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Declaration of Conformity According to ISO/IEC Guide 22 and EN 45014 Manufacturers Name: Manufacturers Address: Declares that the product: Product Name: Description: Part #: 1230740 Rev 197 Biotech,

How to fill out declaration of conformity

How to fill out a declaration of conformity:

1. Gather the necessary information: Before filling out the declaration of conformity, make sure you have all the relevant information at hand. This may include product details, technical specifications, test reports, and any relevant standards or regulations that need to be complied with.
2. Identify the manufacturer: Clearly state the name and contact information of the manufacturer or authorized representative who is responsible for the conformity of the product. Include their address, phone number, and email.
3. Describe the product: Provide a detailed description of the product, including its name, model or serial number, and any identifying characteristics. This should accurately represent the product for which the declaration of conformity is being filled out.
4. Reference applicable standards or regulations: Identify the standards or regulations that apply to the product and indicate compliance with them. This may involve referencing specific clauses or sections, providing test reports or certificates of compliance.
5. State the conformity assessment procedure: Describe the procedure used to assess the product's conformity, such as self-declaration, third-party testing, or certification by a notified body. Specify the relevant conformity assessment modules, if applicable.
6. Include technical documentation: Annex any technical documentation that supports the declaration of conformity. This may include product drawings, schematics, safety data, user manuals, or any other relevant technical information.
7. Date and sign the declaration: Include the date of the declaration and have it signed by an authorized person representing the manufacturer or the authorized representative. This person should have the necessary knowledge and authority to confirm the product's conformity.
8. Keep a copy for records: Make sure to keep a copy of the filled-out declaration of conformity for your own records. It may be required for future reference or in case of any inquiries or audits.

Who needs a declaration of conformity:

1. Manufacturers: Any company or individual who produces or assembles a product and places it on the market is typically responsible for issuing a declaration of conformity. They need to ensure that the product complies with the applicable standards, regulations, or directives.
2. Authorized representatives: If a manufacturer is not based in the region where the product is being sold, they may appoint an authorized representative who takes responsibility for the declaration of conformity on their behalf. The authorized representative should have a registered address within the relevant market.
3. Importers: In some cases, importers may be required to provide a declaration of conformity. This is particularly important when importing products from countries that do not have a mutual recognition agreement or equivalent conformity assessment system in place.
4. Market surveillance authorities: Market surveillance authorities, such as government agencies or regulatory bodies, may request a declaration of conformity as part of their monitoring, enforcement, or audit activities. This is done to ensure that products available in the market are safe and compliant with applicable regulations.

For pdfFiller’s FAQs

What is declaration of conformity?

It is a document stating that a product or service meets the requirements set out in applicable standards or regulations.

Who is required to file declaration of conformity?

Manufacturers or suppliers who place products on the market are required to file declaration of conformity.

How to fill out declaration of conformity?

Declaration of conformity can be filled out by providing necessary information about the product, standards or regulations it complies with, and the manufacturer's details.

What is the purpose of declaration of conformity?

The purpose of declaration of conformity is to demonstrate that a product meets the necessary requirements for safety, quality, and compliance with regulations.

What information must be reported on declaration of conformity?

Information such as product details, standards or regulations complied with, manufacturer's details, and date of issue must be reported on declaration of conformity.

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