International certification organization in Slovakia

The CE Marking is an official authorization that allows certified products to be legally sold in the European Community countries and within the European free trade area. It offers several key benefits:

1. Facilitates Unrestricted Market Access: The CE Marking enables smooth transportation and unrestricted movement of products within the single European market.
2. Demonstrates Compliance: It serves as proof that the product meets the required standards and directives, providing assurance to customers about its quality and safety.
3. Builds Trust in the Manufacturer: The CE Marking promotes trust and confidence in the manufacturer's commitment to producing compliant and reliable products.
4. Boosts Sales and Consumer Satisfaction: Having the CE Marking can lead to increased sales volume as it instills confidence in consumers and demonstrates adherence to European regulations, thereby enhancing consumer satisfaction.

To obtain the CE Mark, manufacturers must complete the following mandatory procedures:

1. Conduct Risk Assessment: Assess the product's safety and ensure its compliance with EC Directives.
2. Prepare Detailed Product Instructions: Develop comprehensive instructions that guide users on proper product usage and maintenance.
3. Perform Product Testing: Conduct necessary tests to validate the product's compliance with relevant standards and regulations.
4. Prepare Technical Documentation: Compile all relevant information and documentation required for the CE Marking application, commonly referred to as the Technical Documentation File.

By adhering to these procedures, manufacturers can successfully obtain the CE Marking, paving the way for successful market entry and consumer acceptance of their products.

Directives according to which we carry out certification for CE marking:

1. Directive 2009/49/EC Safety of toys
2. Directive 92/42/EEC Hot-water boilers
3. Regulation (EU) No 305/2011 Construction Products (CPR)
4. (ex-Directive 89/106/EEC Construction products (CPD Directive)
5. Directive 93/42/EEC Medical devices (Directive MDD)
6. Directive 2014/34/EU Equipment and protective systems intended for use in potentially explosive atmospheres. Applicable from 20 April 2016. (ex-Directive 94/9/EC ATEX)
7. Directive 89/686/EEC Personal protective equipment (Directive PPE)
8. Directive 2006/42/EC Machinery (Directive MD)
9. Directive 2014/33/EU Lifts and safety components for lifts. Applicable from 20 April 2016. (ex-Directive 95/16/EC Lifts)
10. Directive 2014/68/EU Pressure equipment. Applicable from 19 July 2016. (ex- 97/23/EC PED Directive)
11. Directive 2014/30/EU Electromagnetic compatibility. Applicable from 20 April 2016. (ex-2004/108/EC Directive EMC)
12. Directive 2014/35/EU Electrical equipment designed for use within certain voltage limits. Applicable from 20 April 2016. (ex-2006/95/EC Low voltage (Directive LVD).
13. Directive 2014/29/EU Simple pressure vessels (SPVD). Applicable from 20 April 2016 (ex-2009/105/EC SPVD Directive)
14. Directive 2009/142/EC Appliances burning gaseous fuels (GAD Directive)
15. Directive 2014/53/EU Radio equipment. Applicable as of 13 June 2016. (ex-1999/5/EC R&TTE Directive)

The above-mentioned New Approach Directives are provided for affixing of the CE mark on the products (CE marking).
Individual EU Directives are not provided for affixing of the CE mark. These Directives are:

1. Directive 2001/95/EC General Product Safety (GPSD)
2. Directive 94/62/EC Packaging and packaging waste
3. Directive 2011/65/EU Restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS)
4. Regulation (EC) No 1907/2006 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
5. Regulation (EC) No 1223/2009 Cosmetic products

Almost all directives require the involvement of an independent certification body to verify compliance.
We have a team of experts with relevant qualifications in the field of each of the Directives. Our specialists will provide you with the necessary qualified assistance at all stages of product certification.

When introducing a product to the market, manufacturers and/or importers are obligated by the CE marking Directives to adhere to the requirements of the EC Declaration of Conformity. This declaration ensures that the products meet the necessary regulations for CE marking. The conformity of a product with CE standards can be demonstrated through the EC Declaration of Conformity documents.

It is of utmost importance for manufacturers and/or importers to ensure that the Declaration of Conformity fully complies with all formal obligations and requirements. This serves as proof that their products or equipment are in compliance with the relevant directives.

If you require a quick scan of your Declaration, please find the inquiry form below.
We also offer the issuance of EC Declarations of Conformity in accordance with the latest applicable regulations. If you have any further questions regarding CE labeling or EC Declaration of Conformity, please feel free to contact us using the provided contact form.

SK Certification renders assistance to enterprises in the preparation of documents and certification of products in accordance with the European Union Directives.

SK Certification is the authorized partner of many leading European notified bodies and testing laboratories, and for that reason, it can offer the most relevant decision.

CE Certificate of Conformity shall be prepared and issued upon receiving positive test results and after examination of documentation and inspection of production.

Compliance verification is a complicated procedure, because schemes, models, and requirements are different depending on the Directive applied to the products.

Proper preparation of the Technical Documentation File is essential for the European certification procedure because, once approved, this document gives the Certification Authority the right to make an assessment of the compliance of the products with the applicable European directives. CE Certificate of Conformity shall be issued subsequent to the results of carrying out all compliance verification procedures.
The following information should be provided for execution of the CE Certificate of Conformity:

• Product name
• Information on manufacturer
• Product description and field of application
• HS Code
• Test reports and certificates (if any)

SEVEN STEPS OF EUROPEAN CERTIFICATION

1. Determination of the European Directives, list of applied European standards, and certification schemes for compliance verification.
2. Examination of the manufacturer's Technical Documentation File for compliance with the requirements of the European Directives.
3. Performance of product tests by the accredited test laboratory.
4. Assessment of production (or assessment of the Quality Management System, as may be necessary).
5. Assessment of documentation by the European notified body.
6. Preparation and issuance of the CE Certificate of Conformity.
7. Conduct of the compliance audit to prove compliance of the products with imposed requirements.

SK Certification specializes in conducting voluntary product certifications in areas that are not regulated by mandatory European directives.

Our team at SK Certification is experienced in performing comprehensive assessments to confirm product compliance with applicable requirements. Upon successful completion of the certification process and achieving positive results, we proceed with registration and issue the Voluntary Certificate of Conformity, attesting to the product's compliance with European standards.

The manufacturer, regardless of their location, is required to appoint an Authorized Representative in the EU. This Representative should be authorized by the manufacturer to carry out specific tasks as mandated by the relevant Directives. According to the CE marking Directive, the appointed Representative in the EU acts on behalf of the producer.

The responsibilities assigned by the manufacturer to the Representative must be clearly defined in writing, outlining the scope of tasks and the Representative's authority.

For instance, the Authorized Representative in the EU, acting on behalf of the producer, can ensure and declare that the product complies with all the requirements specified by the applicable conformity assessment procedure and Directive. They are also empowered to affix the CE marking, prepare and sign the EC declaration of conformity, and present the declaration and technical documentation to the National surveillance authority on behalf of the manufacturer.

At SK Certification, we possess the necessary expertise and services to act as an Authorized Representative for manufacturers in the EU. We have extensive experience in fulfilling this role and can serve as the official European authorized representative for manufacturers who meet all European safety requirements. If you require more information, please feel free to contact us using the form below.

In order to thrive and operate effectively in today's business landscape, organizations require a powerful and modern tool: the Quality Management System (QMS) described in the ISO 9000 family of standards. While the adoption of ISO 9001:2015 is voluntary for companies, paying attention to quality assurance offers leaders a chance to gain a competitive edge in the future. Implementing a QMS represents a crucial stage in the development of any business.

The development of a Quality Management System aligns with current international trends. By implementing and maintaining a QMS in accordance with the ISO 9000 family of standards, companies not only enhance the quality of their products and services but also positively impact their overall operational efficiency. A QMS covers not only quality-related aspects but also other supporting processes such as resource management, planning, improvement, and risk management.

For companies, implementing a QMS according to the requirements of ISO 9001:2015 and obtaining certification serves as additional confirmation of their well-managed operations at all levels. This encompasses quality assurance and other aspects of their activities. Detailed procedures are thoughtfully devised, documented, and every employee is aware of their responsibilities down to the smallest detail. One of the advantages and distinctive features of ISO 9001:2015 is the identification and management of risks associated with business activities. When staff members clearly understand and skillfully execute their functions, they are equipped to make sound decisions even in emergency situations. This significantly enhances performance, making ISO 9001:2015 certification a meaningful achievement for companies.
The international standard ISO 9001 is recognized and accepted in over 140 countries worldwide and establishes a set of requirements for a company's QMS.

The ISO 9001 certificate is a document that confirms the effective functioning of a company's QMS in delivering products and services. Since the effectiveness of the QMS is regulated by requirements, the certificate serves as evidence that the system has been assessed by a Certification Body and found to be in conformity with European standards.
The certificate remains valid for a period of three years, with the possibility of renewal. To ensure ongoing conformity with ISO 9001 requirements, the certification body conducts annual inspections throughout the validity period of the certificate.

ISO 14001 is a primary management system standard that outlines the requirements for establishing and maintaining an effective Environmental Management System (EMS). This standard focuses on monitoring how an organization's products and services interact with the environment.

Organizations set objectives to comply with environmental standards and demonstrate their commitment by documenting their efforts. These objectives are aimed at improving the overall environmental performance of the organization.

ISO 14001 requires a fundamental commitment that drives the overall performance of an organization. It promotes pollution prevention, compliance with legislation, and continuous improvement of the EMS.

It is mandatory for organizations to identify relevant legal and statutory requirements and understand how these regulations impact their business. This knowledge enables them to take appropriate measures and ensure effective implementation by their employees.
ISO 14001 is accompanied by ISO 14004, which provides general guidelines on principles, systems, and support techniques for environmental management. It addresses key issues related to establishing, maintaining, and enhancing a management system.

Modern environmental principles in enterprise management include resource conservation, effective use of renewable resources, recycling, and waste reduction. Certification of companies for compliance with the environmental standard ISO 14001:2015 is a competitive advantage for products among customers.

Implementing the ISO 14001:2015 system allows companies to assess their impact on ecosystems and manage ecological resources effectively.
The ISO 14001:2015 environmental management system is an instrument that enables companies to:

• Identify the environmental aspects of their activities, production, and services and measure their impact on the environment.
• Develop and implement actions to prevent pollution, control company activities, and comply with ecological, legislative, and regulatory requirements.
• Set and achieve environmental objectives, improve environmental performance, balance economic and ecological interests, and adapt to a dynamic environment.

The potential benefits of implementing an environmental management system include:

• Improvement of the company's image in the eyes of the public, government authorities, investors, suppliers, and consumers.
• Development of expense management practices.
• Reduction in incidents that could lead to legal liabilities for non-compliance with environmental legislation.

The Machinery Directive, also known as Directive 2006/42/EC, applies to a wide range of machinery, mechanisms, equipment, components, and their combinations.

This directive outlines safety requirements, including the evaluation of risks and the responsibilities of market surveillance authorities within the European Union Member States.

To be placed on the European Union market, products covered by the Machinery Directive must comply with its provisions and bear the CE marking. In many cases, products falling under the scope of the Machinery Directive may also need to adhere to other directives, such as the Low Voltage Directive and Electromagnetic Compatibility Directive. Depending on the regulatory and directive requirements, the evaluation procedure may involve one or more assembly units.
During the design and development process, manufacturers are obligated to identify potential risks and implement appropriate measures to mitigate them. The primary goal of the Machinery Directive is to minimize hazards to human health and safety. Manufacturers must address risks associated with factors like noise, vibration, fire hazards, electrical shock, falls, compression, high temperatures, and more. Additionally, the safety of repair work, including safe access to components and assemblies, should be considered during product design and manufacturing.
Materials used in the production of these products must be safe for human health and life.

Products must also feature clear and indelible information, including:

• Manufacturer's name and address
• Product name
• Product type
• Serial number (if applicable)
• Year of manufacture
• CE marking
• All necessary hazard labels, pictograms, and warning signs

By adhering to the requirements of the Machinery Directive, manufacturers can ensure the safety and compliance of their machinery and equipment in the European Union market.

The Low Voltage Directive 2014/35/EU (LVD) is responsible for ensuring the safety of electrical equipment that operates within a nominal voltage range of 50 to 1000 V for AC and 75 to 1500 V for DC.

The Electromagnetic Compatibility Directive 2014/30/EU (EMC Directive) covers electrical and electronic equipment that emits electromagnetic waves or is susceptible to electromagnetic interference (EMI) from other devices.

The LVD & EMC Directive applies to various products, including electrical appliances, electrically operated tools, lighting fixtures, and other electrical equipment.

To comply with the Low Voltage Directive, products must demonstrate adherence to the harmonized standards of the European Union. Certification procedures involve submitting the product to a testing laboratory accredited by a notified body.

Upon successful completion of the testing and examination of documentation, the manufacturer or their authorized representative will receive a CE Certificate from the notified body.
It is mandatory for the manufacturer or authorized representative to maintain the Technical Documentation File and CE Declaration of Conformity for a period of 10 years after the production of the last product. These documents must be made available to the European Competent Authorities upon request.

The Technical Documentation File should include the following information:

• General description of the electrical equipment
• Design documentation, working drawings, and schematics
• Description and explanatory notes for drawings and schematics
• List of harmonized standards applied
• Test reports and results

By complying with the LVD & EMC Directive, manufacturers ensure the safety and conformity of their electrical equipment, apparatus, and lighting fixtures in accordance with European Union regulations.

The European Construction Products Regulation No. 305/2011, which replaced the Construction Products Directive 89/106/EEC, governs the certification of construction materials and products within the European Union. This regulation, effective since July 1, 2013, establishes specific methods for evaluating and examining the consistency of characteristics in construction products, emphasizing conformity assessment procedures.

Construction materials and products intended for use in construction activities must comply with European standards and directives to be placed on the European Union market.

Manufacturers or their authorized representatives based in the European Community bear full responsibility for ensuring that the products meet European standards, approved technical specifications, and EU directives. This includes compliance with health and environmental requirements.

Regulation No. 305/2011 and European standards related to construction materials and products outline the certification procedure, which involves evaluating and inspecting the production process to ensure compliance with technology and product specifications.

Manufacturers or their authorized representatives are responsible for affixing the CE marking on products that have demonstrated compliance with European standards and directives. The CE marking should be placed on the product label, packaging, and accompanying commercial documents in accordance with European guidelines for CE marking application.

European Union member states enforce strict control over the circulation of construction products in the market. Regulatory authorities are responsible for continuous monitoring of product compliance with European standards and directives. Products covered by harmonized European standards must bear the CE marking, and those without it will be withdrawn from the market, holding the manufacturer or authorized representative legally liable.

European Community countries are obligated to notify the European Commission about any construction materials and products that do not meet European or national standards and are present in the European Union market.

Construction products must be suitable for their intended use and meet requirements such as mechanical resistance, stability, fire safety, compliance with hygiene standards, safety in use, noise protection, and energy efficiency.

Manufacturers are required to prepare Declarations of Performance and apply the CE marking to construction products in accordance with Articles 4 and 6 of Regulation No. 305/2011.

All products with the CE marking must be accompanied by product information in the format specified in the Declaration of Performance. This allows for comparison between similar products and provides customers with relevant information to make informed decisions.

The Declaration of Performance provides essential information on the performance characteristics of construction products, which have been tested by independent laboratories and certified by European authorities.

The turnover of children's toys on the Internal Market of the European Union Member States is subject to strict control and regulations. The European Union imposes tight restrictions on children's toys, including age suitability, materials, components, and substances used.

Directives within the European Union aim to strengthen control and provide clearer definitions regarding the safety of toys, including responsibilities for ensuring toy safety. Directive 2009/48/EC establishes stricter requirements for the maximum allowable concentration of hazardous substances in toy materials.

Only toys that bear the CE marking can be placed on the European Union market.

The certification of children's toys requires several documents, including:

1. Application for certification
2. List of toy types or models subject to certification
3. Information on the toy's marking, including the intended age range
4. Detailed instructions for use, safety information, and relevant warnings
5. Characteristics of the raw materials used in toy production, accompanied by relevant certificates, safety and health certificates, test reports, and material certificates
6. Description of the manufacturing process used for making the toys

Toys that may be dangerous for children under 36 months must be accompanied by warnings such as "Not suitable for children under 36 months" or "Not suitable for children under three years," along with the age warning symbol. These warnings should also be included in the toy's instructions for use.

The CE marking must be affixed to the toys, and they should be accompanied by instructions, safety information, required warnings, and a Declaration of Conformity. The Declaration of Conformity allows for comparison between similar products and provides relevant safety information to customers.

The Technical Documentation File is a collection of documents that outline the technical requirements applicable to the design, development, production, maintenance, operation, and disposal of products. It is a vital document that needs to be maintained by the manufacturer or authorized representative of the manufacturer in the European Union, or by manufacturers located outside the EU.

Typically, the Technical Documentation File must be retained for a period of 10 years after the production of the last product for which the technical documentation was created. Most New Approach Directives require manufacturers to develop and provide the Technical Documentation File, which contains the necessary information to demonstrate that the product complies with the requirements set forth in specific EU Directives. Each Directive specifies the content requirements for the technical documentation.

According to Decision No. 768/2008/EC of the European Parliament and the Council, the primary objective of the compliance verification procedure, including the application of the CE marking, is to ensure that products introduced to the market are safe for consumers and the environment, and meet the requirements of the European directives.

The Technical Documentation File should include all the necessary requirements and information as required by the applicable European directives. The content of the Technical Documentation File will depend on the specific product, ensuring compliance with harmonized standards and the main requirements of the relevant EU Directive.

It is important to avoid unnecessary repetitions, redundant terms, and irrelevant information in the technical documentation. National authorities have the right to access the technical documentation for verification and control purposes. Manufacturers from non-EU countries who place their products on the EU market must provide the technical documentation for products bearing the CE marking by appointing an authorized representative within the EU territory.
Any individual or entity that places products on the EU market without the required technical documentation may be subject to sanctions.

Typically, the Technical Documentation File should include the following information (note that the contents may vary depending on the applicable Directive):

1. Design drawings and schematics
2. Product description
3. Calculations
4. Test reports
5. Risk prevention methods
6. Operating manual, including safety information and product disposal instructions
7. Declaration of Conformity

All documents within the Technical Documentation File should be provided in one of the official languages of the European Union.