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ISO 9000, 9001, 14001, 13485, 16949, 19011, AS 9000, TL 9100, FDA, GMP Product System Certification
Provide ISO 9000, 9001, 14001, 13485, 16949, 19011, AS 9000, TL 9100, FDA, GMP certification services for product system certification, AS 9000, TL 9100, FDA, GMP for product system certification
ISO 13485:2003 PRODUCT & SYSTEM CERTIFICATION
Medical devices Quality Management Systems
About ISO 13485:2003 standard
ISO 13485:2003 (Medical devices - Quality management systems - Requirements for regulatory purposes) is actually an application of the ISO 9001 standard adapted to meet the requirements of the medical device industry and this standard addresses most FDA requirements (21CFR820). The main difference between ISO 9001 and ISO 13485 is that ISO 13485 is more focused on ensuring medical device safety and efficiency rather than enhancing customer satisfaction and continual improvement.
Comply with ISO 13485:2003 Standard
Once you implement processes and procedures that comply with the requirements listed in ISO 13485:2003, you can be audited by a third party organization called Registrar such as TUV or UL who will certify your organization to this standard. It will also meet most of the FDA requirements to have a Quality System in compliance with the QSRs set forth by 21CFR820.
Achieve ISO 13485:2003 certification
To achieve compliance, you can train employees who will drive the implementation internally, and/or use a consulting firm that can assist in the training and implementation. Providing training on the basis of the standard and the FDA's current Good manufacturing Practice (GMP) for key players (Quality Control personnel, QA personnel, RA personnel, engineering staff, production personnel) in your organization so that they can understand what it entails, is a good starting point.
This web site offers affordable training classes online, and ISO 13485:2003 course, ISO 13485:2003 Auditor course or CGMP for Medical Device course would be good training to take.
ISO 13485:2003 Solution
The road to certification of your Medical devices - Quality Management systems - Requirements for regulatory purposes to ISO 13485:2003 is critical to succeed, but it adapts to meet the requirements of the medical device industry and it addresses most FDA requirements (21CFR820). The Road to Certification data sheet can help you prepare for an independent audit. And, the Accredited Certification data sheet explains what the RISK Based certification process entails.
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CUSTOMER TESTIMONIAL
“CompetitiveXpert was essential to our organization being registered under ISO 9001 in record time. They quickly and accurately assessed the readiness of our business to pass the final audit by making the intellectual effort to really understand our business requirements and processes. This allowed us to focus our efforts on those things that were really needed both to improve our business and to obtain the certification…”
Dave Lilly
President
SiteROCK
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