ISO 17025: 2017 Clause 6.4 Equipment (6.4.8 & 6.4.9)

 

Clause 6.4.8 specifies requirements related to the identification of equipment that requires calibration or has a defined period of validity. The purpose of this clause is to ensure that users of the equipment can readily identify the calibration status or the period during which the equipment is considered valid for use. The explanation of this clause are as follows:

1.  Equipment Requiring Calibration:

 This refers to measuring instruments, devices, or equipment used in the laboratory that need to undergo calibration at specific intervals to ensure their accuracy and reliability in measurements.

2.  Defined Period of Validity:

Equipment have a predefined period during which they are considered valid for use without requiring calibration. This could be based on factors such as the stability of the equipment or the nature of the measurements it performs.

3.  Labelling, Coding, or Identification:

This emphasizes the need to label, code, or otherwise identify the equipment. This identification should be visible and easily accessible, allowing users to determine the calibration status or the period of validity without ambiguity.

4.  Readily Identify the Status:

 The intention is to make it easy for laboratory personnel to determine whether the equipment is within its valid calibration period or if it requires calibration. This is essential for maintaining the quality and reliability of measurements conducted using that equipment.

5.  User Awareness:

Having a clear labelling or coding system, the laboratory ensures that users are aware of the current status of the equipment they are using. This is critical for making informed decisions about the reliability of measurements and whether recalibration is necessary.

  

Clause 6.4.9 outlines procedures and requirements for handling equipment that has been subjected to certain conditions, such as overloading, mishandling, providing questionable results, or being shown to be defective or outside specified requirements. The explanation of this clause are as follows:

1.  Equipment Condition:

The conditions mentioned include overloading, mishandling, questionable results, or being defective or deviating from specified requirements. These conditions can potentially compromise the accuracy and reliability of the equipment.

2.  Action to Be Taken:

 When equipment falls into any of the specified conditions, it must be taken out of service. This means removing it from active use to prevent any further potential issues or inaccuracies in the results it produces.

3.  Isolation or Labelling:

 The equipment should be isolated, preventing its use by personnel. Alternatively, it should be clearly labelled or marked as being out of service. This is a visual indication to all laboratory personnel that the equipment is not to be used until its performance is verified.

4.  Verification of Performance:

Before the equipment can be reintroduced into service, it must undergo a verification process to ensure that it performs correctly. This verification aims to confirm that the equipment is functioning within specified requirements and can produce reliable and accurate results.

5.  Examination of the Defect or Deviation:

The laboratory is required to examine the nature and extent of the defect or deviation from specified requirements. This examination helps in understanding the potential impact on the equipment's performance and the validity of past results.

6.  Management of Nonconforming Work Procedure:

The laboratory should initiate a management procedure for dealing with nonconforming work. This involves documenting the details of the defect, the actions taken, and any necessary corrective measures to prevent similar issues in the future. It's a part of quality management to maintain and enhance the reliability of laboratory processes.