Internal Audit Program
ANSI/ISO/ASQ 9001 states that internal audits are to be conducted at planned intervals to determine whether a company’s quality management system conforms to planned arrangements, to the quality management system requirements of your company, and is effectively implemented and maintained.
It further states that audit programs must be planned, taking into consideration areas to be audited, as well as the results of previous audits. To maintain independence, auditors must not audit their own work. You will also need to define the audit criteria, scope, frequency and methods. This is done in part as follows:
- Conduct Pre-Audit Meeting with the Management Team, to set expectations.
- Prepare an Audit Plan outlining the entire internal/pre-assessment audit process.
- Prepare an Audit Schedule outlining dates, times and events.
- Review a pre-identified number of processes in each of the functional areas of the Quality Management System Requirements for understanding.
- Review applicable QMS Procedure and Process Documents.
- Conduct on-site Audit Entrance Meeting with the Management Team.
- Conduct on-site audit of a pre-identified number of processes/functional area requirements listed in the QMS.
- Prepare Audit Checklists to determine compliance in given areas.
- Conduct end of day meeting with Management Team, to review activities/issues.
- Conduct on-site wrap-up meeting with the Management Team, or designee(s).
- Review all audit notes and documents.
- Prepare Draft Non-Conformity Report(s) of any findings.
- Prepare Draft Corrective Action(s) of any findings.
- Prepare a Draft Audit Report.
- Conduct on-site Closing Meeting with the Management Team.
- Issue Final Audit, Nonconformity and Corrective Action Reports.
The extra time you spend upfront planning for this audit will help to ensure a thorough assessment of your QMS. If you do not currently have the time or resources, consider utilizing an audit consultant to assist your team, or perform this for you, so that you can focus on what’s most important to you - your customers.
At Storti Quality Consulting, we take pride in helping our customers use quality management practices to enhance results and increase profits. If you’d like to talk about Quality, please call us at 215.657.0837, send an email to ralph.storti@storticonsulting.net, or visit our website, www.storticonsulting.net.
