The Regulation of the Infrastructure for Quality and Industrial Security was approved by Royal Decree 2200/1995 of 28 December and amended by Royal Decree 411/1997 of March 21, Royal Decree 338/2010 of March 19, Royal Decree 1715/2010 of 17 December 2010 and Royal Decree 239/2013 of 5 April.

The modification of the Regulation of the Infrastructure for Quality and Industrial Security, which is carried out by this royal decree, operates in two areas: on the one hand, on the control bodies and, on the other, on the standardisation bodies.

I

The transposition of Directive 2006 /123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market by Law 17/2009 of 23 November 2006 on the free movement of goods access to the activities of services and their exercise and Law 25/2009, of 22 December, amending various laws for their adaptation to the Law on the free access to the activities of services and their exercise, the regime of authorisation for the control bodies.

According to Directive 2006 /123/EC of 12 December 2006 on services in the internal market, recitals (40) and (56) and (4) of Directive 2006 /123/EC, and in this way it was laid down by Law 17/2009 of 23 November 2006. Article 3, the concept of overriding reasons of general need covers at least the following areas: public policy, public security and public health, consumer protection, protection of workers, animal welfare, prevention of fraud, prevention of unfair competition, protection of the environment and the urban environment, and road safety among others. The object of industrial safety as laid down in Article 9 of Law 21/1992, of 16 July 1992, of Industry, is fully in line with the areas mentioned above.

However, the judgment of the Supreme Court of 29 June 2011 stated the inapplicability of the need for administrative authorisation to the control bodies, in the absence of the State justifying the concurrence of a overriding reason of general interest or resulting in compliance with its Community or international obligations.

Recently, Law 32/2014 of 22 December, of Metrology, in its third final provision has amended a series of articles of Law 21/1992, of 16 July, of Industry, regulating the requirements and conditions of the control bodies, establishing that the technical competence is assessed through accreditation and that once it has been obtained, it will be sufficient and proportionate to provide a responsible declaration regime for the exercise of the activity.

By accreditation, technical competence, independence and impartiality are assessed, in a regulated manner, based on clear, objective, unique and non-discriminatory criteria. This accreditation constitutes an essential element of guarantee of the market unit, in making the requirements required for the accreditation of the control bodies, which are unique and valid for all the national territory and before any competent authority.

Once accredited, the presentation of a responsible declaration to the competent authority in the field of industry where the control body accesses the activity for which the activity is accessed, shall be necessary for the exercise of its activity. is accredited, without prejudice, where appropriate, to the application of the provisions, for the purposes of determining the authority of origin, in the additional provision of the 10th of the Law 20/2013 of 9 December 2013 on the guarantee of the market unit.

The responsible declaration, always prior to the corresponding accreditation, will enable the control body to carry out the activity for which it has been accredited throughout the Spanish territory, without prejudice, if necessary, to the to have Community legislation in place for the purposes of its recognition in the field of the European Union.

By this Royal Decree, the Royal Decree 2200/1995 of 28 December 1995 is amended to adapt it to the new regulation set out in Law 21/1992 of 16 July of Industry, as amended by Law 31/2014, of December, of Metrology.

On the other hand, the activities covered by this royal decree are largely governed by the rules of European Union law.

In recent years, the European Union has established what has been called the "New Legislative Framework", which consists of two basic provisions:

(a) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 laying down the requirements for accreditation and market surveillance relating to the placing on the market of products and by the repeal of Regulation (EEC) No 339/93, which is of particular relevance in respect of the accreditation of conformity assessment bodies.

In accordance with the provisions of Regulation (EC) No 765/2008, Royal Decree 1715/2010 of 17 December 2010 is hereby designated as the National Accreditation Entity (ENAC) as a national body of accreditation.

In Spain, Law 21/1992 of 16 July, of Industry, in its Title III, regulates industrial safety and quality, attributing the verification of the safety conditions of industrial products and installations to the Competent Public Administrations, by themselves, or through control bodies.

(b) Decision No 768 /2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products and repealing Council Decision 93 /465/EEC determines in its Article R13 that Member States should notify the European Commission and other Member States of the bodies authorised to carry out conformity assessment tasks for third parties, in accordance with the provisions of the applicable legislation, which shall comply with the requirements set out in Article R17. Recognition that such requirements are met may be justified by an accreditation certificate issued by the national accreditation body.

Spain, as a fully integrated state in the European Union, should apply the rules of the European Union, in particular the requirements of products for placing on the market in the internal market, which are contained in the European Union legislation on harmonisation. The need to notify the European Commission and the other Member States of the conformity assessment bodies has been established in this area.

In addition, these rules of European law lay down the conditions and requirements to be met by these bodies in order to be recognised at European Union level. As regards other international treaties or conventions, other than the Treaty on European Union and the Treaty on the Functioning of the European Union, the provisions of the Treaty on European Union and the Treaty on the Functioning of the European Union must be provided for.

Royal Decree 2200/1995 of 28 December 1995 also developed the aspects contained in Title III of Law 21/1992 of 16 July 1992 on Industry, on bodies and entities operating in the field of quality and industrial safety. By means of Royal Decree 411/1997 of 4 March 1997 and Royal Decree 338/2010 of 19 March 2010, certain amendments were made to the text in order to facilitate their implementation and to ensure free access to the activities of services and their exercise, respectively.

II

The standardization bodies are private non-profit entities, whose aim is to develop in the state the activities related to the elaboration of norms, through which criteria are unified in respect of certain subjects and the use of a common language in specific fields of activity is possible.

Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation recognises the important role of standardisation in the competitiveness of enterprises, especially in the field of small and medium-sized enterprises, as standardisation facilitates, in particular, the free movement of goods and services, the interoperability of networks, the functioning of the media, technological development and innovation. It also recognises its importance in the overall competitiveness of European industry and the functioning of the internal market and considers that the technical specifications adopted by a recognised standardisation body can help tackling the major challenges of society, such as climate change, the sustainable use of resources, innovation, an ageing population, the integration of people with disabilities, the protection of consumers, of workers, as well as working conditions and other areas of public policy. That Regulation (EU) No 1025/2012 cites, among the guiding principles of standardisation, independence in relation to particular interests.

In this context, but fundamentally in line with the recommendations on its day made in the "Report on Quality and Safety Certification" issued by the now defunct National Competition Commission in July 2010, which ends with a chapter of recommendations addressed to the Public Administrations "to ensure an environment that allows to increase the competitive pressure in the provision of certification services", in paragraph one of the article two new paragraphs are added to Article 10 of the Infrastructure Regulation for Quality and Industrial Safety, which regulates the conditions and requirements to be met by the standards bodies in the performance of their duties. These new determinations establish a duty to separate the standardisation activities from the conformity assessment activities, ensuring the principles of non-discrimination of the standardisation bodies.

III

On the other hand, it is necessary to amend the final provision of Royal Decree 2200/1995 of 28 December 1995 to update the articles of the Regulation which have the character of basic legislation, since some of these were repealed by the second final provision of Royal Decree 239/2013 of 5 April laying down the rules for the application of Regulation (EC) No 1221/2009 of the European Parliament and of the Council of 25 November 2009 on the voluntary participation of organisations in a Community management system; and environmental audit (EMAS), and by which Regulation (EC) No 761/2001 and Commission Decisions 2001 /681/EC and 2006 /193/EC, and also make an express reference to the competences of the Constitution in which it is amfor such basic regulation.

IV

With regard to the handling of this royal decree, it should be noted that the autonomous communities and those most representative of the sectors potentially affected have been consulted, thus complying with the Article 24 (1) (c) of Law 50/1997 of 27 November 1997, of the Government, collecting from them, in the various stages of the project's processing, its contributions and improvements.

This royal decree has been communicated in its project phase to the European Commission and to the other Member States in compliance with the requirements of Royal Decree 1337/1999 of 31 July, which regulates the remission of information on technical standards and regulations and regulations relating to the services of the information society, pursuant to Directive 98 /48/EC of the European Parliament and of the Council of 20 July 1998 amending the Directive 98 /34/EC laying down a procedure for the provision of information in the field of standards and technical regulations.

This Royal Decree has also been the subject of a report by the Industrial Safety Coordination Council, as provided for in Article 18.3.a) of the aforementioned Industry Law.

In its virtue, on the proposal of the Minister of Industry, Energy and Tourism, with the prior approval of the Minister of Finance and Public Administration, according to the Council of State and after deliberation of the Council of Ministers in their meeting of the day of November 27, 2015,

DISPONGO:

Article first. Amendment of Royal Decree 2200/1995 of 28 December, approving the Regulation of the Infrastructure for the Quality and Safety of Industry.

Royal Decree 2200/1995 of 28 December, approving the Regulation of the Infrastructure for Quality and Industrial Safety, is amended as follows:

One. The third additional provision shall be as follows:

" Additional provision third. Authorisation for the updating of the amount of the civil liability insurance, guarantee or other equivalent financial guarantee, of Article 43.1.

The Minister of Industry, Energy and Tourism is authorised to update by order the minimum amount of insurance claims, guarantee, or other equivalent financial guarantee, covering civil liability, to which it refers Article 43.1 of the Regulation of the Infrastructure for Quality and Industrial Security, as long as it is necessary to maintain the economic equivalence of the guarantee and prior to the report of the Government Delegated Commission for Economic. "

Two. The final first provision is worded as follows:

" Final Disposition first. Basic character and competency titles.

1. Articles 2.1, 5, 14 to 19 and 41 to 48 of the Regulation on the Infrastructure for Quality and Industrial Safety, as far as industrial safety is concerned, are of a basic nature, which is dictated by Article 149.1.13. Constitution, which attributes to the State exclusive competence on the basis and coordination of the general planning of economic activity.

2. Articles 49 and 50 of the Regulation on the Infrastructure for Quality and Industrial Safety, relating to environmental verifiers, are of a basic standard, which are issued under Article 149.1.23. of the Constitution, which attributes to the State exclusive competence in the field of basic environmental protection legislation.

3. The other provisions of the Regulation shall apply in the absence of specific legislation issued by the Autonomous Communities with regulatory competence in matters governed by it. "

Article 2. Amendment of the Regulation of the Infrastructure for Quality and Industrial Security, approved by Royal Decree 2200/1995 of 28 December.

The Regulation of the Infrastructure for Quality and Industrial Security, approved by Royal Decree 2200/1995, of December 28, is amended as follows:

One. The following wording shall be added to Article 10 (l) and (m

:

" l) Legal, functional and contachably legal status of the standardisation activities of any conformity assessment activities.

m) Ensuring that their actions as a standardisation body conform to the principle of non-discrimination, ensuring equal treatment and avoiding discriminatory practices. "

Two. Article 11 (d), (e), (f), (i) and (j) shall be worded as follows:

" d) Develop the appropriate Annual Standards Program.

e) To periodically issue to the competent organ of the Public Administration that recognized the relationship of draft standards in the phase of approval, for submission to public information in the "Official Gazette of the State".

(f) To periodically re-issue to the competent authority of the Public Administration that recognized the relationship of rules approved and annulled in that period, identified by its title and numerical code, for publication in the "Official State Gazette".

i) Carry out the functions of editing and selling standards, the prices of which will be fixed in agreement with the Public Administration that recognized it.

j) Make the updated Spanish rules catalogue available to the public. "

Three. Section 1 'Control bodies' of Chapter IV of the Regulation shall have the following content:

" CHAPTER IV

Accreditable Infrastructure for Industrial Security

Section 1. Control Organisms

Article 41. Requirements of the control bodies.

The control bodies established in Article 15.1 of Law 21/1992, of 16 July, of Industry, are those natural or legal persons who have the capacity to act and have the technical, material and human and impartial and independent independence, can verify compliance with the safety conditions and requirements set out in the safety regulations for the products and facilities, for which they must comply with the following conditions and requirements, depending on their nature and activity:

1. The control bodies shall be independent of the organisation, installation or product they assess.

2. The control bodies, their top management and the staff responsible for carrying out the conformity assessment tasks shall not be the designer, the manufacturer, the supplier, the installer, the buyer, the owner, the user or the in charge of the maintenance of products or installations subject to the regulatory documents, or the authorised representative of any of them. This shall not prevent the use of the evaluated products or facilities which are necessary for the functioning of the control body or for the use of the products or facilities for personal purposes.

The control bodies, their top management and the staff responsible for carrying out the conformity assessment tasks shall not directly intervene in the design, manufacture or construction, the placing on the market, the installation, use or maintenance of such products or facilities, or represent the parties involved in these activities. They shall not engage in any activity that may conflict with their independence of criteria and their integrity in relation to the conformity assessment activities for which they are accredited.

The control bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity and impartiality of their conformity assessment activities.

3. The control bodies and their staff shall carry out the conformity assessment activities with the highest level of professional integrity and with the required technical competence for the specific field, and shall be free from any pressure or pressure. incentive, especially of a financial nature, which could influence its assessment or the outcome of its conformity assessment activities, in particular those which may be exercised by persons or groups of persons having an interest in the results of these activities.

For the purposes of compliance with the requirements of technical competence, impartiality and independence, the control body shall comply with the harmonised standard of the EN-ISO 17000 UNE series which is applicable to it and obtain the relevant accreditation in accordance with Article 42.

4. The control bodies shall be capable of carrying out all the conformity assessment tasks assigned to them in accordance with the rules applicable to the activities for which they have been accredited, irrespective of the to carry out the tasks themselves or to carry out the tasks on their behalf and under their responsibility.

At all times, for each conformity assessment procedure and for each type or category of products or facilities for which they have been accredited, the control bodies shall have:

(a) of the required personnel with sufficient and appropriate expertise and experience to perform the conformity assessment tasks;

(b) of the procedures under which conformity assessment is carried out, ensuring the transparency and reproducibility of these procedures. They shall have appropriate policies and procedures to distinguish between the tasks carried out as a control body and any other activity;

(c) procedures for carrying out their activities taking due account of the size of the companies, the sector in which they operate, their structure, the degree of complexity of the technology of the product or the installation of whether the production process, if any, is in series.

They will also have the necessary means to properly perform the technical and administrative tasks related to conformity assessment activities and will have access to all equipment or facilities that needs.

5. The personnel carrying out the conformity assessment activities shall have:

(a) good technical and professional training to carry out all the conformity assessment activities corresponding to the area for which the control body has been accredited;

(b) adequate knowledge and understanding of the requirements, applicable rules and relevant provisions of the relevant regulations;

(c) the capacity required for the preparation of the certificates, documents and reports showing that the evaluations have been carried out.

6. The impartiality of the control body, its top management and its assessment staff shall be ensured.

The remuneration of the top management and assessment staff of a control body should not influence the outcome of the assessment activities and in no case will depend on the results of those assessments.

7. The staff of the inspection body shall observe the professional secrecy concerning all the information collected in the framework of its tasks, in accordance with the applicable rules or regulations which it considers, except in respect of the authorities. public.

Property rights must be protected.

Article 42. Accreditation of the control bodies.

1. Those wishing to carry out their activities as control bodies shall require their prior accreditation by a national accreditation body in accordance with Royal Decree 1715/2010 of 17 December 2010 designating the National Authority of Accreditation (ENAC) as a national accreditation body in accordance with the provisions of Regulation (EC)^765/2008 the European Parliament and of the Council of 9 July 2008 laying down the requirements for accreditation and market surveillance relating to the placing on the market of the products and repealing the Regulation (EEC) n^or 339/93.

2. The person concerned shall submit to the accreditation body an application for accreditation.

3. The accreditation entity shall assess compliance with the requirements set out in the applicable harmonised standard and in Article 41.

4. Where a positive accreditation decision is placed on the application, a certificate of accreditation shall be issued by the accreditation body specifying the regulatory areas, the specific products or facilities and, his case, the evaluation procedures, for which he has been accredited.

5. Where an application is rejected by a decision rejecting the accreditation, the person concerned may claim that he/she is not in compliance with the accreditation body

Article 43. Enabling control bodies.

1. Those who, having obtained their accreditation, wish to carry out their activity as a control body, must present a responsible declaration to the competent authority in advance, in accordance with Article 15 (4) of Law 21/1992, of 16 July and Article 71a of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure.

By means of such a responsible statement, you must manifest the activities that you intend to carry out and that you comply with the relevant requirements set out in Article 41 and have the documentation that shows you, in the certificate of accreditation, in accordance with Article 42, covering the activities declared and the supporting documentation for the provision of insurance, guarantee or other equivalent financial guarantee covering its civil liability, a minimum amount, per claim, of EUR 1,200,000, without the limit value being responsibility, undertaking to maintain that guarantee during the life of the activity and to provide the necessary information to the competent authority for the control of the activity. This declaration shall contain the necessary data, in accordance with Royal Decree 559/2010 of 7 May, approving the Regulation of the Integrated Industrial Register, for registration by the competent authority in that registry.

The responsible statement may be submitted by electronic means.

2. The submission of evidence of compliance with the requirements together with the responsible statement may not be required. However, this documentation shall be available for immediate submission to the competent Public Administration where it so requires in the exercise of its powers of inspection, verification and control.

3. The responsible declaration, from the time of its submission, enables the control body to act throughout the State and for an indefinite period, without any additional requirements or conditions being imposed, without prejudice, where appropriate, (a) what the Community rules provide for their recognition in the European Union.

4. The control bodies which are to carry out activities as a result of European Union legislation, before commencing their activities, shall comply with the provisions of this Regulation for the purpose of their recognition in the European Union.

The Ministry of Industry, Energy and Tourism shall notify the European Commission and the other Member States of the European Union of the bodies empowered to carry out, for third parties, tasks of assessment of conformity with the harmonised standards or corresponding technical specifications. The notified control body may only carry out the activities for which it has been authorised, if the European Commission and the other Member States have not raised any objections within two weeks of the notification.

The Ministry of Industry, Energy and Tourism shall inform the European Commission and the other Member States of the European Union of any relevant post-notification changes affecting the control bodies. reported.

5. Control bodies without establishment in Spain which are to provide their services as a result of non-harmonised regulation at European level and which have been legally authorised as such in another Member State of the European Union, they must submit a responsible statement to the competent authority of the Autonomous Community where they are to start their activity in relation to:

a) The scope of activities for which it has been enabled in the Member State in which it is established.

(b) Compliance with the requirements of technical competence and impartiality set out in Article 41.

c) Availability of insurance, guarantee or equivalent financial guarantee as set out in this article.

Such requirements are considered necessary and proportionate to protect health and safety risks. The responsible statement enables you to provide the service from the moment of your presentation.

For the purposes of applying Article 46, the authority of origin shall be understood as the authority of origin to the Autonomous Community to which the responsible declaration has been submitted.

6. In the event of cessation of the activity of a control body, the operator must submit the documentation linked to his/her performance as such to the competent authority of the Public Administration where he submitted the responsible declaration.

7. The competent authority of the public administration which receives the declaration responsible for a control body shall register it in the integrated industrial register and, if appropriate, inform the Ministry of Industry, Energy and Tourism of the providing the data necessary for its notification to the European Commission and to the other Member States.

8. The bodies assessing the conformity of products with the safety standards for toys shall be governed by the provisions of Royal Decree 1205/2011 of 26 August 2011 on the safety of toys and the bodies assessing the safety of toys. conformity of the products with the safety standards of the telecommunication equipment shall be governed by the provisions of Law 9/2014, of 9 May, General of Telecommunications and in its regulations of development.

Article 44. Actions of the control bodies.

1. Verification by the control bodies of compliance with the safety conditions of industrial designs, products, equipment, processes and installations shall be carried out by means of conformity assessment procedures. (a) the provisions of the Protocol, the minutes, the minutes, the report or the relevant certificate, which shall be in accordance with Community rules.

2. To this end, the holders of the designs, products, equipment, processes and industrial facilities to be evaluated shall allow the control body's personnel to access their facilities, where the assessment activity so requires.

3. Such operators shall also allow access to the auditors of the national accreditation body, accompanied by the staff of the control body, where necessary as part of the assessment process.

Article 45. Obligations.

1. In general, the control bodies shall have the following obligations

(a) Maintain the conditions and requirements which served as the basis for their accreditation, and shall communicate to the accreditation entity any modification thereof, which shall, if appropriate, issue a new certificate of accreditation.

b) Adopt appropriate measures to safeguard, at all levels of your organization, the confidentiality of information obtained during the performance of your activities.

c) Resolve any requests submitted to them, by issuing the protocols, minutes, reports, and, where appropriate, certifications that are required to be required.

d) Indicate, in the protocols, minutes, reports or certificates issued in the development of their activities for which they have been accredited, their status as accredited.

e) Carry records that record how many controls have been performed and all protocols, minutes, reports, and, where applicable, certifications that they issue in relation to them

(f) Keep the records, documentation and data of the checks carried out for the period of ten years for possible consultation.

g) Notify the owner of the product, equipment or installation and, where appropriate, the projectionist, the installer or the conservator or maintain the deficiencies and anomalies found concerning the applicable safety regulations, indicating the time-limits for the application of the time limits to be remedied, also in the knowledge of the Public Administration competent in the field of industry, in whose territory they are active.

h) Communicate to the Public Administration competent in matters of industrial safety in whose territorial scope they develop their activity and to the holder or responsible of the product, equipment or industrial plant the necessity of to discontinue the placing on the market or the service of the same when it is appreciated that it does not offer the necessary industrial safety guarantees, proposing the necessary measures to correct the situation.

i) Adopt special preventive measures, immediately referring the relevant notification to the competent authorities, in cases of serious risk of accident or emergency.

j) Where appropriate, participate in the relevant standardisation activities and the activities of the notified body coordination group established in accordance with the applicable European harmonisation legislation, that their assessment staff is informed about this and apply the administrative decisions and documents resulting from the work of the group as a general guideline.

k) Maintain the conditions and requirements that served as the basis for its responsible declaration, and must communicate any modification thereof to the Public Administration that received the declaration. The competent public authority may carry out the control measures it deems appropriate and, where appropriate, shall inform the public administration where the responsible declaration has been lodged with any relevant circumstances. which could result in the temporary prohibition of the exercise of the activity or even the revocation of the rating.

l) Answer any claims that may be received from customers, affected parties or others affected by their activities and maintain a record with all complaints received and actions taken with respect to them.

m) Meet with the provisions of this regulation, in Spanish legislation and in European legislation.

2. The control bodies shall provide the competent public authorities for the purposes of enabling and controlling the information which they may require in connection with their obligations and shall cooperate with those public administrations and with the Council for the Coordination of Industrial Security, providing services which are requested to them in the field of industrial safety.

Article 46. Monitoring of the actions of the control bodies.

1. The supervision of the control bodies shall be carried out as laid down in Law 20/2013 of 9 December of a market unit guarantee in Chapter VI thereof.

2. The action of the control bodies shall be in accordance with the nature of the activity which constitutes their object and shall be supervised by the competent public administration.

3. For the purpose of facilitating such supervision, each control body shall send the following information annually to its home authority:

(a) A detailed memory relating to the actions carried out in all the Autonomous Communities in which I develop the activities for which it is enabled, in accordance with Article 43. Referring the Authority of origin to the other Autonomous Communities.

b) Document of the Accreditation Entity, which confirms the maintenance of the accreditation conditions.

Article 47. Complaints to the control bodies.

When a control body issues a protocol, minutes, report or certification with a negative result of compliance with the regulatory requirements, the person concerned may claim to express his/her disagreement with the same person. the control body itself and, in the event of failure to reach an agreement, before the competent public administration, for the purposes of Article 16.2 of Law 21/1992 of 16 July 1992 on Industry.

Article 48. Extinction and temporary suspension of ratings.

1. The clearance of the control bodies for the exercise of the activities for which they have been accredited shall have an indefinite effect, without prejudice to the provisions of the Community legislation in respect of their recognition in respect of the European Union, and provided that the conditions for its granting are maintained, without prejudice to the following paragraphs.

2. During the processing of the sanctioning, revocation or inspection procedures, the measure of suspension of the effectiveness of the rating may be adopted by the competent Public Administration, after hearing the person concerned. concur any of the following circumstances:

(a) The repeated non-compliance with the instructions given by the competent Public Administration.

b) The refusal to admit the inspections or verifications of the competent Public Administration, or the obstruction of their practice.

c) The suspension of accreditation by the national accreditation entity.

(d) The suspension of the ratings may also be agreed upon when the circumstances of Article 10.2 of Law 21/1992 of 16 July of Industry are met.

The temporary suspension of the rating shall imply that the control body ceases to exercise its activity during the period of its validity.

The suspension will be terminated when, upon receipt of the irregularities observed, the competent Public Administration agrees to terminate the suspension.

3. The ratings may be revoked when any of the following causes are present:

(a) The inaccuracy, falsehood or omission, of an essential nature, in the responsible declaration, in accordance with the provisions of Article 71.bis.4 of Law 30/1992 of 26 November 1992, of the Legal Regime of the Administrations Public and the Common Administrative Procedure.

b) Withdrawal of the accreditation of Article 42 by the accreditation entity.

c) Failure to comply with the requirements and obligations set out in this provision, as well as in the other existing rules, where such non-compliance seriously undermines the quality of the services provided or where the non-compliance occurs repeatedly or dilated in time.

d) Extinction or loss of the legal personality of the entity holding the activity, or death or declaration of incapacity of the natural person holding the activity.

If, during the procedure of the procedure, the irregularities observed are remedied, the competent Public Administration may terminate the procedure without agreeing to revoke the rating.

The termination of the revocation rating shall be initiated on its own initiative by the competent authority. This decision shall be taken after the person concerned has been heard and may take the precautionary suspension of the habilitation. In addition, for the reasons referred to in paragraph 3 (a), the decision of revocation may provide, depending on the seriousness of the case, the failure to submit by the control body another responsible declaration with the same object within a period of time. Six months ' time. The decision of the procedure shall be reasoned, after instruction in the relevant administrative procedure, and shall be adopted and notified within the maximum period of six months.

4. The voluntary cessation of the activity by the control body will result in the extinction of the validity of the habilitation, for which the agency must communicate its intention to cease in the activity to the competent Public Administration to which he submitted his responsible statement. "

Single additional disposition. Statutes of the Spanish Association for Standardisation and Certification.

The Spanish Association for Standardisation and Certification must adapt its statutes to the provisions of this Royal Decree within one year of its entry into force, in line with the provisions of paragraph 1 of this Regulation. Article 10 of the Infrastructure Regulation for Industrial Quality and Safety.

Single transient arrangement. Control bodies enabled.

The control agencies authorized, at the entry into force of this royal decree, have a period of one year to adapt to the provisions of this royal decree.

Single repeal provision. Regulatory repeal.

Any provision of equal or lower rank that is opposed to the provisions of this royal decree is hereby repealed.

Single end disposition. Entry into force.

This Royal Decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, on November 27, 2015.

FELIPE R.

The Minister of Industry, Energy and Tourism,

JOSE MANUEL SORIA LOPEZ