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.
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150 €
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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
Documents provided as annexes in the online training package medical devices ISO 13485 version 2016.
See also the training T 22v16 ISO 13485 MD readiness version 2016.
See also the training T 42v16 ISO 13485 MD internal audit version 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.
| 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 | ||
| After discont | 150 | |||
| Price of the package D 82v16 after discount = 150 euros instead of 180 euros. You save 30 euros! | ||||
