ISO 13485... the Quality System Standard for Medical Devices
Need ISO 13485 Quality Management System (QMS) certification to meet new customer requirements?
Do you need EU CE marking?
Need ISO 13485 Quality Management System (QMS) certification to meet pending customer requirements?
Confused about QSR 21 CFR Part 820 and cGMPs?
What is ISO 13485:2003?
ISO 13485, based on ISO 9001:2000 (since replaced by ISO 9001:2008) is the international QMS standard for the design and development, production, customer care, and installation of medical devices. It covers fundamental cGMP (current Good Manufacturing Practice) principles, which normally apply during the manufacture of medical devices.
Note: Third-party registrars audit for ongoing ISO 13485 compliance.
The US FDA regulates the design, manufacturing, packaging, labeling, storage and delivery of medical devices. The laws normally require "manufacturers" to implement a quality system that meets Quality System Regulations (QSR) found in 21 CFR (Code of Federal Regulations) Part 820. This QSR is commonly referred to as current Good Manufacturing Practice (cGMP). cGMP is intentionally harmonized with ISO 13485:2003.
Note: FDA inspectors may audit cGMP compliance.
ISO 13485 requires
- A process approach, supported by procedures for quality
- Focus on the customer, not just customer satisfaction
- Continual improvement, not just corrective/preventive action
What we do
QualityAdvantage provides proven, proprietary implementation and training support to assure that your organization meets applicable ISO 13485 requirements promptly and effectively. A certified ISO 13485 Quality Management System (QMS) will
- Assure you meet all customer quality requirements
- Improve your organization's competitiveness
- Eliminate waste
- Reduce risk
- Control process variation
QualityAdvantage ISO 13485 QMS Implementation Support is loaded with advantages for your organization.
QualityAdvantage always offers Options... you decide just how much support you need. Everything we provide meets one or more ISO 13485 requirements..
- Basic Support provides a process-based, documented, implemented, audited Quality Management System (QMS), acknowledging all ISO 13485 quality requirements, ready for certification.
- Full Support provides everything in Basic Support, plus we will train and mentor an Internal Quality Audit team for your organization.
- QualityAdvantage will witness your certification audit, if you choose.
At QualityAdvantage, we are always all expenses included. "Consultants" often add "ups and extras..." we do not.
QualityAdvantage proven, proprietary implementation and training methods assure your organization meets all ISO 13485 requirements in minimal time and at lowest cost.
When QualityAdvantage leaves, the quality management system is yours, not ours. We provide all the methodology and expertise your organization needs to effectively manage, maintain and continually improve your certified QMS. When we are finished, your organization owns your ISO 13485 quality management system.
QualityAdvantage is our association of experienced, creative, enthusiastic quality professionals committed to building and improving quality systems while permanently reducing quality costs.
This is what we do... we would welcome the opportunity to work with you!
For a more information, please call us now at 888-321-3864.