Are there critical suppliers/ Yes Examples of activities of critical suppliers: ☐ (all of the following activities are considered critical when outsourced) subcontractors? (see below) Design and development, production, population/assembly, packaging, work in clean room, Including „OEMs“, production facilities, sterilisation, labelling, final testing, finished device provision (OEM), involved sister, daughter No ☐ and mother companies with independent QM systems service providers and any regulatory representatives Attach copies of current certificates of your critical suppliers! Nr. Company name Address Activities (select by Description of what is obtained from this company: entering „X“) complete street product manufactured address outsourced processes services provided () EXPLANATION of activities: OEM Original Equipment Manufacturer – EU Representative only where applicable for procedures according to Directive – certified? 93/42/EEC (manufacturer located outside the EU/EWR/CH) facility? certificates! Officer? DEU Safety Officer only where applicable for procedures according to Directive – „OEM“? provider? 93/42/EEC (manufacturer located in Germany) an attach company Safety Representative? this yes, this Production Service DEU EU Is Is If To add more rows, put cursor into the last line and hit [TAB] multiple times. . Connection with other QM systems? Yes If yes, provide ☐ name or related Is the QMS subjected to certification connected to another QMS of your company and No ☐ describe the organisation or of another related company (e.g. QMS of internal or external connection suppliers)? Location of evidence At what sites are documents and records available, that are specified/required by your QMS?
Are there critical suppliers/ subcontractors? Including „OEMs“, production facilities, service providers and any regulatory representatives ☐ Yes (see below) ☐ No Examples of activities of critical suppliers: (all of the following activities are considered critical when outsourced) Design and development, production, population/assembly, packaging, work in clean room, sterilisation, labelling, final testing, finished device provision (OEM), involved sister, daughter and mother companies with independent QM systems Attach copies of current certificates of your critical suppliers! Nr. Company name Address complete street address Is this company certified? If yes, attach certificates! Activities (select by entering „X“) Description of what is obtained from this company: product manufactured outsourced processes services provided () EXPLANATION of activities: OEM – Original Equipment Manufacturer EU Representative – only where applicable for procedures according to Directive 93/42/EEC (manufacturer located outside the EU/EWR/CH) DEU Safety Officer – only where applicable for procedures according to Directive 93/42/EEC (manufacturer located in Germany) Is this an „OEM“? Production facility? Service provider? EU Representative? DEU Safety Officer? To add more rows, put cursor into the last line and hit [TAB] multiple times. . Connection with other QM systems? Is the QMS subjected to certification connected to another QMS of your organisation or of another related company (e.g. QMS of internal or external suppliers)? ☐ Yes ☐ No If yes, provide name or related company and describe the connection Location of evidence At what sites are documents and records available, that are specified/required by your QMS?