QMS Preparation for Initial Assessment (EU) 2018/858
from 14.990,00 €
Development of an effective quality management system within the scope of Regulation (EU) 2018/858 Annex IV for approval by an EU / UN-ECE approval authority — with guaranteed successful completion of the initial assessment.
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
The initial assessment by an approval authority is mandatory for any company wishing to place products requiring type-approval on the market. We provide comprehensive preparation and develop your quality management system.
A positive conclusion to the initial assessment by the approval authority is guaranteed—this also includes all necessary corrective actions following any adverse audit outcome.
Scope of our service
a) Review of existing templates for
- * process descriptions,
- * work instructions, and
- * verification records
- * control of documented information
Drafting of recommendations for improvement
b) Preparation of documents:
- * Process descriptions
- * Work instructions
- * Additional specification documents
c) Assessment of
- * Procedures for the centralized maintenance and implementation of documents and templates
- * Procedures for the approval of documents & templates
- * Definitions of roles and responsibilities – organizational charts
- * Role and job descriptions
- * Tasks, Competencies, Responsibilities (AKV) and knowledge management
- * Regulations for internal audits
- * Description of internal customer and supplier relationships
- * Description of external customer and supplier relationships
regarding compliance with approval-relevant requirements, including recommendations for improvement.
- Designation and training of responsible personnel (via participation in open training sessions).
- Monitoring of project status and initiation of countermeasures in case of delays.
- Continuous coordination with your internal project leads.
- Support for your team during implementation, both remotely and on-site
Note: Only available in combination with "QMS Status Assessment – Initial Assessment".
Applies to companies up to approx. 100 employees. For larger enterprises, we are pleased to provide a customized proposal.
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.
13 reviews for QMS Preparation for Initial Assessment (EU) 2018/858
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Sebastian Thielen – Head of Global Quality, Next e.GO –
Mark Haacke and his team have been supporting us for 1.5 years. We received assistance with the initial assessment and aspects of type testing, benefiting from highly professional support throughout. For about 9 months, Mark Haacke's team has been actively assisting us in defining the CoP scope and executing CoP tests.
Two weeks ago, I attended two training sessions led by Mark Haacke. The training content is delivered in a highly practical manner, leaving ample room for discussion and technical questions, all of which were addressed competently. A key strength is that the training sessions do not focus merely on reading legal texts, but clearly convey how to implement the requirements effectively.
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Rainer Sollmann – Head of Vehicle Division, Karcher AG –
General consulting on type-approval: Mr. Haacke and his team possess exceptional technical expertise, and our experience with them has been excellent. Highly recommended!
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Anonymous attendee –
Straightforward and swift preparation for our initial assessment. Minimal internal effort required, with several existing processes successfully optimized along the way.
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Anonymous –
Highly structured preparation, execution, and follow-up of an internal CoP-Q audit in preparation for our initial assessment by the KBA.
The resulting audit report enabled us to clearly identify precisely where our QMS needed further refinement.
Consequently, the official audit by the authority was conducted without issue.
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Markus Jungermann – Managing Director, PI Labs GmbH –
The type-approval of products intended for automotive installation is exceptionally complex and demanding. The highly competent, targeted, and professional consulting provided by Mark Haacke Training & Consulting GmbH was essential for the time-critical delivery of our latest public transport project. Our sincere thanks once again to Mr. Haacke and the entire team!
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Sebastian Sekira – Vice President R&D, Next e.GO –
Highly competent, fast, solution-oriented, hands-on.
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Sebastian Sekira – Vice President R&D, Next e.GO –
Consulting on Type Approval and CoP: Highly competent, fast, solution-oriented, hands-on.
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Sharon Qu – BLC Poland –
During the initial Assessment, almost every issue we encountered was promptly addressed with professional advice and practical solutions. The team was highly responsive and supportive throughout the process. Even after the on-site audit was completed, they continued to keep us updated on the progress. We felt completely at ease entrusting the process to them – and in the end, we successfully passed the initial assessment. This outcome felt inevitable, given the level of professionalism and support we received.
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Sharon Qu – BLC Poland –
The pre-audit rehearsal and on-site improvement suggestions made passing the preliminary evaluation much easier. Yes, these recommendations were truly helpful and made a real difference.
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Jan Enders, Head of Production and Quality, KBA Representative – PBW Automotive GmbH Reibbelagtechnik –
Immediate response via videoconference on the very same day of the inquiry, clarifying the initial open items.
Shortly thereafter, an internal CoP-Q audit was conducted in preparation for the initial assessment by the KBA – an absolutely clear, objective assessment and presentation of target achievement.
The collaboration was outstanding.
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Jan Enders, Head of Production and Quality, KBA Representative – PBW Automotive GmbH Reibbelagtechnik –
Thanks to the full-service package booked, no additional internal resources were tied up. The fixed price applied without restriction – absolutely everything (!) was covered.
The initial assessment was granted by the authority without any non-conformities.
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Jan Enders, Head of Production and Quality, KBA Representative – PBW Automotive GmbH Reibbelagtechnik –
The type approval of our products was completed through efficient, straightforward cooperation between MH GmbH, the authority, and the technical service.
Crucially, it was identified that the test scope defined by the technical service was excessive, which would have incurred additional expenditure and costs. Through the support of Mark Haacke and his team, the scope was adjusted to the legally mandated minimum and confirmed.
As an OEM, we give our unreserved recommendation.
First-class performance; this is how progress is achieved.
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Ernst Greisiger –
Thanks to exceptional professional guidance, a swift and commercially optimal implementation of the CoP audit was achieved. Highly practical and legally compliant.
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