When a product is placed on the market inside the European Union, the products must be subject to conformity assessments in terms of the essential Health and safety requirements for the specific product.
Definition: A conformity assessment is the process carried out by the manufacturer of the product to demonstrate whether specific requirements relating to the product have been fulfilled.
A product is subjected to conformity assessment both during the design and the production phase.
There are two important elements of every legislative act covering products. They are:
- The legislative requirements governing the characteristics of the products covered
- The conformity assessment procedures the manufacturer carries out in order to demonstrate that the product, before it is placed on the market, conforms to these legislative requirements.
A product must be subjected to conformity assessment, during the design and the production phases. The primary responsibility for conformance assessment is that of the manufacturer. Even if the manufacturer subcontracts design or production, he still remains responsible for the execution of the conformity assessment.
Conformity assessment requirements example: The machinery directive (2006/42/EC)
Article 12 of the directive spells out the available procedure for assessing the conformity of machinery:
Procedures for assessing the conformity of machinery
1. The manufacturer or his authorized representative shall, in order to certify the conformity of machinery with the provisions of this Directive, apply one of the procedures for assessment of conformity described in paragraphs 2, 3 and 4.
2. Where the machinery is not referred to in Annex IV, the manufacturer or his authorized representative shall apply the procedure for assessment of conformity with internal checks on the manufacture of machinery provided for in Annex VIII.
3. Where the machinery is referred to in Annex IV and manufactured in accordance with the harmonized standards referred to in Article 7(2), and provided that those standards cover all of the relevant essential health and safety requirements, the manufacturer or his authorized representative shall apply one of the following procedures:
(a) the procedure for assessment of conformity with internal checks on the manufacture of machinery, provided for in Annex VIII;
(b) the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3;
(c) the full quality assurance procedure provided for in Annex X.
4. Where the machinery is referred to in Annex IV and has not been manufactured in accordance with the harmonized standards referred to in Article 7(2), or only partly in accordance with such standards, or if the harmonized standards do not cover all the relevant essential health and safety requirements or if no harmonized standards exist for the machinery in question, the manufacturer or his authorized representative shall apply one of the following procedures:
(a) the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3;
(b) the full quality assurance procedure provided for in Annex X.
The references in Article 12 of the directive refers to:
- Article 7: Presumption of conformity to harmonized standards
- Annex IV: Categories of machinery to which the procedures referred to Article 12(43) and (4) must be applied
- Annex VIII: Assessment of conformity with internal checks on the manufacture of machinery
- Annex IX: EC type-examination
- Annex X: Full quality assurance
Annex VIII
1. This Annex describes the procedure by which the manufacturer or his authorized representative, who carries out the obligations laid down in points 2 and 3, ensures and declares that the machinery concerned satisfies the relevant requirements of this Directive.
2. For each representative type of the series in question, the manufacturer or his authorized representative shall draw up the technical file referred to in Annex VII, part A.
3. The manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the manufactured machinery with the technical file referred to in Annex VII, part A, and with the requirements of this Directive.
Annex IX
1. The manufacturer or his authorized representative must, for each type, draw up the technical file referred to in Annex VII, part A.
2. For each type, the application for an EC type-examination shall be submitted by the manufacturer or his authorized representative to a notified body of his choice.
The application shall include:
- the name and address of the manufacturer and, where appropriate, his authorized representative,
- a written declaration that the application has not been submitted to another notified body,
- the technical file.
Moreover, the applicant shall place at the disposal of the notified body a sample of the type. The notified body may ask for further samples if the test program so requires.
Annex X
This Annex describes the conformity assessment of machinery referred to in Annex IV, manufactured using a full quality assurance system, and the procedure whereby a notified body assesses and approves the quality system and monitors its application.
As can be seen in the above section, some products, regarded as hazardous products, requires the involvement of a notified body.
Notified body
A notified body is an independent, accredited body which is entitled by an authorized accrediting body. Upon definition of standards and regulations, the accrediting body may allow a notified body to provide verification and certification services. These services are meant to ensure and assess compliance to the previously defined standards and regulations, but also to provide an official certification mark or a declaration of conformity.
Other notified bodies are certification bodies that assesses the quality management system of an organization and issues a certificate to indicate conformance with a specific management system standard, such as ISO 9001.
To help manufacturers with compliance with the legal requirements for the product being placed on the market, the directives and regulation contain the “essential health and safety requirements” for that product. In the machinery directive these requirements are contained in Annex I of the directive, under the title “Essential health and safety requirements relating to the design and construction of machinery”. It contains the general requirements, as well as requirements for specific categories of machinery.
Other information that is provided in the machinery directive include the requirements for the technical file that must be assembled by the manufacturer, as well as the specifications for the CE marking itself. It also gives information pertaining to partially completed machinery that is being placed on the market in the EU.
Other directives also give similar, but product category specific requirements for conformity assessments. Identify the directives or regulations which are applicable to your product, and apply those requirements in order to perform the conformity assessment. Note that, should the directive of regulation require the involvement of a notified body in some cases, it is not negotiable.
The European Union maintains an online database of accredited notified bodies. The Nando (New Approach Notified and Designated Organizations) Information System allows citizens and economic entities to search and validate the status of the notification of a notified body for certain regulations and directives.
Please feel free to contact me regarding conformity assessments for specific products that your organization needs to export. Note that all exports to the European Union must comply with these requirements, while other countries around the world either have their own regulations that must be complied with, or they also specify that the products must conform to the European requirements.
You can contact me at koosgouws10@gmail.com. You can also visit our website at www.sheqmanagementsystem.co.za, or, alternatively, www.sheq-management-systems.webnode.com.
Regards
Koos
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