How to carry out internal audits effectively in ISO 9001

How to carry out internal audits effectively in ISO 9001

The Quality Management System needs to be audited on a systematic basis to ensure that the planned arrangements are being met in practice.

It is the responsibility of the Quality Manager to ensure that:

1) An internal audit program is prepared to cover all elements of the Quality Management System.
2) Suitable personnel are allocated to carry out the internal audits.

Conducting the Audit

1) The Internal Auditor(s) carries out the audits in accordance with the program.
2) Written notes on the findings including variances, non-conformances and omissions are made on the Internal Audit Report and actions taken as appropriate.
3) Where no problems, non-conformances, etc., are found during audit it may be sufficient for the auditor to merely record the audit having taken place on the Internal Audit Program by means of his/her initials.
4) However, where personnel are interviewed, or where documents are used to justify a decision, then a record must be made either on an Internal Audit Report or in a record book/pad, for reporting to the next Management Review Meeting.
5) In addition, the auditor verifies that where signatures, initials, etc. are used for authorizations, the member of staff to which they refer has been properly authorized, either by Top Management or by virtue of the recorded training/skills of the individual. Where this is not the case, any such occurrence is logged as a major non-conformance against the system.
6) Written notes on the findings, including variances, non-conformance and omissions are made on the Internal Audit Report and actions taken as appropriate.
7) Where an audit of the Quality Management System Manual is being carried out the
assigned auditor checks:

1.) That it is controlled;
2.) Amendments are up to date;
3.) The Company and responsibilities are current;
4.) Whether the Quality Policy aims and objectives are being met;
5.) That any definitions given are clear;
6.) The scope is accurate;
7.) And the outline of the procedures is relevant and meets the Company’s operations and the standard.

The results of the quality audits are retained on file for at least three years.