The accreditation system is open to any entity, whether public or private, profit or non-profit, irrespective of its size or whether it performs activities other than those that are the object of accreditation.

The organisation applying for accreditation should be a legally identifiable body, with legal status.

Before applying for accreditation, the body should:

• Have experience in carrying out the activities for which accreditation is requested.
• Be familiar and comply with the accreditation criteria applicable.

Assessment of technical competence is carried out by means of the study of documents describing how the body performs the activities (management system, methods and working procedures, staff competence, etc.) and on-site assessment of how the body works. The results of the assessment are included in a report which is forwarded to the applicant, who must them respond by taking the remedial action seen fit.

With the assessment report and the applicant’s response, the Accreditation Commission takes a decision. If favourable, the accreditation certificate is issued.

ENAC checks that accredited bodies continue to comply to accreditation requirements with regular assessments. If it is observed at any time that the body does not fulfil an accreditation obligation, ENAC may suspend or withdraw the accreditation temporarily until compliance with the accreditation requirement is demonstrated once more.

Find out more about the accreditation process.

• Step one. Application for accreditation
• Step two. Assessment
• Step three. Accreditation decision

Accreditation Process Step by Step

Step one. Application for accreditation

To apply for accreditation, you should fill out the appropriate form and send it to ENAC, supplying all the documentation specified. This documentation will help us to get to know the features of your organisation and the way in which the activities for which accreditation is applied for are carried out and to prepare the assessment properly. You should also attach the receipt for payment of the dossier opening fee in accordance with current rates.

The information received by ENAC, both in the application and in the course of the accreditation process, will be considered as CONFIDENTIAL.

Scope of accreditation

The scope of accreditation is a basic part of the application for accreditation as it will form the Technical Annex that accompanies the “Accreditation Certificate”. The applicant for accreditation establishes the scope for which they wish to be accredited in accordance with their needs and aims.

The application accreditation for a specific scope is a declaration on the part of the body of its technical competence for all the activities included in it, and the ENAC assessment, therefore, sets out to determine whether the body is capable of showing its competence in the whole of the scope declared.

Instructions are provided on every application form for ascertaining under which terms the scope should be defined.

Application acceptance and review

After receiving the application for accreditation, ENAC reviews the documentation supplied in order to check that the activity is suitable for accreditation and informs the applicant of the dossier number assigned and the officer responsible for coordinating the accreditation process.

The officer responsible for the dossier checks that the scope of the activities to be accredited is clearly defined and confirms that all the information needed for preparing and carrying out the assessment properly has been provided. If the documentation is incomplete or unsuitable, the applicant will be asked to rectify this.

If everything is correct and before starting the assessment, ENAC sends the applicant a cost estimate the process for acceptance.

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Step two. Assessment

Designation of the audit team

From amongst its assessors and qualified experts ENAC designates an audit team to carry out the assessment process which will have a lead assessor, with ultimate responsibility for the audit, and as many technical experts as may be needed depending on the activities for which the body requests accreditation.

ENAC informs the applicant of the names of audit team members and, where appropriate, of the organisation to which they belong. If the body considers that there are reasons that could compromise their impartiality, it may turn them down in writing, explaining the grounds.

Documentation study

Prior to the on-site audit, a study is made of the technical documents supplied by the body. The report with the result of the study is forwarded to the body so that it may adopt the measures it considers fit for resolving, where appropriate, the problems detected.

Auditing and accompanying visits

When the documentation study is considered satisfactory, the lead assessor gets in touch with the body to set the date of the audit and forward an Audit Schedule.

During the audit the management system of the body, its operation, the undertaking of the activities and the accreditation requirements are assessed.

In order to verify the correct application and interpretation of the working procedures and the technical competence of personnel, activities representative of the scope of accreditation are selected in order to witness the performance of technical personnel.

• Testing laboratories are asked to carry out a representative sample of the tests that are the object of accreditation.
• Calibration laboratories are asked to calibrate a “transfer standard”, previously calibrated by an accredited laboratory, which is supplied by the audit team.
• At inspection, certifying and assessment bodies, accompanying visits are made whereby technical experts witness the performance of the assessors / inspectors.

At the end of the audit the audit team will provide the representatives of the body with a summary of the results of the investigation and the deviations detected in respect of the accreditation criteria.

Audit team report

When the audit has been carried out, the body is given a written report prepared by the audit team with the results of the assessment carried out.

Applicant’s response

The body should examine the causes of deviations detected, review the impact that they may have on related activities and forward ENAC a schedule of remedial action, providing evidence that they have received the proper treatment to resolve them.

The body may make allegations against those points in the report with which it is not in agreement, putting forward all the evidence that it may consider necessary.

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Step three. Accreditation decision

Accreditation decisions are taken by an independent technical body called the Accreditation Commission.

To confer accreditation, the Accreditation Commission has to be duly convinced that the accreditation requirements are met and that the deviations detected, where applicable, have been suitably rectified. For this purpose it examines the information generated during the assessment process and, on the basis of this, adopts one of these decisions:

• Confer accreditation.
• Determine the extraordinary assessment activities that may be necessary to ensure that deviations detected are rectified.

If not in agreement with the decision, the body may address the Standing Committee, with whatever claims it deems fit.

Accreditation Certificate

The Accreditation Certificates specifically states:

• Name of the body and number of the accreditation granted.
• Scope of the accreditation, by reference to a document referred to as the Technical Annex to the Certificate.
• Date of entry into force of the accreditation.

The accredited body is entitled to make use of the ENAC mark or reference to its accreditee status under the terms and conditions laid down in document CEA-ENAC-01 “Criteria for the use of the ENAC mark or reference to the accreditee status”.

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Maintenance of accreditation

Accreditation is not the result of a one-off process. ENAC assesses accredited bodies on a regular basis, checking that they maintain their technical competence by means of follow-up visits and re-assessment audits. The frequency of visits is determined in accordance with previous results.

Follow-ups

The first follow-up visit is carried out within a period of not more than one year from awarding of the accreditation and subsequent follow-up is made not later than 18 months from the last visit; the body being notified in advance of the date.

Re-assessment

After a maximum of 4 years from the initial accreditation date, the body’s competence is re-assessed by carrying out an audit equivalent to the initial one. The next body re-assessment audit will be scheduled within a period not exceeding 5 years from the previous one.

Extension of the scope of accreditation

Accredited bodies may extend the scope of their accreditation. For this purpose they should make formal application for extension, using the application forms.

To evaluate this extension, the above assessment process is performed, though simplified as required in accordance with the volume and nature of this extension. The costs of the assessment process may be reduced if the extension coincides with a follow-up visit.

Cost of accreditation

Please see the Rates section for rates applicable to accreditation under the different schemes (laboratories, inspection, product certification, management system certification, etc.).

The cost of the process includes a charge for handling and management and the cost corresponding to the number of audit days needed to carry out the assessment, which depends on the scope of accreditation and the features of the body. Prior to conducting an assessment, ENAC forwards the applicant a quotation with the estimated cost of the process for acceptance.

Accredited bodies pay an annual accreditation maintenance fee.

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