Handling of failures under module D or E: UK21/G020
Adopted EU recommendation GEN-041.UK approved recommendation on the actions to take should a product failure be detected during periodical surveillance or an unannounced visit.
Question
What is the procedure to be followed when failures are detected compromising the compliance of the product during a surveillance visit or unannounced visit? Should certification be suspended and/or withdrawn?
Recommendation
Should failures with module D or E be detected compromising the compliance of the product in the course of periodical surveillance or an unannounced visit such as to show that the quality management system no longer complies with the applicable requirements, the Approved Body shall notify the Manufacturer the reasons for which the certificate cannot be endorsed and immediately either reduce the certification in scope or suspend the certification, as appropriate, for all those products which could be affected. This should be accompanied by the indication of the serial number or the date from which the reduction in scope or suspension takes effect and/or any other information necessary to identify the products affected.
Any items of equipment manufactured during the period of suspension for application of module D or E may be marked and marketed, provided that they are subjected to individual verification/testing under module F in accordance with the applicable requirements, where this is foreseen under the Merchant Shipping (Marine Equipment) Regulations 2016 as amended.
The suspension can be removed upon completion of the corrective actions necessary to reinstate the applicability of modules D or E, which is subject to the satisfactory outcome of surveillance to assess their effectiveness. The Manufacturer shall be notified of this by the Approved Body. The Approved Body may withdraw the certification and notify the Manufacturer accordingly in the event that the non‐conformities that led to the suspension are not rectified by the agreed deadline. The applicant shall not submit a further application for surveillance until he has made all those modifications to the quality system which are necessary.
References
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MSN 1874 as amended
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The Merchant Shipping (Marine Equipment) Regulations 2016 as amended
Items affected
- All
More information
Maritime and Coastguard Agency
Bay 2/21
Spring Place
105 Commercial Road
Southampton
SO15 1EG
Telephone: +44 (0) 203 817 2000
Email: MEQA@mcga.gov.uk
Website: www.gov.uk/mca