Inspection and product certification can be considered similar and there is some overlapping in the definitions. They both go beyond simple testing by including tasks related to the ability to assess test results and decide on conformity. They pursue the same goal (i.e., the assessment of the conformity of a product) in slightly different ways.
Products manufactured in compliance with harmonized standards benefit from a presumption of conformity with the corresponding essential requirements of the applicable legislation, and, in some cases, the manufacturer may benefit from a simplified conformity assessment procedure (in many instances the manufacturer’s declaration of conformity, made more easily acceptable to public authorities by the existence of the product liability legislation.
Certification Marks: Assurance of quality
Product certification necessitates giving assurance that a product conforms to specified requirements such as regulations, standards or other technical specifications. A product certification system can include, e.g. type testing or examination, testing or inspection of every product or of a particular product, batch testing or inspection, design appraisal, which could be coupled with production surveillance or assessment and surveillance of the manufacturer’s quality system.
The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements. When you buy a new phone, a teddy bear, or a TV within the EEA, you can find the CE mark on them. CE marking also supports fair competition by holding all companies accountable to the same rules.
By affixing the CE marking to a product, a manufacturer declares that the product meets all the legal requirements for CE marking and can be sold throughout the EEA. This also applies to products made in other countries that are sold in the EEA.
There are two main benefits CE marking brings to businesses and consumers within the EEA:
- Businesses know that products bearing the CE marking can be traded in the EEA without restrictions.
- Consumers enjoy the same level of health, safety, and environmental protection throughout the entire EEA.
CE marking is a part of the EU’s harmonization legislation, which is mainly managed by Directorate-General for Internal market, Industry, Entrepreneurship and SMEs. The CE marking for Restriction of Hazardous Substances is managed by Directorate-General for Environment. Comprehensive guidance on the implementation of EU product rules can be found in the so-called Blue Guide.
The manufacturer or the authorized representative established within the Union must draw up and sign an EU declaration of conformity as part of the conformity assessment procedure provided for in the Union harmonization legislation. The EU declaration of conformity must contain all relevant information to identify the Union harmonization legislation according to which it is issued, as well as the manufacturer, the authorized representative, the notified body if applicable, the product, and where appropriate a reference to harmonized standards or other technical specifications. A single declaration of conformity is required whenever a product is covered by several pieces of Union harmonization legislation requiring an EU declaration of conformity. The single declaration of conformity can be made up of a dossier containing all relevant individual declarations of conformity.
Traceability is the ability to trace the history of the product.
From a regulator’s perspective, traceability matters because it enables effective enforcement through market surveillance via corrective measures including withdrawals and recalls. It enables unsafe or non-compliant products to be traced up the distribution chain and identifies roles and responsibilities of the economic operator throughout the chain. Traceability enables market surveillance authorities to trace products up to the factory gate and from factory to the end- user in certain cases.
From a manufacturer’s perspective traceability matters because it enables effective control of the production process and suppliers before the marketing of the products, and control of their distribution chain after the placing of the product on the market. In case of non-compliance, manufacturers can reduce the impact of recalls or withdrawals depending on the detail of their traceability system.