January 20, 2017
At the end of 2016 international experts from Asia-Pacific Laboratory Accreditation Cooperation (APLAC) granted a positive assessment of the Federal Accreditation Service work concerning the accreditation of calibration and testing laboratories and centers. After the completion of all audit procedures, we can expect that Russia will become a Full Member of the International Laboratory Accreditation Cooperation (ILAC) in autumn and join the Mutual Recognition Arrangement. This will allow providing test reports obtained in accredited Russian laboratories as evidence for certification in many countries throughout the world. The Head of the Federal Service for Accreditation Aleksey Khersontsev told the journal “Economy and Life” about what is necessary and what will help Russian business.
“E&L”: Aleksey Igorevich, APLAC and ILAC – what are these organizations and why is Russia looking forward to joining them?
Aleksey Khersontsev: The global system of accreditation was formed in the last thirty years of the last century. Accreditation is a procedure when an independent body confirms the competence of other independent bodies following inspections of the properties of certain facilities and processes. We are talking about the certification bodies and testing laboratories. The purpose of accreditation is to build trust to the results of tests and inspections they conduct.
For example, let’s take laboratories that test product samples. When measuring, they use the objective laws of physics and chemistry. It is assumed that the result of the studies carried out by different laboratories should be the same or at least comparable. But in order to achieve this, labs must use the same or comparable methods and use similar management procedures. To confirm that a laboratory uses and correctly applies such methods and procedures and has all necessary equipment, we carry out its accreditation.
It would be expensive and inefficient to check laboratories of all countries from a single center. Therefore, the world's leading players once agreed that the competence of a laboratory located in one of the countries will be proved at the global level if its national accreditation is conducted in accordance with international requirements and global participants have confidence in the national authority for accreditation in this country.
Thus, a multi-level mechanism for regulating testing and certification was established. ILAC performs its activities within this framework. This is an organization that unites the accreditation bodies of the countries throughout the world that are engaged in the process of accreditation of testing and calibration laboratories.
ILAC assesses national accreditation bodies by delegating this task to regional cooperation bodies, for example, the European Accreditation Organization which unites European bodies, or the association of the national accreditation bodies of Asia-Pacific region APLAC.
Russia prefers to enter ILAC through membership in APLAC and join the Mutual Recognition Arrangement within this organization. As soon as we become member to this arrangement, we will automatically be able to join the global Mutual Recognition Arrangement within ILAC.
Now Russia is already a member of APLAC, but has not yet joined the Mutual Recognition Arrangement for this organization. We will be able to do this after the elimination of minor shortcomings identified during the audit and obtaining a positive conclusion. The official accession to APLAC Mutual Recognition Arrangement takes place at APLAC General Assembly, the next one is scheduled for June 2017. In case of a positive decision and accession to the arrangement, RusAccreditation without any additional assessments will join the Global Recognition Arrangement under the auspices of ILAC.
“E&L”: Why do we join ILAC through membership in the Asia-Pacific Association and not in the European Union?
Aleksey Khersontsev: First of all we assessed the terms of the procedures and then considered that APLAC includes the largest economies, its participants are our long-standing trading partners. At the same time, some members of the EEA, for example Belarus, went to ILAC through the European Accreditation Organization (EA).
“E&L”: How are certification activities in the world regulated?
Aleksey Khersontsev: Certification is understood as the activity of independent bodies that conduct an audit and shape an opinion on the conformity of products and production organization systems with established requirements. For example, certification of a quality management system or environmental management is now in demand.
It's a myth that it’s easy to establish a certification body: a table, a chair, a printer - that's the whole body. This requires qualified personnel. After all, most certification systems proceed from the fact that the testing expert works "blindly" - which means that the certification body should properly select and transfer samples to the laboratory in such a way that the reliability of the results is ensured. For all such procedures standards and requirements have been worked out.
Inspection bodies are one of the varieties of accredited persons. For example, in the context of contractual relations such a body may be engaged in pre-shipment inspection or monitoring construction. The inspection bodies satisfy the need for a third independent party that would ensure control over the other parties' compliance with the conditions and would be more competent than the customer. Certain requirements and standards for the work of such inspections have also been developed.
Thus, the accreditation system confirms the correspondence of the widest range of bodies engaged in direct assessment of the conformity of specific processes and objects. To perform all these functions at the global level, there are standards for accreditation bodies activities as well as standards for accredited individuals activities.
This global competence-building system is based on the work of two organizations: ILAC, which regulates the field of instrumental assessments, laboratory and metrological research, and the International Accreditation Forum (IAF), which unites certification bodies in the field of accreditation. At the national level in different countries, accreditation is performed either via single body, as in Russia, or several bodies. But the world tendency is developing towards uniting all accreditation process in one body – such a system exists now in many IAF and ILAC countries.
EA unites the accreditation of testing and metrology laboratories and certification bodies. In Asia and the Pacific, these functions are divided. The Pacific Accreditation Cooperation (PAC) unites the national accreditation systems for certification bodies.
Now we are preparing documents in order to obtain the government's permission for membership in PAC, so that we can proceed to the IAF International Forum after the assessment procedure. According to the procedure for joining the IAF, Russia also has to go through the assessment as a regional organization.
“E&L”: Do you suppose the joining procedure to PAC will be harder or easier than to APLAC? The technical part in Russia is usually stronger than the organizational one, besides the certification market is strongly contaminated by organizations that issue fake certificates, which can prevent the international recognition of the domestic accreditation system for certification.
Aleksey Khersontsev: The key requirement for test laboratories is the correct organization of work: management system, availability of competent personnel, correct definition of what the laboratory can and what cannot measure and test. Not all the laboratories in ILAC member countries have the most up-to-date equipment of the necessary range. It is important that they observe the principles of organization, which allows them to produce a reliable result.
In Russia, the introduction of such standards began not so long ago. This does not mean that we had bad labs. But compliance with standards will make the results of their activities comparable with laboratories in other countries.
As for the certification bodies whose work does not meet civilized requirements, within five years of RusAccreditation activities about 3,000 persons were removed from the market: they either stopped working themselves or their activities were terminated by supervisory methods. Now the Federal Service for Accreditation pays special attention to about 100 accredited persons. Now it’s not quite clear in which areas of accreditation they work as printers, evading the necessary conformity assessment procedures, and in which they actually certify and affirm the results. In total, about 970 certification bodies and 6200 testing laboratories are accredited in Russia.
One of the problems associated with the activities of dishonest certification bodies is that demand creates supply. Those who want to raise money quickly and receive documents try to get around the rules. If some tests are to be conducted for several months and at the same time there is an offer to issue a certificate for a couple of days, an unscrupulous manager of the manufacturer or importer can go for it because for him it is a completely different solution from the economic point of view.
In many cases manufacturers, importers, employees of such companies are aware that their products are not certified or certified in a negligent way and should share responsibility.
Unfortunately, there is no substantial practice of bringing to criminal or other responsibility those who openly cheat and create a negative atmosphere for certification activities. RusAccreditation has only such a tool as fines in relation to certification bodies. It also can pass the information on counterfeits and those who launch them into circulation to supervisors in the relevant markets.
Manufacturers or trading networks should understand that if they allow their managers to simplify business in illegal ways, they can seriously pay for it. This also applies to the declaration system: the one who acts as an applicant is liable for misreporting in accordance with the Administrative Code of the Russian Federation.
The manufacturer is responsible for the safety and quality of any products marketed. The certification body is responsible for the fact that, in accordance with existing procedures, it actually conducted a conformity assessment before issuing the certificate. The testing laboratory takes the responsibility for the fact that the samples of the products received from the certification body were tested on the parameters requested by the certification body. It may happen that the manufacturer gave the product of due quality for the testing and in reality produces a harmful product. To prevent such cases, the laboratory or certification body must select samples for certain procedures, analyze production and conduct inspections. Therefore, if they detect forgery, they will share responsibility with the manufacturer, but they will take responsibility within their competence and authority.
But there are still problems concerning bringing such companies and people to justice. There are always specific people – experts - behind any unscrupulous schemes for issuing certificates. At the same time, the Administrative Code of the Russian Federation mentions officials who are responsible for such violations. And we always proceeded from the fact that certification experts are the very same officials and mainly they were brought to justice.
However, in court practice the prevailing opinion is that experts signing the certificates are not officials, and regulations on liability are not applicable to them. At the same time, it should be understood that the certification body, especially in case of obligatory certification, is actually an executive power authorized by the state, this body has the authority to admit products to the market, therefore, the violator in this sphere should take responsibility. The Ministry of Industry and Trade of Russia has prepared a draft law that fixes the status of an expert of the certification body more clearly. We expect that it will be adopted in the near future.
Another draft law developed by the Ministry of Economic Development of Russia clarifies accreditation legislation that will allow supervisors to terminate certificates in cases when the certification body that issued them ceased its activities. In this case, so many problems with false certificates will be solved: for example, we have caught the "bad" certification body or the organization itself, being under verification, ceased its activities. But the certificates issued to them continue to be valid and the goods with such certificates are traded on the market.
In this situation, no one can now "turn on a red light" in the register of certificates, because such a right has only the certification body itself.
“E&L”: Why first of all did we start to achieve international recognition of the accreditation system for laboratories and not the certification bodies?
Aleksey Khersontsev: Because this is more important. From the point of view of the result to the entrepreneur, of course, the final certificate is important. But it is the recognition of the protocols that will make it easier for him to obtain a foreign certificate. The chances for international recognition of certificates issued in Russia, even if we become a full member of IAF, are much less than the same chances with respect to protocols. Most countries, including Russia, do not allow issuing certificates in the mandatory sphere by foreign bodies. But the laboratory can be recognized by certification bodies in another country, and its test reports will be used to issue a certificate, for example, on goods exported to that country. For the manufacturer this will mean that he can test the exported goods on site, cheaper, in clear conditions and simultaneously with certification for the Russian market. In addition, the main time and financial expenses for certification and declaration fall on testing.
“E&L”: Why should we make efforts on international recognition of the Russian accreditation system, if domestic certificates still will not work in other countries?
Aleksey Khersontsev: In addition to recognizing the protocols of laboratory testing, global membership in IAF will improve the position of Russian certification bodies in a voluntary, non-mandatory sphere. It only seems that voluntary certification is of little significance. In many fields it is even more significant than mandatory. For example, the ISO 9000 quality management system standards and the ISO 9001 certificate are in great demand as these serve as the evidence of the supplier's reliability.
“E&L”: But there is no trust in voluntary certification systems, first of all, on the Russian market. How can we ensure trust from inside?
Aleksey Khersontsev: Trust cannot be established by law. It may or may not be due to subjective reasons. Someone wants to buy goods with a label of the foreign certificating body. But what’s the reason? Participating in various international methodological events we see that the same problems are discussed: how to check, how to verify this or to make sure in that. Foreigners have the same problems as us. Any voluntary certification system is based on rules adopted within it: product requirements, processes, established procedures for verifying compliance and methods to test it in practice.
The results of work of certification bodies in the voluntary sphere are as publicly significant as those in the mandatory sphere. They are provided to an unlimited number of persons, while the parties to legal relations are in unequal conditions from the point of view of professional competence: consumers cannot evaluate something independently and therefore trust the certification body. Such legal relations require serious but flexible regulation.
In Russia, there is an institute of notification registration of voluntary certification systems - any person can apply for registration in Rosstandart, which de facto cannot refuse registration. There is the following problem: when the voluntary certification system enters the register, its participants begin to refer to the fact that the system, and therefore the services or goods they confirm, are recognized by the state. But in fact it is not true - the fact of registration does not imply this; it’s just a way of system accounting. When RusAccreditation accredit the certification body of a voluntary system registered in such a registry, it checks only for compliance with certain national criteria, which is not related to its actual activities.
Now we are discussing the idea of creating a national voluntary certification system. Our position is that if voluntary systems want to refer to state accreditation, they should enter into legally binding relations with the national accreditation body. These should be such relations that will allow analyzing the work of the certification system, find out what rules it is based on, and make sure that the necessary competence of the certification body work is provided.
Within regulated verification procedures it will be unlikely to achieve what can be called “confidence” - it can only be achieved with constant contact and understanding of what is happening on the counterparty's side.
Now with the current verification procedures an unscrupulous laboratory or a certification body can successfully and for a long time interfere with the inspection process, simply by preventing inspectors of RusAccreditation from conducting the inspection. It is more profitable for unscrupulous participants to avoid any inspection. Penalties for this are low compared to fines for violating the rules of certification. In addition, the failure of RusAccreditation staff to enter some premises or a facility does not allow us to make a conclusion about the non-compliance of the object with the established requirements - hence we find it difficult to deprive of accreditation those who intentionally go to violations. Therefore, now the deprivation of accreditation is preceded with large-scale legal work. They did not let us in, did not submit the document - we are returning for a second inspection. Then we bring to justice and analyze: were there certificates or test reports issued at that time? If we came, and they did not open the door, but the test reports and certificates had been issued by the company, we can prove in the court that, although de jure the company didn’t have any activities at that moment, something was done de facto. So, the documents were issued just like that, without carrying out the necessary work. But this chasing is in the style "catch-me-if-you-can". A certain resource of the Service is engaged into these catch-ups, which is wrong. If the inspector cannot get into an entity or laboratory, their accreditation should automatically be suspended. Who is not ready for a system of trust - must get out of it.
I am convinced that trust cannot be ensured through the introduction of strict administrative procedures. For example, now the Service cannot trust a laboratory which provided a set of documents that have all the necessary equipment and personnel. But we understand that at this time in this place the required equipment cannot be there. Nevertheless, the laboratory in court may require us to issue a decision on accreditation based on formal compliance with all criteria. This seems to me wrong, we need to have more flexible tools here.
The accreditation bodies in different countries have their own criteria and standards. But in most countries the decision to accredit is made on the basis of the experts' internal conviction, not just on the basis of formal accordance with the criteria, but also on the business culture of the accredited organization, its actual results allow trusting what it does. In our state the process is more formalized: there is a required set of documents, a positive conclusion of the involved appraisers - it should be accredited. In most foreign systems, formalities end at the stage of initial assessments and documentary inspections. And then the inference mode turns on. And the task of the accreditation body is to ensure that those who make these conclusions have authority, honesty and clearly adhere to open and transparent procedures. I believe that in this respect we should still work on legislation shifting it from the field of formal procedures to the shaping of a system based on trust. This is what the word "accreditation" means.
The interview was prepared by А. Khavina.