QMS Audit Preparation Checker

1. Documentation

Quality manual exists and is current Documented procedures for all key processes Work instructions at point of use Quality records maintained and retrievable Document revision control system in place

2. Process Control

Process flow diagrams for all product lines Control plans developed and reviewed PFMEA completed and updated regularly MSA / Gage R&R conducted for critical measurements SPC applied to critical-to-quality characteristics

3. Internal Audits

Annual audit schedule defined and followed Auditors trained and qualified (internal or IRCA) NCR tracking system with closure verification Management review conducted per schedule

4. Corrective Action

8D or equivalent corrective action process defined Root cause analysis methodology standardised Effectiveness verification conducted after closure Lessons learned shared across the organisation

5. Supplier Quality

Approved supplier list maintained and current Incoming inspection procedures defined Supplier audit programme in place

6. Customer Focus

Customer requirements documented and accessible Complaint handling process with CAR tracking OTIF performance tracked and reported

QMS Audit Preparation Checker

Your QMS Readiness Report

What's Missing — Action Items

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