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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 42v16 - Set of documents - ISO 13485 internal audit version 2016

Document set of online training module - ISO 13485 version 2016 medical devices quality management system internal audit

D 42v16 - Set of documents - ISO 13485 internal audit version 2016
  • Added the: 10/08/2016
  • Last update: 01/04/2019
  • Number of pages: 118
See other documents

See the set of documents D 22v16 ISO 13485 Readiness

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 42v16 Internal audit ISO 13485 2016


D 42v16 Medical devices quality management system ISO 13485 v 2016 internal audit
Codification Title Pages
PQBD42v16S ISO 13485 internal audit training module (support), example first 10 pages in pdf 31
PQBD42v16A01 ISO 13485 QMS internal audit plan (example) 3
PQBD42v16A02 ISO 13485 process internal audit plan (example) 3
PQBD42v16A03 ISO 13485 QMS internal audit questionnaire, 419 questions 29
PQBD42v16A04 ISO 13485 process internal audit questionnaire, 165 questions 9
PQBD42v16A05 ISO 13485 internal audit report (template) 2
PQBD42v16A06 Glossary 12
PQBD42v16A07 Internal audit procedure (example) 5
PQBD42v16A08 Audit programme (example) 1
PQBD42v16A09 Scoring method for audit findings 1
PQBD42v16A10 Good practices QMS ISO 13485 4
PQBD42v16A11 Bad practices QMS ISO 13485 4
PQBD42v16A12 MCT ISO 13485  12
PQBD42v16A13 Auditor competence 1
PQBD42v16List List of ISO 13485 internal audit documents 1
Total 118