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ISO 9000, 9001, 14001, 13485, 16949, 19011, AS 9000, TL 9100, FDA, GMP And CE Marking
Provide ISO 9000, 9001, 14001, 13485, 16949, 19011, AS 9000, TL 9100, FDA, GMP and CE marking solution for product system certification
CE Marking Certification Solution
If your company needs exacts guidance on what needs to be done to comply with the EEC International Standards, CE Marking service is the right solution. The European Union introduced a series of measures to simplify the movement of products throughout the European Union (EU) and the European Free Trade Area (EFTA). Some of these measures are known as New Approach Directives. They provide controls on systems and products design, but they harmonize product safety requirements across Europe. The directives cover a wide range of product areas including toys, medical devices, etc. The primary objective is to ensure that the products and systems are well designed, and safe for consumers. We can help expedite the process of getting CE Marking and minimize the cost as we work in close relationship with TUV-Essen, a prestigious European Notified Body.
CE Marking Certification Compliance
CE marking is referred to as a Legal Requirement that allows organizations to sell their products, including packaging and documentation, throughout the European market. The label CE Marking, promotes public health and safety, enhances product credibility, leads more sales and greater customer satisfaction. CE notified on the packaging indicates to governments that the quality product meets designated minimum safety standards and therefore a minimum level of quality
CE marking requirements vary from Directive to Directive, and even within Directives. Third party testing, quality systems assessment and technical file assessments can be mandatory. If you claim that your product complies but it doesn't, you can be prosecuted.
CE Marking New Approach Directives
The European Community (EC) has implemented standards to protect the health of their consumers. EC Directives and harmonized ISO International Standards were created to ensure products comply with safety and quality International Standards in all the member states of the EC. The directives are enforced by laws for each country. A review of your product's certification can be requested by customs, competitors, or because of an accident. European distributors will typically request the CE certification before carrying your product. If you want to export your products to anyone of the following countries, CE Marking is required:
Austria - Belgium - Denmark - Finland - France - Germany - Greece - Iceland -
Ireland - Italy - Luxembourg - The Netherlands - Norway – Portugal – Spain -
Sweden - United Kingdom
A New Approach Directive, Which provides the legal requirements is in place in many countries in Europe. CE marking is mandated by New Approach Directives. Usually, the emphasis is strongly on the manufacturer to ensure that their products comply with the European market, and display CE marking on packaging.
CE Marking Certification Implementation
Your products must comply with the applicable EC Directives, and post a "CE Marking" as a label of conformity and compliance. With the CE marking shown on your packaging and, on the package, it can be sold in EC. The CE Marking helps your organization obtain also authorizations for your products (Medical), for non-EC countries. But, how to obtain the CE Marking Certification?
- Select the applicable EC directives to your industry
- Determine the applicable harmonized International Standards and essential health and safety requirements
- Perform the appropriate conformity assessment procedure
- Incorporate the requirements into the quality system and product design
- Assemble the Technical File
- Prepare the Declaration of Conformity
- Affix the CE Marking
CE Marking Certification Time Delivery
Achieving CE marking for your product can be a long and complex process, but with the help of experts you may be able to speed up the process. There are more than 16 New Approach Directives. We can help your organization achieve CE marking efficiently and cost effectively. We parallel process step 1-4 and steps 5-8, and achieve substantial time and cost savings for you. Our quality Six Sigma approach in close working relationship with the Notified Body, save you time, money, resources and most important of all, your product with be out there sooner.
However, the duration of the project depends on the size and complexity of your organization. We have experts not only in Europe Check our ISO GMP FDA CE Marking Certification A href="files/expertise/storiescertified. Success Stories
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Clients that our Xperts have helped!
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CERTIFICATION GUARANTEE
We offer “Total Satisfaction Refund Policy” for all eConsulting services that you purchase from CompetitiveXpert. If for any reason you are not satisfied with our eBusiness services or one of our experts, we will refund you. We will not charge you for our remaining time, and we will discontinue our collaboration. We are proud of our achievement, and want to show it through the explicit satisfaction of the clients that we have helped.
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CUSTOMER TESTIMONIAL
“Caliso was essential to siteROCK being registered under ISO 9000 in record time. They quickly and accurately assessed the readiness of siteROCK to pass the final audit by making the intellectual effort to really understand our business processes. This allowed us to focus our efforts on those things that were really needed both to improve our business and to obtain the certification…”
Dave Lilly
President
SiteROCK
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