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Products Certificates
Push Braces materials are manufactured and produced in Western Europe under the following Certifications by the International Standards Organization:
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ISO 13485 – Quality Management for Medical Devices
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ISO 14001 – Environmental Management
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ISO 9001 - Quality Management for Systems
ISO 13485:
Quality Management – Medical Devices
This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support).
Learn more: https://www.iso.org/iso-13485-medical-devices.html.
ISO 14001:
Environmental Management
This international standard specifies requirements for an effective environmental management system (EMS). The International Organization for Standardization (ISO) defines an environmental management system as “part of the management system used to manage environmental aspects, fulfill compliance obligations, and address risks and opportunities.” The framework in the ISO 14001 standard can be used within a plan-do-check-act (PDCA) approach to continuous improvement.
Learn more: https://asq.org/quality-resources/iso-14001.
ISO 9001:
Quality Management - Systems
This International Standard certifies that a company meets the criteria and continuously works toward standards that provide guidance and tools that ensure their products and services consistently meet customer’s requirements, and that quality is consistently improved.
Learn more: https://www.iso.org/iso-9001-quality-management.html.