I for INFRASTRUCTURE of QUALITY
11. 06. 2024
Standardisation is the harmonisation and adoption of standards – norms that prescribe minimum requirements in some way. Standards are not mandatory, and we are talking about the so-called voluntary use of standards, unless they are made mandatory by a legislative framework, which can in a sense be considered as falling within the scope of standardisation in this respect. In the European Union and beyond, we call them harmonised standards. The advantages of standardisation are primarily from the point of view that the requirements are the same for everyone. So that a customer can buy a product (if we are talking about a product, the same can also apply to services and systems, but I am focusing on products here), anywhere and from anyone. So, if a manufacturer manufactures a product that meets a standard, and if a buyer wants a standard product, in principle both have a lot of advantages. The manufacturer has a bigger market, somehow knows how to make the product in such a way that there are no health and safety issues … while the buyer probably gets a certain level of quality. We would also expect the price of this type of product to be lower, because by making a larger quantity, the manufacturer can make the production process better, more efficient … but this is not necessarily the case, but it is more likely.
Standards are a kind of rules. They are the professionally agreed, harmonised and published rules of the game on the recognised and important aspects of a product. About how a product should be made or designed or how it should perform or how it should protect health or how it should be protected for safety or whatever. Standards are basically about defining the aspects of a product that are safety and health related, that are functionally important, that allow connectivity … it is about some kind of standardisation of a product so that it can be incorporated into an assembly, it can be connected … Standards can be internal (agreed at manufacturer level), national (agreed at country level), regional (agreed at regional level) or international (agreed at global level). There are many aspects that are described in the standards, yet they want to give manufacturers as much freedom as possible to develop, design … the product. On the one hand, standards prevent products from evolving in any direction, while on the other hand they allow products to be standardised in order to better protect the customer, to give them easier access, more choice … Standards change over time, just as technology changes, technological developments, advances, new insights. Yet standards do not change as fast as developments change. It is a principle that standards change every five years or so, if there is a need for change.
Certification, the second pillar, ensures that products actually comply with the rules of the game set by standardisation. These procedures may also have specific names in different areas, such as homologation in the area of vehicles, such as conformity assessment in the area of products, such as accreditation in the area of conformity assessment bodies … Depending on the risks associated with the product, the legislator opts for different schemes. In the European Union, we talk about conformity assessment modules. Module A, which represents the lowest level of risk, is subject to a so-called “self-declaration”, where the manufacturer assesses conformity himself (carries out the certification process). Furthermore, Module B is the so-called “Type Certificate” (formerly known as the “Attestation”). These products are in a sense already risky, at least from a health and safety point of view. In principle, the type-examination should be carried out by an independent third party – i.e. an organisation that is not in any way linked to the product. It is independent because it has to make an impartial assessment of the conformity of the product. In the European Union, these are Notified Bodies. If a Notified Body has been involved in the certification process, the four-digit number of the Notified Body is displayed on the product, which anyone can check on the Nando website. The most risky products should have, in addition to the type examination, an additional control of the production process. This is arranged in various ways, with the Notified Body checking at least annually, in one of the prescribed ways, that the manufacturer has actually produced (is producing) the products as they were subjected to the type-examination. The stability of the production process is checked. Any change should be notified to and verified by the same Notified Body. The primary purpose of the certification procedure is to verify and assess the fulfilment of the requirements (conformity assessment) laid down by standardisation for a product. The CE marking, which is a European Union marking, means that the essential requirements of European legislation relating to a product have been met. In order to carry out the certification process objectively (impartially), it is necessary to obtain evidence of compliance with the requirements.
This is where the third pillar, metrology, comes in. Metrology is the science of measurement. So, if there is a required property for a product that can be measured, then this is done in the testing process. A test is the process of determining one or more properties of a product (which can also be a material, raw material… any sample). Testing is also basically carried out according to the same principles as certification. The rules of the game (product requirements) are set within standardisation (or legislation). In the European Union, there is a so-called presumption of conformity, which states that if a product conforms to a harmonised standard, then it is consequently in conformity with the legislation. Products for which harmonised standards exist (far from existing for all products) can be certified and tested under a simplified procedure. This in no way means that a product does not have to meet strict requirements. There are no shortcuts here. Metrology deals with other professional tasks, so testing serves here as an example of application. Metrology is concerned with measurement at all levels, from the primary level, where we talk about the definition of units of measurement such as metre, kilogram, second, kelvin, mole, candela, ampere, derived units of measurement, prefixes to units of measurement, etc., right down to the transfer to lower levels of measurement. At the highest level, the BIPM, or the so-called National Metrology Institutes, operate. At the end of the day, you make a measurement with a balance, a tape measure, a dial gauge, a torque wrench, etc. If the properties are determined by testing, the measuring instruments shall be calibrated. The calibration process shall establish the actual condition of the instruments. By comparing the reading of the gauge with a reference value (etalon) under specified conditions, the error of the gauge reading is determined. The calibration process provides each user with the state in which his instrument is located. Simply put, by calibration the user will know how much his gauge is reading wrong.
While all products are subject to a pre-market conformity assessment (before the manufacturer can even put them on the shelf), those with safety concerns over time are also subject to a periodic inspection. There are a number of such products, probably the best example for any individual is vehicle roadworthiness tests. Every vehicle owner is required by law to have his vehicle checked every so often. In Slovenia, the system is 4-2-2-1-, which means that you have to take a new vehicle for an inspection after four years (with a few exceptions), then the sixth and eighth year, and then every year thereafter. There are a number of other products that are subject to periodic inspections, but you wouldn’t know it unless you were directly involved. Every passenger lift in a public institution or multi-residential building has to be inspected annually. Every crane has to be inspected when it is installed. All pressurised equipment where the hazard level is high. All measures used for invoicing have to be periodically verified by law (a special term is used for measures) – you have such measures in your home. Water, electricity or heat consumption meters are legally verifiable measures. The scales in the grocery store where you buy your fruit or vegetables are periodically verified by law at least every two years. The fuel flow meter at a petrol station is legally verified at least every two years. Last but not least, vehicles transporting temperature-sensitive goods have to be inspected regularly. And a whole bunch of other equipment, apparatus, machinery, etc.
All this and more is the infrastructure of quality behind the scenes to make sure everything runs as it should. In principle, as users, you do not wonder whether you are getting the right amount of fuel, whether you are getting the right quality of fuel. Because there is a sufficiently reliable system that takes care of that for you, so that there is a high probability that the aforementioned is the case. The system is working, so not many people question the adequacy of the system. Of course, the system is not faultless, as none is. Yet the infrastructure of quality seems to be a strong enough system that it is not questioned too much.
Primož
Next time, 26th June 2024, ME (I see, hear and speak)