Basic Data Organisation MD DQS MED Reference Nr.: (6-digit) Completed on: 2017-09-19 Last saved on: 2019-01-03 IMPORTANT: Please turn on „Track changes“ when revising this record! Shortcut [Ctrl+Shift+E] Information about organisation Official name of the organisation Company name as in official registration (register of commerce, FDA or other) Official address of the organisation Complete street address as in official registration (register, FDA or other): Number and street, place, ZIP/postal code, state/province, country Invoicing address Additional addresses – optional, if required P. O. Box address, any other addresses Homepage, telephone, fax Please provide homepage address and fax number! VAT-No. Bank details Name of the bank, IBAN, BIC Beneficiary (Trade Register Excerpt)
Contact person in top management* e.g. CEO or Managing Director – Name, position, telephone, fax, e-mail* ☐Mr. ☐Ms. Responsible for the management system* e.g. Management Representative – Name, position, telephone, fax, e-mail* ☐Mr. ☐Ms. Contact person in the accounting* Name, position, telephone, fax, e-mail* ☐Mr. ☐Ms. Additional contact person* Name, position, telephone, fax, e-mail* ☐Mr. ☐Ms. Type and size of business Activities, main processes and products/services offered on the market, Number of sites and employees/staff Existing certifications? (not from DQS MED) If yes, provide copies of certificates! ☐ Yes (copies attached) ☐ No Legal obligations What law/regulations apply to your management system? Belonging to larger organisation? Does your organisation belong to a larger organisation, such as a holding or group of companies? ☐ Yes ☐ No If yes, please provide the larger organisation’s name and your organisation’s role in it Use of consulting?* Has your organisation used support of an external service provider for its management system?* ☐ Yes ☐ No If yes, please provide the service provider’s name
Information on certification DQS MED certifications Please choose the desired or existing DQS MED certifications by entering crosses in the right column Activities (examples) Certification standard or regulation “X“ Medical device manufacturer QMS requirements, DAkkS accredited EN ISO 13485 / DIN EN ISO 13485 / ISO 13485 ☐ Medical device manufacturer QMS requirements, SCC accredited ISO 13485 ☐ General QMS requirements ISO 9001 (Caution: additional cost to ISO 13485) ☐ Manufacturer of primary packaging for pharmaceuticals ISO 15378 ☐ Medical device manufacturer for the EU/EWR/CH, CE certification Directive 93/42/EEC Class I (sterile/with measuring function), Class IIa, Class IIb Procedure according to Annex II without No. 4 ☐ Class I (sterile/with measuring function), Class IIa Procedure according to Annex V ☐ Class IIa (only active medical devices) Procedure according to Annex VI ☐ Class III Annex II with No. 4 (EC Design Examination) ☐ Other please specify: ☐ List of Product/Services -required for ISO 13485- DQS MED requires an up-to-date list of products and services covered by certification for all medical device certifications ☐ Attached, dated: Klicken Sie hier, um ein Datum einzugeben. Use the form 410.141 Basic Data – List of Medical Devices Table Products and services ISO 13485 Please also mind No. 3.4 for Directive 93/42/EEC. Enter here the revision date of the attached list.
Locations of your organisation All sites involved in the certified activities, belonging to your QM system. Include any operations sites and the head office of your organisation! NOTE: Involved sites that operate a different, independent QM system, can be considered as suppliers and listed in Nr. 2.4. No. Site name e.g.: head office, factory, warehouse Address complete street address Total count of employees (full-time equivalent) Activities (select by entering „X“) Technologies used (select by entering „X“) Design and development Production Final testing Storage Distribution (shipping) Installation Servicing/repair 191 187 171 172 190 177 178 179 180 170 143 185 189 188 186 Blood bank Chemical technology Electronics / electrical Growth media Medical gases Metal processing Optics Plastics processing Resin Software development Sterilisation Textile material Animal material/tissue Human material/tissue Wood processing To add more rows, put cursor into the last line and hit [TAB] multiple times.
Information for certification to Directive 93/42/EEC Are you “manufacturer” of “medical devices” in Europe? Are medical devices of classes III, IIb, IIa, or class I (sterile or with measuring function) placed on the European market under the name of your organisation as manufacturer, or is this planned in near future? ☐ Yes ☐ No skip to No. 4 EXPLANATION of terms: Medical device – see Art. 1 (2) a) Class - see Annex IX and Manufacturer – see Art. 1 (2) f) Are you located outside Europe (EU/EEA/CH)? (EU Representative) If you, as manufacturer, are located outside the EU/EEA/CH, please provide details on your EU Representative in No. 2.4. ☐ Yes details in 2.4 ☐ No EU Representative – see Art. 1 (2) j) (any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive) DIMDI registration Manufacturer – if manufacturer located in Germany DE/00000__________ EU Representative – if EU Representative located in Germany DE/00000__________ List of Medical Devices -Part Medical Devices EU- ☐ Attached – see No. 2.2 Use the form 410.141 Basic Data – List of Medical Devices Table Medical Devices EU Location of all evidence At what locations are all records required by your QMS available, including product documentations according Directive 93/42/EEC Annex II No. 3, Annex V No. 3 or Annex VI No. 3?
Substantial changes (not required in case of initial certification request) When is this information required? You are transferring your certification from another certification body to DQS MED DQS MED asked you to update Basic Data In case of any planned substantial changes, without request If you are certified by DQS MED to Directive 93/42/EEC – before or immediately on performing a recall, issuing an advisory notice, field safety action, incident notification etc. (Section 5.3 of ). Changes in your organisation? e.g. company name, contact persons, activities, certifications granted by other certification bodies, company size, ownership, consultant etc.? ☐ Yes ☐ No If yes, please explain Changes to your QMS? e.g. products/services, essential processes, locations, suppliers/subcontractors etc.? ☐ Yes ☐ No If yes, please explain Regulatory information? Only for MDD e.g. new or discontinued medical devices, etc.? ☐ Yes ☐ No ☐ N/A If yes, please explain Regulatory actions? Only for MDD Have you performed any of these regulatory actions since your last audit? ☐ Yes ☐ No ☐ N/A If yes, please explain Recalls, advisory notices, FSCA Reportable incidents Any other reporting obligations Additional remarks