![]() The publication and release of ISO earlier this year is a significant movement for the medical device industry. The checklist is best used by trained and practicing auditors to evaluate or assess Quality Management Systems requirements based on the standard. The last major revision of this quality management system standard happened. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. ![]() Download a complimentary checklist (PDF) This diagram outlines the steps for your ISO 13485:2016 implementation. This International Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. implementing a quality management system in conformance with ISO 13485:2016: Medical Devices QMS Requirements for Regulatory Purposes. This easy-to-follow format shows the process at a glance, allowing you to track every stage, including: Establishing the project. ![]() Identifying customer and other requirements. This amendment A11 modifies the European Standard EN ISO 13485:2016 it was approved by CEN on 12 April 2021. Requirements of this International Standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes CEN and CENELEC members are bound to comply. The Czech Office for Standards, Metrology and Testing promulgated the standard EN ISO 13485:2016 as harmonized with the European directives 93/42/EEC, 90/385/EEC and 98/79/EC, which permits their use for demonstration of conformity with requirements of the above European directives. With respect to increased demands on quality management system of medical devices suppliers and manufacturers EN ISO 13485:2016 standard was elaborated. This standard contains criteria for the whole scope of the medical devices quality management system. The revisions are intended to reducecompliance and recordkeeping burdens on devicemanufacturers by harmonizing domestic and international requirements. ![]() The certificate according to EN ISO 13485:2016 standard covers the whole system of management of the organisation manufacturing or supplying medical devices and appropriate services. ![]()
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