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  Promotion of the week Promotion of the week

For week 12 the set of documents D 15 ISO 9001 readiness documents is at 18 euros (instead of 36 euros) 

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For March the course T 39v18 IMS QSE internal audit version 2018 is with a 50% decrease (from 100 euros to 50 euros)

D 22v16 - Set of documents - ISO 13485 readiness version 2016

Document set of online training module - 15 documents ISO 13485 medical devices QMS course version 2016

D 22v16 - Set of documents - ISO 13485 readiness version 2016
  • Added the: 25/02/2017
  • Last update: 01/03/2019
  • Number of pages: 173
See other documents

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 training course T 22v16 ISO 13485 2016 readiness


D 22v16 Medical devices - ISO 13485 v 2016
Codification Title Pages
PQBD22v16S ISO 13485 v 2016 training module (support, first 31 pages in pdf) 72
PQBD22v16A01 Certification project plan 3
PQBD22v16A02 Quality manual 22
PQBD22v16A03 List of procedures 2
PQBD22v16A04 List of processes 1
PQBD22v16A05 Management review 3
PQBD22v16A06 Glossary 12
PQBD22v16A07 Process review 2
PQBD22v16A08 Good practices 5
PQBD22v16A09 Bad practices 6
PQBD22v16A10 MCT (multiple choice test) ISO 13485 v 2016 14
PQBD22v16A11 List of risks 6
PQBD22v16A12 Risk level 2
PQBD22v16A13 Process approach 3
PQBD22v16A14 New requirements 9
PQBD22v16A15 Specific processes 4
PQBD22v16A16 Quiz requirements ISO 13485 v 2016 6
PQBD22v16List List of documents D 22 v 2016  1
Total 173