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Management of Equipment in an ISO/IEC 17025:2017 Accredited Laboratory

Part 1: Classifications of Laboratory Equipment

2.2 Measuring Instrumentation Categories

The risks associated with laboratory instrumentation usually increases, significantly, as the complexity, of the instrumentation, increases. Thus, the effort required to provide the required level confidence that the instrument can provide valid results is often dependent on the complexity of the respective equipment Therefore, classifying instrumentation according to its complexity will ensure that instrumentation of similar complexity is qualified to a level that is constantly consummate with risks associated with the instrument. The scheme presented here is particularly useful in laboratories carrying out physical testing or calibrations.

1. Category 1 includes standard equipment with no measurement capability but are used to establish a reference standard. Examples of equipment in this category are standard weights used to calibrate balances and fixed-point temperature cells, such as the water triple point cell, used to calibrate thermometers.

2. Category 2 includes standard equipment and instruments that are capable of measurement but have no capacity for adjustment. Examples of equipment in this capacity include platinum resistance thermometers and float densitometers.

3. Category 3 includes commercial off the shelf equipment that is either:

i. Firmware controlled

ii. Controlled by software with limited functionality and internal to equipment

iii. Capable of independent adjustment in order to conform to specifications

iv. Does not have a computer with a full operating system controlling the system

Examples of equipment in this category include: a precision thermometry bridge, pH meter, laboratory balance.

4. Category 4 includes commercial off the shelf equipment with a computer, with a full operating system driving the equipment. But which have no capacity for configuration, apart from that required to enable users to operate the equipment and to assign user privileges. Examples of equipment in this category includes UV and FTIR spectrophotometers, and gas and high performance liquid chromatographs.

5. Category 5 includes commercial off the shelf computer driven equipment, which do have capacity for configuration, with single or multiple terminals capable of controlling, and/or, monitoring, and/or processing data, from multiple sensors of items of equipment. Examples include a networked environment monitoring system or a networked instrument control, data capture and processing system. It may also be necessary clarity a situation of whether adding a new instrument to an existing network is a category 5, or some other category determined by the characteristics of the instrument if it was not connected to the network. There are several potential solutions to this type of scenario, probably the most universally applicable is to apply change control procedures and/or establish a process addressing the addition of new instruments and sensors to the respective network when it is first installed.

6. Category 6 includes all bespoke equipment.


2.2 Analytical Instrumentation Categories

1. Category 1 includes standard equipment with no measurement capability or usual requirement for calibration. Examples of equipment in this group are nitrogen evaporators, magnetic stirrers, vortex mixers, and centrifuges.

2. Category 2 includes standard equipment and instruments providing measured values as well as equipment controlling physical parameters (such as temperature, pressure, or flow) that need calibration. Examples are balances, melting point apparatus, light microscopes, pH meters, variable pipets, refractometers, thermometers, titrators, and viscometers, muffle furnaces, ovens, refrigerator-freezers, water baths, pumps, and dilutors.

3. Category 3 includes instruments and computerised analytical systems, where user requirements for functionality, operational, and performance limits are specific for the analytical application.

4. Category 4 includes all networked or customised instruments and customised analytical systems. The comment discussed category 5 equipment in Section 2.2 also apply here.

5. Category 5 includes all bespoke equipment


2.3 Software Categories

All equipment with associated software shall be allocated a software category according to the following criteria:

1. Category 1 Infrastructure Software.

This includes:

Operating systems

databases

programming languages

middleware

office software

statistical programming tools and spreadsheet packages.

network monitoring software

anti-virus

backup

help desk

IT configuration management tools and other network software.

2. Category 2 Firmware

This is software which is embedded into a piece of laboratory equipment, such as laboratory balances, pH meters or digital thermometers, to make it work.


3. Category 3 Non – Configured Software.

This is software that can be installed and is capable of operation without modification. Included in this is the software that controls much of the analytical equipment used in the laboratory, such as spectrophotometers and chromatographs.

4. Category 4 Configured Software.

This software that can be configured, by the user, to optimise its performance to meet the user’s requirements. Included in this is software that controls networked equipment control, and data collection and monitoring systems. Also included in this category are configured Excel spreadsheets not containing macros.

5. Category 5 Custom Software.

This is software that has been developed and written for a specific organisation and purpose. This includes applications which contain a configuration or scripting language which allows the user to modify a program’s functions. This includes macros for Microsoft Office applications.



3 References

1. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. International Organisation for Standardisation, Geneva, 2017

2. UKAS Guidance LAB 11 Traceability of Temperature Measurement: Platinum Resistance Thermometers, Liquid-in-glass Thermometers and Radiation Thermometers, Ed 4, United Kingdom Accreditation Service, Staines-upon-Thames, 2012


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