Publication new version of explanatory document T046 concerning explanatory notes on ISO/IEC 15189:2012 (Dutch).

08-08-2019

Explanatory document T046 describes how the RvA deals with a number of requirements of the EN ISO 15189:2012.
This standard applies to all medical laboratrories and is not only intended for accreditation purposes.
A number of reguirements is explained to harmonise the application.

In comparison with version 1, dated October 2017, the following significant changes have been made:

  • The text in the explanation on requirement 4.15.5 concerning the internal audits has been adjusted to the RvA-policy regarding internal audits.
  • An explanation on requirement 5.4.3 regasding verbal applications has been added.
  • The text of the explanation on requirement 5.5.1.4 regarding measurement uncertainty has been revised.

Click here for latest version of explanatory document RvA-T046 (Dutch).

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