D 82v16 - ISO 13485 medical devices package QMS version 2016 - Set of documents

This set of 304 documents covers all the requirements of an medical device Quality Management System (QMS), from readiness to certification, according to ISO 13485: 2016. This comprehensive 982-page document kit is a key resource to help quality managers and their teams implement, maintain, audit, and continually improve their QMS. The documents are ready to use and editable (Word) to adapt to your specific context and needs. These documents include the annexes for the online training courses "ISO 13485 readiness" and "ISO 13485 internal audit" as well as sets of quality and medical devices procedures and instructions, job descriptions, and processes. You save €30 compared to purchasing the documents individually.

150 €

Ex. VAT

D 82v16 - ISO 13485 medical devices package QMS version 2016 - Set of documents

Added the: 03/03/2017
Last update: 25/02/2026
Number of pages: 982

See the online training package T 82v16 ISO 13485 medical devices quality management system

See the online game G 22 IZOGOOD® 13485 - Decrypt the ISO 13485 requirements while having fun

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

Objectives of the ISO 13485:2016 document kit

to cover all the requirements of the medical device Quality Management System (QMS) according to the ISO 13485:2016 standard, from preparation to certification
to facilitate the implementation, maintenance, auditing, and continual improvement of the QMS for quality managers and their teams
to provide a complete, ready-to-use, and editable (Word) document kit (304 documents, 982 pages), adapted to the specific needs of each organization
to include various resources:
- annexes to the online training courses "ISO 13485 readiness version 2016" and "ISO 13485 internal audit version 2016"
- 107 MD procedures and instructions, 40 job descriptions, and 115 processes
to optimize costs: savings of €30 compared to purchasing the documents individually

Target audience

quality managers, quality teams, and organizations seeking to certify, maintain, or improve their QMS according to ISO 13485:2016

Medical devices procedures and instructions are in set D 13v16.

ISO 13485 medical devices readiness and internal audit are in document set D 22v16 and in set D 42v16.

The medical device risk documents are in set D 64v19.

Part of the documents are provided as annexes in the online training package medical devices ISO 13485 version 2016.

Free quiz without registration on the requirements of the ISO 13485 standard that you can exercise by clicking on the "QUIZ" button:

Quiz requirements ISO 13485 version 2016

D 82v16 ISO 13485 version 2016 package
Codification	Title	Documents	Pages	Unit price (€)
PQBD01	Job descriptions	40	44	14
PQBD02	Processes	115	240	42
PQBD13v16	Medical devices procedures and instructions version 2016	107	302	50
PQBD22v16	ISO 13485 readiness version 2016	25	233	42
PQBD42v16	ISO 13485 internal audit version 2016	17	163	32
Total		304	982	~~180~~
After discont				150

Price of the package D 82v16 after discount = 150 euros instead of 180 euros. You save 30 euros!