WHY CONFORMITY ASSESSMENT?

What is conformity assessment?  Conformity assessment is the name given to processes that are used to demonstrate that a product or a service or a management system or a person meets specified requirements.  The specified requirements may be contained in a technical standard, a regulation or a contract

How Conformity assessment works Conformity assessment activities can be characterized as:  First party - this is the technical term used when conformity assessment to a standard, specification or regulation is carried out by the supplier organization itself. In other words, it is a self-assessment. This is known as a supplier's declaration of conformity.  Second party - this is defined as the conformity assessment activity which is performed by the customer of the organization. For example the manufacturer would allow his customer to do an assessment of the product against the requirements.  Third party - this is defined as the conformity assessment activity that is performed by a body that is independent of the organization that provides the product and is not a user of the product. An example of this would be when an independent certification body certifies that another organization complies with ISO 9001 and issues it with a certificate to this effect.

Mechanisms for performing conformity assessment  Testing  This is the most common form of conformity assessment. Testing also provides the basis for other types of conformity assessment like inspection and product certification. Here a product is tested against a specified set of criteria. It can be used to make decisions on the performance of the product.  The general requirements for laboratories or other organizations to be considered competent to carry out testing calibration and sampling are specified in the joint International Standard ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories.

Mechanisms for performing conformity assessment  Inspection bodies  These organizations examine a huge range of products, materials, installations, plants, processes, work procedures and services, in the private as well as the public sector, and report on such parameters as quality, fitness for use and continuing safety in operation. The overall aim is to reduce risk to the buyer, owner, user or consumer of the item being inspected.  The general requirements for the operation of various types of inspection body are given in the joint International Standard ISO/IEC 17020:1998 General criteria for the operation of various types of bodies performing inspection.

Mechanisms for performing conformity assessment  Product certification Relevant product standards and guides are used to demonstrate that a product complies with specified criteria. There are other standards within this family of standards that give guidance of the various types of product certification schemes which can be used. ISO/IEC Guide 65:1996 specifies general requirements for bodies operating product certification systems

Mechanisms for performing conformity assessment  Management system certification  The most well-known examples are the certification of quality management systems and environmental management systems as conforming, respectively, to ISO 9000 and ISO standards. More than organizations worldwide have been certified to ISO 9001 and/or ISO It should be noted that ISO itself does not assess the conformity of quality or environmental management systems to ISO 9000 or ISO standards. ISO does not issue certificates of conformity to these standards. ISO 9001 and ISO certification is carried out independently of ISO by the many certification or registration bodies active nationally or internationally.  Although ISO does not control the certification bodies, it contributes to best practice and consistency in their activities through the development of standards and guides. ISO/IEC 17021:2011 gives general requirements for bodies providing audit and certification of management systems.

Mechanisms for performing conformity assessment  Personnel certification Personnel certification is a requirement in certain technical professions. Welders, Boiler Operators are two examples. ISO/IEC 17024:2003 specifies requirements for a body certifying persons against specific requirements, including the development and maintenance of a certification scheme for personnel.

Why conformity assessment is important Conformity assessment provides benefits to everyone in the supply and demand chain. This includes the consumer, manufacturer and the supplier. It also includes regulators who are responsible for ensuring the health and safety of the general public.

Why conformity assessment is important (continued) The consumer benefits from conformity assessment, as it is a mechanism providing confidence to consumers that the products and services they purchase are fit for the purpose. It may also allow the consumer the possibility to seek appropriate remedies should the product be found not to meet the specified requirements. 10

Why conformity assessment is important (continued) For manufacturers, it allows them to have peace of mind that they have implemented systems within their own organizations to ensure that the products and services they deliver meet the necessary criteria. The fact that their product or service meets National or International Standards also gives them a competitive edge over those that do not. 11

Why conformity assessment is important (continued) For regulators, it allows them to use the conformity assessment infrastructure as part of the process they use to ensure health and safety as well as environmental conditions are being continuously met. The regulator will often make conformity assessment obligatory when it involves health, safety and/or environmental issues. Without official assessment and approval the regulator may prohibit the sale of products and services. 12

National quality infrastructure Parliament of Sri Lanka Government of Sri Lanka National Standards Body (SLSI) National Metrology Institute (MUSSD) National Accreditation Body (SLAB) Regulatory Bodies 13

14 VOLUNTARY SECTOR CUSTOMER REQUIREMENTS CONFORMITY ASSESSMENT Prove technical requirements are met Testing & calibration Inspection Certification SUPPLIERCUSTOMER MEASUREMENTS Underpins testing & calibration through national measurement standards ACCREDITATION Assures competence REGULATED SECTOR GOVERNMENT Sets policy, laws & technical regulations REGUALATORS Administer regulations STANDARDS Specific technical requirements of product or system

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