D 22v16 - ISO 13485 medical devices QMS readiness version 2016 - Set of documents
Document set of online training module - 24 documents ISO 13485 medical devices QMS readiness course version 2016
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See the online training T 22v16 ISO 13485 readiness version 2016 See the set of documents D 42v16 ISO 13485 Internal audit See the set of documents D 72v16 ISO 13485 package |
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 online training ISO 13485 readiness version 2016.
See also the training package ISO 13485 version 2016.
ISO 13485 procedures and instructions are in set D 13v16 version 2016.
Documents related to the quality management system are in set D 15v15 version 2015.
See also the documents in set D 54v19 Risk management DM ISO 14971 (soon).
| D 22v16 Medical devices - ISO 13485 version 2016 | |||
| Codification | Title | Pages | |
| PQBD22v16S | ISO 13485 version 2016 training module (support, first 33 pages in pdf) | 77 | |
| PQBD22v16A01 | Certification project plan | 3 | |
| PQBD22v16A02 | Process review | 2 | |
| PQBD22v16A03 | List of processes | 1 | |
| PQBD22v16A04 | Process approach | 3 | |
| PQBD22v16A05 | New requirements | 9 | |
| PQBD22v16A06 | Glossary | 12 | |
| PQBD22v16A07 | Risk level | 2 | |
| PQBD22v16A08 | Quality manual | 22 | |
| PQBD22v16A09 | List of procedures | 2 | |
| PQBD22v16A10 | Management review | 3 | |
| PQBD22v16A11 | List of risks | 8 | |
| PQBD22v16A12 | Manage risks process | 2 | |
| PQBD22v16A13 | Risk mitigation action plan | 1 | |
| PQBD22v16A14 | Risk management procedure | 8 | |
| PQBD22v16A15 | Risk management activities | 2 | |
| PQBD22v16A16 | Specific processes | 4 | |
| PQBD22v16A17 | Toxicity of a MD | 1 | |
| PQBD22v16A18 | Root causes MD incidents | 3 | |
| PQBD22v16A19 | Quiz requirements ISO 13485 | 6 | |
| PQBD22v16A20 | Good practices | 5 | |
| PQBD22v16A21 | Bad practices | 6 | |
| PQBD22v16A22 | MCT (multiple choice test) ISO 13485 | 14 | |
| PQBD22v16A23 | Case studies ISO 13485 | 20 | |
| PQBD22v16List | List of documents D 22v16 | 1 | |
| Total | 217 | ||
