Quality infrastructure of the global market and the role of accredited laboratories

Transcription

1 Presenter: Stajdohar-Paden, Olga Quality infrastructure of the global market and the role of accredited laboratories Author: Stajdohar-Paden O. Energy Institute Inc, Zagreb, Croatia Abstract: The most important activity for the prosperity of every economy is the exchange of goods and services. Nothing happens until somebody sells something to somebody else. The more often, the better. In order to facilitate that exchange of goods and services, every country must ensure complete trust between sellers and buyers. The buyer must be convinced that what he or she buys is safe and of declared quality. And that is why in the past as well as nowadays, there always has been established a certain quality infrastructure. Laboratories play important role in safety and quality of products appearing in the global market and in achieving confidence and trust between suppliers and consumers. That s why it is also important to have confidence into the test reports laboratories issue. This leads us to the accreditation of laboratories, for instance according to the internationally recognized standard ISO/IEC The article shows the modern quality infrastructure, place and role of each participant in it with special attention to the accreditation and accredited laboratories. Key words: quality infrastructure, global market, laboratory, accreditation, technical competence 1. Introduction The most important activity for the prosperity of every country is the exchange of goods and services. Nothing happens until somebody sells something to somebody else. The more often, the better. When selling-buying transaction takes place, many positive things happen, too: the buyer gets what he needs the seller gets the money he can use to purchase something else, to pay his suppliers and employees, to invest in the new production the state gets taxes which can be used for many purposes, investments in roads and railways, social security and healthcare of citizens, culture, sports and so on. So, a vivid exchange of goods and services is in the best interest of every country. In order to facilitate that exchange, every country must ensure complete trust between sellers and buyers. The buyer must be convinced that what he or she buys is safe and of declared quality. And that is why, in the past as well as nowadays, there always has been established a certain quality infrastructure. Quality infrastructure as a notion is relatively new. It relates to the whole network (or sometimes a patchwork) of laws, regulations, standards, institutions and bodies organized in such a manner to support the trust of buyers and exchange of goods and services. One of the possible ways to present the quality infrastructure is shown in the Figure Quality infrastructure in the past Many, many years ago, before the so-called globalization, it was easier to obtain the trust between seller and buyer. People used to live in smaller communities and they used to manufacture goods mainly for them-selves. Food, clothes, tools, furniture, houses, everything was home-made. If they ever had to buy or sell something, it was to, or from, their neighbours, friends and relatives. The trust was automatically obtained. Every shopkeeper or craftsman in a medieval city knew, if he cheated on scale or sold spoiled goods, his cocitizens would firstly stop buying from him, then cover him with tar and feathers and push him out of the city. He would lose everything.

2 3. Modern quality infrastructure Nowadays, the situation is completely different. The goods are manufactured thousand of kilometres far from our homes, they are manufactured by people we have never met and we never will. The goods are then transported by trucks, rails, ships or airplanes, stored and kept in who knows what kind of storerooms, placed on the shelves of our shops and we, as consumers, have very limited insight into the whole process. Figure 1: One possible presentation of modern quality infrastructure [1] Declarations on products are so tinny, one can barely find out the land of origin in it. If a declaration says it is 100% cotton, how do we know it is? If it says it is without artificial colours, how do we know it really is? The reality is that we, as consumers, have no choice, we simply trust or don t trust the declared quality and safety. And in spite of that, we do buy many things every day. Generally speaking, we may say, we as consumers trust the established quality infrastructure. We believe that somebody takes care and controls the safety and quality of products which can be freely purchased on the market. And we are right somebody does. Yet, better to say, many people and many institutions do take care. Take a look at the Figure 1. As we ve already said, the main relationship and the driver of the economy of every country is the relation between the seller and the buyer. The seller is greedy and wants to earn as much as possible, the buyer is avaricious and wants to save as much as possible. No trust, no business. This relationship is regulated by laws and regulations, more and more accent is given on manufacturer responsibility for his products put on market, on requirements for general safety of products, and of course, market surveillance plays an important role in obtaining the trust of buyer. It is common to say nowadays, we do not trust people, we trust papers. And it is true, but also, it is logical. Since we do not know personally the people who manufactured the product we want to buy, we trust certificates and declarations. We trust them because these certificates issued by certification body are not issued out of nothing; they are issued based on some testing and examination done by laboratories. And these testing laboratories use some testing equipment which should be adequately calibrated in competent calibration laboratories.

3 Figure 2: Accreditation of certification bodies [2] In order to trust testing laboratories, calibration laboratories, inspection and certification bodies, somebody independent has to confirm their competence, and this is accreditation body. In every country of European Union, there are many certification bodies, inspection bodies and laboratories, but there is only one accreditation body. The Figures 2 and 3 show the areas of accreditation and standards by which the accreditation is done. These standards are listed under the Literature of this paper. Figure 3: Accreditation of laboratories and inspection bodies [2]

4 Certification bodies can be accredited for certification of products, persons, quality management systems, environmental management systems and eco-management audit schemes. Laboratories can be accredited for testing, calibration or as medical laboratories, inspection bodies can be accredited for various inspection activities. To avoid retesting of products when they are exported to other countries, accreditation bodies sign multilateral agreements on mutual accepting the accreditations they perform (see Figure 4). That means, the certificates and test and inspection reports of the accredited bodies are valid in other countries and the idea of tested once, accepted everywhere is realized. This is one part of removing technical barriers to trade. Figure 4: Signatories of multilateral agreements of The European cooperation for Accreditation, state on [2] To have a complete picture of modern quality infrastructure, we have to mention standards. Standards are documents prepared by technical committees working at international and national standardization bodies. Technical committees consist of representatives of all interested parties manufacturers, consumers, laboratories, regulatory bodies. Theoretically speaking, every standard is a balance among all interested parties and gives the best possible solution for the current state of art. But in reality, only big manufacturers can support their experts to participate in the standardization work and those experts have only one task to push into the standard the requirements their factory can obtain and to obstruct putting into the standard a requirement their factory cannot fulfil yet. A standard is a weapon and a shield. Standards are all around us, as for instance in the Figures 5 and 6. They are very useful in many senses, they facilitate the agreements there is no need to put all technical details into the agreements and contracts; and they facilitate our lives. Every credit card fits into every cash machine, every memory stick fits into USB slot of every computer, batteries and light bulbs can be interchanged, even cellular phone charger in Europe have to be standardized by the year 2012.

5 Figure 5: A part of a promo brochure issued by CEN and CENELEC on standards for recreation activities [12] The world with standards is like a well organized hotel you don t notice kitchen, cleaning ladies or garbage disposal. In a world without standards you certainly wouldn t like to live.

6 Figure 6: A part of a promo brochure issued by CEN and CENELEC on 20 years of New Approach and CE marking [12] 4. Role of the accredited laboratories Laboratories play an important role in safety and quality of products appearing in the global market and in achieving confidence and trust between suppliers and consumers. As we can see in the Figure 1, they are in the foundations of the quality infrastructure. If we pull out the laboratories, the whole quality infrastructure is falling down. So, that s why it is important to have confidence into the test reports laboratories issue. And this requirement leads us to the accreditation of laboratories, for instance, according to the internationally recognized and accepted standard ISO/IEC [9]. Accreditation is a process through which laboratories have to prove they: operate a management system for quality, administrative and technical operations [9] are independent, impartial and maintain integrity in their operations are technically competent issue technically valid test results. Technical competence includes: competent personnel adequate accommodation and environmental conditions adequate test equipment, calibrated and maintained adequate test methods, validated, implemented adequately estimated measurement uncertainty reporting the results in an agreed manner, with all relevant data included. Accreditation certificate is usually given for a period of five years with a yearly scheduled surveillance audits. It is important to point out that an accreditation body takes no responsibility for the test results issued by its accredited laboratories. By an accreditation certificate given to a laboratory, the accreditation body only confirms that the laboratory is competent to issue technically valid results. Whether the laboratory will issue technically valid results each time, it is the responsibility of the laboratory.

7 5. Conclusion A vivid exchange of goods and services is the driving force of progress and prosperity of every country. That exchange cannot be achieved without trust between the buyer and the seller. The buyer must believe that the desired product is safe and of the declared quality. In order to achieve that trust in this modern world, where the seller and buyer do not know each other personally, it was necessary to develop a whole new infrastructure of laws, regulations, institutions and documents, it was necessary to develop a new quality infrastructure. Laboratories form the fundaments of the quality infrastructure and it is necessary to trust their test reports. Accreditation of laboratories is a tool to prove technical competence of laboratories and as such it is also a tool to facilitate the world trade. Literature: [1] O. Stajdohar-Paden: book Plivati s ISO-om i ostati živ Što je kvaliteta i kako njome upravljati u poslovnom i privatnom životu, issued by Kigen, Zagreb, 2009 (title To swim with ISO and stay alive What is quality and how to manage it in business and private life ) [2] official web pages of The European Cooperation for Accreditation [3] ISO/IEC 17011:2004 Conformity assessment -- General requirements for accreditation bodies accrediting conformity assessment bodies [4] ISO/IEC 17021:2006 Conformity assessment -- Requirements for bodies providing audit and certification of management systems [5] ISO Guide 65:1996 General requirements for bodies operating product certification systems [6] EN 45011:1998 General requirements for bodies operating product certification systems [7] ISO/IEC 17020:1998 General criteria for the operation of various types of bodies performing inspection [8] ISO/IEC 17024:2003 Conformity assessment -- General requirements for bodies operating certification of persons [9] ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories [10] ISO 15189:2007 Medical laboratories -- Particular requirements for quality and competence [11] Regulation (EC) No 761/2001 of the European parliament and of the council of 19 March 2001 allowing voluntary participation by organisations in a Community eco-management and audit scheme (EMAS) [12] Olga Stajdohar-Paden s basic education is electrical engineering but since many years she has been involved in quality issues. She became the quality manager of the first accredited laboratory in Croatia while it was preparing for accreditation in the year She actively participates in domestic and international conferences and seminars as organizer and presenter and is the author of many published articles. She participates in standardization at Croatian Standards Institute. She is the author of a book To swim with ISO and stay alive What is quality and how to manage it in business and private life. She believes in life long learning and takes every opportunity to improve her knowledge and skills in many areas.