ISO/IEC 17025, the standard for quality management in testing and calibration laboratories

If you work in a lab, you'll know that your reputation depends entirely on the quality of your testing and calibration. So it's crucial that you label your samples carefully, always use the right materials and follow the prescribed procedures meticulously, for example. The ultimate way to safeguard that quality is a quality management system that offers your lab the best guarantee of accurate and valid results.

Leave nothing to chance. You can count on the international standard for quality management in laboratories to have that covered: ISO/IEC 17025, or to give it its full name: NBN EN ISO/IEC 17025:2017. If you decide to go for this option, you can have your lab accredited to ISO/IEC 17025 by BELAC. This gives an extra boost to your credibility with internal and external clients. In other words: a win-win!

  1. What is ISO/IEC 17025?
  2. Why implement ISO/IEC 17025?
  3. For whom is ISO/IEC 17025 intended?
  4. Accreditation ISO/IEC 17025
  5. External audit ISO/IEC 17025
  6. Training options for ISO/IEC 17025

Effective quality and risk management are a must for every ambitious lab.

 

Bob Van Doorsselaere, trainer for ISO/IEC 17025 at NBN Learning Solutions

Would you like to know which requirements your lab has to meet in order to guarantee accurate and valid results?

The standard is available in English, Dutch and French.

1. What is ISO/IEC 17025?

ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories) helps labs move towards a strong quality management system. The standard indicates 'what' you must do but leaves enough scope for 'how' you meet the requirements.

In the last revisions in 2017, not only was ISO/IEC 17025 adapted to current market conditions and technological possibilities, but international experts also adjusted the standard to ISO 9001, the standard for quality management.

Important: you are not required to have a quality management system on the basis of ISO 9001 before you start with ISO/IEC 17025. The standard simply allows labs to install a more specific system for quality assurance.

 

ISO/IEC 17025: 8 chapters

Unlike other ISO management standards, such as ISO 14001 and ISO 31000, ISO/IEC 17025 does not adhere to the High Level Structure (HLS). The standard has its own classification which comprises these 8 chapters:

  1. Area of application
  2. Normative references
  3. Terms and definitions
  4. General requirements
  5. Structural requirements
  6. Requirements for resources
  7. Process requirements
  8. Management system requirements
     

2. Why implement ISO/IEC 17025?

The major advantages of a quality management system in accordance with ISO/IEC 17025:

  • Qualitative results: the standard develops your technical competence so that you always deliver accurate and valid results.

  • Lower costs: by guaranteeing quality from the start, you will not be incurring costs for the rectification of mistakes later.

  • Digitisation: the importance of IT is increasing. The standard outlines requirements for such items as computer systems, digital files and online reports.

  • More solid reputation: a lab that implements ISO/IEC 17025 proves to the outside world that their results are reliable and meet all quality requirements.

  • Asset in collaborative partnerships: if you collaborate with other labs or organisations, the standard immediately gives all parties concerned a sound basis. 

  • Transparency: the lab process is fully outlined, from the quotation request through the selection of method to the reporting. This also allows new staff to pick things up more quickly.

  • In line with other standards: thanks to the structure of the latest version of ISO/IEC 17025, it is more in line with other standards, such as ISO 9001 (quality management) and ISO 15189 (quality management for medical labs).

 

3. For whom is ISO/IEC 17025 intended?

This standard is intended both for organisations with their own laboratories and labs which work for external clients. Every lab that makes use of testing and calibration, regardless of the size or type of the operations, can implement it. Other organisations also benefit from the implementation of ISO/IEC 17025, including universities, research centres, government, regulatory bodies, inspection institutes and organisations that carry out product certification or other conformity assessments.

Medical labs have their own quality standard

Although in theory medical labs can also apply ISO/IEC 17025, they focus mainly on a quality management standard developed specifically for medical labs: ISO 15189.

 

4. Accreditation for ISO/IEC 17025

If you apply the standard, accreditation for NBN EN ISO/IEC 17025:2017 is a profitable route. If your testing or calibration laboratory is already accredited for the older version of the standard, you can make the switch in 2020 and be accredited for the latest version.

 

What is accreditation?

Accreditation is objective and written proof that your lab meets all the requirements of ISO/IEC 17025. In Belgium, this certificate is awarded by BELAC, the Belgian accrediting agency, and is valid for 5 years. Once this period has elapsed, you go through a new accreditation process to renew the certificate.

 

Why obtain accreditation for ISO/IEC 17025?

Accreditation allows you to prove your lab's technical competencies, independence and impartiality, which in turn increases trust on the part of stakeholders. Obtaining accreditation requires a quality system according to established procedures. That quality system should stimulate efforts in such areas as infrastructure, personnel, internal inspection and a process of continual improvement.

Moreover, if your lab is accredited, you can use your testing and calibration results abroad with confidence because accreditation guarantees that applicable international requirements have been met, elevating your international standing.

 

How do you obtain accreditation for ISO/IEC 17025?

Although ISO, IEC and the NBN facilitate the development of standards, they are not involved in the accreditation part of the process. In other words, you cannot have your organisation accredited by ISO, CEN or the NBN. Accreditation is carried out by BELAC, the Belgian accrediting agency, following a thorough audit of your quality management system. BELAC falls under the responsibility of the Belgian government department known as FPS Economy.

 

5. External audit ISO/IEC 17025

During an external audit, BELAC checks whether your quality management system meets all requirements of the standard. This is the final step in the accreditation process.

 

How does an external audit work?

The BELAC auditors have multiple aims:

  • to check whether your documentation meets all the requirements of the standard

  • to check whether all staff members are aware of both their role in the quality management system and the requirements of ISO/IEC 17025 that go with their role

  • to assess whether all procedures and processes of the standard are adhered to correctly

  • to check whether the technical activities (analyses, calibrations, etc.) are carried out as required.

To complete their inspection, your auditor will want to see all relevant documentation. They will also carry out interviews to test your knowledge of the quality management system and to get an idea of your vision. This can be a bit stressful, but as Miguel de Cervantes said: to be prepared is half the victory.

 

What happens after the audit?

After the audit, the auditor will decide whether you are implementing the quality management system correctly. The following results are possible:

  • In the case of an adverse opinion, you will receive a report containing minor and/or major non-conformities and points to work on. Often, you will have to request a new audit.
  • In the case of a qualified opinion, accreditation can take place only when the points listed have been corrected and an accompanying plan of action has been drawn up.
  • In the case of an unqualified opinion, your laboratory is accredited. You can apply to have your accreditation renewed every five years, the duration of the certificate's validity.

 

How do you prepare for an external audit?

These 4 tips will increase your chances of success:

  1. Carry out an internal audit, with or without external help, to track down any gaps and weaknesses. Incidentally, this is a requirement in an accreditation process. Auditors know this and will ask for your findings from the internal audit. Make a list of the steps you took afterwards and how they benefited the quality management system.
  2. Every lab gets feedback from stakeholders. Sometimes, this takes the form of complaints. Make sure that everything is documented according to ISO/IEC 17025 requirements. Also make clear which lessons you have learned from the feedback and how you have implemented them in your lab's daily operations.
  3. Your quality manual is the heart of your quality management system. Print out a number of copies beforehand, so that you and each of the auditors has one during the audit. Invaluable tip: do not give any original documents to auditors. Loss or damage is always a possibility, so make copies of all relevant documents.
  4. Your staff are the backbone of your lab. How well-trained they are is important for testing and calibration activities, so auditors will ask about any plans for training and goals in this area. Try and have the information to hand.
     

6. Training options for ISO/IEC 17025

The NBN organises training and learning pathways for ISO/IEC 17025 at centrally situated locations or at your place of business. It offers a customised programme:

You can see all the possible dates in our training calender. If you're not yet sure which course would suit you best, let us help you on the overview page of ISO/IEC 17025 training options.

If you would prefer to get to work on your own on NBN EN ISO/IEC 17025

Purchase the standard in the NBN online store. It will give you a summary of all the requirements for an effective quality management system for your lab at a glance.

 

Would you like to stay informed on the latest standardisation developments?

Register for our monthly newsletter