New targets for testing and calibration laboratories

The revised text of the standard for testing and calibration laboratories brings new features, but not everything is new. Certain sections of the text have been moved within the standard, as the previous specifications were good and recognized. The change was necessary because the structure of the standard was adapted to the ISO/IEC 17000 series of standards,

"The new standard requires a less formalistic test.").

which in each case follows the natural process flow, from planning to testing to control management. If a laboratory is already certified according to the ISO 9001 quality management system standard, it can use this management system and only has to update the technical aspects.

Other topics shape the standard
New in the standard 17025:2017 for testing and calibration laboratories is a stronger risk-based thinking. This means that laboratories must analyse and assess potential risks and take appropriate measures. Furthermore, the standard specifies the decision rules (so-called pass-fail decisions). This affects testing and calibration laboratories, which previously did not have to show what their decisions were based on. This is now different: the decisions must be justified and made transparent and the laboratory must know the risks of a wrong decision. An adjustment has also been made with the term impartiality replacing the term independence. Impartiality is the more appropriate term in the context of risk-based thinking. La- bors must therefore not allow themselves to be put under pressure, for example for economic reasons or due to an interconnection with the commissioning party.

Card index boxes are passé
But why was an adaptation of ISO/IEC 17025 urgently needed? Several national standardization bodies provided the impetus to revise this standard. The current standard from 2005 was outdated, since it originated from a time when card index boxes and calculators were still frequently used. Work on the new standard began in 2014. ISO's stringent project management made it possible to develop the new standard within the time frame specified by ISO. Around 150 international experts contributed to the text of the standard. During the public surveys in 138 ISO member countries, a total of more than 6000 comments were received, which had to be taken into account by the ISO working group. The final challenge was to formulate the contents in the working group in such a way that they were capable of achieving consensus.

Transition period well prepared
The International Association of Accreditation Bodies for Laboratories and Inspection Bodies (ILAC) stipulates that laboratories must have implemented the updated standard by November 2020. The Swiss Accreditation Service (SAS) has prepared well for the changeover and already provided new accreditation principles on 1 March 2018. By the end of May 2020, the SAS wants to have assessed all laboratories in Switzerland with regard to the new standard, so that the laboratories have sufficient time for any corrective measures and the two-stage review process of the SAS can be carried out properly. This ensures that all laboratories concerned will have gone through the accreditation process based on the new standard by the end of November 2020.

Fewer checklists, more personal responsibility
What is certainly new with regard to ISO/IEC standard 17025 is that the assessments are carried out using a risk-based approach and require a case-based assessment. Thomas Hilger, Deputy Head of Metrology and Engineering at SAS, states in this regard:
"The new standard requires a less formalistic assessment and puts the main responsibility on the laboratories themselves." And David Rais, lead assessor of the SAS, emphasises: "For us it is more demanding and more interesting, also because you have to delve deeper into the matter so that the assessments of the laboratories can be understood and judged".