Conformity Magazine - October 2008 - (Page 34)

T he process of determining whether products, processes, systems or people meet specified requirements has been given the name conformity assessment. There are a number of tools used to provide confidence in compliance classified as conformity assessment (see Table 1). The primary goal of conformity assessment is to provide a user or purchaser or regulator with the needed confidence that a product, service, process, system or person meets relevant requirements. ISO’s Committee on Conformity Assessment (CASCO) provides several ISO/IEC standards on the subject. The tools of conformity assessment are listed roughly in the order of their emergence in Table 1 with an identification (*) of their use by first parties (suppliers), second parties (customers, regulators, trade organizations or others who demand compliance with requirements) and third parties (bodies independent from both suppliers and their customers and having no interest in their transactions). Some form of conformity assessment is used for virtually every customer-supplier transaction. The most appropriate and cost-effective mix of these tools should be used for each product area. This mix will be different for different types of products. For many products, a simple self-declaration will suffice without any third-party product or management system certification or accreditation of the conformity assessment bodies involved. Products that pose a higher risk of incurring significant costs of failure (i.e., producing harm to human safety, health or environment) generally will need greater assurance of conformity, and thus second or third-party forms of conformity assessment. Supplier’s Declaration of Conformity by the other forms of conformity assessment: typically inspection and/or testing of the product, auditing of related product production systems and processes, and, more recently, certification (or registration) of the supplier’s quality management system. Inspection, testing and auditing are the most common types of conformity assessment. Most products fall into the category in which supplier’s assurance is sufficient. The international standard covering this activity is ISO/IEC 17050:2003, Conformity Assessment: Suppliers declaration of conformity. Inspection Inspection is a tool used by first, second or third parties. Inspection processes demonstrate conformity of the actual products inspected or a lot from which sample products are drawn. Inspection works for product characteristics that can be easily examined. Inspection is also used to ensure component parts have been installed correctly, such as in building construction. Inspection of critical mechanical components on machinery that inevitably wear out over time is particularly important to ensure human safety. Elevators, construction cranes, and airplanes are typical examples where inspection is essential and obviously mandatory. Inspection bodies usually have to demonstrate varying degrees of independence from the products and processes subject to their inspection. The standard for inspection bodies is ISO/ IEC 17020:1998, General criteria for the operation of various types of bodies performing inspection. Testing Laboratories perform tests and report data. These data are used to determine whether tested samples demonstrate conformity with requirements. Type testing are tests conducted on samples representing production. Other testing may be used to control production processes and check actual production units, or as part of an inspection process. Laboratories can be first, second, or third parties. Virtually all products can be subject to one or more tests from design through production, distribution and final use or consumption. Testing is most useful to check for compliance with specification requirements that cannot easily be discerned by the consumer. Electromagnetic compatibility (EMC) is a typical example of a product characteristic in this category. With the growing use of electronic controls, demonstration of EMC testing for a variety of devices is a must. The standard for laboratories is ISO/IEC 17025:2005 Conformity Assessment - General requirements for the competence of testing and calibration laboratories. Certification Certification is defined in ISO/IEC 17000:2004 as third party attestation related to products, process, systems or persons. Certification has two essential aspects. It is done by a third party, and it includes surveillance activity. A supplier’s declaration of conformity (commonly called firstparty conformity assessment) is, according to the definition under ISO/IEC 17000:2004, a conformity assessment activity that is performed by the person or organization that provides the object. Low-risk products in which the market or regulation reduces adverse consequences of non-conformities before those consequences become unacceptable to society rely on conformity assessment by the first party. The supplier performs all the necessary conformity assessment activities resulting in a self-declaration of conformity. The declaration may be in the form of a certificate, brochure, manual or product or packaging markings. A supplier’s declaration of conformity may be supplemented First Party Second Party Third Party 1. Suppliers’ declaration 2. Inspection 3. Testing 4. Certification 5. Accreditation Table 1 3 Conformity oCtober 2008 * * * * * * * * *

Table of Contents Feed for the Digital Edition of Conformity Magazine - October 2008

Conformity Magazine - October 2008 Contents Editor's Note FCC Releases Annual Report on National Do-Not-Call Registry Commission Cracks Down (for the Fourth Time!) On Junk Fax Marketer FCC Releases Quarterly Reports on Consumer Inquiries and Complaints Greenpeace Ranks Electronics Manufacturers Standards List For The EU’s Energy Consumption Directive Published EU Commission Publishes Standards List for Directives on Pressure Equipment, Pressure Vessels Standards List for the EU’s Medical Devices Directive Available The IEEE Product Safety Engineering Society: The First Five Years ESD Open Forum Improving Election Security and Accuracy: The Future of Voting System Certification Conformity Assessment and Accreditation: Their Role in the Global Market Design Issues in Extreme EMC Environment Focus On... Test Equipment Buyers Guide Product News Updated Standards List for EU Directive on Active Implantable Medical Devices FDA Warns of Effects from CT Scans on Electronic Medical Devices FDA Provides Report Card on Its PMA Review Process CPSC Releases Import Safety Strategy Other CPSC Actions in the News IEC Standards Update Product Reviews UL Standards Update Telcordia Standards Update From Our “You Can’t Make This Stuff Up” Department Looking Back: Items from Past Issues of Conformity Advertisers

Conformity Magazine - October 2008

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.