Quality management for production and tech — without corporate bureaucracy.
You build hardware, industrial IoT, robotics, special machinery or processed products. B2B customers require ISO 9001, some IATF 16949, AS 9100 or EN 13485. We build that with you — lean, scalable, in sprints.
Six topics tech startups should clarify early.
Processes and responsibilities
Who decides what, who documents what, who verifies what. With 5 people everyone knows — with 20 the absence of a process map is a main cause of complaints.
Complaints and change management
Capture complaints structurally, analyse root causes (8D, A3), implement actions, verify effectiveness. Changes with impact analysis — before they become complaints.
Inspection planning
Which inspection where, at what effort and with what evidence. It is asked in audits and decides about damages and blame in disputes.
Supplier qualification
Evaluation matrix, release workflow, annual re-evaluation. For A-suppliers on-site audits — tech startups with complex supply chains particularly need this.
Document control
Versioning, release, storage, archiving. Sounds dry, but in audits it is the second most common findings area. A good DMS / ERP solves 80 % of the problems.
Staff and knowledge
Training matrix, qualification records, onboarding. Anyone planning growth needs a learning architecture that scales without bottlenecks.
From ISO 9001 baseline to industry standard.
ISO 9001 is usually the baseline. Industry standards come after — IATF for automotive, AS 9100 for aerospace, EN 13485 for medical devices. Here is a typical path.
Step 1: ISO 9001 as foundation
The baseline — required by practically every B2B major customer. Realistic with Lean-QA in 6-9 months. Policy, processes, risks, audits, CIP — lean but complete.
Step 2: Industry standard
Automotive → IATF 16949 (FMEA, APQP, SPC, suppliers). Aerospace → AS 9100 (configuration management, special processes). Medical devices → EN ISO 13485 (risk management, validation, MDR compliance).
Step 3: Integration and scaling
ISO 9001 + industry standard + possibly ISO 14001 / 45001 as an integrated management system. Documentation consolidation, joint audits, lean maintenance. Only makes sense above a certain size.
ISO 9001 or industry standard coming up?
30 minutes of initial conversation — we frame your situation and show the fastest path.