1

Company statutes

2

Extract of company registration or enrolment act (Company register)

3

Documentation on the activities of the organisation to which the conformity assessment body belongs (if any) and its relationship with the conformity assessment body

4

Documentation on entities the conformity assessment body owns (if any), either within the Member State or outside, and the relationship with those entities

5

Description of legal ownership and the legal or natural persons exercising control of the conformity assessment body

6

Description of organisational structure and the operational management of the conformity assessment body

7

Descriptions of functions, responsibilities and authorities of top-level management

8

List of all staff who have an influence in the conformity assessment activities

9

Documentation on other services provided by the conformity assessment body (if any) (e.g. consultancy relevant to devices, training etc.)

10

Documentation on accreditation(s) relevant to this application

11

Documentation on structures, policies and procedures to safeguard and promote the principles of impartiality throughout the organisation, personnel and assessment activities, including ethical rules or codes of conduct

12

Description of how the conformity assessment body ensures that the activities of subsidiaries, subcontractors and external experts do not affect its independence, impartiality or objectivity

13

Documentation on the impartiality of the top-level management and personnel involved in conformity assessment activities, including their remuneration and bonuses

14

Documentation on conflict of interest and resolution of potential conflict procedure/form

15

Description of independence of the conformity assessment body from the designating authority and from the competent authority, in particular when this body is a public entity/institution

16

Documentation on professional secrecy procedure including protection of proprietary data

17

Documentation of the liability insurance, proof that the liability insurance covers cases where the notified body may be obliged to withdraw or suspend certificates

18

Documentation of the financial resources required to conduct the conformity assessment activities, related operations, including the ongoing commitments for certificates issued to demonstrate the continuing viability of the notified body and consistency with the range of products certified

19

Quality Manual and a list of related documentation on the implementation, maintenance and operation of a quality management system, including policies for assignment of personnel to activities and their responsibilities

20

Documentation on the procedure(s) for control of documents

21

Documentation on the procedure(s) for control of records

22

Documentation on the procedure(s) for management review

23

Documentation on the procedure(s) for internal audits

24

Documentation on the procedure(s) for corrective and preventive actions

25

Documentation on the procedure(s) for complaints and appeals

Resource requirements

26

Description of own laboratories and testing facilities

27

Employment contracts and other agreements with internal personnel, in particular in relation to impartiality, independence, conflict of interest (attach a standard contract template)

28

Contracts and other agreements with subcontractors and external experts, in particular for impartiality, independence, conflict of interest (attach a standard contract template)

29

List of all permanent and temporary personnel (technical, administrative etc.) including information on professional qualification, past experience and the types of contracts held

30

List of all external personnel (e.g. external experts, external auditors) including information on professional qualification, past experience and on the types of contracts held

31

Qualification matrix linking the body's staff and its external experts to the functions to be accomplished by them and to the fields of competence for which the body has been notified or wishes to be notified

32

Qualification criteria for the different functions (see point 31)

33

Documentation on the procedure(s) for selection and assignment of internal or external personnel involved in the conformity assessment activities, including conditions for the attribution of tasks to external personnel and the supervision of their expertise

34

Documentation demonstrating that the management of the conformity assessment body has appropriate knowledge to set up and operate a system for:

• the selection of the personnel deployed during the conformity assessment,

• the verification of the knowledge and experience of this personnel,

• the assignment of the personnel to their tasks,

• the verification of the performance of the personnel,

• the definition and the verification of their initial and ongoing training

35

Documentation on the procedure assuring ongoing monitoring of competences and performance monitoring

36

Documentation on standard training programmes conducted by the conformity assessment body relevant to the conformity assessment activities

37

List of all subcontractors (not individual external experts) used for conformity assessment activities

38

Subcontractor policy and procedure

39

Documentation demonstrating adequate core competence within the conformity assessment body to assess, select, contract, and to verify the appropriateness and validity of subcontractor activities

40

Examples of standard template contract, prohibiting further subcontracting by legal persons and specifically including provisions to ensure confidentiality and conflict of interest management with subcontractors (attach examples)

41

Documentation on procedures relating to conformity assessment activities and other related documents reflecting the scope of conformity assessment activities including, in particular procedures relating to:

• Qualification and classification

• Quality system assessments

• Risk management

• Pre-clinical data evaluation

• Clinical evaluation

• Representative sampling of technical documentation

• Post-market clinical follow up

• Communications from regulatory authorities including competent authorities and designating authorities

• Communication and analysis of the impact of vigilance reports on device certification

• Consultation procedures for drug-device combination products, devices utilising animal tissue, devices utilising human blood derivatives

• Review and decision making on certificate issuance including approval responsibilities

• Review and decision making on certificate suspension, restriction, withdrawal and refusal including approval responsibilities

42

Checklists, templates, reports and certificates used for the conformity assessment activities

Name and signature of an authorised representative of the applicant conformity assessment body (unless electronic signature is accepted)

Place and date