Directive 2007/46/EC of the European Parliament and of the Council (repealed)Show full title

Appendix 2 Procedure for the assessment of the technical services

1. PURPOSE OF THIS APPENDIX

1.1. This Appendix establishes the conditions according to which the assessment procedure of the technical services should be conducted by the competent authority referred to in Article 42 of this Directive.

1.2. These requirements shall apply mutatis mutandis to all technical services, irrespective of their legal status (independent organization, manufacturer or approval authority acting as technical service).

2. PRINCIPLES OF ASSESSING

Assessing is characterised by reliance on a number of principles:

• independance which is the basis for the impartiality and objectivity of the conclusions,

• an evidence-base approach which guarantees reliable and reproducible conclusions.

Auditors must show trust and integrity, and must respect confidentiality and discretion. They must report truthfully and accurately findings and conclusions.

3. SKILLS REQUIRED OF THE AUDITORS

3.1. The assessments may only be conducted by auditors having the technical and administrative knowledge necessary for such purposes.

3.2. The auditors must have been trained specifically for assessment activities. In addition, they must have the specific knowledge of the technical area in which the technical service will exercise its activities.

3.3. Without prejudice to the provisions of points 3.1. and 3.2., the assessment referred to in Article 42 paragraph 4 must be conducted by auditors independent of the activities for which the assessment is conducted.

4. APPLICATION FOR DESIGNATION

4.1. A duly authorised representative of the applicant technical service must make a formal application to the competent authority that includes the following:

(a)

general features of the technical service, including corporate entity, name, addresses, legal status and human and technical resources;

(b)

general information concerning the technical service such as its activities, its relationship in a larger corporate entity if any, and addresses of all its physical location(s) to be covered by the scope of designation;

(c)

an agreement to fulfil the requirements for designation and the other obligations of the technical service as applicable in the relevant directives;

(d)

a description of the conformity assessment services that the technical service undertakes in the framework of the applicable directives and a list of the directives for which the technical service seeks designation, including limits of capability where applicable;

(e)

a copy of the quality manual of the technical service.

4.2. The competent authority must review for adequacy the information supplied by the technical service.

5. RESOURCE REVIEW

The competent authority must review its ability to carry out the assessment of the technical service, in terms of its own policy, its competence and the availability of suitable auditors and experts.

6. SUBCONTRACTING THE ASSESSMENT

6.1. The competent authority may subcontract parts of the assessment to another designation authority or ask for support from technical experts provided by other competent authorities. The subcontractors and experts have to be accepted by the applicant technical service.

6.2. The competent authority must take into account accreditation certificates with adequate scope in order to complete its global assessment of the technical service.

7. PREPARATION FOR ASSESSMENT

7.1. The competent authority must formally appoint an assessment team. The former must ensure that the expertise brought to each assignment is appropriate. In particular, the team as a whole:

(a)

must have appropriate knowledge of the specific scope for which designation is sought, and

(b)

must have understanding sufficient to make a reliable assessment of the competence of the technical service to operate within its scope of designation.

7.2. The competent authority must clearly define the assignment given to the assessment team. The task of the assessment team is to review the documents collected from the applicant technical service and to conduct the on-site assessment.

7.3. The competent authority must agree, together with the technical service and the assigned assessment team, to the date and schedule for the assessment. However, it remains the responsibility of the competent authority to pursue a date that is in accordance with the surveillance and reassessment plan.

7.4. The competent authority must ensure that the assessment team is provided with the appropriate criteria documents, previous assessment records, and the relevant documents and records of the technical service.

8. ON-SITE ASSESSMENT

The assessment team must conduct the assessment of the technical service at the premises of the technical service from which one or more key activities are performed and, where relevant, must perform witnessing at other selected locations where the technical service operates.

9. ANALYSIS OF FINDINGS AND ASSESSMENT REPORT

9.1. The assessment team must analyse all relevant information and evidence gathered during the document and record review and the on-site assessment. This analysis must be sufficient to allow the team to determine the extent of competence and conformity of the technical service with the requirements for designation.

9.2.

The competent authority’s reporting procedures must ensure that the following requirements are fulfilled.

9.2.1. A meeting must take place between the assessment team and the technical service prior to leaving the site. At this meeting, the assessment team must provide a written and/or oral report on its findings obtained from the analysis. An opportunity must be provided for the technical service to ask questions about the findings, including nonconformities, if any, and their basis.

9.2.2. A written report on the outcome of the assessment must be promptly brought to the attention of the technical service. This assessment report must contain comments on competence and conformity, and must identify nonconformities, if any, to be resolved in order to conform to all of the requirements for designation.

9.2.3. The technical service must be invited to respond to the assessment report and to describe the specific actions taken or planned to be taken, within a defined time, to resolve any identified nonconformities.

9.3. The competent authority must ensure that the responses of the technical service to resolve nonconformities are reviewed to see if the actions appear to be sufficient and effective. If the technical service responses are found not to be sufficient, further information must be requested. Additionally, evidence of effective implementation of actions taken may be requested, or a follow-up assessment may be carried out to verify effective implementation of corrective actions.

9.4. The assessment report must include, as a minimum

(a)

unique identification of the technical service;

(b)

date(s) of the on-site assessment;

(c)

name(s) of the auditors(s) and/or experts involved in the assessment;

(d)

unique identification of all premises assessed;

(e)

proposed scope of designation that was assessed;

(f)

a statement on the adequacy of the internal organisation and procedures adopted by the technical service to give confidence in its competence, as determined through its fulfilment of the requirements for designation;

(g)

information on the resolution of all nonconformities;

(h)

a recommendation of whether the applicant should be designated or confirmed as technical service and, if so, the scope of designation.

10. GRANTING/CONFIRMING A DESIGNATION

10.1. The approval authority must, without undue delay, make the decision on whether to grant, confirm or extend designation on the basis of the report(s) and any other relevant information.

10.2. The approval authority must provide a certificate to the technical service. This certificate must identify the following:

(a)

the identity and logo of the approval authority;

(b)

the unique identity of the designated technical service;

(c)

the effective date of granting of designation and the expiry date;

(d)

a brief indication of or a reference to the scope of designation (applicable directives, regulations or part of them);

(e)

a statement of conformity and a reference to the present directive.

11. REASSESSMENT AND SURVEILLANCE

11.1. Reassessment is similar to an initial assessment except that experience gained during previous assessments must be taken into account. Surveillance on-site assessments are less comprehensive than reassessments.

11.2. The competent authority must design its plan for reassessment and surveillance of each designated technical service so that representative samples of the scope of designation are assessed on a regular basis.

The interval between on-site assessments, whether reassessment or surveillance, depends on the proven stability that the technical service has reached.

11.3. When, during surveillance or reassessments, nonconformities are identified, the competent authority must define strict time limits for corrective actions to be implemented.

11.4. When the corrective or improvement actions have not been taken within the agreed timeframe or are not deemed to be sufficient, the competent authority must adopt appropriate measures such as, conducting a further assessment, suspending/withdrawing the designation for one or more of the activities for which the technical service has been designated.

11.5. When the competent authority decides to suspend or withdraw the designation of a technical service, it must inform the latter by registered mail. In any case, the competent authority must adopt all the necessary measures to ensure the continuity of the activities already undertaken by the technical service.

12. RECORDS ON DESIGNATED TECHNICAL SERVICES

12.1. The competent authority must maintain records on technical services to demonstrate that requirements for designation, including competence, have been effectively fulfilled.

12.2. The competent authority must keep the records on technical services secure to ensure confidentiality.

12.3. Records on technical services must include at least:

(a)

relevant correspondence;

(b)

assessment records and reports;

(c)

copies of designation certificates.