Service provider for quality management, certification support, quality inspection, sorting and rework as well as regulatory affairs for medical technology
Q-4-U Qualitätsmanagement
Wangen im Allgäu (headquarters) · Baienfurt (business address)New on Amplifa
About Q-4-U
Q-4-U Qualitätsmanagement is a consulting and service company for quality management based in Wangen im Allgäu with a business address in Baienfurt in the Lake Constance region. The company supports industrial and medical technology companies in implementing and optimizing management systems according to DIN EN ISO 9001, ISO 14001, ISO 13485 and DIN EN 9100 – from the GAP analysis through project implementation to accompanying the certification audit. In the field of medical technology, Q-4-U covers regulatory affairs: technical documentation according to EU MDR, risk management according to ISO 14971, clinical evaluation, usability engineering according to IEC 62366-1 as well as national and international product registrations. For industry, the company offers quality inspection, metrology concepts, sorting work, rework, pre-assembly of assemblies, supplier management, complaint management, 8D problem solving and FMEA moderation. Founder Günter Schneckenburger has 20 years of experience in quality management in Europe and Asia and leads a team of consultants and quality inspectors.
- Site
- Baienfurt
- Processes
- Quality inspection (internal/external, metrology for quality control), Rework (rework of non-conforming products), Sorting work (sorting of non-conforming products), Pre-assembly of assemblies (assembly according to customer specification, with 100% inspection of, Implementation and optimization of management systems (DIN EN ISO 9001, DIN EN ISO 14001, DIN EN, GAP analysis and audit plan creation, Accompaniment through certification audits (external, certification body selection), Internal audits according to ISO 9001
- Materials
- DIN EN ISO 9001, DIN EN ISO 14001, DIN EN ISO 13485, DIN EN 9100, EU-MDR 2017/745, ISO 14971, IEC 62366-1, VDA Volume 2
- Certificates
- ISO 9001 (consulting/certification support), ISO 13485 (consulting/certification support), ISO 14001 (consulting/certification support), EN 9100 (consulting/certification support)
- Industries
- Medical technology, Automotive, Mechanical engineering, Aerospace/Defense, Pharmaceuticals, High-tech
- 01
GAP analysis / status assessment
- 02
Action plan and project implementation
- 03
Effectiveness review and training
- 04
Accompaniment of the certification audit
- 05
Quality inspection, sorting and rework
- 06
Pre-assembly with 100% inspection
- 07
Supplier and complaint management
Services and Standards
DIN EN ISO 9001
Implementation and optimization of quality management systems for industrial companies.
DIN EN ISO 14001
Consulting on setting up environmental management systems.
DIN EN ISO 13485
Quality management systems for medical technology companies, including process validation.
DIN EN 9100
Quality management for aerospace and defense including EASA/FAA requirements and configuration management.
EU-MDR 2017/745
Technical documentation, UDI and EUDAMED registration for medical devices.
ISO 14971
Risk management and risk management files for medical devices.
IEC 62366-1
Usability engineering process and usability engineering file.
VDA Volume 2
Planning, execution and documentation of sampling for product release approval.
Locations
Wangen im Allgäu
DECompany headquarters
Baienfurt
DEBusiness address
Services
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Quality inspection (internal/external, metrology for quality control)Inspection | – | – | – | – | – |
| Rework (rework of non-conforming products)Inspection | – | – | – | – | – |
| Sorting work (sorting of non-conforming products)Inspection | – | – | – | – | – |
| Pre-assembly of assemblies (assembly according to customer specification, with 100% inspection ofAssembly | – | – | – | Small series | – |
| Implementation and optimization of management systems (DIN EN ISO 9001, DIN EN ISO 14001, DIN ENEngineering | – | – | – | – | – |
| GAP analysis and audit plan creationEngineering | – | – | – | – | – |
| Accompaniment through certification audits (external, certification body selection)Inspection | – | – | – | – | – |
| Internal audits according to ISO 9001Inspection | – | – | – | – | – |
| Supplier audits according to ISO 9001Inspection | – | – | – | – | – |
| Supplier management (selection, evaluation, continuous improvement)Engineering | – | – | – | – | – |
| Complaint managementEngineering | – | – | – | – | – |
| 8D method including tools and methods for RCA (root cause analysis)Engineering | – | – | – | – | – |
| FMEA moderation (failure mode and effects analysis)Engineering | – | – | – | – | – |
| Sampling according to VDA Volume 2Inspection | – | – | – | – | – |
| Creation of sorting and rework conceptsEngineering | – | – | – | – | – |
| Interim management (temporary management/specialist functions)Engineering | – | – | – | – | – |
| Support during project launch (from planning to start of production)Engineering | – | – | – | – | – |
| Post-market surveillance (PMS), vigilance and reporting obligationsEngineering | – | – | – | – | – |
| Usability engineering process according to IEC 62366-1 (usability engineering file)Engineering | – | – | – | – | – |
| European registrations (EU-MDR 2017/745, UDI, EUDAMED registration)Engineering | – | – | – | – | – |
| International registrations (IMDRF concepts, China/Japan, USA, Brazil, Mexico, Canada, Australia)Engineering | – | – | – | – | – |
| Technical documentation according to EU MDR (Annex II and III)Engineering | – | – | – | – | – |
| Risk management according to ISO 14971 (risk management file, risk analysis, risk minimization)Engineering | – | – | – | – | – |
| Clinical evaluation and clinical investigation of medical devices (research of published data)Engineering | – | – | – | – | – |
| Design control / design change control (product lifecycle management)Engineering | – | – | – | – | – |
| Validation of processes (non-verifiable processes, DIN EN ISO 13485 / FDA)Engineering | – | – | – | – | – |
| Change management (ensuring conformity across product changes)Engineering | – | – | – | – | – |
| CAPA process (corrective and preventive action)Engineering | – | – | – | – | – |
| Maintenance and review of product files, product registration national/internationalInspection | – | – | – | – | – |
| Preliminary work (contract work)Assembly | – | – | – | – | – |
| Certification consulting DIN EN 9100 (aerospace and defense, incl.Engineering | – | – | – | – | – |
Additional services
Quality and Standards
Q-4-U develops customized inspection methods together with partners and uses modern metrology for conformity testing, including 100% inspection of significant characteristics behind the pre-assembly. In addition, the company supports internal and external audits according to ISO 9001, ISO 13485 and other standards.
| Evidence | Baienfurt |
|---|---|
| ISO 9001 (consulting/certification support) | |
| ISO 13485 (consulting/certification support) | |
| ISO 14001 (consulting/certification support) | |
| EN 9100 (consulting/certification support) |
Background
20 years of experience in quality management in Europe and Asia
Cooperation with the Kontor Group for bundled support in quality management and process optimization