Section 3 Approval

301. Notification and announcement of approval

1. After satisfactory completion of the documentation assessment and plant audit, the Society is to is- sue the Manufacturer Approval Certificate such as FORM AC-6A in Annex 5 and send it to the applicant.

2. The Society announces the manufacturers who have been granted Manufacturer Approval Certification in the “List of Approved Manufacturer & Type Approved Equipment” containing the types of products and the main conditions of approval.

302. Validity of the certificate

1. The Approval Certificate for Manufacturer Approval will be valid for five years from the date of issue. In case where the approval certificate is reissued in accordance with the requirements speci- fied in the preceding 304., the expiration date will not be changed.

2. This approval maintains its validity under the acceptance of periodical audit in 203. above.

3. The manufacturer who intends to have a continuation of the approval is to submit an application to the Society three months before the due date together with the contents of the alteration if there is any alteration to the manufacturing facilities and to the quality assurance systems.

4. Where for operational reasons, the renewal audit falls outside the period of approval, the manu- facturer will still be considered as approved if agreement to this audit date is made within the pe- riod of three months after expiry of the validity, in this instance if successful, the extension of ap- proval will be back dated to the original renewal date.

303. Suspension and withdrawal of certification

1. When non-conformities are found in the periodical audit, renewal audit or occasional audit or when conditions for the issuing of the certificate or those for its maintenance have deteriorated, the man- ufacturer is to correct the non-conformities. Such corrections are to be verified by the Society. In case corrective actions are not taken within the specified period, the Society may suspend the ap- proved certificate for a given period. In case the corrective actions are not taken for the suspended period, the Society may withdraw the Manufacturer Approval.

2. The Society can withdraw the Manufacturer Approval and Type Approval of products if any of the following conditions happens:

(1) When important changes having significant effect on the quality system is not communicated to the Society.

(2) When the periodical, occasional or renewal audit is not carried out in the relevant period.

(3) When a request for withdrawal is made by the manufacturer.

(4) When the approval fees are not paid.

(5) When considered inappropriate for approved condition by the

3. Society.

A manufacturer whose approval has been withdrawn, may apply for re-approval provided that the

reasons which resulted in cancellation are corrected, and the Society is to issue the approval certifi-

4. cate after it is confirmed that the corrective action has effectively been implemented.

Where an application for re-approval is made for product which had its the manufacturer approval

and type approval withdrawn, such application shall be handled according to initial design approval requirements. But, it may be considered as exceptional case in case where the Society specially

304. Changes in the approved contents

1. In case of any change having effect on the manufacturing process and the quality system, it is to be promptly communicated by the manufacturer to the Society. The Society may request an occa- sional plant audit, where deemed necessary upon reviewing the contents of alteration.

Guidance for Approval of Manufacturing Process and Type Approval, Etc. 2015 257

2. When the manufacturing sites (including that of subcontractor's works) were relocated, changed or added, the manufacturer is to submit the application for alteration to the Society together with the detailed documents of the alteration(where practicable, to be mentioned with a comparison table form between new and old). The Society is to carry out the plant audit for the manufacturing proc- ess and quality system by visiting.

258 Guidance for Approval of Manufacturing Process and Type Approval, Etc. 2015