Accreditation – a driver, making system of technological regulation work
- Good afternoon, dear Dmitry Aleksandrovich, dear colleagues!
I am grateful for opportunity to make a speech today at this conference as Russian Business Week is a significant annual event within which the key problems facing economy of our country are discussed. Today's event is especially significant for me because it takes place while we have something to tell about the Russian system of accreditation.
In order to characterize the current situation in this system, let me give the following comparison. Let us imagine that technical regulation is a car. The car will drive only if there is an engine. I would just compare accreditation with this engine, which makes the system of technical regulation work. If there is no accreditation, the car will not drive. If we develop this idea further, I would say that Federal Accreditation Service is being repairing this engine two years and subsequently creates the new one. Today we can already tell that we have come to the finish line. The new engine – new accreditation system – will be implemented into the car of technical regulation on July 1, 2014. And in my report I would like to emphasize those basic things which characterize the new accreditation system that have been created in Russia.
First of all, it is required to name the bases of this system without which it cannot exist. First, it is normative legal acts. The absence of appropriate regulation long time tied our hands. The Federal Service for accreditation, as well as any other public authority, cannot carry out any actions in case of lack of legal basis for work – legal basis for carrying out appropriate examinations, for accountability of the experts who are unfairly carrying out the duties, for suspension of activity of unfair market participants. Currently, such legal basis has been created and stated in the law “On Accreditation", which comes into force on July 1, 2014.
The second element, which the system of accreditation is based on, is information infrastructure. The Russian accreditation system includes more than 10 thousand accredited entities, that should constantly interact with RusAccreditation. It is possible to carry out this interaction also on paper, however, I have already said that this process will be very difficult due to a huge number of documents. In order to collect materials of one state service or inspection, it is necessary to load the car “Gazel” with papers. It is clear, that in the 21st century it is impossible to work in such a way, first of all, due to the fact that such work demands huge human resources and time costs. For minimizing these costs and in order to work maximum effectively, we have created and actively put the required information infrastructure.
The next major factor, defining high-quality work of accreditation, is interaction with the public. Any public authority will not be able to work effectively if behind it there is no normal public control. Now we can safely tell that the Public council at Federal Accreditation Service is not only created, but already successfully works. Moreover, the Public council has been created not only as a certain base, but as a number of platforms for discussion of the major issues within such a base. Consequently, the third meeting of the Council will take place next week, whereat reports of work of the operating experts and working groups will be submitted.
And, at last, the fourth element, without which full functioning of accreditation system is impossible, is the international cooperation. In activity of RusAccreditation much attention is given to this issue as the accreditation system in one state does not meet modern challenges and requirements.
Now let me shortly tell about characteristics of new accreditation system in Russia, its main components and differences from old system.
I’ll begin with features and differences in procedure of obtaining accreditation. First, accreditation becomes termless. It means that there is no necessity for accredited entity to pass the procedure of obtaining the new certificate. The "paper" certificate of accreditation in general will become non-obligatory. If someone wants to receive the certificate of accreditation on paper, he can make the corresponding inquiry into RusAccreditation and we will issue this certificate. However, the key factor confirming accreditation existence is a registration of the accredited organization in the register of the accredited entities.
To continue being in this register, the accredited person shall undergo the competence confirmation procedure within certain intervals. According to the international standards, it should be carried out in the first year of work and each two years further. Let me emphasize that competence confirmation is a duty and a task of the accredited persons. In the framework determined by the law it will be possible to choose convenient time and convenient form, to combine the process of competence confirmation with process of expansion of accreditation area. In other words, the most flexible system was created in order make convenient for the accredited entities to address to us both on time and from the point of view of integration of functional and other resources.
What else should be noted about features of accreditation procedure? The new accreditation system is characterized by detailed requirements to 13 types of the accredited persons. This is a new word in the legislation. Earlier, as you know, detailed criteria of accreditation were established only for certification bodies and testing laboratories. Now criteria are differentiated and it is very important because we actually come to consolidation of different types of accredited persons and this did not exist earlier in the Russian legislation. The list of types of the accredited persons will include not only certification bodies and testing laboratories: it will include both inspectorates, authorities for certification of the personnel, bodies for certification of management systems and others.
In addition, the accredited persons will get some kind of right to correct mistakes that is very important as well. If within procedure of accreditation or competence confirmation any problems are revealed, the accredited person is given the chance to easily and quickly correct them without refusal in accreditation or cancellation of the certificate.
At last, one more important innovation is creation of a new institute – the appeal commission, to which those entities, who are dissatisfied with results of our work, could address with complaints. The appropriate specific question will be considered jointly.
What else should I say? The most important part of work of RusAccreditation is interaction with experts, who help to estimate the competence of accredited persons. Two key requirements, in my opinion, are imposed to experts: professionalism and responsibility. Without this the system will not work. Thus within three years after coming into force of accreditation law all accreditation experts shall pass recertification in our Service.
Appearance of the new participant of accreditation system, who existed in practice earlier, but was not fixed in the legislation, should be referred to the number of important innovations of the law as well. These are the expert organizations which will be organizationally responsible for work of experts. There are new requirements for terms and for the required cost of expert services. Techniques of cost formation of experts services will be defined by the Government and anyone, who will request for the services exceeding the established limit cost, will be obliged not only to pay money back under accreditation law: he will be brought to administrative responsibility. The relevant amendments to the Code of Administrative Offences have been already prepared.
In addition to accreditation procedure, changes established by law concerned the supervision as well. Control procedures of RusAccreditation is the subject causing the greatest number of questions. For example, we are often asked: "Tell us when, at last, the situation with false certificates disappear?". A problem is very sharp and it is impossible to solve it in one stage, but already now we feel the results of our work in this field. Let me provide you with several figures. Only during January and February 2014 accreditation of more than 220 organizations has been terminated. Accreditation of more than 100 organizations has been suspended. When we talk to people who work at the certification market, they tell us that actually false certificates are issued not by certification bodies, but by special intermediary firms, contacts of which can be found in the Internet. And there is a very important item. Law enforcement agencies should join the fight against such firms as this sphere is already uncontrollable for RusAccreditation. These are swindlers who forge documents. I will give an example. Recently I held a meeting of the personnel commission in our Service. The woman came to take part in our competition and told that she worked in intermediary firm between the market and certification body. She said: "I want to leave because, unfortunately, recently it became difficult to work". I asked her, why. She answered: "Earlier people came to us asking to find such certification body in which it would be possible not to select samples, not to carry out test, and we easily solved this problem because our services were demanded. And now we address to those bodies, with which we worked with earlier, and they say that can not issue certificates of conformity without samples and without tests any more. Therefore we cannot satisfy requests of the market for search of such organizations". And these are visible results of our work as well. However, in this field there are still a lot of things that should be made.
What else should I note? We introduce obligatory reporting of the accredited persons in our electronic system. It means that activity of the accredited persons for us will be transparent both from the point of view of particular procedures for certification but from the point of view of carrying out tests as well. This, in its turn, will help us to pass from total control of all accredited persons to the aim, dot control based on the analysis of the existing risks.
Moreover, we receive more bases for carrying out inspections by law. In particular, the mentioned analytics will become one of such bases. From the other side, we will apply more seldom the measures dealing with accreditation suspense. Now we are obliged to take the appropriate actions in case of each revealed violation. In the future we will pass to new model according to which the actions will be taken when there is a real danger. If the organization is ready to quickly eliminate defects of the work and these shortcomings are insignificant, there is no sense to suspend its activity.
In conclusion, I would like to tell you about one essential detail concerning the supervision. An important innovation in this field is emergence of responsibility both of the expert organizations and experts for the unfair conclusion, for unfair work. Now, for example, more than 30 experts out of 500 are deprived of certificates due to violations in their activity. It is an important indicator as well.
I shall also tell how work in RusAccreditation will be organized. Implementation of information system, about which I told at the beginning, will facilitate not only collecting the reporting from the accredited persons, but will also simplify our internal processes as well. This information system which is global will allow us to refuse papers in work of the Service and in interaction of the Service with experts and the accredited persons. We shall admit that the system is complicated and it is difficult to introduce it. We constantly conduct monitoring of its operation with certification bodies, we constantly improve it and we hope that since July 1 the system will work perfectly.
In addition, one of the major processes currently carried out in RusAccreditation is introduction of management system. It is both internal and external task as the results will be asseessed by representatives of ILAC and IAF.
I have already mentioned Public Accreditation Council and its working and expert groups, in activity of which I urge everybody to participate actively. We now recognize everyone, who wishes to join these platforms in addition, shall be provided with such an opportunity.
Just a couple of words concerning the international cooperation. It is very important, especially within today's conference to tell about results of this cooperation within CIS. I consider that in this field there has happened some kind of historical event. Seven states: Armenia, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Ukraine signed the document on creation of regional association of accreditation bodies of the CIS countries. This memorandum was signed in January and now RusAccreditation comes to the particular organizational measures directed on creation of such regional association. For us work within the Customs union is the same importance because we constantly receive questions from certification bodies and testing laboratories, and we by ourselves, analyzing practice, come to several offers. I would like to thank Valery Nikolaevich Koreshkov and all his colleagues for preparation of the system aimed at staff quality improvement. It is a very significant work wherein we will take part with pleasure. One of the main directions of our work is joining to ILAC and IAF. In this area we actively work with accreditation experts of the European organization for cooperation who not only examine the law "On Accreditation", but are currently considering drafts of regulations prepared within its adoption, which become effective in July.
At last, one of the most important activities of RusAccreditation is implementation of Good Laboratory Practice System (GLP). This subject, which directly is not connected with accreditation, is very important for the laboratories which are engaged in preclinical testing. RusAccreditation has been recently obtain the power of GLP monitoring authority and already now we have the first applications from laboratories for recognition of their compliance with GLP principles.
At the end of my speech, I would like to say that the last step to be made until July 1, is connected with adoption of a package of bylaws. I would like to take an opportunity and to ask all participants of the conference to take part in discussion of these projects. Over 20 drafts of regulations are published on the website of RusAccreditation at the moment. I ask everybody to study them and to make the offers and suggestions because it is the final stage of creation of new accreditation system and we have to pass it most effectively.
Thank you for your attention.
Savva V. Sipov
The Head of RusAccreditation