Print: ECE Global, LLC - Services - Pre-Certification & Consulting - Pre-Certification Overview
CE Marking, ASME, ASME BPE, CFR/GCP Guidelines are requirements of Product and QM/QA System compliance, applicable to all companies, regardless of the nature of their business. ECE Global Pre-Certification Services are vital for all national and international organizations involved in projects requiring this compliance.
ECE inspections and approvals services focus on tasks such as: engineering, quality assurance, compliance, documentation and certification (legal affairs and validation), as related to the Biotechnology, Pharmaceutical, Petrol, Chemical and Rail Industries. Our clientele include plant operators, plant and equipment design professionals, fabrication, construction management, retailers, importers, and skid & module manufacturers.For information on how ECE can assist you, Contact ECE today!
Our Pre-Certification services for the EU provide solutions according to European Directives, including:
- Pressure Equipment Directive (PED 97/23/EC)
- Transportable Pressure Equipment Directive (TPED 1999/36/EC)
- Simple Pressure Vessel Directive (SPVD 87/404/EEC)
- Machinery Directive (98/37/EC) / (2006/42/EC)
ECE professionals provide an experienced team for each project. We offer support during the selection process of ISO Registrars or Notified Bodies, which may require inside knowledge and considerations to your business plan. We train companies on the requirements of CE Marking, CFR Compliance, ISO 9000, and ISO 17025, and consult with the system implementation personnel (e.g., compliance gap analyses, documentation reviews, system and standards training, pre-audits, continual improvement).
Our staff of experts provides hands-on experience and superior knowledge of certification, quality management, and requirements. We optimize cost for certification, while rendering additional benefits such as pre-audits, training, manpower support, procedure development, and detailed reporting.
In many cases, ECE Global acts as the link between our clients and the third-party Certification/Approval Organization, especially with international projects. We always act with our clients best interests in mind.
Our scope of services include, but is not limited to:
| CE Marking | Pi Marking (Transportable Pressure Equipment) |
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CE Marking - Pre-Certification in Agreement with Notified Body
Pre-Certifications Services by ECE include:
- European Union Directive such as:
- Pressure Equipment Directive (PED 97/23/EC)
- Transportable Pressure Equipment Directive (TPED 1999/36/EC)
- Simple Pressure Equipment Directive (SPVD 87/404/EC)
- Potentially Explosive Atmosphere (ATEX 94/9/EC)
- Evaluation of Customer Requirements
- Customer Relationship support in conjunction with Consideration of National Requirements
- Determination of Minimum Requirements for CE Compliance
- Outlining of all Options for Compliance via Assessment Procedures
- Design Reviews and Support
- Risk and Hazard Analysis
- Type Approvals – Scope, Strategy and Benefits
- Quality Assurance System Reviews
- Quality Assurance System Development and Implementation
- Material Compliance Review
- Material Appraisals (PMA)
- Welding Procedure Approvals (e.g. EN 15607, ISO 9606)
- Welder and Welding Operator Certifications (e.g. EN 15614, EN 1418)
- Technical Documentation and CE Marking Technical Compliance Files
- Operation, Maintenance and Inspection Manuals
- Declaration of Conformity vs. Certificate of Compliance
Additional Services which are not part of the Agreement with DNV:
- 2D / 3D Drafting
- Software Solutions
- Design Calculations according to EN Standards
- Training for CE Marking (General or Directive Specific)
- CE Marking Seminar Customized for Your Organization and Product (save on time and travel expenditure)
For more information on EU requirements for your project, Contact ECE Today!
Where is CE Marking Required?
CE-marking compliance is a legal requirement in the European Union member states and the European Economic Area countries. The countries are:
| Austria | France | Lichtenstein | Slovakia |
| Belgium | Germany | Lithuania | Slovenia |
| Bulgaria | Greece | Luxemburg | Spain |
| Cyprus | Hungary | Malta | Sweden |
| Czech Republic | Iceland | Norway | The Netherlands |
| Denmark | Ireland | Poland | UK |
| Estonia | Italy | Portugal | |
| Finland | Latvia | Romania |
Why ECE Global?
Are the following questions familiar to you?
- How much does it cost to certify my equipment?
- How much work needs to be done?
- Are my welders good to go?
- Can you quote your services?
- How much time does it take to get the required certification?
- If I comply with ASME, can we meet CE Marking requirements?
- Why am I unsuccessful selling my products with CE Marking?
- I need answers now, can you help?
We are constantly receiving the questions listed above. We can provide sound, reasonable answers to all of them. The missing link was an optional service solution, which is sound, affordable, and effective. You need to reduce cost, enhance the service outcome, while creating “win-win” solutions for all involved parties.
ECE Global, LLC (ECE) and DNV (Det Norske Veritas – European Notified Body) signed an Agreement of Recognition, defining certification and pre-certification services for CE Marking. With this agreement, both parties implemented procedures allowing cost effective project executions for certification and consulting related to CE Marking. According to international accreditation requirements, a Notified Body (NB) cannot consult and certify. This is deemed a conflict of interest, which could lead to the termination of the NB’s accreditation.
The “win-win” solution is the ECE Pre-Certification Services. Our industry leading consulting service enables you to achieve the required certification, while experiencing a cost and time related value adding service.
Furthermore, Pre-Certification Services are provided by ECE, not by DNV, in accordance with procedures utilized and recognized by DNV. This Effective Compliance Engineering (ECE) Service results in an optimization of the certification process.
The final certification process is done by DNV, hence applying the required independent certification process.
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How can we guarantee a positive certification outcome?
Selected ECE Staff participates in DNV’s training programs, thereby receiving the required training according to the N.B.’s certification procedures. Passing an extensive written test is mandatory for every training class.
Large Scale Manufacturing (LSM) Project:
ECE was contracted to support a US Organization (Plant Owner & Operator), as well the contracted engineering company during a large scale project. The scope of the project was to support four U.S. Manufacturing companies with the CE Marking compliance. Besides supporting each original manufacturing organization (OEM) individually, ECE focused strongly on the overall compliance with all project requirements (CE Marking, cGMP, FDA, EU National). Nearly all aspects of CE Marking (e.g. Strategy Development, Design Reviews, Manufacturing Procedures, Quality Assurance Systems, Welding Compliance, Material Compliance) have been part of this project.
ECE Global and the Plant Owner & Operator jointly introduced the developed strategies and procedure to the Notified Body (DNV), as well as the European National Authority (Denmark). Both legal authorities granted acceptance. Prior to the meetings, changes were implemented based on constructive and effective exchanges during meetings between the Owner & Operator, ECE, and the engineering company.
Due to our Pre-Certification Services and the strong relationships built during the project, the required support for certification, as well as a significant reduction in certification cost and time was realized.
Project Experience
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