ISO 17025: 2017 Clause 6.4 Equipment (6.4.3 & 6.4.4)

 

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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