Management systems must include critical business processes – one of which is Audit. Audits offer an unbiased and objective measurement methodology that can lead to improvements.

Without audits, management and other personnel remain less-informed of the status and the extent of deterioration of systems over time.

Effective auditing, enables a learning-environment and contributes positively to organizational culture.

Quality Audit is the process of systematic examination of a quality management system (QMS) carried out by an internal or external quality auditor / team. It is an important part of an organization's QMS and is a key element in the ISO quality management system standard, ISO 9001.

Quality audits are typically performed at predefined time intervals and ensure that the institution has clearly defined internal system monitoring procedures linked to effective action. This can help determine if the organization complies with the defined QMS processes and can involve procedural or results-based assessment criteria.

With increasing experience in systems and audits, the focus of the audits has shifted from purely procedural adherence towards measurement of the actual effectiveness of the QMS and the results that have been achieved through the implementation of a QMS.

Audits are an essential management tool to be used for verifying objective evidence of processes, to assess how successfully processes have been implemented, for judging the effectiveness of achieving any defined target levels, to provide evidence concerning reduction and elimination of problem areas. For the benefit of the organization, quality auditing should not only report non-conformances and corrective actions, but also highlight areas of good practice. In this way other departments may share information and amend their working practices as a result, also contributing to continual improvement.

Quality audits can be part of compliance or regulatory requirements, customer assurance, internal / external stakeholder confidence etc.

Audits are an important tool in performance evaluation of other systems too, such as environment, occupational health & safety etc.

Apart from the generic system requirements such as quality, audits can focus on the specific organizational needs such as quality costs, fitness for use, emergency preparedness, safety performance, financial performance, business continuity etc.

ISO 19011 provides guidelines to audit management systems. The key focus areas include:

Auditing principles

• Integrity: the foundation of professionalism
• Fair presentation: obligation to report truthfully and accurately
• Due professional care: application of diligence and judgement in auditing
• Confidentiality: security of information
• Independence: impartiality and objectivity
• Evidence based approach: rational method to reach reliable and reproducible audit conclusions
• Risk based approach: consider risks and opportunities

Auditing techniques for effective audits:

• Audit trails: eg. top-down, start-end, close-the-loop sequences
• Audit check-list to ensure due coverage
• Close-ended, open-ended questions to cover what, why, where, when, which, how
• Verification of auditee’s statements with actual practices: adequacy and compliance
• Audit time management
• Active listening, less speaking
• Focus on audit matter, no digression
• Observe and record accurately, clarify if in doubt
• No criticism / judgements on auditee or organization
• Personable appearance, grooming, affable questioning
• Benefit of doubt to auditee, not auditor
• Understand the auditee organization and processes in advance, to the extent possible

Sound auditing systems ensure that the organization is able to identify areas of concern, find opportunities for improvement, learn lessons, receive feedback, monitor performance and enable management review of the system as a whole.