3. Required Knowledge and Skills

The table below, inspired from CEN TS 18072’s Annex A [8], defines the knowledge and skills required for the different roles, which are then defined in greater details in the rest of the section.

In the table below, a “B” indicates a competence requirement for Module B assessments, an “H” indicates a competence requirement for Module H assessments and an “(X)” indicates a conditional competence requirement (typically, a requirement for all stakeholders involved in a related activity). The assumption is here that a conformity assessment body may be notified for performing only some activities (e.g., Module B assessments, but no module H assessments). A “X*” indicates a partial coverage of a competence requirement.

The following guidelines can be used:

• A mark in the “ Evaluator ” column indicates knowledge and skills that are required for all relevant evaluators.
• A mark in the “ Evaluation lead ” column indicates knowledge and skills that are required for lead evaluators, in addition to the other skills of an evaluator, or with higher expectation levels.
• A mark in the “ Evaluation team ” column indicates knowledge and skills that are required for at least one member of the evaluation team.
• A mark in the “ Personnel preparing the evaluation ” column indicates knowledge and skills that are required for the persons involved in the application review to determine the evaluation team competence required, to select the evaluation team members and to determine the evaluation time
• A mark in the “ Personnel reviewing reports and making decisions ” column indicates knowledge and skills that are required for the person in charge of reviewing reports and making conformity assessment decisions.

In all cases, additional details are provided below.

Figure 2: Summary of knowledge and skills

practices

with digital elements

digital elements

documentation structures, hierarchy

and interrelationships

tools, methods, techniques and their

application to the design, development

and production of products with digital

elements

management

security may be relevant or an issue

assessment terminology, principles,

practices and techniques

normative documents

defined in schemes, standards and

other normative documents

assessment body’s processes

evaluation of products with digital

elements

sector

client’s business sector

governance, structure, functions and

relationships on the design,

development and production of the

product with digital elements

evaluation process and the evaluation

team

This section covers the competences of the personnel performing evaluations, which includes the individual evaluators, the evaluation lead, and the evaluation team.

NOTE : Evaluation covers all selection and determination activities, including inspection, audit, testing, validation and verification.

This section covers the competences of the personnel involved in the application review to determine the evaluation team competence required, to select the evaluation team members and to determine the evaluation time.

NOTE : These personnel may be involved in the performance of evaluations or not, but they need to have enough knowledge to understand how an evaluation is performed, the set of skills that will be required for a given evaluation and the time required to perform the evaluation However, this role does not require any operational skills on the performance of evaluation activities.

This section covers the competences of the personnel in charge of reviewing reports and making conformity assessment decisions.

NOTE : These personnel are essential in a conformity assessment body. They also need to be independent from those performing the conformity assessment activities, while mastering many of their competences, with the notable exception of the skills to actually perform the conformity assessment activities. These personnel provide the guarantee that the processes and procedures defined by the notified body are appropriately applied in every conformity assessment project.