ISO/IEC 17025:2017 Requirements, Benefits & Applications!

ISO 17025 is a crucial standard for laboratories to help them harmonise their procedures and methods. This harmonisation will facilitate the coordination between laboratories and other companies. In addition, the results of the laboratory sampling, testing and conformity assessment will be accepted between various countries all over the world.

What is ISO 17025? What are its benefits? 

We will answer these questions and bring insights on the application of ISO 17025.

ISO 17025:2017 is the most recent and revised standard of the ISO 17025 series. Historically it started with ISO/IEC Guide 25 that was published in 1990 which was the fruit of the collaboration between the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). In 1999, the first ISO 17025 was issued based on the ISO/IEC Guide 25. In 2005 the first revision of the ISO/IEC 17025 followed by a second revision 12 years later and published in 2017, making the ISO/IEC 17025 the third version of the standard which is adopted today.

What is ISO 17025?

ISO 17025 provides the “General requirements for the competence of testing and calibration laboratories”. This standard can be applied in all laboratories and it specifies the requirements of their practices to raise confidence in their ability to provide reliable and valid testing, calibration and sampling results. All this being possible thanks to a good quality system.

The ISO 17025:2017 standard contains 5 main requirements for the accreditation of laboratories. The figure below shows the requirements of each criterion of the standard.

The management system requirements of ISO 17025 are in line with the ISO 9001 standard. This was one of the main reasons of the previous revisions of the standard to include the management to the technical competence of the laboratory. A company or a laboratory can get ISO 9001 certification without having the ISO 17025 accreditation. To get accredited there are accreditation bodies that assess the laboratories and their conformities in meeting the requirements for the ISO 17025 standards. Among these accreditation bodies, we can mention the International Accreditation Service, UKAS the National Accreditation Body for the United Kingdom, ANAB the ANSI National Accreditation Board and many more exist in each country.

What are the main benefits?

First of all the ISO 17025 standard can be applied in all corporations that have laboratory activities regardless of their size. There are many benefits when the laboratory has ISO 17025 accreditation. They can vary from the brand image and promoting confidence, to the constant internal improvement of the processes and work quality.

Here are some examples of the benefits:

Better reputation and enhanced client confidence. The ISO 17025 standard is internationally recognised. It shows that a laboratory is operating successfully and providing valuable results, efficiently and effectively. And it shows that your laboratory operates with high levels of confidentiality and impartiality that attract a lot of clients and promote confidence in the brand image.

Constant improvement of the activities and documentation. Constantly improving the system processes and protocols in place and adopting a risk based approach drives laboratories to always improve in a less costly way their activities. This will generate and increase operational efficiency and productivity. Hence the protocols in place are always updated and adaptable to all the new conditions and technologies that might be added to the activities. This will contribute to defining quality objectives and a more reliable and confident working environment. All these procedures, activities, protocols and objectives require proper documentation. It is in the ISO 17025 requirements and well conducted documentation provides stability and better results for the laboratory and the workers are more responsible.

Gaining credibility and maintaining it. All the processes and procedures are reviewed and audited frequently. This is to ensure that the laboratory is well up to date with the new and evolving approaches. The auditing of the laboratory and the review of the protocols bring more credibility to the results, testing and calibration. This will also improve the reputation and reliability of the laboratory. The assessment (audit) is usually conducted by an accreditation body to make sure that everything is done correctly according to the ISO 17025 requirements and performed by well-trained personnel.

Enhanced employees’ satisfaction. The standard underlines the necessity for a well-trained staff. This provides the opportunity for the employees to constantly improve and develop new skills. Thus, the personnel will be more responsible and provide good quality performance in their activities. Motivating the employees and giving them the opportunities and the means to evolve will greatly improve their satisfaction and the quality of their work life.

How can a digital tool help you get the ISO 17025 accreditation?

The arrival of digital technology into our companies has reshaped the way the processes and protocols are implemented. It will allow an organisation to stand out from the competition and to be well prepared in the case of obtaining the ISO 17025 accreditation.

The documentation of all the processes, protocols and procedures in the ISO 17025 requirements is highly important. A single digital platform with its Electronic Document Management (EDM) system can greatly reduce the paperwork and the dispersion of all the necessary documents. Everything is centralised on the platform and can be easily accessed from your computer, tablet or smartphone. The EDM can help you keep track of old versions of procedures and protocols, consult and modify them to have the newest version to comply with the requirements of the ISO17025.

Accessibility can be adapted and limited to each department, depending on their needs and activities.

A digital checklist can help you to successfully put in place all the necessary requirements and mandatory documents of the ISO 17025 standard. In addition, there are self-evaluation modules to make sure that all is correctly implemented before an accreditation audit. You can configure your evaluation in the form of customisable grids to answer all the basic criteria of the standard. You can easily add proofs to these grids by attaching photos, videos or related documents.

The ISO/IEC 17025:2017 standard is applicable in all types of organisations regardless of their size and type of industry. It is an international standard allowing international recognition of laboratories when they are accredited. In addition to the ISO/IEC 17025:2017, there is the ISO 15189:2012 standard that is important for biomedical laboratories. So, are you well prepared to obtain the accreditation?

Take the first step towards success by starting your certification preparation now, thanks to the QMS app.