Quality Events for Jira

What Quality Events does

Quality Events is a Jira Cloud app that manages the five most common quality events in regulated manufacturing: Corrective and Preventive Actions (CAPA), Nonconformities (NC), Deviations (DEV), Concessions, and Opportunities for Improvement (OFI). Each event type is a native Jira work item with its own fields, workflow and project, so your quality team works in the tool your engineers already use.

Who it's for

Quality Events is built for regulated manufacturers: medical device (medtech) and IVD companies, pharmaceutical and biotech manufacturers, and organizations in aerospace, automotive, food and other industries that operate a formal quality management system. If you already run product development in Jira and manage quality events in spreadsheets, shared documents or a disconnected QMS, this app closes the gap.

Standards it helps you comply with

• ISO 13485:2016
• ISO 9001:2015
• FDA 21 CFR Part 820 (QMSR)
• EU MDR 2017/745
• Pharma GMP
• IATF 16949