| Título: | Guidelines for the validation and verification of chemical test methods |
| Tipo de documento: | texto impreso |
| Editorial: | Sydney [AUSTRALIA] : NATA, 2006 |
| Colección: | Technical Note, num. 17 |
| ISBN/ISSN/DL: | 41540 |
| Nota general: | ISBN: |
| Langues: | Inglés |
| Clasificación: | |
| Resumen: | A test method must be shown to be fi t for purpose before use by a laboratory to ensure clients will be able to use the results generated by application of the method with confi dence. Method Validation provides objective evidence that the particular requirements for a specifi c intended use are fulfi lled. For these reasons, method validation is an essential requirement of laboratory accreditation to ISO/IEC 17025. Accordingly, laboratories accredited to this Standard must demonstrate the validity of all methods used, by validating all in-house and modifi ed standard methods and verifying standard methods. The ISO/IEC Standard recognises that validation is always a balance between costs, risks and technical possibilities (Note 3 to 5.4.5.3). The extent of validation required will depend on the status of the method under consideration and the needs relating to its intended application. A newly developed in-house method will normally require rigorous validation whereas minor modifi cations to a procedure previously validated in the laboratory may require only a comparative bias check before implementation for its intended scope. |
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