Information To Be Included In the EU NB

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Information To Be Included In the EU NB Partners Audit Report Albert T. W. Li Center for Measurement Standards Industrial Technology Research Institute EU-Chinese Taipei Workshop 2005 ITRI Industrial Technology Research Institute 1

For European Manufacturers Export to Taiwan l factory layout l production process diagram l quality system documentation (QSD) including quality manual and procedures l ISO 13485 equivalent certificate issued by accreditation organization l Cover letter l Audit report prepared by EU NB Partners l ISO 13485 certificate issued by EU NB Partner l Certificate for Free Sale issued by Competent Authority European Manufacturer QSD Submission Taiwan Authorized Distributor ITRI Industrial Technology Research Institute 2

Cover Letter • Issued by EU NB Partner • EU NB Partners format • Certify • • • Refer to TCP Name and address of the manufacturer Date of the most recent audit Type of regulatory audit Validity of the audit report and report No. (if available) • Validity of ISO 13485 certificate ITRI Industrial Technology Research Institute 3

Cover Letter • Clarify when necessary • Manufacturer’s address • Product scope • CAPA of non-conformities • Signed by responsible person ITRI Industrial Technology Research Institute 4

ISO 13485 Audit Report • Issued by the EU NB Partner • EU NB Partner format • The most recent and certification audit • Regulatory audit • Audit and certification by EU NB Partner • If the most recent audit is not a certification audit, then certification audit and the most recent audit report should be submitted • Type of audit ITRI Industrial Technology Research Institute 5

ISO 13485 Audit Report • Audit standard • Auditee’s information including name and address • Product scope covered by this audit • Non-conformity (if any) • Conclusion of the audit ITRI Industrial Technology Research Institute 6

Additional Information • The following information should be included in the audit report since Nov 2005: – List of medical devices or product families that are relevant for the Taiwan market and if these products are included in the audit. – Subcontracting (if applicable) – Manufacturer establishes procedure to ensure the devices delivered to Taiwan are registered. – Manufacturer establishes procedure to communicate with its Taiwanese distributor with regard to postmarket monitoring/vigilance, complaint handling, labeling control and advisory notice/recall. – EU NB Partner’s conclusion of CAPA taken by the manufacturer regarding non-conformities observed in the audit. ITRI Industrial Technology Research Institute 7

ISO Certificate • Issued by EU NB Partners • EN ISO 13485: 2000 or later • Manufacturer’s information including name and address • Product scope • Issued date • Expiration date ITRI Industrial Technology Research Institute 8

Certificate for Free Sale • Issued by EU Competent Authority or its designated organization • Manufacturer’s information including name and address • Product scope • Certify the device compliance to AIMD/MDD/IVDD and national regulation (if applicable) • Eligible for manufacture and sale in the country ITRI Industrial Technology Research Institute 9

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