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Orkla Care Declaration of Conformity Procedure Pack 2016-2025 free printable template

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DECLARATION OF CONFORMITY PROCEDURE PACK This is a declaration made in accordance with the requirements in Article 12 of the Medical device directive 93/42/EEC including amendments to date as implemented
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How to fill out Orkla Care Declaration of Conformity Procedure Pack

01
Gather all necessary product information, including specifications and intended use.
02
Review relevant standards and regulations applicable to the product.
03
Complete the declaration form by entering the product name and description.
04
Include details about the manufacturer's and importer's information.
05
List all applicable standards and directives that the product complies with.
06
Provide any relevant test reports or certification documents.
07
Sign and date the declaration, certifying that all information is accurate.
08
Keep a copy of the completed declaration for your records.
09
Submit the declaration to the relevant authority or keep it available for inspection.

Who needs Orkla Care Declaration of Conformity Procedure Pack?

01
Manufacturers of products sold under the Orkla brand.
02
Importers of Orkla products.
03
Distributors who need to comply with regulatory requirements.
04
Retailers who sell Orkla products and require conformity documentation.
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The Orkla Care Declaration of Conformity Procedure Pack is a set of documents that outlines the compliance of products with applicable safety and quality standards within the Orkla Care portfolio.
Manufacturers and importers of products within the Orkla Care brand are required to file the Declaration of Conformity to demonstrate compliance with relevant regulations.
To fill out the Orkla Care Declaration of Conformity Procedure Pack, you need to accurately complete all specified sections, including information about the product, compliance standards, and relevant test results, ensuring that all data is truthful and verifiable.
The purpose of the Orkla Care Declaration of Conformity Procedure Pack is to assure customers and regulatory bodies that the products meet all necessary safety and quality requirements.
The information that must be reported includes product identification, applicable standards, test results, manufacturer details, and declarations regarding compliance.
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