Control of records of ISO 17025
Control of records of ISO 17025
Clause 4.13
4.13.1 General
4.13.1.1 The laboratory shall establish and maintain procedures for identification, collection, indexing, access, filing, storage, maintenance and disposal of quality and technical records. Quality records shall include reports from internal audits and management reviews as well as records of corrective and preventive actions.
4.13.1.2 All records shall be legible and shall be stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss. Retention times of records shall be established.
NOTE Records may be in any media, such as hard copy or electronic media.
4.13.1.3 All records shall be held secure and in confidence.
4.13.1.4 The laboratory shall have procedures to protect and back-up records stored electronically and to prevent unauthorized access to or amendment of these records.
4.13.2 Technical records
4.13.2.1 The laboratory shall retain records of original observations, derived data and sufficient information to establish an audit trail, calibration records, staff records and a copy of each test report or calibration certificate issued, for a defined period. The records for each test or calibration shall contain sufficient information to facilitate, if possible, identification of factors affecting the uncertainty and to enable the test or calibration to be repeated under conditions as close as possible to the original. The records shall include the identity of personnel responsible for the sampling, performance of each test and/or calibration and checking of results.
NOTE 1 In certain fields it may be impossible or impractical to retain records of all original observations.
NOTE 2 Technical records are accumulations of data (see 5.4.7) and information which result from carrying out tests and/or calibrations and which indicate whether specified quality or process parameters are achieved. They may include forms, contracts, work sheets, work books, check sheets, work notes, control graphs, external and internal test reports and calibration certificates, customers’ notes, papers and feedback.
4.13.2.2 Observations, data and calculations shall be recorded at the time they are made and shall be identifiable to the specific task.
4.13.2.3 When mistakes occur in records, each mistake shall be crossed out, not erased, made illegible or deleted, and the correct value entered alongside. All such alterations to records shall be signed or initialed by the person making the correction. In the case of records stored electronically, equivalent measures shall be taken to avoid loss or change of original data.
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This entry was posted
on Tuesday, November 24th, 2009 at 1:16 pm and is filed under ISO 17025 standard.
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