Understanding Product Certification Relating to ISO/IEC 17065

His areas of expertise include transmitter certification and testing for US and foreign markets, FCC testing and regulations, CE Marking, and international compliance regulations. As an internal auditor for Elite’s quality assurance team, he assists with the administration of Elite’s ISO 17025 quality system and ISO Guide 65 certification systems.  Finally, Dan is actively involved in transmitter standards development--including ANSI C63.10 and ANSI C63.26, the Telecommunication Certification Body Council, and the IEEE EMC Society.

The purpose of ISO/IEC 17065 is for conformity assessment or the certification of products, processes and/or services. More than any other type of conformity assessment activity, product/process/service certification is primarily focused on the establishment of confidence in the certified products, processes or services. The users of goods and services that carry formal certification marks are much less interested in the process of certification than in its results. 

Overview of certification:
 
ISO/IEC 17065 articulates the process of certification to contain the 5 steps pictured below. These five steps underpin all certification processes and therefore, the management system that supports them (in ISO/IEC 17065) is geared towards allowing the certification body to issue certificates that enhance trust in the safety and performance of the products examined.
 
Understanding Impartiality:
 
The concept of impartiality is the following: decisions made for certification are based solely on the defined merits or criteria related to the object of certification (product, service or process), or its operation, or some other aspect related to it. Only those things can be used in the certification decision – nothing else, and certainly nothing related to the decision maker. 
 
Conflict of interest is the notion that something other than those defined merits or criteria are influencing the decisions related to that thing. People or organizations are deemed to be in conflict of interest when they are associated with any condition or organization that might have an interest in influencing the outcome of the decisions. Rock solid demonstrations of impartiality require the CB to ensure that its own staff are not involved in any aspect of ownership, design, manufacture, or other relationship as regards the object of certification or its manufacturer / supplier. It requires that all sub-contracted organizations that participate in the evaluation processes also are visibly free of such conflicts. ISO/IEC 17065, cl 7.6.2 requires that all persons involved in the review and decision must be independent of the evaluation.


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