Initial Assessment / CoP-Q – Internal Audit (Gap Analysis)
from 3.900,00 €
Assessment of the quality management system in preparation for an initial assessment or re-audit by an approval authority.
- .Focus: Compliance with approval-relevant requirements.
Scope of services per package
| Service | Budget | Balanced | Premium |
|---|---|---|---|
| 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 |
Description
Objective
During the initial assessment, the approval authority evaluates the effectiveness of the processes implemented to fulfill approval-relevant requirements.
Only organizations that successfully pass this audit are qualified to become approval holders. These requirements apply not only initially, but permanently, and are verified through regular authority audits.
Please also refer to the information provided directly by the authorities:
a) KBA:
b) RDW:
(Note: This represents an illustrative selection; these requirements are mandated by all authorities.)
Scope of Our Services
Through an on-site "internal audit" at your premises, we evaluate whether your quality management system meets the applicable requirements and provide actionable recommendations.
The audit includes:
- Preliminary meeting to assess the baseline situation and define objectives
- "Internal audit" on-site for up to 3 days
- Examination of all approval-relevant processes and their interfaces with adjacent workflows
- Examination and evaluation of policies governing responsibilities and deputy regulations
- Examination and evaluation of the competence of relevant personnel
- Preparation of a gap analysis in the form of an audit report, including recommendations for action
Note: Please review our 3 pricing tiers and their corresponding differing scopes of service.
The Budget tier is calculated individually based on effort; please request a quote for this option.
Delivered by Mark Haacke compliance engineering GmbH – with over 20 years of experience.
Contact
Require a customized proposal or have questions? Simply contact us.
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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