Is FMEA necessary for ISO 9001:2015

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/

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

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.