ISO 13485 CAPA & Nonconformance Kit

CAPA is where most ISO 13485 audits find problems: weak root causes and no proof that actions worked. This kit covers nonconforming product, concessions, corrective and preventive action, root cause analysis and effectiveness checks.

What's inside (11 files)

• Procedure: Nonconformance, Concession and CAPA SOP.
• Registers and Tools: CAPA Effectiveness Follow-Up Register; CAPA Initiation Checklist; CAPA Register; Nonconformance and Incident Register; Root Cause Analysis Toolkit.
• Training: CAPA training module (slides, trainer guide, workbook, assessment).

How to use it

1. Adapt the SOP: who can raise a nonconformance, who decides on concessions, and CAPA timescales by risk.
2. Log every nonconformance in the register, and decide with the checklist whether it needs a CAPA.
3. Use the root cause toolkit (5 whys, fishbone) and record the evidence for the cause.
4. Track each CAPA to closure and check effectiveness with data after a set period.
5. Train CAPA owners with the training module.

Who it's for

Quality teams who need a working NC and CAPA process, or who have CAPA findings to close.

Good to know

• Instant download. Editable Microsoft Office files, no macros.
• Includes a Start Here guide with the contents and how to use them.
• Licensed for one organization, including its sites.
• Templates don't reproduce ISO standards. You need your own licensed copies.
• Also in the ISO 13485 Starter Kit and the Complete QMS Kit, which cost less than buying kits separately.