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    • increased effectiveness
    • bigger individualization
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    • learn in a fun way
    • to be enriched by the skills of others
    • assimilate the content of clauses and sub-clauses
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15 August 2019:

Added the document set D 06v18 Food safety - Procedures and instructions ISO 22000 version 2018

  Promotion of the week Promotion of the week

For week 42 the pack of documents D 07 Environmental procedures version 2015 is at 12 euros (instead of 25 euros) 

  Promotion of the month Promotion of the month

For October the training package T 68v18 ISO 45001 version 2018 is with a 50% decrease (from 225 euros to 112 euros)

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

Document set of online training module - 18 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: 19/10/2019
  • Number of pages: 190
See other documents

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 training course T 22v16 ISO 13485 2016 readiness


D 22v16 Medical devices - ISO 13485 version 2016
Codification Title Pages
PQBD22v16S ISO 13485 version 2016 training module (support, first 31 pages in pdf) 74
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 Specific processes 4
PQBD22v16A16 Root causes MD incidents 2
PQBD22v16A17 Quiz requirements ISO 13485  6
PQBD22v16A18 Good practices 5
PQBD22v16A19 Bad practices 6
PQBD22v16A20 MCT (multiple choice test) ISO 13485 14
PQBD22v16List List of documents D 22v16  1
Total 190