Consulting for lean quality management and ISO 9001 certification for small and medium-sized enterprises
Lösungsfabrik Thode und Partner, QM-Berater
Heidelberg (DE)New on Amplifa
About Lösungsfabrik
Lösungsfabrik Thode und Partner is a consulting firm founded in 2011 and based in Heidelberg that supports small and medium-sized enterprises in introducing or adapting a lean and efficient quality management system in accordance with DIN EN ISO 9001. The service portfolio includes full service for ISO 9001: process check, preparation of the complete standard-compliant documentation (manual, process descriptions, work instructions), conduct of internal audits, management review, and support up to certification. In addition, external quality management representatives are provided, QM seminars and workshops are offered, and a funding support service (e.g. BAFA) is available. Additionally, Dr. Janet Thode offers GMP consulting for the life science, pharmaceutical and laboratory sector, including validation of analytical methods in accordance with ICH Q2(R1) and the preparation of SOPs. Practical experience extends to service companies, trading companies, manufacturing SMEs as well as dental practices and tax advisory firms. Consulting services are provided in southern Germany.
- Site
- Heidelberg
- Processes
- ISO 9001 quality management consulting, External QMB (Quality Management Representative), Conduct of internal audit, QM and ISO 9001 seminar / training, Quality management ISO 9001 workshop, Preparation of QM documentation (manual, process descriptions, work instructions), Audit preparation and management review, Certification support (selection of certification body, audit accompaniment)
- Materials
- ISO 9001 Full-Service Consulting, External Quality Management Representative, Internal Audit and Management Review, QM and ISO 9001 Seminars and Workshops, GMP Consulting and ICH Q2(R1), Funding Support Service
- Certificates
- Quality Management Auditor (TÜV Süd Akademie), Quality Management Representative (TÜV Süd Akademie), Quality Management Specialist (TÜV Süd Akademie)
- Founded
- 2011
- Industries
- Small and medium-sized enterprises (SMEs), Service companies, Trading companies, Manufacturing industry, Life Science / Pharma / Laboratory / MedTech, Dental practices
- 01
Process check and identification of core processes
- 02
Preparation of lean, standard-compliant documentation
- 03
Conduct of internal audits
- 04
Management review
- 05
Certification support up to the certificate
Services and Methods
ISO 9001 Full-Service Consulting
Complete consulting service including preparation of the entire QM documentation up to certification.
External Quality Management Representative
Taking over QM representative support and operational QM tasks for SMEs.
Internal Audit and Management Review
Conduct of internal system audits and joint preparation of the management review.
QM and ISO 9001 Seminars and Workshops
Trainings and workshops for building QM competence within the company.
GMP Consulting and ICH Q2(R1)
GMP consulting for pharmaceutical and laboratory, validation of analytical methods and SOP preparation.
Funding Support Service
Review of and active assistance with applications for grants, e.g. BAFA funding programme.
Location
Heidelberg
DECompany location / Office
- Materials
- ISO 9001 consulting, GMP consulting
- Consulting, audits, training
Service Areas
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| ISO 9001 quality management consultingEngineering | – | – | – | – | – |
| External QMB (Quality Management Representative)Engineering | – | – | – | – | – |
| Conduct of internal auditTesting | – | – | – | – | – |
| QM and ISO 9001 seminar / trainingEngineering | – | – | – | – | – |
| Quality management ISO 9001 workshopEngineering | – | – | – | – | – |
| Preparation of QM documentation (manual, process descriptions, work instructions)Engineering | – | – | – | – | – |
| Audit preparation and management reviewEngineering | – | – | – | – | – |
| Certification support (selection of certification body, audit accompaniment)Engineering | – | – | – | – | – |
| Funding support service (e.g. BAFA)Engineering | – | – | – | – | – |
| GMP consulting / validation of analytical methods in accordance with ICH Q2(R1)Testing | – | – | – | – | – |
Additional services
Qualifications
Michael Thode is a trained quality management auditor with certificates from the TÜV Süd Akademie as Quality Management Auditor, Quality Management Representative and Quality Management Specialist. The consulting specifically prepares companies for the certification audit.
| Evidence | Heidelberg |
|---|---|
| Quality Management Auditor (TÜV Süd Akademie) | |
| Quality Management Representative (TÜV Süd Akademie) | |
| Quality Management Specialist (TÜV Süd Akademie) |
History
- 2011
Founding of Lösungsfabrik as a solo freelance activity to support SMEs in introducing lean quality management systems
- 2015
Conversion of the freelance activity into Lösungsfabrik Thode und Partner, QM Consultants