Key points
If every process is only as good as the devices used to measure it, then every one of those devices needs to be as accurate as possible. The ISO17025 standard has been created to help ensure consistency in the way that equipment, including measurement instruments, is tested and calibrated in order that its accuracy can be relied upon by end users.
Dr Jonathan Farrington of ABB explains more about the standard and what it means both for end users and providers of testing and calibration services.
Despite the ISO17025 standard having been around since 1999, there is still a lot of uncertainty around who it applies to, what it means and its benefits for both end users and testing and calibration laboratories alike. The following is an attempt to cut through the confusion and explain the importance of the standard.
What is ISO17025?
The main aim of calibration is to introduce a known standard against which the accuracy of a measurement can be made. For providers of calibration and testing services, it is necessary to show how that known standard was itself arrived at, in order to provide the traceability needed between the end measurement and how it was arrived at.
The purpose of ISO17025 is to introduce a recognised and verifiable level of best practice so that end users can be confident that a provider of calibration and testing services has undertaken the correct steps when calibrating their equipment.
ISO17025 Standard requires providers to be able to prove:
1. That they operate and adhere to a clear set of management procedures which can be subsequently checked against in order to ensure that a test or calibration was properly carried out.
Specific areas covered under this category include:
- Organisation
- Document control
- Corrective and preventive actions
- Management reviews- Internal audits
2. That they are technically competent to perform the tests and calibration they are offering.
This category extends to:
- Personnel, including their ability/experience in testing and calibrating specific equipment
- Premises and environmental conditions – The test and calibration methods being employed
- Equipment used to perform the tests/calibrations- The demonstration of measurement traceability
- Sampling, handling and transportation of the equipment being tested and/or calibrated
- Assuring the quality and consistency of test and calibration results- Reporting the results
Who and what does ISO17025 cover?
The ISO17025 standard covers any organisation offering testing and calibration services. Its purpose is to ensure that anyone purporting to calibrate a device is competent to do so, in order to ensure the accuracy of the resulting data from their calibration process.
Recognising that different laboratories often use different methods to test and calibrate a device, ISO17025 covers both standard and non- standard methods, as well as any procedures developed by the laboratories themselves.
For end users, this means that as long as an organisation and its procedures have been accredited to ISO17025, they will be able to count on the credibility of the calibration and the conditions under which it was performed.
When was ISO17025 introduced?
The current iteration of ISO17025 was introduced in 2005 in order to bring it up to date following the launch of the ISO90001:2000 quality standard.
The original version was published in 1999 and replaced the ISO/IEC Guide 25 and EN 45001 standards which had previously applied to calibration and testing services to create a single standard setting down universal requirements for both management and technical competence.
Who does ISO17025 apply to?
As mentioned above, the ISO17025 standard applies to anyone performing testing and calibration services, regardless of the number of people involved or the scale of the activities being undertaken.
Why was ISO17025 introduced?
Although there are recognised standard methods for testing and calibrating equipment, there is no single set that applies universally to everything. Manufacturers that also calibrate their own equipment, for example, will almost certainly operate methods that may differ both from the standard approach and those operated by other manufacturers.
For this purpose, ISO17025 puts in place the required management and technical competence needed to ensure that a test or calibration result is consistent irrespective of the method used. A key part of this includes being able to demonstrate to an end customer how their equipment was calibrated and how the end calibration was arrived at.
What does ISO17025 mean for providers of calibration services?
ISO17025 is not a mandatory requirement but instead seeks to introduce best practice into testing and calibration services. Although it is not a mandatory requirement, ISO17025 is like any best practice standard, in that it will be used as the benchmark against which a provider of calibration services will be compared in the event of any consequences arising from an incorrectly calibrated product.
As this may potentially include liability for personal injury and/or the destruction of plant leading to public injury or loss of life, the financial and reputational benefits of being accredited to the standard soon become clear.
How to become ISO17025 accredited?
To become accredited, an organisation must have their procedures and competence inspected and ratified by a recognised accreditation body, which has itself been accredited to international standards.
This last requirement, regarding accreditation to international standards, helps to ensure that an accreditation awarded in any particular country will be globally recognised as long as the organisation that awarded it was itself an accredited body.
In the UK, all accreditations for testing and calibration are managed by the United Kingdom Accreditation Service (UKAS), which operates in accordance with ISO17011:2004, a global standard governing the general requirements for accreditation bodies.
What does iso17025 mean for end users?
The efficiency of any industrial or utility process ultimately relies on accurate measurement. Whether the data from an instrument is used to help maximise product quality or as part of a critical safety system, it is vital that a plant operator can count on the accuracy of that device.
For end users, the ISO17025 standard provides a basic level of confidence that a provider of testing and calibration services is capable of calibrating their device.
The role of ISO17025 in ensuring that testing and calibration service providers are accredited to a single recognised standard offers a number of benefits.
Firstly, in the event of a problem, the ability to demonstrate that they used an accredited provider will enable end users to show that they took every possible measure to ensure the accuracy of their measurement instruments.
Secondly, it effectively enables end users to shop around between providers rather than being tied to a single provider, enabling them to explore different solutions for their calibration requirements.
ISO17025 standard
ABB’s flow calibration facility at Stonehouse can be used for testing and calibration of flowmeters sized from 1mm to 2.4 metres at accuracies down to ±0.1%.
How can I check whether a calibration and testing provider is accredited to ISO17025?
Organisations offering test and calibration services in the UK that have been accredited by the United Kingdom Accreditation Service (UKAS) will be able to demonstrate a Schedule of Accreditation.
The schedule features details including their UKAS laboratory number, the address of the accredited facility, the date it was issued and the types of testing and calibration that it has been accredited for.
What happens if the organisation that calibrated/ tested my product was not ISO17025 accredited?
As mentioned previously, there is no legal requirement for testing and calibration laboratories to adopt the ISO17025 standard or to be accredited. The standard exists as a benchmark of best practice for the testing and calibration of equipment.
It is not illegal to have a device calibrated or tested by a non-accredited organisation or to use it in your process. However, in the event of problems such as impaired product quality, injury or loss of life caused by a faulty instrument, it is highly likely that blame will be apportioned according to whether the parties involved took every reasonable step to avoid the situation from occurring.
While a faulty or poorly calibrated instrument may not be the direct cause of the problem, its contribution to the chain of causation will almost certainly be considered.
In such instances, courts and other regulatory bodies have a tendency to look towards recognised best practices as the minimum standard. This has an implication on both end users and testing and calibration organisations.
For end users, there is the need to demonstrate that they did everything possible to make sure that their device was fit for duty. Where testing and calibration organisations are concerned, meanwhile, there is the requirement to demonstrate their competence.
ABB in the UK operates two accredited calibration laboratories, both located at its manufacturing facility in Stonehouse, Gloucestershire. Both facilities are available for use by third parties.
