A for ACCREDITATION
07. 02. 2024
All of us who work in the world of quality infrastructure (letter Q and I), which includes metrology (letter M), are familiar with the word accreditation. I have been dealing with it myself since my early days, back there at the turn of the millennium (letter T) – how interesting that those of us currently living (letter Z) can use the phrase “at the turn of the millennium” In fact, accreditation has been closely associated with me (letter J) throughout my career. So, it is no wonder that I chose this word (topic) to begin with.
Accreditation means official (including internationally recognized) approval to carry out a specific activity. Official refers to the fact that the recognition is carried out by an accredited organisation that is qualified to do so (letter U) and guarantees full independence and impartiality (letter N). In Slovenia, this is the public institute Slovenian Accreditation (www.slo-akreditacija.si). The European continent has a rule (law) that it has to be (letter B) a national accreditation body (NAB), which is non-profit and acts in the interest of the public (the system) and does not act in a competitive sense (the list of NABs can be found at www.european-accreditation.org – EA under MLA signatories). This is why each country in Europe has only one NAB, which dedicates the realised income solely to its own activities and to the development of the accreditation field. Cross-border activities are allowed only exceptionally, and at the same time only with the permission and cooperation of the domestic NAB. This is an international system, but the other continents do not follow the logic described above. For example, in quite a few countries outside Europe, there are several ABs (accreditation body), which in a way compete with each other. Of course, competition is welcome from many points of view, but it also brings with it some risks. Any system has to be balanced and has to provide both incentives and rules (the so-called “checks and balances” or, more popularly, the “carrot and stick”).
All organisations aiming to achieve accreditation as a goal (letter G) have to comply with very clear rules (given in standardisation). Accreditation is designed for different fields of work, so these rules are different too. ISO/IEC 17025 is aimed at calibration and testing laboratories and provides the basic requirements for a management system (letter S). So how such a laboratory should operate, how it should be organised, how it should train its staff (letter C), what premises, equipment, procedures (letter R), etc., it should have, and how it should maintain them on an ongoing basis throughout its operation. How it keeps it all in form (letter F), how it upgrades, develops, modifies and disseminates the whole system to the staff. Ultimately, this is an ongoing process, influenced by both external influences (e.g. changes in standards) and internal influences (e.g. growth of the organisation, change of staff, equipment, premises). That’s why understanding the rules, the requirements if you like, is very important. Most often I find that the understanding, the rationality of the requirements is unclear, incomprehensible. It is particularly problematic to understand why a certain requirement is written into a standard, because there is always a logical explanation. No requirement is illogical, no requirement is written unnecessarily. And each laboratory implements the requirements in its own way, normally in the Quality Manual (letter P). Because the rules in the form of requirements are only “what” is required, but the standards do not talk about “how” something should be implemented. It is up to each laboratory to draw up its own documentary system describing how it will work.
Once an organisation has assessed itself as meeting all the pre-known conditions, it can apply for the accreditation process. This is followed by an assessment (audit) by the AB, where both the systemic part (management) and the technical part (work processes) are assessed. The assessments are carried out by professionals who are experts in their field. If an AB expert identifies a deviation from the rules, they write down the non-conformity (letter X), which the organisation has to correct (take action) and demonstrate the appropriateness of the change in its work (letter D). So, it is a professional process of determining compliance with the rules of the game. Finally, the organisation receives an accreditation certificate, together with an annex detailing what the organisation is accredited to do. It means that it is officially recognised to carry out specific activities.
To try to put it a little more simply. An organisation that decides to calibrate (letter C) weights (letter W) has to satisfy a number of rules. If it has never encountered this before, it will probably take at least 2 years to implement. A management system needs to be put in place, which means a documented management system. How we behave in relation to everything the rules say. In fact, everything we do in our work. The organisation should purchase all necessary equipment to meet the requirements of the standards in the field of weight calibration (the most commonly used standard for weight calibration is OIML R111-1). This means all the measuring and auxiliary equipment, consisting at least of a reference standard (letter E) (a weight of known mass), a balance (to determine the mass or the difference in mass between the reference weight and the weight to be calibrated), an instrument to monitor the ambient conditions in the laboratory (to determine the density of the air, since the determination of mass depends on the buoyancy of the air), the laboratory (air-conditioned room with weighing tables to ensure a sufficiently low level of vibration), the software (for the calculations and the generation of the calibration certificate) and the equipment for handling the weights (since the weights shall not be handled with bare hands, as this would imply a change in mass, which would be pointless). Furthermore, it must ensure that the equipment has adequate metrological traceability (the reference etalon should also be calibrated to a higher level, which in our case means that the weights are sent annually to the Metrology Institute of the Republic of Slovenia, which in this case is the higher level laboratory), ensure the validity of the results (e.g. by comparison with other higher level laboratories), and ensure that the staff performing the calibration have adequate skills and know-how. Of course, there are many details, methods, tools to be put in place, but these are details. And yes, the devil is in the details.
Most of you are familiar with the certification process (for example ISO 9001), which is to some extent similar to accreditation, but at different levels of complexity. The ISO 9001 certificate that an organisation receives is at the same level as the calibration certificate issued by LOTRIČ Metrology (letter L) or any other accredited calibration laboratory. Of course, we are talking about a different type of activity, but nevertheless the certification body issuing the ISO 9001 certificate is also accredited by AB (except that the rules for certification bodies are described in ISO/IEC 17021-1 and not ISO/IEC 17025). The scope of the assessment is also inappropriately different. While ISO 9001 certification at LOTRIČ Metrology takes 1-2 days of assessment each year, accreditation takes 20-30 days of assessment each year. The important difference is that during these days just as many experts are rotated, each covering their own area of expertise. Yet the accreditation system means to our customers (the letter K) that we are trustworthy. This is confirmed by a third independent organisation (AB) which is internationally recognised. In fact, we can say that the calibration certificate issued by LOTRIČ Metrology and bearing the Slovenian Accreditation logo is internationally recognised. Moreover, the measurements stated on this certificate have guaranteed metrological traceability, which means an unbroken chain of comparisons up to the definition of the basic unit of measurement.
Finally, I have the utmost respect for everyone who has ever defended accreditation. That is what we call it in the profession. To defend accreditation. I still remember very well my early days when I didn’t sleep for a day or two before an accreditation visit (AB). It’s different nowadays and I have to say that when you accept that all the rules are just there to help you, you sleep much easier. And the day of the assessment is actually a day for learning. It’s a day for responsibility (letter O). The first ten years it’s a bit harder, then it gets easier. After all, I am very fond of saying that after a year you realise that you have no idea. And that’s when school starts. If you are grateful (letter H). Love it or hate it. That is the only question.
Primož
Next time, 21 February 2024, (to) BE