Expert Advice Community

Guest

Estimation of timeline for ISO 13485 certification

  Quote
Guest
Guest user Created:   May 27, 2019 Last commented:   May 27, 2019

Estimation of timeline for ISO 13485 certification

We as a company are thinking about achieving 13485 certification. Is there a rough estimated time schedule on how long the certification process will take starting from zero? We have already looked into the ISO and implemented some processes, however for planning further steps we wanted to setup a timeline.
0 0

Assign topic to the user

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Verlene Law May 27, 2019

Answer:

The implementation process will usually take between 3 months to 18 months depending on the size of the company. You can utilize this link to calculate the time that might be needed: https://advisera.com/9001academy/iso-9001-duration-calculator/ For the certificate stage, you should give yourself around 2 months to prepare.

For more information, please read article:

Checklist of ISO 13485 implementation and certification steps
https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

May 27, 2019

May 27, 2019

Suggested Topics

Guest Created:   Jan 12, 2023 ISO 13485 & EU MDR
Replies: 1
0 0

Preventive action

Guest Created:   Jan 11, 2023 ISO 13485 & EU MDR
Replies: 1
0 1

Purchase (vendors) scorecards