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Accreditation process

Accreditation process

This page provides an overview of the accreditation process as an idea of the key aspects of the process and some tips on how to get the most out of accreditation.

If you have already decided to apply for accreditation, check the step-by-step accreditation process, which offers a detailed description of the entire process with references to the relevant documents and forms.

If you have any questions, you can send us your request for information through the Spanish website.

Can I get accredited? Accreditation standards

If your organisation carries out assessment activities (such as tests, controls, measurements, analyses, inspections, technical audits, verifications, etc.) you will probably be able to request accreditation from ENAC.

ENAC accreditation is applicable to any organisation that conducts assessment activities regardless of the legal nature of the organisation, whether public or private, and regardless of its size, whether it performs other activities or if the assessment activity is a service provided by the organisation for its clients or carried out as part of its internal processes (quality controls, inspections of the reception of materials, control of suppliers, etc.).

For access to accreditation, you must identify the activity for which you would like accreditation and demonstrate that your organisation meets the international standard that best fits the activity. Therefore, the first step is to identify the relevant standard.

Below you will find information on the international standards for accreditation of the different activities with an explanation of their purpose and the types of organisation that perform them.

If you believe that none of these fits in with your activity or if you are unsure as to which would be the most appropriate, please contact us through the enqueries application of our website (in Spanish).

See activities and accreditation standards:

What they are: the tests consist of experimentally determining one or more product characteristics. Terms such as measurement, determination, analysis or even control may be used instead of "test" in different sectors.

What type of organisations perform them: tests can be offered to the market, in the case of independent laboratories, or done internally to support manufacturing processes (quality control or receipt of materials), assessment of legislative compliance (e.g. environmental), etc.

What is the reference standard for accreditation: the accreditation of testing laboratories is based on the UNE-IN ISO/IEC 17025 standard..

What it is: the determination of instrument error through the measurement of a standard of a known value and its associated uncertainty.

What type of organisations perform it: independent laboratories that offer their calibration services to the market or internal laboratories that calibrate the instruments of a large manufacturing company, for example.

What is the reference standard for accreditation: the accreditation of testing laboratories is based on the UNE-IN ISO/IEC 17025 standard.

What they are: tests done on biological materials, usually for diagnostic purposes.

What types of organisation perform them: independent laboratories or the internal laboratories of clinics or hospitals.

What is the reference standard for accreditation: the accreditation of a medical laboratory is based on the UNE-EN ISO 15189 standard.

What it is: inspection is intended to assess how the inspected object conforms to certain demands, sometimes on the basis of an expert professional assessment. The inspection may include visual controls, measurements or functional tests on physical objects, documentary examinations of specifications, comparisons of results with specific requirements or good practices of the area. Inspection is not limited to products. Facilities, buildings, machinery and even drawings or projects may be subject to inspection.

What types of organisation perform them: inspection may be the only service offered to the market by the organisation (as is the case of regulatory inspections and compulsory vehicle inspections), it may be a service associated with a product or installation (e.g. an inspection service after the installation of, for example, a boiler, to confirm successful installation), or it can be done internally in support of manufacturing processes (quality control or reception of supplies) or to evaluate providers (control of suppliers).

What is the reference standard for accreditation: the international standard applicable in this case is UNE-EN ISO/IEC 17020.

What it is:: certification is a "check" by a third party carried out on products, processes, systems and people. It is intended to provide confidence to the client of a company or the buyer of a product or service that the company, service or product meets certain requirements.

There are three basic types of certification:

Certification of products or services

This can refer to an object (e.g. low energy bulbs), a service (e.g. passenger transport) or a process (e.g. organic farming, traceability of the origin of a wood, etc.).

Certification of management systems

This certification ensures that the system implemented by an organisation for the management of quality, environmental matters, safety, etc. conforms to the standards in force (e.g. international standards ISO 9000 for quality, ISO 14001 for the environment, ISO 22000 for food safety).

Certification of persons

This verifies the competence of certified persons to carry out specific technical activities.

What types of organisation perform them: certification is a third-party activity, which means that certification bodies must be independent.

What is the reference standard for accreditation: the international standard applicable to product certification is UNE-IN ISO/IEC 17065, for the certification of management systems it is UNE-IN ISO/IEC 17021 and for the certification of persons it is UNE-IN ISO/IEC 17024.

The standards outlined here cover the vast majority of activities that can be accredited by ENAC. However, there are other, more specific activities such as reference material production, proficiency testing schemes and Good Laboratory Practice that can also be accredited. The 'What we do' section of our website contains detailed information on all these standards.

What is EMAS verification?

The EMAS Regulation requires that the management system of entities which aims for EMAS registry must be verified under the requirements of the EMAS Regulation and the content of their environmental statement must be validated. Both verification and validation must be performed by an accredited environmental verifier. Any organisation which takes on the commitment of the continuous improvement of its environmental performance, of the full compliance with the environmental legal requirements in regards and of the periodical publication of certain information about its environmental performance. The management system that supports the whole compliance must be verified in accordance to the requirements of the Regulation and the Environmental Statement must be validated by the verifier.

What kind of organisations carries out the verification and validation: Always independent entities from the organisation that aims for EMAS registry.

What is the reference standard for accreditation: Regulation (EC) No 1221/2009 of the European Parliament and of the Council of 25 November 2009 on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS), repealing Regulation (EC) No 761/2001 and Commission Decisions 2001/681/EC and 2006/193/EC.

What is the verification of greenhouse gas emissions: Is the ratification -after an objective assessment- that the content of an emission statement is free of inaccuracies and mistakes and the ratification of the compliance with the requirements of the Program that causes the need of a statement.

What kind of organisations carries out the verifications: Always independent entities always independent from the organisations that issue the statement.

What is the reference standard for accreditation: UNE EN ISO 14065: 2013

What PTP are: Proficiency testing exercises provide an independent assessment of the laboratory data and compare it to reference values or the performance of similar laboratories, providing the Management a confirmation that the technical aspects of its services are satisfactory or alerts them as to the need to investigate potential problems in the laboratory. Through their participation, laboratories can also test performance in new tests or measurements or those carried out only rarely and compare the results using different methods (or different concentration levels, etc.), helping them to select the most appropriate method for their characteristics and the needs of their clients.

What kind of organisations do PTP: Organisations that work offering PTP exercises, keeping the confidentiality of the results of the participation of the different laboratories.

What is the reference standard for accreditation: UNE-EN ISO / IEC 17043

What they are: Reference materials are a key tool to give reliability to the work of the test and calibration laboratories. They are used to calibrate, to validate methods, to estimate the uncertainty of the tests, verify the proper functioning of a method or to performance regular quality control.

What type of organisations do these: Companies that develop, produce and commercialize reference materials

What is the reference standard for accreditation: ISO 17034: 2016

What is GLP: It is a quality system for the organisational processes and conditions under which non-clinical health and environmental safety studies are planned, conducted, controlled, recorded, archived and reported.

What kind of organisations perform GLP: testing organisations which carry out local field test and laboratories of Physico-chemical and plant protection products, feed additives and industrial chemicals, thereby ensuring compliance with the regulation in order to register or authorize these products.

What is the reference standard for GLP certification: Royal Decree 1369/2000

Further information:

Does accreditation cover all my activity? The scope of accreditation

Accreditation always covers a scope defined specifically by you. The scope identifies the types of activities for which the applicant would like accreditation and, hence, the ones in which it would like ENAC to declare that it has sufficient technical competence. Scope is described in terms of specific assessment activities and includes, for example, test methods, types of inspections and certification categories in which the organisation has demonstrated competence.

See the instructions on scope definition found on the individual application forms to ascertain the terms under which the scope should be defined.

Where do I start? The accreditation application

Before applying for accreditation, you need to be familiar with the accreditation requirements set out in the standard and the ENAC documents developing them. You will also need to set up a system allowing you to prove to ENAC your compliance with all requirements.

You can also attend the informative sessions on accreditation that are organised periodically by ENAC, details of which can be found in agenda (only available in Spanish) on our website.

To apply for accreditation, you will need to complete an application form, which contains a series of legal commitments that you must read carefully, along with a number of annexes detailing the information that you must submit.

On receipt of your application, a member of staff will be put in charge of your file and act as your ENAC contact. The file manager will review the documentation and guide you through the accreditation process.

If everything is correct, before the assessment begins, you will receive an estimated quotation of the cost of the process application form for your approval. We will also inform you of the make-up of the most suitable audit team for your organisation's technical assessment.

How will I be evaluated? The audit

The initial audit will be conducted by an audit team made up of a Chief Auditor with in-depth knowledge of the reference accreditation standard and one or more senior Technical Experts with a thorough knowledge of the activities to be accredited and sufficient knowledge to issue a professional assessment on whether the activity is being carried out to the required levels of quality and competence. The duration of the visit will depend primarily on the requested scope and the size of your organisation.

  • During the audit:
  • An opening meeting will be take place to confirm the visit schedule and answer any questions.
  • A detailed examination will be conducted of the records of the organisation relating to the activities for which it has applied for accreditation. Interviews will be held with staff and managers to examine both technical and operating procedures and the records and reports resulting from their application, the availability of technical resources (facilities and equipment) and the suitability of these.
  • Performance of the activity being accredited will be observed in real conditions to confirm the solid and efficient application of all of the above premises (staff, technical processes and equipment). Activities such as inspection, tests or certification audits “in place” will be scheduled in advance with the organisation.
  • A final meeting will be held to report on the conclusions of the assessment, identifying each of the deviations detected.

At the end of the audit, a comprehensive report will be submitted with a summary of the assessment and the deviations detected, if any.

If deviations were detected, you will need to respond with a plan of action to address the problems identified.

ENAC will assess whether the corrective action plan has resolved the issues identified, in which case accreditation will be granted and the corresponding accreditation certificate will be issued. Otherwise, extraordinary assessment actions will be implemented.

Decisions on accreditation are agreed by the Accreditation Committee. Its composition and responsibilities are set out in the Articles of Association of ENAC

For how long is accreditation valid? Maintenance of accreditation

ENAC accreditation is valid indefinitely, provided that the accreditation maintenance activities are passed. ENAC assesses accredited bodies on a regular basis, checking that they maintain their level of technical competence with follow-up visits and re-assessment audits. The frequency of visits is based on the previous results, the characteristics of the organisation and the accredited activity.

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.

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 re-assessment at the organisation will be scheduled within 5 years of the previous one.

How can I include new activities in my scope? Extension of the scope of accreditation

Accredited bodies may extend the scope of their accreditation. To do so, they should make a formal application for an extension using the appropriate application forms. To evaluate the extension, the assessment process outlined is adapted to the volume and nature of the extension. Note that the costs of the assessment process may be reduced if the extension coincides with a follow-up visit.

If you wish to be accredited for another assessment activity), you must apply for accreditation again. An accreditation certificate can only cover one accreditation standard and, hence, one assessment activity.

How to make the most out of accreditation

As an accredited organisation, you will be entitled to use the ENAC accreditation mark. The terms of use of the accreditation mark are set out below (CEA-ENAC-01).

To support your marketing and communication activities, we encourage you to use and distribute the promotional material issued by ENAC to promote the value of having an accredited organisation. These resources include videos and brochures to help you to emphasise the value of your accreditation.