2. Getting involved
3. Standards Committees
4. NAGESUTECH

DIN Standards Committee Health Technologies

Overview

This standard contains principles and requirements for the competence and impartiality of certification of products (including services) and processes as well as bodies offering those services; certification bodies operating to this future standard need not offer all types of product, process and service certification. Certification of products, processes or services is a means to ensure that they correspond with specified requirements in standards and other normative documents. The overall aim of product, process or service certification is to give confidence to all interested parties that a product, process or service fulfils specified requirements. The value of certification is the degree of confidence and trust that is established by an impartial and competent demonstration of fulfilment of specified requirements by a third party. Parties, for example, the clients of the certification bodies, the customers of the organizations whose products, processes or services are certified, governmental authorities, non-governmental organizations and consumers and other members of the public can expect or require the certification body to meet all the requirements of this standard as well as when relevant, those of the certification scheme. Some product, process or service certification schemes may include initial testing or inspection and assessment of its suppliers' quality management systems, followed by surveillance that takes into account the quality management system and the testing or inspection of samples from the production and the open market. Other schemes rely on initial testing and surveillance testing, while still others comprise type testing only. This document can be used as a criteria document for accreditation or peer assessment or designation by governmental authorities, scheme owners and others. The general requirements specified here may have to be amplified when specific industrial or other sectors make use of them, or when particular requirements such as health and safety have to be taken into account. This document does not set requirements for schemes and how they are developed. Furthermore, it is not intended to restrict the role or choice of scheme owners. However, scheme requirements should not contradict or exclude any of the requirements of this document. While this document is concerned with third parties providing product, process or service certification, many of its provisions may also be useful in first- and second-party product conformity assessment procedures. The underlying International Standard ISO/IEC 17065:2012 corresponds with the revision of ISO/IEC Guide 65:1996, which has been adopted as DIN EN 45011:1998-03 into the German body of standards. The revision has been carried out in Working Group WG 29 of ISO/CASCO, in collaboration with Technical Committee CEN/CENELEC/TC 1. Regarding the German collaboration, Subcommittee NA 147-00-03-29 UA "Produktzertifizierung" ("Product certification") in Working Committee NA 147-00-03 AA "Zertifizierungsgrundlagen (Grundlagen zur Konformitätsbewertung)" ("Basic principles for certification (Basic principles for conformity assessment)") of NQSZ is responsible.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 147-00-03-29 AK - Product certification  

Responsible european committee

CEN/CLC/JTC 1 - Criteria for conformity assessment bodies