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Valid and reliable testing/calibration is vital for businesses across various industries. Organisations that rely on testing/calibration services need assurance that the results they receive are from a competent laboratory, and that they adhere to the highest quality standards. ISO/IEC 17025 accreditation plays a crucial role in establishing this assurance for laboratories and their clients.
What is ISO/IEC 17025?
ISO/IEC 17025:2017 is an international standard that sets out the general requirements for the competence, impartiality, and consistent operation of laboratories. Developed by the International Organization for Standardization (ISO) in collaboration with the International Electrotechnical Commission (IEC), ISO/IEC 17025 emphasises the need for laboratories to prioritise quality practices and demonstrate their competence.
Definition and scope
ISO/IEC 17025 applies to any organisation that performs testing, sampling, or calibration and aims to ensure the reliability and validity of their results. The scope of ISO/IEC 17025 is broad, encompassing a wide range of sectors and industries. From forensics and asbestos testing to food production and textiles, laboratories in diverse fields seek ISO/IEC 17025 accreditation to demonstrate their quality practices and competence.
Importance of quality management systems
One of the key aspects of ISO/IEC 17025 accreditation is the establishment of a robust quality management system. A quality management system ensures a laboratory has the necessary processes, procedures, and controls in place to consistently deliver valid and reliable testing/calibration results. It encompasses various factors, including but not limited to the qualifications and training of staff, appropriate calibration and maintenance of equipment, adherence to validated or verified test methods, and traceability of measurements to national standards.
By having a quality management system in accordance with ISO/IEC 17025, laboratories can demonstrate they have well-implemented policies and processes to control the testing/calibration activities and provide clients with the assurance that their services adhere to internationally recognised standards.
Global recognition of ISO/IEC 17025
ISO/IEC 17025 accreditation is globally recognised and demonstrates laboratories have achieved a level of competence, impartiality, and operational consistency.
Accreditation and reliability
Accreditation to ISO/IEC 17025 is important for the perception of an organisation as credible, trustworthy, and competent. Accredited laboratories are more likely to gain the confidence of current and potential customers or business partners. Additionally, many government organisations worldwide require ISO/IEC 17025 accreditation as a prerequisite for collaboration.
Proficiency testing as a measure of competence
Proficiency testing is a fundamental component of ISO/IEC 17025 accreditation to ensure the validity of results using interlaboratory comparisons. Proficiency testing not only provides an objective measure of a laboratory’s competence but also contributes to improving overall practices and ensuring consistency in results.
Obtaining ISO/IEC 17025 accreditation
Obtaining ISO/IEC 17025 accreditation involves a systematic process that includes assessment by a recognised accreditation body, which is UKAS in the United Kingdom.
Accreditation application process
The application process can include a pre-assessment where UKAS will assess the readiness of an organisation to proceed with accreditation and suggest any additional work that needs to commence prior to the main assessment. This stage, often referred to as a gap-analysis can be very useful and may reveal areas where the laboratory’s quality management system requires improvement or modernisation. This stage (if requested) would be followed by the initial assessment to check conformance with the standard requirements
The Readiness Assessment tool
UKAS has developed a Readiness Assessment tool, which is a valuable resource for testing laboratories looking to obtain ISO/IEC 17025 accreditation. This tool enables laboratories to answer a series of online questions that assess their readiness for accreditation with UKAS. By evaluating various aspects of laboratory operations, quality management systems, and technical competence, the tool provides laboratories with a clear indication of their preparedness for accreditation. The results of the tool offer valuable insights and guidance on areas where improvements can be made to enhance readiness for assessment and accreditation.
Maintaining ISO/IEC 17025 accreditation
Once a laboratory obtains ISO/IEC 17025 accreditation, it is essential to maintain compliance with the standard. UKAS conducts regular surveillance assessments and full re-assessments to ensure laboratories continue to meet the requirements.
Surveillance and re-assessment Process
During the surveillance period, UKAS will carry out regular assessments to ensure ISO/IEC 17025 compliance is being maintained. These assessments occur annually. Additionally, every four years, a full re-assessment is conducted to thoroughly evaluate the laboratory’s compliance with the standard. The specific surveillance and re-assessment processes may vary dependant on assessment outcomes, but the goal remains the same: to ensure ongoing compliance and competence.
The risks of unaccredited laboratories
Choosing to use an unaccredited laboratory can pose several risks, compromising the reliability and validity of the results. It is crucial for organisations to understand these risks and make informed decisions when selecting a laboratory. These risks include:
Inexperienced staff and insufficient resources
Unaccredited laboratories may employ inexperienced staff or lack the necessary resources to perform testing or calibration services competently. Competence is built on qualifications, training, experience, and adherence to best practices. Without independent verification of competence through accreditation, organisations run the risk of receiving results that may not be fit for purpose.
Lack of impartiality and feedback mechanisms
Accredited laboratories are committed to impartiality and provide formal mechanisms for feedback and complaints. Unaccredited laboratories may lack these essential components of a quality management system, compromising the integrity and objectivity of the testing process. Without a formal complaints process or accountability to UKAS as the National Accreditation Body, organisations may face challenges in resolving issues or addressing concerns.
Unreliable test results and quality concerns
Perhaps the most significant risk of using an unaccredited testing / calibration laboratory is the potential for unreliable results. Results that are not fit for purpose can lead to quality concerns within an organisation, affecting product development, compliance, and customer satisfaction. By choosing an accredited laboratory, organisations minimise the risk of producing or supplying faulty products or services, ensuring their reputation as a responsible and reliable entity.
The benefits of accredited testing / calibration
Accredited testing / calibration offers numerous benefits for organisations seeking reliable and valid results:
Minimising risk and maintaining reputation
Accredited laboratories minimise the risk associated with unreliable results, helping organisations maintain their reputation as responsible entities. By choosing an accredited laboratory, organisations demonstrate their commitment to quality and ensure that their products have undergone thorough evaluation by an independent and competent testing / calibration facility. Customers can have confidence that accredited laboratories have the necessary expertise, equipment and processes in place to deliver valid and reliable results.
Demonstrating credibility and reducing costs
The credibility that comes with accreditation can enhance the confidence of customers and stakeholders, leading to increased business opportunities and a competitive advantage. Additionally, accredited laboratories using professionally managed processes can reduce costs by implementing efficient practices that can reduce costly mistakes and improve overall productivity
Access to international markets and supply chain confidence
Increasingly, organisations require accredited testing / calibration as a prerequisite for acceptance into supply chains. Accreditation serves as a reliable indicator of a laboratory’s technical competence and adherence to recognised quality standards, providing assurance to both purchasers and consumers worldwide.
Pre-requisite for government organisations
ISO/IEC 17025 accreditation is often a strict prerequisite for government organisations before they engage in collaborations with testing or calibration laboratories. Government agencies require the assurance that the laboratories they work with adhere to recognised quality standards. By obtaining ISO/IEC 17025 accreditation, testing or calibration laboratories position themselves as eligible and trustworthy partners for government projects and contracts.
It is advisable for organisations to prioritise ISO/IEC 17025 accreditation and make informed decisions when selecting testing partners. Valid and reliable testing and calibration is the cornerstone of numerous industries, and ISO/IEC 17025 accreditation provides the assurance needed for businesses to thrive in today’s competitive landscape.