D 22v16 - ISO 13485 medical devices QMS readiness version 2016 - Set of documents
This set of 25 documents, specifically designed to help you implement and obtain certification of an ISO 13485 version 2016 medical devices quality management system (QMS), is a key resource for documenting your QMS. The documents are ready to use and editable (Word format) to adapt to your specific context and needs. These documents are the annexes to the online training course "ISO 13485 readiness version 2016" and include, among other things, training support, process approach, list of risks, quality manual, risk process and procedure, specific processes, root causes MD incidents, management review, good practices, bad practices, multiple-choice tests (MCTs), quiz requirements, case studies and true stories.
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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 82v16 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
Main Content
- 25 documents specifically designed to prepare for and obtain certification of a medical device quality management system (QMS) according to ISO 13485:2016
- these documents are provided as annexes in the online training ISO 13485 readiness version 2016. Examples of documents included:
- training materials
- process approach
- quality manual
- management review
- risk list
- risk processes and procedure
- specific processes
- root causes of incidents
- good and bad practices
- multiple-choice tests and quiz on requirements
- case studies and true stories
Advantage
- the documents are ready to use and editable (Word format) to adapt to the specific needs of each organization in the medical device sector
Target audience
- medical device manufacturers, quality managers, and teams wishing to prepare for ISO 13485 certification or improve their quality management system
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 64v19 Risk management DM ISO 14971
See also the pack "Oxebridge Totally Free ISO 9001:2015 QMS Documentation Template Kit"
| D 22v16 Medical devices - ISO 13485 version 2016 | |||
| Codification | Title | Pages | |
| PQBD22v16S | ISO 13485 version 2016 training module (support, first 33 pages in pdf) | 83 | |
| 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 | 23 | |
| PQBD22v16A24 | True stories ISO 13485 | 7 | |
| PQBD22v16List | List of documents D 22v16 | 1 | |
| Total | 233 | ||
