maximum safety.
Using the lot certificates from Merck, it is sufficient for the customer, as part of their own quality assurance, to focus on the review of their performance using standard solutions. Occasionally it is also useful to check the data quality for critical samples. For this purpose, Merck supplies Spectroquant® CombiCheck products for many of the test kits.
 

 

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© Merck KGaA, Darmstadt, Allemagne, 2014


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