Equipment Selection, Calibration and Maintenance

Purpose

To define how the Laboratory selects, acquires, accepts, identifies, calibrates, labels, handles, stores, maintains, checks, controls and retires the equipment used for calibration so that every item is fit for purpose and its calibration status is always known.

What is inside

10 sections, about 4 pages when printed.

1. 1. Purpose
2. 2. Scope
3. 3. References
4. 4. Definitions
5. 5. Responsibilities
6. 6. Procedure
7. Records generated by this procedure
8. Monitoring and performance indicators
9. Assessment readiness notes
10. Related documents

Records it generates

Applying this procedure produces the following records, which are the evidence an assessor samples.

• –Equipment register
• –Equipment history cards
• –External calibration certificates and review (CHK-06)
• –Maintenance records
• –Out-of-service records and return-to-service authorisation
• –Correction implementation verification

What an assessor looks for

The document closes with these points, so you can check your own practice before someone else does.

• –Choosing an item from the bench and checking its label, register entry, latest certificate, the review of that certificate, and that the corrections are actually applied in the worksheet or spreadsheet.
• –Asking for the history of an item found out of tolerance and following the impact assessment.
• –Checking that reference instruments' adjustment functions are locked.
• –Confirming hired or borrowed equipment was verified before use.

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.

• SOP-30

  Intermediate Checks of Reference Standards and Equipment

  Checks between calibrations that maintain confidence in the calibration status of reference standards.

• SOP-33

  Calibration Interval Determination and Review

  Setting and reviewing calibration intervals for reference standards and equipment using history and risk.

• FRM-18

  Equipment Register

  Master list of all measuring equipment with identity, location, status and calibration due dates.

• FRM-19

  Equipment History Card

  Lifetime record for one item: acceptance, calibrations, checks, maintenance, damage, adjustments.

• FRM-20

  Equipment Maintenance Log

  Planned and unplanned maintenance with results and return-to-service authorisation.

• FRM-21

  Equipment Out-of-Service and Quarantine Label

  Label and record for withdrawn, suspect or overdue equipment.

• FRM-35

  Intermediate Check Record

  Result of a check between calibrations against defined acceptance limits.