Laser at your service During the acquisition process of a new FOBA laser system, one of the documents you ask our customer support for is a supplier self assessment. The following list provides you with the most important company information you may need.Company InformationAddress, Contacts, County Court ALLTEC Angewandte Laserlicht Technologie GmbH An der Trave 27 - 31 | 23923 Selmsdorf | Germany Managing Directors: Sebastian Bloesch, Hannes Napp, Lin Wei Tel. +49(0)38823 55-0 Website: https://www.fobalaser.com | E-Mail: [email protected] Local Court: Schwerin HRB 7884 Organizational Information Founded: 1985 Employees: >200 Mother Company: Veralto Corporation Bank Account □ Bank Address: Deutsche Bank AG, Unter den Linden 13/15, 10117 Berlin □ Bank account No. 167 397 900 □ Bank code 100 700 00 □ Swift code DEUTDEBBXXX □ IBAN DE 75 1007 0000 0167 3979 00 Portfolio/Business Operations □ Laser marking systems, spare parts and related software □ Development and manufacturing of innovative laser marking and engraving machines □ Customised laser marking systems for OEM and integrators □ Vision-inspection systems for part validation, mark alignment, and post-mark validation/verification As supplier to medical device manufacturers, ALLTEC seeks to comply with parts of the following standards: ALLTEC Angewandte Laserlicht Technologie GmbH | FOBA Laser Marking + Engraving An der Trave 27-31 | 23923 Selmsdorf | Germany T + 49 38823 55-0 | [email protected] | www.fobalaser.com © 2024 ALLTEC Angewandte Laserlicht Technologie GmbH - All rights reserved. FOBA_Self-Asses

□ ALLTEC/FOBA Quality Policy: "We are committed to providing the best solutions for laser-based marking and engraving and the best service for our customers." □ ALLTEC/FOBA has a Quality Management System (QMS) in place which is certified according to ISO 9001:2015 (first certification 2002, current certification expires 2025). □ ALLTEC/FOBA is commited to the over all Veralto policies and established its own market-specific quality policy. □ The structure of ALLTEC/FOBA's QMS is process-oriented and includes three different process categories: Management, Core and Support processes. □ All processes...

Quality Records and Retention (according to EN ISO 9001:2015 7.5, ISO 13485:2003 Sec. 4.2.3 & 4.2.4 – 21 CFR Part 820.181, 820.184, & 820.186, ISO 17025:2005 Sec. 4.4, 4.8, 4.13, 5.4.7, 5.17) □ Records of each individual product are maintained in a product data base. These include bills of material, final test results, installation records as well as later service case records and complaints. □ ALLTEC/FOBA uses a database system software to track all transactions with systems after installation. Required information is entered into mandatory fields. Thus all necessary information is on hand when...

Handling, Storage & Distribution (according to ISO 13485:2003 Section 7.5.5 – 21 CFR Part 820.150 and 820.160 - ISO 17025:2005 Section 5.8.4) □ Material is stored in a Kanban system close to the production areas. The Kanban system assures a FiFo consumption and replenishment of the inventory. Inventory level and turns both are key perfomance indictors (KPI) for operations and reviewed on a daily basis. □ Obsolete parts are sorted out during the process of implementing new revisions. Rejected, damaged or deteriorated material is separated in a restricted area, labeled and reprocessed or scraped....

□ The ALLTEC/FOBA Supplier Quality Management (SQM) process is part and in line with the Veralto Enterprise System (VES). The SQM includes processes for supplier selection, performance measurement and development. □ Supplier selection includes self assessment and initial supplier audits among others. Performance measurements base on performance indicators like quality, cost and delivery. □ Supplier development includes training and developing suppliers and their associates to the desired level of performance. □ Each laser marking system is identified by an unique serial number. □ The serial number...

□ With every delivery, ALLTEC/FOBA provides a customer manual, including safety instructions as well as installation and maintenance FAQ. □ Documents are available in the languages German, English, French, Spanish, Italian, Portuguese, Chinese, Dutch, Czech, Polish, Slovenian, Lithuanian, Romanian, Hungarian, Danish. □ For every product and option, a dedicated maintenance procedure and protocol is available. □ We provide additional maintenance steps and separate protocol for MQ to meet IQ/OQ customer needs. □ Annual maintenance or maintenance on demand options, based on committed service-contract....