PDF 3409KB - DAR - Bundesanstalt für Materialforschung und ...
PDF 3409KB - DAR - Bundesanstalt für Materialforschung und ... PDF 3409KB - DAR - Bundesanstalt für Materialforschung und ...
Summary of national notification system: UNITED KINGDOM Liability insurance Notified Bodies are required to have professional indemnity and public liability insurance from an independent insurer. Evidence of this should be submitted to UKAS and to the responsible Department when a body makes an application to be appointed as a Notified Body. The responsible Department assesses the adequacy of the insurance cover, prior to designation and thereafter, the Notified Body should make available to UKAS evidence of insurance at each annual surveillance undertaken by UKAS. 1. Amount Varies according to the Directive and the scope of the notified body activity 2. Type of risks covered Professional indemnity and public liability insurance 3. MONITORING & SURVEILLANCE Responsibility for monitoring 1. designation authority Receives reports and recommendations from UKAS and takes action as necessary. 2. accreditation body (if applicable) UKAS will advise the responsible Department of the outcome of annual surveillance, four yearly reassessment and any other necessary monitoring. UKAS will advise the responsible Department if it believes that a Notified Body fails to continue to comply with the terms of its letter of designation, including the minimum criteria of the relevant Directive(s). In the case of a Notified Body which has also been accredited for a scope included within the scope of the relevant Regulations, UKAS will advise the responsible Department if that accreditation is suspended, withdrawn or reduced in scope and, following any appropriate appeals procedure, will recommend to the responsible Department whether it considers that constitutes a failure to continue to comply with the minimum criteria of the relevant Directive(s). UKAS will notify the responsible Department when an accreditation which supports notification is re-instated following suspension, withdrawal or reduction in scope. Practical aspects Where UKAS is responsible for the surveillance of notified bodies, it applies normal accreditation practice in terms of means and frequency of surveillance and re-assessment. 1. means of surveillance (witnessed assessments, audits, documentation review, etc.) See above. 2. frequency See above. Witnessed assessments, in which UKAS shall from time to time accompany the Notified Body during the latter’s assessment of a manufacturer, is one of the methods employed by UKAS in carrying out surveillance/re-assessment of Notified Bodies. 4
Summary of national notification system: UNITED KINGDOM • of surveillance Annual. • of re-assessment, if applicable Every four years. Reporting requirements Once a Notified Body has been appointed , the responsible Department will generally request UKAS to carry out, on its behalf, monitoring of that body in accordance with the terms of its letter of designation and to advise the responsible Department of the results of monitoring. The frequency of that monitoring will generally be consistent with UKAS accreditation practice, that is surveillance annually and full reassessment every four years, following an initial surveillance after 6 months for new applicants, and will be specified in the Notified Body’s letter of designation.. Additional monitoring may be carried out at more frequent intervals if justified by the circumstances. 1. written reports? UKAS submits a written report on surveillance and re-assessment to the responsible Department. (The responsible Department may require a notified body to produce a report of its activities, but this is not general practice.) • Content The report by UKAS consists of its assessment made following a visit to a notified body and copied to the responsible Department. • Frequency Surveillance (annual) and full re-assessment of the notified body (every four years). 2. Reporting of information to competent authorities on incorrect use of CE mark and/or certificates issued by NB Monitoring of subcontracted activities and activities of foreign subsidiaries These duties are the responsibility of the enforcement authorities although notified bodies do report to the authorities such instances which come to their attention. UKAS are responsible for monitoring these activities. 5
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Summary of national notification system: UNITED KINGDOM<br />
• of surveillance Annual.<br />
• of re-assessment, if applicable Every four years.<br />
Reporting requirements<br />
Once a Notified Body has been appointed , the responsible Department will generally request UKAS to carry out, on its behalf,<br />
monitoring of that body in accordance with the terms of its letter of designation and to advise the responsible Department of the results<br />
of monitoring. The frequency of that monitoring will generally be consistent with UKAS accreditation practice, that is surveillance<br />
annually and full reassessment every four years, following an initial surveillance after 6 months for new applicants, and will be specified<br />
in the Notified Body’s letter of designation.. Additional monitoring may be carried out at more frequent intervals if justified by the<br />
circumstances.<br />
1. written reports? UKAS submits a written report on surveillance and re-assessment to the responsible Department. (The responsible Department may<br />
require a notified body to produce a report of its activities, but this is not general practice.)<br />
• Content The report by UKAS consists of its assessment made following a visit to a notified body and copied to the responsible Department.<br />
• Frequency Surveillance (annual) and full re-assessment of the notified body (every four years).<br />
2. Reporting of information to<br />
competent authorities on incorrect use of CE<br />
mark and/or certificates issued by NB<br />
Monitoring of subcontracted activities and<br />
activities of foreign subsidiaries<br />
These duties are the responsibility of the enforcement authorities although notified bodies do report to the authorities such instances<br />
which come to their attention.<br />
UKAS are responsible for monitoring these activities.<br />
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