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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

D 22v16 - ISO 13485 medical devices QMS readiness version 2016 - Set of documents
  • Added the: 25/02/2017
  • Last update: 12/01/2024
  • Number of pages: 217
See other documents

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.


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