Compliance And Regulatory Services
Generally speaking ‘compliance’ is achieved by conforming given rules, dictated by thing such as specifications, policies, standards or the law. Regulatory compliance is a business goal covering the awareness and steps taken in order to comply with relevant laws, policies, and regulations.
Mandatory conformity certification, or conformance is a process through which a Product passes ensuring that is has passed performance and quality assurance tests as well as complying to the specific qualification criteria that is stipulated in applicable regulations and “certification schemes”.
European Conformity mark
In Europe, for example, the conformity certification applicable is CE (Conformité Européenne meaning European Conformity) and is a clear marking recognisable worldwide. This conformance certification will clearly indicate adherence to health, safety and environmental standard for terminal devices sold throughout the European Economic Area.
Federal Communications Commission mark
In a similar fashion the FCC (Federal Communications Commission) Declaration of Conformity is used on specific electronic devices sold within the United States of America.
Numerous countries have their own standards for ‘CE’ certification testing.
The CE marking directives are written into European law with the directives converted into each EU member state’s national law. Failure to comply will incur penalties which will differ depending upon the location of the business and, if financial, will have to be paid in the local currency. For example, UK CE marking directives are covered by criminal law and as such penalties applied could range from fines, through stock impoundment and potential prison sentences.
The Radio Equipment Directive (RED) establishes a regulatory framework for placing radio equipment on the market. The Radio Equipment Directive ensures a Single Market for radio equipment by setting essential requirements for safety and health, electromagnetic compatibility, and the efficient use of the radio spectrum. It applies to all products using the radio frequency spectrum. The Directive requires equipment to be constructed for efficient use of the radio spectrum, as well as electromagnetic compatibility, to avoid interference with terrestrial and orbital communications.
All product in scope of this directive and placed on the EU market must be compliant with this directive from June 13, 2017. RED repeals the Radio and Telecommunications Terminal Equipement (R&TTE) directive since June 13, 2016.
IoTAS have successfully managed numerous RED approval processes and can offer full consultation delivery programming for customers wishing to achieve this regulation standard, including harmonisation management. We would also advise that if you are intending to place a new radio enabled product on the market, continuing to market an existing radio product, installing a radio module into your product, or re-branding someone else’s radio product then you should be adhering to Radio Equipment Directive.
How IoTAS can help you
Radio and telecommunications terminal equipment require CE conformity and marking as dictated by this directive. IoTAS can assist in the goal of achieving CE compliance certification and have provided this service to customers who are seeking approval. With our knowledge and experience we have developed a guideline process to ensure success:
- Initial consultation to confirm CE requirement
- Selection of correct compliance directives and regulatory standards that apply
- Ensure appropriate ‘Harmonisation’ of directives is adopted
- As CE marking is a ‘self-declaration’ process it may be appropriate to use a ‘third party’ for control audits, etc.
- Test (Lab/Field/Live/etc.)
- Compilation of results, technical documents, certifications, etc.
- Formal request (completion) for ‘Declaration’, such as EU Declaration of Conformity although others exist (e.g. the Technical Conformity Mark in Japan).