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Occupational Health and Safety Management Systems
Published in Thomas P. Fuller, Global Occupational Safety and Health Management Handbook, 2019
Conformity assessment refers to the activities associated with determining whether an implemented management system conforms with a formal OHSMS standard, such as ISO 45001. Activities and distinctions associated with conformity assessment are certification; auditing; first, second, and third parties; registrar; and accredited. It is important to understand and consider conformity assessment issues and how they relate to management systems because they are central to strategic considerations regarding the rationale for implementing and measuring the performance of a management system (NRC, 1995).
Conformity Assessment
Published in Robert D. Hunter, for Engineers, 2017
Federal conformity assessment processes provide assurance that the products and services regulated or acquired by federal agencies meet the necessary requirements. Agency conformity assessments include many different activities including sampling, testing, inspection, and certification by the agency or another organization. All three methods (first-party, second-party, and third-party) of conformity assessment are used by federal agencies.
On Rehabilitation Robotics Safety, Benchmarking, and Standards
Published in Paolo Barattini, Vicentini Federico, Gurvinder Singh Virk, Tamás Haidegger, Human–Robot Interaction, 2019
In Europe, products are allowed on the market when their safety is ascertained through formal procedures of safety certification, generally known as CE marking (main steps in the process are indicated in Figure 7.1 ). Conformity assessment is the activity of assuring that the specific requirements as defined by regulation(s) or directive(s) that apply for the type of product are actually met.
Product performance - a review of construction product conformity assessment
Published in Australian Journal of Structural Engineering, 2021
Emad Gad, Lam Pham, Jessey Lee, Anita Amirsardari
There is, in general, a consensus that the current Australian conformance practice needs to be improved to reduce the risk of not-fit-for-purpose products being used in construction. This paper has provided an overview of the current operating system in Australia, the five causes for a product becoming not fit-for-purpose, and the issues related to the identification of these problematic products. A multi-level conformity assessment approach consisting of Registration, Evaluation, Certification and Surveillance activities is considered best practice and adopted in many countries. It has been discussed how each of these activities needs to be improved as part of a holistic approach to improve the Australian conformity assessment. In particular, it has been highlighted that the current Australian system is lacking a comprehensive Evaluation scheme. There is currently no single institution in Australia which is capable of doing this on its own. An Australian Technical Evaluation Network has been proposed to assist with this task. While waiting for a comprehensive National Framework to be devised and implemented, two immediate tasks can be carried out are: (i) a Guide or Protocol for performance evaluation of new products or processes, (ii) a Guide or a Code of Conduct for presenting clear, precise, up-to-date, relevant and understandable technical information for new products.
American and European legislation on border medical devices
Published in Expert Review of Medical Devices, 2022
Miriam Fraga-García, Raquel Taléns-Visconti, Octavio Díez-Sales, Amparo Nácher
For lower risk MD (class I), the manufacturer self-certifies the product and can immediately put it on the market. For the rest of the classes, the intervention of a Conformity Assessment Body is necessary to verify technical documentation. Depending on the class (IIa, IIb, III), the manufacturer may choose between: Conformity Assessment based on a Quality Management System and on Assessment of Technical Documentation (Annex IX), Conformity Assessment based on Type-Examination (Annex X), Conformity Assessment based on Product Conformity Verification (Annex XI – part A), Product Verification (Annex XI – part B).