D 42v16 - ISO 13485 internal audit medical devices quality management system version 2016 - Set of documents
Document set of online training module - ISO 13485 version 2016 medical devices quality management system internal audit
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See the online training T 42v16 Internal audit ISO 13485 See the set of documents D 22v16 ISO 13485 readiness |
You have an unlimited access for one year to the whole set of documents. This includes access to all the modifications (improvements) which could be made during that period.
Description
Documents provided as annexes in the training course Internal audit ISO 13485 version 2016.
See also the training package ISO 13485 version 2016.
Other documents procedures and instructions ISO 13485 version 2016 medical devices are in the set D 13v16.
| D 42v16 Medical devices quality management system ISO 13485 version 2016 internal audit | |||
| Codification | Title | Pages | |
| PQBD42v16S | ISO 13485 internal audit training module (support), example first 11 pages in pdf | 50 | |
| PQBD42v16A01 | Audit program (example) | 1 | |
| PQBD42v16A02 | Internal audit procedure (example) | 5 | |
| PQBD42v16A03 | ISO 13485 process internal audit plan (example) | 3 | |
| PQBD42v16A04 | ISO 13485 QMS internal audit plan (example) | 3 | |
| PQBD42v16A05 | ISO 13485 QMS internal audit questionnaire, 419 questions | 29 | |
| PQBD42v16A06 | Glossary | 13 | |
| PQBD42v16A07 | ISO 13485 process internal audit questionnaire, 165 questions | 9 | |
| PQBD42v16A08 | MD questionnaire | 4 | |
| PQBD42v16A09 | Good practices QMS ISO 13485 | 5 | |
| PQBD42v16A10 | Bad practices QMS ISO 13485 | 6 | |
| PQBD42v16A11 | Scoring method for audit findings | 1 | |
| PQBD42v16A12 | ISO 13485 internal audit report (template) | 2 | |
| PQBD42v16A13 | Auditor competence | 1 | |
| PQBD42v16A14 | MCT ISO 13485 | 12 | |
| PQBD42v16A15 | Audit case studies | 8 | |
| PQBD42v16List | List of ISO 13485 internal audit documents | 1 | |
| Total | 153 | ||
