Procedure · SOP-02
Control of Records and Technical Records
Identification, storage, protection, retention, amendment and disposal of quality and technical records.
Purpose
To define how the Laboratory identifies, collects, indexes, accesses, stores, protects, backs up, archives, retrieves, amends, retains and disposes of quality records and technical records so that they remain legible, readily retrievable and secure for their retention period and allow any calibration to be reconstructed.
What is inside
10 sections, about 4 pages when printed.
- 1. Purpose
- 2. Scope
- 3. References
- 4. Definitions
- 5. Responsibilities
- 6. Procedure
- Records generated by this procedure
- Monitoring and performance indicators
- Assessment readiness notes
- Related documents
Records it generates
Applying this procedure produces the following records, which are the evidence an assessor samples.
- –Records Retention Schedule and Disposal Log
- –Job files (technical records)
- –Backup and restoration test records
- –Record amendment approvals after issue
What an assessor looks for
The document closes with these points, so you can check your own practice before someone else does.
- –Selecting a certificate at random and asking to see the complete job file, then checking that every reference standard used, every raw reading, the environment and the calculation can be identified and that the calibration could be repeated.
- –Checking that the person who made the observations, the person who checked them and the authorising signatory are identified and were authorised on the date of the work (FRM-16).
- –Looking for corrections made with correction fluid, overwritten digits or undated changes.
- –Verifying that electronic records (logger exports, spreadsheets) are the originals and that the audit trail or version history is intact.
- –Confirming that backup restoration has actually been tested.
Before you use it
- Replace every square-bracket token, starting with [LABORATORY NAME], [ADDRESS] and [EFFECTIVE DATE]. The full token list is in GD-01 Read Me First.
- Have the content technically reviewed against how your laboratory actually works, then approved by the responsible manager before it becomes a controlled document.
- Update the Word fields after editing so the table of contents and page numbers are correct: select all, then press F9.
- Record the document in your own document register and set its review date.
- Delete the assessment readiness notes if you do not want them in your controlled version; they are guidance for you, not requirements.
Related documents
- QM-01
Quality Manual
Top-level description of the management system against every clause of ISO/IEC 17025:2017.
- FRM-03
Records Retention Schedule and Disposal Log
Retention periods by record type and a log of authorised disposals.
- FRM-42
Job File and Technical Record Cover Sheet
Index of every record in a job file so the calibration can be reconstructed.
- FRM-36
Temperature Calibration Worksheet
Raw data, references, environment and calculations for a temperature calibration.
- FRM-37
Humidity Calibration Worksheet
Raw data, references, stabilisation and calculations for a humidity calibration.
- FRM-38
Pressure Calibration Worksheet
Raw data, references, corrections and calculations for a pressure calibration.
- FRM-39
Electrical Calibration Worksheet
Raw data, references and calculations for a DC/LF electrical calibration.
- FRM-40
Dimensional Calibration Worksheet
Raw data, references, temperature corrections and calculations for a dimensional calibration.