Test Method Development
The laboratory shall use appropriate methods and procedures for all tests and/or calibrations within its scope. These include sampling, handling, transport, storage and preparation of items to be tested and, where appropriate, an estimation of the measurement uncertainty as well as statistical techniques for analysis of test data.
The laboratory shall have instructions on the use and operation of all relevant equipment, and on the handling and preparation of items for testing, where the absence of such instructions could jeopardize the results of tests. All instructions, standards, manuals and reference data relevant to the work of the laboratory shall be kept up to date and shall be made readily available to personnel. Deviation from test methods shall occur only if the deviation has been documented, technically justified, authorized, and accepted by the customer.
NOTE: International, regional or national standards or other recognized specifications that contain sufficient and concise information on how to perform the tests do not need to be supplemented or rewritten internal procedures if these standards are written in a way that they can be used as published by the operating staff in a laboratory. It may be necessary to provide additional documentation for optional steps in the method or additional details.
The laboratory shall use test methods, including methods for sampling, which meet the needs of the customer and which are appropriate for the tests and/or calibrations it undertakes. Methods published in international, regional or national standards shall preferably be used. The laboratory shall ensure that it uses the latest valid edition of a standard unless it is not appropriate or possible to do so. When necessary, the standard shall be supplemented with additional details to ensure consistent application. When the customer does not specify the method to be used, the laboratory shall select appropriate methods that have been published either in international, regional or national standards, or by reputable technical organizations, or in relevant scientific texts or journals, or as specified by the manufacturer of the equipment.
Laboratory-developed methods or methods adopted by the laboratory may also be used if they are appropriate for the intended use and if they are validated. The customer shall be informed as to the method chosen. The laboratory shall confirm that it can properly operate standard methods before introducing the tests. If the standard method changes, the confirmation shall be repeated.
The laboratory shall inform the customer when the method proposed by the customer is considered to be inappropriate or out of date.
The introduction of test and calibration methods developed by the laboratory for its own use shall be a planned activity and shall be assigned to qualified personnel equipped with adequate resources. Plans shall be updated as development proceeds and effective communication amongst all personnel involved shall be ensured.
When it is necessary to use methods not covered by standard methods, these shall be subject to agreement with the customer and shall include a clear specification of the customer’s requirements and the purpose of the test. The method developed shall have been validated appropriately before use.
NOTE For new test methods, procedures should be developed prior to the tests being performed and should contain at least the following information:
- Appropriate identification
- Description of the type of item to be tested or calibrated
- Parameters or quantities and ranges to be determined
- Apparatus and equipment, including technical performance requirements
- Reference standards and reference materials required
- Environmental conditions required and any stabilization period needed
- Description of the procedure, including…
- Affixing of identification marks, handling, transporting, storing and preparation of items
- Checks to be made before the work is started
- Checks that the equipment is working properly and, where required, calibration and adjustment of the equipment before each use
- The method of recording the observations and results
- Any safety measures to be observed
- Criteria and/or requirements for approval/rejection
- Data to be recorded and the method of analysis and presentation
- The uncertainty or the procedure for estimating uncertainty