Quality Levels
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سطوح MQ برنامه M-Clarity این شفافیت را فراهم می کند تا بتوانید با اطمینان محصولات مناسبی را انتخاب کنید که نیازهای شما را با توجه به موارد زیر برآورده کند:
انطباق با کیفیت مناسب و استانداردهای نظارتی
شفافیت پورتفولیو
تغییر سرویس اطلاع رسانی
مستندات و پشتیبانی
ماتریس M-Clarity شامل 6 سطح MQ از MQ100 تا MQ600 است که ویژگی های کیفیت و تغییرات قابل اطلاع در هر سطح را تعریف می کند.
| Quality Levels | ||||||
| MQ 100 | MQ 200 | MQ 300 | MQ 400 | MQ 500 | MQ 600 | |
| Application scope | For non-regulated applications with no change notification requirements | For non-regulated applications with limited change notification requirements |
For products used in applications requiring enhanced change control and quality agreement | For critical products and applications driven by high expectations and requiring verified process control or manufacturing control | For regulated applications |
For highly-regulated applications under authority surveillance
|
| Discriminating features | Standard control | Increased control | Enhanced Control | Driven by customer expectation | Driven by authority regulations | Driven by authority regulations and surveillance |
| ISO 9001 | ISO 9001 | ISO 9001 | ISO 9001 | IPEC GMP and/or HACCP, FSSC 22000 and/or ISO17025 and/or ISO 13485 | ICH Q7 or 21 CFR medical device | |
| Quality attributes | ✔ | ✔ | ✔ | ✔ | ✔ | ✔ |
| Basic change control | ✔ | ✔ | ✔ | ✔ | ✔ | |
| Enhanced level of control | ✔ | ✔ | ✔ | ✔ | ||
| Notifiable changes | ✔ | ✔ | ✔ | ✔ | ✔ | |
| Verified process | ✔ | ✔ | ✔ | |||
| Certified/validated process | ✔ | ✔ | ||||
| Highly regulated application | ✔ | |||||
MQ 100
| Application scope | For non-regulated applications with no change notification requirements |
| Discriminating features | Standard control |
| Quality systems | ISO 9001 |
| Quality attributes | ✔ |
MQ 200
| Application scope | For non-regulated applications with limited change notification requirements |
| Discriminating features | Increased control |
| Quality systems | ISO 9001 |
| Quality attributes | ✔ |
| Notifiable changes | ✔ |
| Basic change control | ✔ |
MQ 300
| Application scope | For products used in applications requiring enhanced change control and quality agreement |
| Discriminating features | Enhanced Control |
| Quality systems | ISO 9001 |
| Quality attributes | ✔ |
| Enhanced level of control | ✔ |
| Notifiable changes | ✔ |
MQ 400
| Application scope | For critical products and applications driven by high expectations and requiring verified process control or manufacturing control |
| Discriminating features | Driven by customer expectation |
| Quality systems | ISO 9001 |
| Quality attributes | ✔ |
| Enhanced level of control | ✔ |
| Notifiable changes | ✔ |
| Verified process | ✔ |
MQ 500
| Application scope | For regulated applications |
| Discriminating features | Driven by authority regulations |
| Quality systems | IPEC GMP and/or HACCP, FSSC 22000 and/or ISO17025 and/or ISO 13485 |
| Quality attributes | ✔ |
| Enhanced level of control | ✔ |
| Notifiable changes | ✔ |
| Verified process | ✔ |
| Certified/validated process | ✔ |
MQ 600
| Application scope | For highly-regulated applications under authority surveillance |
| Discriminating features | Driven by authority regulations and surveillance |
| Quality systems | ICH Q7 or 21 CFR medical device |
| Quality attributes | ✔ |
| Enhanced level of control | ✔ |
| Notifiable changes | ✔ |
| Verified process | ✔ |
| Certified/validated process | ✔ |
| Highly regulated application | ✔ |