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Medical Device Quality Management System | BASE SYSTEM
The ISO 13485 BASE Quality Management System (QMS) product contains procedures that serve as the foundation for your QMS needs. ISO 13485 and FDA QSR compliant. Products installed in 46 countries and growing!
- Quality Management System Manual
- 23 Procedures and Related Forms (MS Word and Excel)
- ISO 13485:2016 and FDA QSR Compliant
- MDR EU 2017/745 Compliant
- Digital Content - Instant Download
Medical Device Quality Management System (QMS) | BASE
BASE Quality Management System (QMS) Procedures Benefits
BASE Quality Management System Procedures Compliance
Download the QMS Content List with References to ISO 13485 Clauses and FDA QSR Sections Here:
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Frequently Asked Questions |
DO THE MATH
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How long does it take to install the BASE Quality Management System?
The quality management system (QMS) can be implemented in as little as 3-4 weeks. The major advantage of this quality system product is 85% of the work is already completed upon purchase. The remaining 15% is expended in aligning the quality system with your unique organizational structure, the markets you wish to serve, and quality system training. Can the content be integrated with EQMS software? Yes! Many of our customers are using our products to either establish or augment their EQMS content. The procedures can be easily aligned with EQMS work instructions, workflows and forms. Does A.P. Lyon provide support with quality system installation? Absolutely! Many of our clients will leverage our resources to either install the system or ask us to audit their quality management system (QMS) post installation. Is the BASE QMS product content ISO 13485 and FDA QSR Compliant? Yes! This BASE quality management system content is ISO 13485:2016 and FDA compliant and addresses the regulatory gaps between ISO 13485 and the FDA QSR. Have the Quality Systems been audited? Yes! Our quality management systems have been successfully audited by notified bodies, FDA, and been challenged by numerous third party audits. |
When you consider the hours required to develop a system internally or the cost associated with hiring an outside consultant to develop a quality management system for you we trust that you will see the value of our product offerings.
PRODUCT TESTIMONIALS
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I have purchased several of your products and I have always been happy with the quality of your work. Thanks for providing a great product.
Karen Atwood
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Map of Countries Served |
RELATED LINKS
Medical Device Quality Management System BASE PLUS
Medical Device Quality Management System DESIGN
Medical Device Quality Management System DESIGN PLUS
Medical Device Quality Management System MANUFACTURING
Medical Device Quality Management System MANUFACTURING PLUS
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