Consulting service

Initial Assessment / CoP-Q – Regulatory Authority Audit Support

from 3.490,00 €

We prepare you for the audit, including typical questions and core focus areas of the auditors, and support the regulatory authority audit as an independent assessment body.

Scope of services per package
ServiceBudgetBalancedPremium
Contract type Service contract Contract for work Contract for work
Consultant level (Junior / Senior) 80% / 20% as required as required – min. 80% Senior
Performance guarantee subject to billing of additional expenditure limited (additional expenditure billed at daily/hourly rate) unlimited
Payment terms 25% advance payment, balance monthly (7 days) 30 days, monthly interim billing 60 days, installment payment 0.00% interest
Liability none tbd
Price (net) —

"On request" packages are not ordered directly — they are collected for a formal quotation request.

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Description

Objective

During the initial assessment, the approval authority evaluates the effectiveness of the processes implemented to fulfill approval-relevant requirements.

Audited companies are typically inexperienced regarding the specific requirements and expectations. We prepare you for the audit and typical lines of questioning.

 

Scope of Our Services

We support the authority audit as an independent assessment body. Through our many years of experience and established cooperation with numerous authorities, we identify genuine non-conformities or "misunderstandings" and help resolve potential conflicts before they arise.

  • Preparation of the audited areas by clarifying audit scope, typical audit questions, and simulating corresponding dialogues
  • We clarify potential misunderstandings regarding possible questions about your products (which should not be part of the audit, but are frequently addressed)
  • We attend the audit and document it as an independent party
  • Where necessary, we intervene and resolve potential misunderstandings
  • Audit debriefing ("lessons learned") and initial review of identified non-conformities
  • You receive an audit report from us including comments on the auditor's assessments

 

Note: Please review our 3 pricing tiers and their corresponding differing scopes of service.

Contact

Require a customized proposal or have questions? Simply contact us. 

Mark Haacke

Mark Haacke

Founder & Managing Director

Compliance Engineering, Type Approval, Functional Safety

For over 25 years, Mark Haacke has combined deep technical expertise with regulatory foresight. He guides manufacturers from the early conceptual phase through to market launch, translating complex regulations into technical implementation during product development and modification, product failure analysis and assessment, and the definition of corrective actions.

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