Contact Us
- sales@fdaiso.com
We respond to most inquiries within 24 hours
Shop with Confidence
- Download your packages immediately after paying with your credit card or Paypal account.
- Your information is protected at all times by industry-standard SSL encryption.
| Product includes... | ISO 9001 | ISO 9001 + CE | FDA QSR | FDA QSR + Risk | FDA QSR + ISO 13485+ CE + CMDR | ISO 13485 + CE + CMDR | ISO 13485 + CE |
|---|---|---|---|---|---|---|---|
| Quality Manual | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Quality Management | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| General Requirements | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| General Doc. Requirements | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Control of Documents | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Control of Quality Records | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Management Responsibility | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Management Commitment | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Customer Focus | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Quality Policy | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Quality Planning | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Respons./Authority/ Comm. | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Resource Management | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Provision of Resources | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Human Resources | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Infrastructure | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Work Environment | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Product Realization | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Planning - Product Realization | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Customer Related Processes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Design Control | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Purchasing | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Process Control | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Monitoring Measuring Devices | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Analyze/Improve | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| General | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Monitoring and Measurement | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Non-Conform Product | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Analysis of Data | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Improvement | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| CE Marking | Yes | Yes | Yes | Yes | |||
| Conformity Assessment | Yes | Yes | Yes | Yes | |||
| Declaration of Conformity | Yes | Yes | Yes | Yes | |||
| International Labeling | Yes | Yes | Yes | Yes | |||
| Technical Files | Yes | Yes | Yes | Yes | |||
| Product Vigilance | Yes | Yes | Yes | Yes | |||
| CMDR (Canada) | Yes | Yes | |||||
| FDA QSR | Yes | Yes | Yes | ||||
| ISO 13485 | Yes | Yes | Yes | ||||
| Risk Analysis (FMEA) | Yes | Yes | Yes | Yes | Yes | ||
| Cost | US$299 | US$529 | US$449 | US$499 | US$629 | US$599 | US$549 |
ISO 9001 System™ is one of the seven comprehensive systems available from FDAISO.com.
ISO 9001 System™ covers all four major sections and the 24 subsystems of the ISO 9001 standard.
ISO 9001 System™ is easy-to-use and customizable.
Note: for latest prices, check product page