CEI-MS-15 — procedure

§4Procedure

The procedure below is written in the second person, which is the only place in the Institute's document set where that register is used. A procedure is an instruction and is written as one.

1. Obtain the preparation through the ordinary supply route rather than as a sample supplied for testing. A sample selected by the supplier is not a random sample of its output.
2. Record the container’s labelling, batch code and apparent condition on receipt, with the date and the shipping conditions observed.
3. Retain a sealed portion of the original container as a reserve sample under the storage conditions the compound requires.
4. Submit to a laboratory holding ISO/IEC 17025 accreditation for the scope of the determinations requested, and confirm that the accredited scope covers them; accreditation for one technique does not extend to all.
5. Blind the laboratory to the supplier identity. Where the compound identity must be disclosed to permit method selection, disclose the compound and withhold the supplier.
6. Specify the determinations required by reference to a method standard rather than by a generic description, and require the report to state the conditions actually used.
7. Require the report to be issued directly to the requester by the laboratory, not routed through the supplier.
8. Compare the independent result against the supplier’s certificate field by field, and record agreements and disagreements separately rather than as an overall impression.
9. Where a disagreement is material, notify the supplier in writing, record the response, and publish both.

References cited on this page

References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.

1. International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute

Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.