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Quality Management: ISO 9001, IATF 16949, AS/EN 9100, EN 13485

We build QMS that hold up in the audit and carry the daily business — from mid-sized manufacturers to OEM suppliers.

What it is about

Positioning

Quality management is not a filing cabinet — it is a control system. We bring your processes, responsibilities and evidence into a state where audits become predictable and the system delivers value between audits as well. Whether you are facing an initial certification, a switch of standard or the rescue of an existing system — we step in exactly where you stand.

What you achieve with us

  • Audit-ready QMS to the chosen standard — ISO 9001, IATF 16949, AS/EN 9100 or EN 13485.
  • Clear process documentation that is actually used in daily operations.
  • Demonstrable effectiveness through KPIs, internal audits and management review.
  • Fewer non-conformities and less rework — up to a 100% first-time pass rate.
  • Capable internal QM owners who can run the system without external support.
Scope of services

What we actually do

Gap Analysis against the target standard

Structured assessment of current vs. target state, documented in writing with risks and effort estimate.

Process and document structure

Process mapping, procedures and work instructions, control of documents and records.

Risk and opportunity management

FMEA methodology, risk register, action tracking including effectiveness checks.

Training for staff and managers

Practice-oriented training on site or remote — no death-by-slides.

Internal audit and management review

Execution, documentation and support of senior management during the review meeting.

Certification audit support

Preparation, presence during the audit, handling of any non-conformities through to closure.

Approach

Certification in four phases

1

Gap Analysis

Assessment of the current state against the target standard — in writing, with effort estimate.

2

Concept

Action plan, document structure, responsibilities and timeline.

3

Implementation

Support with documentation, training and embedding processes in daily operations.

4

Certification audit

Internal audit, management review, support during the external certification audit.

Frequently asked questions

What clients ask at the start

How long does an initial ISO 9001 certification take?

Typically 4 to 9 months from project start, depending on the maturity of your existing processes and the available internal capacity. We give a reliable estimate after the gap analysis.

Can you also cover IATF 16949 on top of ISO 9001?

Yes. IATF builds on ISO 9001 — we set up the integrated system so both standards work in parallel, including the core tools (APQP, PPAP, FMEA, MSA, SPC).

We already have a QMS but it is not effective. Do we have to start from scratch?

No. In most cases a structural analysis focused on effectiveness pays off: where does the system bite, where is it bypassed? That usually leads to targeted interventions rather than a full rebuild.

Do you take on the role of QM representative?

On request, on an interim basis — typically 6 to 18 months, until an internal successor is in place. We always recommend filling the role internally in the medium term.

Which industries do you cover?

Focus on the mid-market: food, aerospace, medical devices, automotive suppliers, metal working and machinery. Other industries on request.

Do you also work remotely?

Yes — many phases (concept, documentation, training) are efficient remotely. We use on-site visits deliberately — typically for gap analysis, internal audit and audit support.

From practice
"The second certification was remarkably quiet compared to the first. We knew what to do because the system was actually built for it." Plant manager, metalworking, 80 employees, southern Germany

Fits these industries

Free initial consultation

30 minutes, no obligation to follow up. We clarify your situation and the target standard.