Product related changes such as an obsolete part replacement, a firmware/software or hardware upgrade, or changes to the regulating test standard may trigger a reevaluation of the original compliance assessment hence the need for a compliance management program to handle the range of eventualities.
Compliance Management
Compliance steps are known to vary by the standard/regulating authority and the standard enacting process itself differs by market/geography. For example, standards issued by the European Telecommunications Standards Institute (ETSI) tend to change often, and manufacturers need to keep up to date on the latest standard requirements that apply for CE-marking of their product. ETSI’s standards making process is different from that of the American National Standards Institute (ANSI) that issues a number of US based standard procedures the Federal Communications Commission (FCC) reckons with for product electromagnetic compatibility compliance. Telcron understands these subtleties that inform the need for a compliance strategy in alignment with market specific regulatory requirements.
A typical product development lifecycle and engagement points for compliance management are illustrated in the following:
Typical Product Development Cycle
Technology manufacturers seeking ongoing compliance to regulatory requirements during each product’s lifecycle have to assess their products to requirements that include the following:
and other harmonized R&TTE Directive standards , harmonized Low Voltage Directive standards , and harmonized EMC Directive standards as applicable; non-harmonized standards may apply in other cases that may require expert determination. Products are ass essed to these standards in order to meet CE mark, FCC, IC, C-Tick, and other mandatory or market preferred certifications in the European Union, US, Canada, and Australia. In the European Union, i nformation technology and radio equipment within our scope are regulated under the EMC Directive , R&TTE Directive , and the Low Voltage Directive . Other Ecodesign regulations that may apply include Regulation No. 1275 of 2008 and Regulation No. 278 of 2009 .
Besides regulations issued by agencies such as the FCC, Industry Canada , and the CEPT, major hubs to obtain standard/regulatory requirements include: IHS Global ,BSI Group,IEC Webstore,TechStreet,Document Center,ANSI Webstore,Comm-2000, ETSI .
Techstreet also offers a Standard Tracker tool to track updates to any number of standards per user. A listing of standards that may be accessed by qualifying customers from Telcron’s library are here