The Declaration of Conformity Template is an indispensable document in the product certification process, particularly within the industrial automation sector. This document verifies that a product meets the requirements set out in relevant EU directives, such as the Machinery Directive 2006/42/EC. In this article, we will discuss the key aspects of creating a Declaration of Conformity and provide a detailed template for implementation.
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What is a Declaration of Conformity?
A Declaration of Conformity is a formal statement by the manufacturer asserting that the product complies with all applicable EU directive requirements. This document is a crucial component of the CE certification process for machinery and must be signed by an authorized individual, including key information about the product, its compliance with specific standards, and manufacturer details.
Declaration of Conformity Template: Legal Requirements
According to the Machinery Directive 2006/42/EC, any manufacturer introducing machinery to the EU market must draft a Declaration of Conformity. This document must include:
- Manufacturer’s name and address
- Product description
- Statement of compliance with relevant directives and standards
- Date of issuance
- Signature of the authorized person
Declaration of Conformity Template: Key Elements
Manufacturer Information
The manufacturer’s name and full address must be clearly specified to identify the responsible entity unequivocally.
Product Description
A precise description of the product, including its type, model, serial number, and other identifiers that allow for its unambiguous identification. In the context of industrial automation, this could be a production line or an industrial robot.
Statement of Compliance
A statement that the product complies with the relevant EU directives and harmonized standards. For products covered by the Machinery Directive 2006/42/EC, all applicable standards must be indicated.
Date and Signature
The date of issuance and the signature of the person authorized by the manufacturer. It is important that the signature is authentic and legible.
Declaration of Conformity Template:
| Declaration Element | Description |
|---|---|
| Manufacturer’s Name and Address | ABC Manufacturing Ltd., Technological St. 15, 00-200 Krakow, Poland |
| Product Description | Assembly line for radiator assembly model LPC-3000 |
| Model, Type, Serial Number | Model: LPC-3000, Type: Assembly line, Serial No: 789123 |
| EU Directives and Harmonized Standards | Machinery Directive 2006/42/EC, EN ISO 12100:2010, EN 60204-1:2018, EN ISO 13849-1:2015 |
| Date of Declaration | August 5, 2024 |
| Authorized Person’s Signature | John Nowak, Technical Director |
XYZ Machines Ltd.
Industrial St. 12,
00-100 Warsaw, Poland
We hereby declare with full responsibility that the product:
Automatic production line model APL-5000
Model: APL-5000, Type: Production line, Serial No: 123456
complies with the following directives and standards:
- Machinery Directive 2006/42/EC
- EN ISO 12100:2010 – Risk assessment according to PN-EN ISO 12100:2012
- EN 60204-1:2018 – Machine safety — Electrical equipment of machines — Part 1: General requirements
Date of Declaration: August 5, 2024
Authorized Person’s Signature:
John Kowalski
Technical Director
XYZ Machines Ltd.
Declaration of Conformity Template: Conformity Assessment Procedures
Internal Production Control
Internal production control is the simplest conformity assessment procedure and can be applied to low-risk products not listed in Annex IV of the Machinery Directive 2006/42/EC.
Steps:
- The manufacturer ensures that the product meets the essential health and safety requirements set out in the directives.
- The manufacturer prepares technical documentation including drawings, descriptions, test results, and risk analyses.
- The manufacturer issues the Declaration of Conformity and affixes the CE mark on the product.
EC Type Examination
EC type examination is a procedure where a notified body assesses the conformity of a product prototype with essential requirements.
Steps:
- The manufacturer submits an application to a notified body along with the product prototype and technical documentation.
- The notified body conducts tests and evaluations to confirm the prototype’s compliance with requirements.
- If the product meets the requirements, the notified body issues an EC type examination certificate.
- The manufacturer applies internal production control to ensure that manufactured products conform to the approved prototype.
Full Quality Assurance
Full quality assurance is the most comprehensive procedure, encompassing the manufacturer’s quality management system and is applied to high-risk products.
Steps:
- The manufacturer implements a quality management system covering design, production, final inspection, and testing of products.
- The manufacturer submits an application to a notified body for assessment of the quality management system.
- The notified body conducts an audit of the quality management system and evaluates its compliance with requirements.
- If the quality management system meets the requirements, the notified body issues a quality management system approval certificate.
- The manufacturer applies the approved quality management system and conducts regular internal audits.
- The notified body conducts regular checks to ensure that the manufacturer continues to meet the requirements.
EC Type Examination with Internal Production Control
This is a combination of two procedures, where EC type examination is used to assess the prototype, and internal production control is used to assess serial production.
Steps:
- The manufacturer submits an application to a notified body for EC type examination.
- The notified body conducts prototype tests and issues an EC type examination certificate if the product meets the requirements.
- The manufacturer applies internal production control for serial production.
- The manufacturer issues a Declaration of Conformity according to the template and affixes the CE mark on the product.
Choosing the Right Procedure
Choosing the appropriate conformity assessment procedure depends on several factors, such as:
- Product category and risk (whether it is listed in Annex IV of the Machinery Directive 2006/42/EC).
- Complexity and degree of risk associated with product use.
- Requirements of specific EU directives.
Importance of the Declaration of Conformity
Issuing a declaration of conformity according to the template is a key element in ensuring the safety of products introduced to the EU market. This is particularly important in industries such as production automation, industrial machinery construction, and production process automation, where compliance with standards and directives is crucial for ensuring safety and operational efficiency.
Manufacturers are advised to work closely with design offices, notified bodies, and certification specialists to ensure full compliance with legal requirements.
In the era of increasing automation of production processes and dynamic changes in regulations, it is important for manufacturers to stay updated with the latest requirements and standards. This way, they can not only meet legal requirements but also gain a competitive advantage in the market.
It is also worth familiarizing oneself with the Machinery Regulation 2023/1230, which will soon be the primary document regulating the machinery construction market. This document also expands the list of machines requiring special procedures in the certification process.
FAQ: Declaration of Conformity Template
A Declaration of Conformity is a formal document that confirms a product meets all relevant EU directive requirements, such as the Machinery Directive 2006/42/EC. This document is a key component of the product certification process and allows products to be legally introduced to the EU market.
The Declaration of Conformity must include: Manufacturer’s name and address, Product description including model, type, and serial number, Statement of compliance with relevant directives and harmonized standards, Date of issuance, Signature of the authorized person.
Conformity assessment procedures include: Internal production control for low-risk products, EC type examination conducted by notified bodies, Full quality assurance for high-risk products, including the manufacturer’s quality management system.
The Declaration of Conformity is important because it confirms that a product meets the health and safety requirements specified in relevant EU directives. It is a key document in the CE certification process, ensuring the legal introduction of the product to the EU market.
Non-compliance with the Declaration of Conformity can lead to serious consequences, such as: Prohibition of product introduction to the EU market, Product recalls, Financial penalties for the manufacturer. Therefore, manufacturers must ensure their products comply with directive and harmonized standard requirements to avoid these issues.