2. Basic Concepts

Article 39 of the CRA defines the requirements relating to notified bodies, and paragraph 7 focuses on the competences of the personnel:

7.The personnel responsible for carrying out conformity assessment activities shall have the following: (a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified; (b) satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments; (c) appropriate knowledge and understanding of the essential cybersecurity requirements set out in Annex I, of the applicable harmonised standards and common specifications, and of the relevant provisions of Union harmonisation legislation and implementing acts; (d) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

These requirements are a basis, but they need to be interpreted in the light of the competence requirements defined in the 17000 family of standards. The ISO/IEC 17000 series of standards also provides a means of assessing compliance with the generic requirements for all sectors. However, accreditation under the ISO/IEC 17000 series or equivalent is neither required nor necessarily sufficient to justify designation as a notified body under CRA, as the requirements have to be defined by the notifying authority in each Member State.

Nevertheless, the aim of the present document is to define competence requirements that can be used by Notifying Authorities and National Accreditation Bodies across the EU with the objective to harmonise the practices across Member States.

The roles are directly inspired from the roles defined in the ISO/IEC 17000 series of standards:

• An evaluator is member of the evaluation team, who will perform evaluation tasks.
• A lead evaluator is the person who is responsible for the evaluation of a product.
• An evaluation team is a team of persons in charge of the evaluation of a product, including one lead evaluator, one or more evaluators, and as required, additional members such as technical experts and observers.

NOTE : The lead evaluator may be the only evaluator in the evaluation team. NOTE : Technical experts do not need to demonstrate the competences of an evaluator, but they can only perform activities under the supervision of an evaluator.

The personnel preparing an evaluation is in charge for a given product or group of products to review the application, to determine the specific competences required for the evaluation team, to select the evaluation team members, and to determine the evaluation time.

NOTE : This role is usually endorsed by management personnel who interact with clients before the start of the evaluation.

The personnel reviewing reports and making certification decisions are in charge of ensuring that the evaluation has been performed according to the rules defined in the conformity assessment scheme.

NOTE : As per EN ISO/IEC 17065, the personnel reviewing reports must be independent from the evaluation team.

A competence is defined as the “ability to apply knowledge and skills to achieve intended results” in EN ISO/IEC 17021-1 (3.7). It is clearly composed of two aspects:

• knowledge and skills;
• the ability to apply them to achieve intended results.

Competence requirements therefore need to cover both aspects as well. ISO/IEC TS 17027 adds more relevant definitions:

• An ability is defined as the capacity to perform an activity (2.1).
• Knowledge is defined as facts, information, truths, principles or understanding acquired through education, training, experience or other means (2.56, slightly modified to match 2.74).
• A skill is defined as ability to perform a task or activity with a specific intended outcome acquired through education, training, experience or other means (2.74).