ISO/IEC 17025 Clause 6.4.3 Handling, Transport, Storage, Use, and Planned
Maintenance of Equipment
1. Procedure
Requirement:
The laboratory is
required to have a documented procedure. This means there must be a set of
written instructions that detail how the laboratory manages equipment regarding
handling, transport, storage, use, and planned maintenance.
2. Handling:
The procedure should cover how equipment is handled
within the laboratory. This includes activities such as commissioning of
equipment and also the equipment should be used by the authorised person to
ensure its proper and safe use.
3. Transport:
Procedures should address the transportation of
equipment, both within the laboratory and potentially between different
locations when required. This ensures that equipment is not damaged during transit,
affecting its performance.
4. Storage:
Proper storage procedures are necessary to
prevent contamination or deterioration of equipment (Chemicals, Media, CRM, RM,
Glassware etc.). This may involve considerations such as environmental
conditions, security, and protection from potential hazards.
5. Use:
The procedure should specify guidelines for
the correct and intended use of equipment. This ensures that equipment is
utilized in a manner that aligns with its design and intended functions.
6. Planned
Maintenance:
Planned maintenance is a
proactive approach to ensure that equipment continues to function properly. The
procedure should define how the laboratory plans and carries out maintenance
activities to prevent unexpected breakdowns or deviations in performance.
7. Prevention
of Contamination or Deterioration:
The overarching goal is
to prevent contamination or deterioration of equipment. This involves
implementing measures that safeguard equipment from environmental factors,
misuse, or any other conditions that may compromise its integrity or accuracy.
Compliance: Adhering to this clause ensures that the
laboratory is compliant with international standards, demonstrating a
commitment to quality and reliability in testing and calibration activities.
Reliability of Results: Properly handled and maintained equipment
contributes to the reliability and accuracy of test and calibration results.
Risk Management: By addressing handling, transport, storage,
use, and maintenance, the laboratory minimizes the risk of errors,
contamination, and equipment failure.
This clause from ISO/IEC 17025:2017 emphasizes the
importance of ensuring that laboratory equipment meets specified requirements
before it is put into service or returned to service. Let's break down the key
elements of this clause:
Clause 6.4.4 - Verification of Equipment performance
1. Verification
Requirement:
The laboratory is mandated to verify that the
equipment conforms to specified requirements. This involves a systematic
process of checking and confirming that the equipment meets the established
criteria, standards, or specifications.
2. Before Placement
or Return into Service:
The verification process occurs at two
critical points in the equipment's lifecycle: before it is initially placed
into service and before it is returned to service after maintenance,
calibration, or any other form of intervention. This ensures that the equipment
is in compliance with requirements at these crucial stages.
3. Conformance
to Specified Requirements:
The equipment must adhere
to specific requirements, which could include technical specifications, performance
criteria, calibration standards, or any other criteria set forth by regulatory
bodies, manufacturers, or internal laboratory standards.
By verifying equipment performance,
the laboratory ensures that the equipment meets the necessary quality
standards. This is essential for producing reliable and accurate test results.
Risk Mitigation: Verifying equipment before placement or return
to service helps mitigate the risk of using faulty or non-compliant equipment,
which could lead to inaccurate results and compromise the integrity of
laboratory activities.
Traceability: Verifying conformance provides a basis for
traceability, allowing the laboratory to demonstrate and document that
equipment used in testing or calibration meets the necessary standards.
Documentation: The laboratory is expected to have documented
procedures for the verification process, outlining the steps to be followed and
the criteria for determining conformance.
Authorized Personnel: The verification process may involve qualified
and authorized personnel who are responsible for ensuring that the equipment
meets the specified requirements.
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