Summary

In this course module, we cover the steps required to run a Document Control Audit (internal or external).

• What is an Audit and what does it entail?
• What are the steps of a Document Control Audits?
• How to run an Document Control Audit?

 This course is both for:

• Document Control Professionals who wish to gain an understanding of what is a Document Control Audit and what are the steps to run one

• Professionals planning an audit on Document Control Systems

• Document Controllers who wish to grow their knowledge in this area

• Any person who wish to gain a better understanding of Document Control Audits

Content

1. Audit Fundamentals & Principles 

What is an audit? What are the different types of audits? What is a Document Control audit? What are the objectives of an audit?

2. Document Control Audits Criteria

Elements of the Document Control Systems; Investigation and Document Control Audit; ISO 9001 Audit on Document Control; Case Study

3. Phases of an Audit

What are the phases of an audit? What do they entail?

4. Audit Preparation

Selection of the audit team; Audit objectives, scope and criteria; Audit plan; Communication with auditee

5. On-Site Activities

Audit Work documents; Information gathering; Evidences gathering and Analysing; Audit findings & conclusions

6. Audit Report

Content of the Audit report: Non-conformity items; NCR (Non-Confirmity Report); Corrective actions

7. Audit Follow-Up

What are the Audit follow-up activities?

Certificate

• A certificate of completion is sent by email immediately upon completion of the module

• Assessment is done through online tests and checks  

 Pre-Requisites

• No formal qualification or experience required

• Courses are delivered in English: a functional level in English language is recommended

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