ISO 13485 helps an organization design a quality man-agement system that establishes and maintains the effectiveness of its processes. It reflects a strong com-mitment to continual improvement and gives custom - ers confidence in its ability to bring safe and effective products to market. Purdue Manufacturing Extension Partnership (800) 877-5182 www.mep.purdue.edu ISO QUALITY MANAGEMENT SYSTEMS STANDARD Overview. The Design Plus QMS system is configured for companies desiring ISO certification and FDA QSR compliance. Quality Management System Manual; 46 Procedures and Related Forms (MS Word and Excel) ISO and FDA QSR Compliant; MDR EU 2017/745 Compliant Digital Content - Instant Download.
ISO 13485 and ISO/TR 14969 Quality Management Systems Medical Devices Package
The ISO 13485 and ISO/TR 14969 Quality Management Systems Medical Devices Package specifies the requirements and procedures to implement a quality management system for an organization that needs to consistently meet regulatory requirements applicable to medical devices and related services. The guidance standard ISO/TR 14969 provides approaches to establish objectives, implement, monitor and measure the processes to improve performance. The requirements and process approach are relevant to any regulated organization that designs and develops, produces, installs or services medical devices or provides related services. This package has a total savings of 30% off the list price and includes:
ISO 13485:2016
ISO 13485:2016 - Medical devices - A practical guide
ISO/TR 14969:2004 Historical Document
ISO 13485 and ISO/TR 14969 Quality Management Systems Medical Devices Package includes:
- ISO 13485:2016
- ISO 13485:2016 - Medical Devices - A Practical Guide
- ISO/TR 14969:2004
Content Provider
International Organization for Standardization [ISO]
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Iso 13485 Audit Checklist Download
