This is a collection of rules, procedure, and forms related to CAPA in a form consistent with the FDA QSR.
FDA requires quarterly internal audits.
The necessary procedure and forms must be in place to conduct Quality Audits.

List of Forms
The following forms are included with your purchase.
・MD-QMS-K9 Quality Audit Provision
・MD-QMS-S901 Quality Audit Procedure
・MD-QMS-F901 Quality Auditor Certification List
・MD-QMS-F902 Quality Auditor Certification
・MD-QMS-F903 Quality Audit Plan
・MD-QMS-F904 Quality Audit report
・MD-QMS-F905 Correction Instructions for Internal Audit Results
・MD-QMS-F906 Corrective Action Plan
・MD-QMS-F907 Corrective Action Completion Report
・MD-QMS-F908 Quality Audit Completion Report

Table of Contents

Provision

1 Purpose
2 Scope
3 Definition of Terms
4 Internal Auditor
5 Frequency of internal audits
6 Conducting audits
6.1 Audit Plan
6.2 Consideration of audit items
6.3 Conducting audits
6.4 Content and classification of nonconformities and requests for improvement
6.5 Reporting of audit results
6.6 Corrective and corrective actions
6.7 Prepare internal audit completion report
6.8 Internal Audit File
6.9 Internal Audit Results
6.1 Record keeping
7 Improvement of internal auditors’ competence
8 Reference
9 APPENDICES

Procedure

1 Purpose
2 Scope
3 Definition of Terms
4 Roles and Responsibilities
5 implementation procedure
5.1 Certification of Internal Auditors
5.2 Audit Plan
5.3 Consideration of audit items
5.4 Conducting audits
5.5 Reporting of audit results
5.6 Corrective action and corrective action instructions
5.7 Internal Audit File
5.8 Internal Audit Completion Report
5.9 Reporting to Management
5.1 Record keeping
6 Form
7 Reference
8 APPENDICES