Get 4 FREE months of Conformio to implement ISO 27001

Expert Advice Community

Guest

Is FMEA necessary for ISO 9001:2015

  Quote
Guest
Guest user Created:   May 26, 2017 Last commented:   Apr 18, 2022

Is FMEA necessary for ISO 9001:2015

I don't want to use the FMEA method because that would be another form to have to keep up with. We only manufacture 1 product which is part of a gun but we do buy the rest of the parts to fully assemble the bolt carrier according to what our customers. I know the risk since I have been working on the project for 10 years. I just can't figure the best route to take to address the risk. Any suggestions?
0 0

Assign topic to the user

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Strahinja Stojanovic May 26, 2017

Answer:

FMEA is definitely not necessary, and even if you use it, it wont cover the entire scope of QMS since it is mostly applicable to production and design processes and fails to cover risks arising from the external context. It is meant for companies that have complex processes and products and it is crucial for them to cover all risks emerging from the processes.

In your case, FMEA would be redundant and I would avoid using it. You can conduct SWOT analysis or arrange a brainstorming session with relevant people in the company and make a list of risks and opportunities to be addressed and then plan actions to address those risks. In the Procedure for Addressing Risks and Opportunities, you can just delete the reference to the FMEA and use only the procedure.

For more information, see: How to address risks and opportunities in ISO 9001 https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/

Quote
0 0
Guest
Sharif khan Apr 15, 2022

Sir ISO 9001:2015 certificate company is responsible to prepare the FMEA for vendor requirement or vendor who is qualified for IATF 16949 is responsible to prepare supplier FMEA do reply sir

Quote
0 0
Expert
Fırat İnceli Apr 18, 2022

If you are producing parts for an IATF-certified customer, your customer may request FMEA from you. Normally, it is not a subject required by the ISO 9001 standard. You can get training support for FMEA, or you can request a deviation from your customer in this regard.

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

May 26, 2017

Apr 18, 2022

Suggested Topics

Guest user Created:   Oct 20, 2023 ISO 9001
Replies: 1
0 0

Procurement and ISO 9001

Guest user Created:   Sep 29, 2023 ISO 9001
Replies: 1
0 0

ISO 9001 in Maintenance Companies