| qms_version |
2.2.0 |
| sop_id |
CSC PR.015 |
| sop_version |
2.0.1 |
| template_id |
CSC F.001 |
| template_version |
2.0.1 |
|
|
| Template ID |
CSC F.001 |
| Template Version |
2.0.1 |
| QMS Version |
2.2.0 |
| SOP ID |
CSC PR.015 |
| SOP Version |
2.0.1 |
| Regulatory References |
ISO 13485:2016 Sec. 6.2 and 4.2.5 |
|
|
| Name of Training |
|
| Date of Training |
|
| Training Method |
|
| Trainer |
|
| Content |
|
| No. |
Name |
Signature |
Successful |
| 1 |
|
|
|
| 2 |
|
|
|
|
|
|
|
Hereby, the training supervisor confirms the successful completion of this training for all participants as
indicated in the table above.
| Action |
Name |
Team / Role |
Date |
Signature |
| Confirmation |
|
|
|
|
To be applied after training which has no included effectiveness check (e.g. electronic test): assessment of
effectiveness should be typically carried out by a supervisor. By derogation, a self-assessment is possible,
provided that no second person can adequately evaluate the effectiveness.
| Action |
Name |
Team / Role |
Date |
Signature |
| Review |
|
|
|
|
| Aspect |
Objectives (largely) not achieved |
Objectives partially achieved |
Objectives (largely) achieved |
Commentary |
| Applicability and practical relevance |
|
|
|
|
| Comprehensibility |
|
|
|
|
| Depth |
|
|
|
|
[ ] The training has sufficiently achieved the objective. No further actions are necessary.
[ ] The training has not sufficiently achieved the objective. The following actions are proposed.
Actions:
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