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George Anastasopoulos


Accreditation in Europe: Monopoly in the Making?

Who should decide on the quality of accreditation?

Published: Wednesday, December 12, 2012 - 11:15

In July 2008, the Council of the European Union and the European Parliament agreed to provide a legal framework that creates one monopoly in each member state of the European Union (EU) for the provision of accreditation services across Europe.

This action could be understood (but even then that’s debatable) if it served only compulsory conformity-assessment needs introduced by EU legislation; however, it’s also becoming obligatory for accreditation related to voluntary conformity assessment.

Therefore, accreditation bodies are free to provide inefficient services at a costly rate under the protection of the legal monopoly. Further, certification bodies (including laboratories) have no choice in selecting alternative accreditation services. According to the EA-2/13 M: 2012—EA Cross Border Accreditation Policy—October 2012: “EA members shall not compete with other EA members in the EA region.”

But let’s start from the beginning. What is accreditation?

According to International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC), accreditation is defined as “the independent evaluation of conformity assessment bodies against recognized standards to ensure their impartiality and competence.”

The International Organization for Standardization (ISO) also defines accreditation in its conformity assessment standard, ISO 17011 subclause 3.1: “Third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks.”

ISO 17011 provides general requirements for accreditation bodies accrediting other conformity-assessment bodies. In subclause 4.1 on legal responsibility, it reads: “The accreditation body shall be a registered legal entity.” This is followed by a note explaining what is applicable in the case of a governmental” accreditation body. It is obvious that, for ISO, accreditation bodies can be either private or governmental entities.

In a thorough search of all relative documentation issued by IAF, ILAC, and ISO, no mention or requirement for single-sourced, state accreditation could be found. In fact, the IAF provides Multilateral Recognition Arrangement Documents on its website and clearly recognizes that: “The primary purpose of IAF is to establish Multilateral Recognition Arrangements (MLA) between its accreditation body members in order to contribute to the freedom of world trade by eliminating technical barriers to trade.”

It is clear that the monopolistic, state-offered accreditation is not a requirement by any international organization related to the issue. What was then the driving force that led the EU to become so anachronistic in its approach to accreditation?

In the Regulation (EC) No. 765/2008 of the European Parliament and of the Council, dated July 9, 2008, on “Setting out the requirements for accreditation and market surveillance relating to the marketing of products,” it provides a rationale that seemingly justifies the decision for a monopolistic state accreditation. For example, in subclause 10: “(10)... The lack of common rules for that activity [i.e., accreditation] has resulted in different approaches and differing systems throughout the Community, with the result that the degree of rigor applied in the performance of accreditation has varied between Member States.”

But this case could be easily handled by the peer-assessment process already functioning for the European cooperation for accreditation multilateral agreement (EA MLA).

Where is the need for a monopoly? Perhaps the answer is provided in Regulation 765/2008 subclause 19, where we are treated to a statement even Stalin would admire for its pure socialist inspiration: “(19) Competition between national accreditation bodies could lead to the commercialization of their activity, which would be incompatible with their role as the last level of control in the conformity assessment chain.”

We could easily replace the word “accreditation” with other critical or high risk social services to create the ideal social utopia. For example (and for your entertainment), I would paraphrase it as: “Competition between health institutions (hospitals) could lead to the commercialization of their activity, which would be incompatible with their role as the last level of control in human health chain.”

Or even better: “Competition between air carriers could lead to the commercialization of their activity, which would be incompatible with their role as the last level of safe transportation.”

The same could apply for making safe food (state monopolistic restaurants), or in building safe houses (state monopolistic construction companies). It will be difficult to explain why accreditation is more critical for consumers than building a safe house, or conducting a surgery, or piloting an airplane.

If competition on accreditation leads to commercialization, which reduces the level of accreditation’s quality, why not also assume that competition on certification leads to commercialization, which reduces the level of certification’s quality?

Therefore, should we replace all certification bodies/labs with one state certification body/lab per country, to increase their service quality?

It’s interesting to note that in Regulation 765/2008 subclause 19, Brussels bureaucrats and their counterparts in member states are clearly mentioning “competition between national accreditation bodies” because they cannot even think of the existence of a nonprofit, private accreditation body.

To be 100-percent sure that such an “evil thing” as private accreditation would never appear, they are adding subclause 20: “(20)... conformity assessment bodies should request accreditation by the national accreditation body." The regulation says “should,” so it’s optional, right? Well, according to EU bureaucrats, “should” apparently means “shall.”

According to a member of the European Commission, “The regulation’s chapter on accreditation applies to the regulated and voluntary sectors alike. The aim of the regulation is to make accreditation a noncommercial, noncompetitive public authority activity that is the last level of control in the conformity assessment system.”

If you wonder what a “national accreditation body,” is, you get your answer in Chapter I, Article 2, the “Definitions” of Regulation 765/2008. Listed as No. 11: “ ‘National accreditation body’ shall mean the sole body in a Member State that performs accreditation with authority derived from the State.”

It’s also important to understand that under the term “conformity assessment,” they include all kinds of accreditation as defined in Chapter I, Article 2, No. 12: “ ‘Conformity assessment’ shall mean the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled.”

And the last piece that completes the puzzle of the monopoly is found in Chapter II, Article 3 “Scope” of the Regulation 765/2008: “This Chapter shall apply to accreditation, used on a compulsory or voluntary basis, relating to conformity assessment, whether that assessment is compulsory or not....”

In this subclause, regulation is officially “locking” voluntary-basis certification under its monopolistic framework.

It should be noted that establishing accreditation state monopolies in EU members, through Regulation 765/2008, is also an action against the following agreements:

• Treaty of Rome, 1957, Establishing the European Community, Part Three, Community Policies (Arts. 8–130), Title I. Free Movement of Goods (Arts. 9–37) and Title III. Free Movement of Persons, Services and Capital (Arts. 48–73)(3)
• World Trade Organization, Uruguay Round General Agreement on Trade in Services (Article I — XXVI)(4)

It is obvious that a state monopoly cannot and will not improve the level of quality of accreditation services offered in Europe. It will only facilitate a few public accreditation officers who will be guaranteed of their work security and their salaries, for good. It will also guarantee a lack of interest for any improvement on the efficient operation of the accreditation bodies.

As long as their market is secured, they have no reason to reduce their expenses, as long as they can always increase their fees without any consequences. Their customers are stuck with them, by force. It will be illegal for them to choose another accreditation.

Such policy directly reduces the competitiveness of accreditation customers, but it seems that is of no importance for the bureaucrats who drafted Regulation 765/2008 and for the politicians who approved it.

In this case, the bureaucrats demonstrated their ignorance to the elementary lessons of economics 101: “Government monopoly creates an inefficient provision of a service or product. The favored business has no incentive to improve; its profits are guaranteed by the government. As a result, there is no true customer service or quality assurance. In comparison, competition instead forces companies to stay the best or lose market share, which in turn is assumed to be better for the customer.”

On the free market, it’s a happy fact that maximizing the wealth of one person or group redounds to the benefit of all; but in the political realm, the realm of the State, a maximization of income and wealth can only accrue parasitically to the State and its rulers at the expense of the rest of society.

The questions to answer are: What kind of accreditation will be offered in EU, and at what cost? And who is to decide on the quality of accreditation?

On the free market, decisions on how much, and at what quality level, for any product or service are made by voluntary purchases by individuals. In the “socialist” Europe, this should not be decided by the market but by the euro-bureaucrats and public servants who are always eager to “protect” the citizens from the “dangers” of a free and competitive market.

Regulation 765/2008 is making a step toward Soviet Socialist Republics of Europe. A small step indeed, but after all, everything big starts from a small step.

Editor's note: Quality Digest contacted the EC and confirmed that regulations will create only one recognized accreditation body for each EU state. It is also true that a certified body (CB) will be required to use that single nationally-recognized accreditation body (AB) in its state, that it may not choose an AB from another state, essentially forcing the CB to do business with the one and only AB.

http://www.iaf.nu//articles/About/2 and www.ilac.org/



About The Author

George Anastasopoulos’s picture

George Anastasopoulos

George Anastasopoulos is the chairman and CEO of the Chicago-based, personnel certification body STAREGISTER, and the general secretary of the International Personnel Certification Association (IPC) based in Athens, Greece. He has served as Secretary-General for Industry of the Hellenic Ministry of Development. He has also served as lead assessor, lead tutor, and committee and board member of many certification and accreditation bodies at the global level. He holds a Ph.D. from Northwestern University. Anastasopoulos has written many books and articles, and participated as keynote speaker in many international conferences and television broadcasts. He now lives in Athens, Greece.


Accreditation Lobbies

Yes, George, it's more lobbysm than monopoly. Take the case of medical devices, for example, which is quite a public issue. Italy's Notified Bodies are accredited by Accredia - that is, Italy's official accreditation body - for registration according to the Standard ISO 13485; but they have to be accredited by Italy's Ministry of Health for registration according to the EU Directive 93/42/CEE, and / or amendments or equivalents. And - according to my knowledge - USA's FDA does not recognize this EU Directive. In a former column of mine - you may have read it - I questioned the value of accredited registration, because I think to know what's behind it, and underneath. The fact is, that both Registration and Accreditation have become businesses by themselves, instead of being services to Betterment. Thank you.

Accreditation / the quality of.

I's more like assimilation,

Rigorous expanding over the backs of the general population.

A One way direction towards an ever growing crowd of failing officials

These failing officials collect (don't earn) a salary of  ± 14,000,- gross a month

Drive with tax free EU licenceplates, live mainly taxfree outside their own country.

And who are they in fact ? They are the failed civil servants*** of the EU member countries.

What they should have seen: The PIGIS countries, see also LIBOR

(Smart) Northern European banks*** invested in the 90ties in the hype of

a 2nd. holliday home at the Mediterrean ,

They knew the hype would burst around 2008 and sold everything timely ('06-'07) out to local banks.

Now the even the population and companies of the Northern Europens States go bankrupt due to

their own banking systems.

You wanted assimilation ?

You get it, We don't forget and don't forgive.

*** Names, persons, documentation and proof stored online.

( identical names with initials come up in government and banks)