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Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations. [1]
Canadian certification label on a bag of rockwool Counterfeit electrical cords with false UL certification marks. A certification mark on a commercial product or service is a registered mark that enables its owner ("certification body") to certify that the goods or services of a particular provider (who is not the owner of the certification mark) have particular properties, e.g., regional or ...
Compliance refers to adhering with the mandated boundaries (laws and regulations) and voluntary boundaries (company's policies, procedures, etc.). [ 7 ] [ 8 ] GRC is a discipline that aims to synchronize information and activity across governance, and compliance in order to operate more efficiently, enable effective information sharing, more ...
product certifications (many nations) Product certification or product qualification is the process of certifying that a certain product has passed performance tests and quality assurance tests, and meets qualification criteria stipulated in contracts, regulations, or specifications (sometimes called "certification schemes" in the product certification industry).
Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance.. It is a position mostly found within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare ...
Certification is part of testing, inspection and certification and the provision by an independent body of written assurance (a certificate) that the product, service or system in question meets specific requirements. [1]
Weighing up expenditure versus profit has always been a significant issue, with the estimated cost of compliance being around €5 billion over 11 years, and the assumed health benefits of saved billions of euro in healthcare costs. [13] However, there have been different studies on the estimated cost which vary considerably in the outcome.
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 regulations, but also to provide an official certification mark or a declaration of conformity. [4] [5]