ISO 17025: 2017 Clause 6.4 Equipment (6.4.13)

Clause 6.4.13 of ISO 17025 focuses on maintaining records for equipment that can impact the laboratory's activities. This ensures the laboratory has documented information to demonstrate the equipment's suitability, performance, and control throughout its lifecycle.

a) Identity of equipment, including software and firmware version: This ensures clear identification of the equipment being used, including any relevant software or firmware versions that might affect its operation.

b) Manufacturer's name, type identification, and serial number: This provides traceability to the equipment's origin and allows for specific identification in case of issues or recalls.

c) Evidence of verification: This demonstrates that the equipment meets the necessary requirements for its intended use. This verification could involve calibration, validation, or other suitable methods.

d) Current location: Knowing the equipment's location is crucial for managing its use, maintenance, and accessibility within the laboratory.

e) Calibration details: This section emphasizes the importance of recording calibration dates, results, adjustments made (if any), acceptance criteria used to assess the calibration effectiveness, and the next calibration due date or the calibration interval. This information ensures timely recalibration and maintains confidence in the equipment's accuracy.

f) Reference materials: If the equipment relies on reference materials for its operation, the clause requires documenting these materials, including their results, acceptance criteria, relevant dates (e.g., acquisition or manufacturing date), and their period of validity. This ensures the continued reliability of the reference materials and the validity of the measurements made using them.

g) The maintenance plan and maintenance carried out to date, where relevant to the performance of the equipment: This ensures that the laboratory has a documented plan for maintaining the equipment and that maintenance activities are being performed as scheduled. This helps to prevent equipment failures and ensure its continued proper functioning.

h) Details of any damage, malfunction, modification to, or repair of, the equipment: Recording any incidents of damage, malfunction, modification, or repair of the equipment is crucial. This information helps track the equipment's history, identify potential trends or recurring issues, and assess any impact on the equipment's performance or the validity of results.

Following table summarizes the key elements of clause 6.4.13, providing a clear and concise overview of the required records for equipment in a laboratory:-

Record Item	Description	Example
a) Identity	Equipment name, software/firmware version	Balance: Model XYZ, Software v1.2.3
b) Manufacturer	Manufacturer name, type, serial number	XYZ Instruments, Serial #123456
c) Verification	Evidence of conformance	Calibration certificate
d) Location	Current location	Room 101, Lab A
e) Calibration	Calibration dates, results, adjustments, acceptance criteria, next due date/interval	Last calibration: 2023-10-26, Passed, Next due: 2025-10-26
f) Reference	Reference material details, results, acceptance criteria, validity period	Certified reference material (CRM) ABC, Valid until: 2025-05-31
g) Maintenance	Maintenance plan, history	Regular cleaning every 3 months
h) Damage/Malfunction/Modification/Repair	Details of damage, malfunction, modification, repair	Replaced sensor on 2024-02-15

 

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