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Sub-clause 6.4.2

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Guest user Created:   Oct 27, 2020 Last commented:   Oct 27, 2020

Sub-clause 6.4.2

Good Day! Please explain further sub-clause 6.4.2 for our reference.
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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Tracey Evans Oct 27, 2020

Clause 6.4.2 states that When the laboratory uses equipment outside its permanent control, it shall ensure that the requirements for equipment of this document are met.

Firstly it is important to note that "Equipment" is considered as any item used to generate a result, so this also applies, for example,  to software, reference materials, chemicals and reagents.

This clause can cover a number of scenarios, for example
1) When equipment is shared within the laboratory facility or another department of the organisation,
2) When items are stored in a storeroom not managed directly by the laboratory,
3) When equipment is calibrated offsite by a service provider or another department and returned for use by the laboratory, and 4) If a service provider performs a service on an item, even if onsite.

In all these cases the activity must comply with ISO 17025 requirements for equipment. This includes facilities and environment, handling, storage, use, verification, performance checks, and appropriate records.

For more information see

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Oct 27, 2020

Oct 27, 2020