Audit Scenario – Internal Audit
The following is a typical auditing scenario that might be found when auditing an ISO 9001:2008 quality management system for clause 8.2.2 Internal Audit. Read the scenario to determine if you think it would be conforming or nonconforming, then read the answer and explanation.
Support Information – ISO 9001:2008 Clause 8.2.2
The organization shall conduct internal audits at planned intervals to determine whether the QMS:
a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and
b) is effectively implemented and maintained.
An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and the methods shall be defined. The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.
A documented procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results.
Records of the audits and their results shall be maintained (see 4.2.4).
The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.
Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2).
When asked about completing internal audits, the QA manager indicated, with no excuse, that he just didn’t get them done because he had been so busy. While the auditor was making notes, the QA manager continued to complain about never getting any help or support.
Sound familiar? The standard requires that audits be conducted at planned intervals, and this is one of the most important processes for driving improvement. Although not specifically stated in the standard, there is an expectation from all registrars that the system will be audited a minimum of once per year.
Furthermore, the standard also states that the organization must “provide the resources needed to implement and maintain the quality management system” (6.1 Provision of resources). This includes resources for conducting internal audits.