The ISO 17025 accreditation outlines a series of protocols required to accredit the technical capabilities and quality standards of a testing and calibration laboratory. This ISO certification therefore evidences the capability of a laboratory to consistently provide accurate results in addition to complying with regulations in effect and fulfilling customer expectations.
What does ISO 17025 mean?
ISO 17025 is an international standard developed by ISO (International Organization for Standardization) and the International Electrotechnical Commission (IEC) under the coordination of the ISO Conformity Assessment Committee (CASCO), which establishes the requirements that testing and calibration laboratories must meet. Besides, this standard provides the necessary requirements to be met by testing and calibration laboratories, facilitating the harmonization of quality criteria.
The ISO 17025 standard is based on two main sections: The first consists of performance requirements. The second is based on technical requirements. The standard also gives requirements related to quality management such as document control and corrective action.
What is the purpose of ISO 17025?
The main objective of ISO 17025 is to ensure the technical competence and reliability of analytical results. For them, it uses both management requirements and technical requirements that affect the improvement of the quality of the work carried out in the laboratories.
These requirements are used as tools for the dissemination of collective knowledge, which facilitates the integration of staff, provides flexibility in adapting to changes in the environment and allows problems to be detected for early resolution.
For this reason, this standard is useful for any organization that needs to realize packaging testing methods for their products. This includes all types of laboratories, whether they be owned and operated by government, industry, or, in fact, any other organization.
Benefits of implementing the ISO 17025 standard
As with the rest of the ISO standards, complying with ISO 17025 implies work and effort for a laboratory. However, being able to accredit that a laboratory meets all of the requirements outlined in the standard implies a number of benefits:
>It certifies the quality of a laboratory at a national and international level
ISO 17025 accreditation enables laboratories to guarantee that they operate in a skillful manner, generating results that are valid worldwide. Therefore, it implies a way to obtain a competitive advantage.
>Facilitates the collaboration between laboratories and other organizations
This certification facilitates the cooperation between organizations beyond national borders, since it establishes a quality standard for obtained results. Therefore, it also boosts international commerce.
>Guarantees excellence in the service offered to the customer.
ISO 17025 accreditation guarantees processes, such as an adequate communication with the customer or the protection of the customer’s confidentiality. As a result, complying with the ISO 17025 standard does not only imply accrediting the testing or calibration capabilities of a laboratory, but also elevating the excellence of its actions as much as humanly possible.
Among other measures, it fosters preventive management and continuous improvement processes, in addition to guaranteeing the qualification of laboratory personnel.
ISO 17025 requirements
The ISO 17025 standard outlines a series of technical requirements that result in an increase in the quality of the work performed in laboratories:
- How the qualifications of the technical staff are guaranteed
- Procedures that are followed to ensure the quality of the equipment, the facility and environmental conditions.
- How the testing and calibration methods performed by the laboratory are chosen
- Methods used for sampling, measure traceability and handling of objects during testing
- Procedures chosen to ensure quality and generate results reports
In addition, the laboratory must specify a series of administrative requirements:
- information about the organization, its legal status and the processing of confidential information
- How the Quality Management System is implemented
- Procedures in place for documentation control
- How customer service and possible complaints are managed
- Outsourcing protocols
- Procedures followed for the improvement of the management system and QMS: preventive and corrective actions, record control, internal audits and senior management review methods
Who must comply with the ISO 17025 standard
The certification of this standard is targeted at any organization that performs testing or calibration.
Some laboratories – both public and private – that can benefit from complying with the ISO 17025 standard include research laboratories of various sectors (university, government, industry, etc.) and product certification organizations. Some examples could be microbiological or packaging testing laboratories, as well as acoustic and temperature calibration laboratories.
How to apply to get certified
In order to have access to the benefits of complying with the ISO 17025 accreditation, it is necessary to follow a series of steps.
First, you must contact the competent accreditation authority, which will study the capabilities of the laboratory to comply with the ISO 17025 standard. Each ISO member country has at least one accreditation body that will be in charge of setting the process in motion. Some examples include the Entidad Nacional de Acreditación in Spain, UKAS in the United Kingdom and SCC in Canada.
This is how the accreditation phase begins, where the laboratory must demonstrate that it meets the requirements outlined in the standard, as mentioned above in this article.
Before being officially granted the ISO 17025 accreditation, it is possible to perform a pre-evaluation to detect possible weak spots of the laboratory’s operational model and redesign them.
Different methods, such as document and testing or calibration equipment inspections are applied, as well as interviews with the technicians in charge of the equipment, among others.
By the end of the evaluation period, the laboratory can be declared to be compliant with the ISO 17025 certification, or points of improvement can be pointed out, which are to be redesigned for reevaluation. In any case, the second evaluation will be confined to the area that was to be redesigned or the issues that were to be addressed.
Once this standard accredited, laboratories guarantee their users that the quality and validity of their tests and services fulfill the requirements of the certification, by working as per this standard.
Differences between ISO 17025 and ISO 9001
The ISO 17025 standard has some differences with respect to the ISO 9001 standard. Although both are quality systems that can be applied to any industry, their scope has great differences. ISO 17025 is specific to calibration and testing laboratories, while ISO 9001 can be applied to any other organization.
Besides, the requirements of ISO 9001 on resources and processes are general for any industry, whereas ISO 17025 is more specific and detailed for testing and calibration laboratories.
Along with it, ISO 17025 does not specify in its methodology the identification of internal or external problems. Therefore, you must still determine and show the context of the organization, in addition to developing the scope of the QMS. On the other hand, the ISO 9001 standard includes the formulation of quality objectives.
Do you want to know more about ISO 17025 or other laboratory certifications? At Safe Load Testing Technologies we have a track record of two decades in the industry of transportation simulation and packaging optimization. Get in touch with us and let’s discuss how we can help you.