I have been asked several times by some of my students/clients on how to develop an Internal Quality Audit Checklist. And so I decided to make a post on it so that everyone can have an online reference whenever they need it.

First and formost, you need to understand the Plan-Do-Check-Act concept. This concept is applied at the QMS and the process levels. Always apply this concept when preparing your audit checklist. And also, always audit a process. Never audit a clause from the ISO 9001 standard. This is called process auditing.

Secondly, the QMR or the QMS Committee (whichever is convenient or relevant) must come up with questions derived from the ISO 9001 standard - for every clause, where appropriate. To do this, just re-phrase the requirements into questions. You may need to develop several questions for a single requirement - you decide what's best for your organization because you know best! Then you need to review the questions to see if they are adequate and effective in extracting the necessary information out of the auditees (remember, the three audit methodologies: Interview; Inspection; Observation)

Thirdly, add and/or modify those questions to suit the process that is to be audited. For example, you are going to audit the Purchasing/Procurement Department and you're sitting down with the Audit Team trying to come up with relevant questions.

Note 1: As an Audit Team Leader/Lead Auditor, you need to do this with your Audit Team so that everyone is aware of the audit objectives or what to look for.

Note 2: Audit Checklists serve as guidelines only. You must be able to introduce and/or modify a particular question in order to meet the objectives of your audits.

Modify the audit questions so that they are relevant to the Purchasing process only. Further additions or modifications to the Audit Checklist may happen during the actual audit. If this happens, just make sure you record everything in your Audit Notes.

Note 1: You may need to review/refer to the specific documentation related to that process in order to do this effectively.

The main objective in auditing any process is to extract adequate information and evidence in order to verify that the process is conformant to the ISO 9001 requirements and that, it is effective in achieving its objectives. As an auditor, you need to be able to investigate, assess and verify the conformity and effectiveness of a given process, in terms of its planning, implementation, monitoring & measurement and improvement. As a Lead Auditor, preparing your Audit Team for the actual audit is crucial in ensuring success of the audit excercise. There is no better way to do that than by developing the audit questions with them.

In conclusion, the steps are:

  • Develop audit questions from the ISO 9001 standard (Previously prepared by QMR)
  • Review related documents of the process that is to be audited (To be done by the Audit Team)
  • Modify/Add/Delete/Rephrase the questions to suit the process that is to be audited (To be done by the Audit Team, under the direction of the Lead Auditor)