Required Scope of Certification What types of product will be included in the scope of the certification and which Implementing Regulation (IR) or MED Amendment was used to derive these references? [ Where more than 3 types list in separate document] Please note TUV SUD BABT are unable to accept transfers for product items outside our scope IR/ Amendment Decision Number Sector Item Types . Are all these item types on your current Certificate: If No Please list the new items: . Please identify the products to be included in the scope of the certification No of issuing Expiry Date of the Product Name TEC Certificate number Notified Body Certificate If you have more than 6 products please provide the details for all the products in a separate document and reference it in the first above Product Name Number of Facilities to be included in this Certificate Applicant Company Details Internal Quality A copy of our Internal Audit Schedule and process is attached to this application Where you have selected a later date please state the proposed date Note: The Schedule should show the date/month when you plan to conduct the Audit of the Fabricator for compliance to the relevant requirements of the MED and BABT 340. A copy of our PQC compliance plan is attached to this application Where you have not provided the documents Date indicate the date when they will be sent A copy of the manufacturing Test Plan for each Product is attached to this application Where you have not provided the documents Date indicate the date when they will be sent
Required Scope of Certification What types of product will be included in the scope of the certification and which Implementing Regulation (IR) or MED Amendment was used to derive these references? [ Where more than 3 types list in separate document] Please note TUV SUD BABT are unable to accept transfers for product items outside our scope IR/ Amendment Decision Number Sector Item Types . Are all these item types on your current Certificate: If No Please list the new items: . Please identify the products to be included in the scope of the certification Product Name TEC Certificate number No of issuing Notified Body Expiry Date of the Certificate If you have more than 6 products please provide the details for all the products in a separate document and reference it in the first above Product Name Number of Facilities to be included in this Certificate Applicant Company Details Internal Quality A copy of our Internal Audit Schedule and process is attached to this application Where you have selected a later date please state the proposed date Note: The Schedule should show the date/month when you plan to conduct the Audit of the Fabricator for compliance to the relevant requirements of the MED and BABT 340. A copy of our PQC compliance plan is attached to this application Where you have not provided the documents indicate the date when they will be sent Date A copy of the manufacturing Test Plan for each Product is attached to this application Where you have not provided the documents indicate the date when they will be sent Date
babt789-i05.docx