When internal personnel are selected to perform an audit, a mechanism needs to be established to ensure objectivity, for instance, a representative from another department may be selected to do the audit.Īudits are demanding and require various forms of expertise. Auditors may be external or internal personnel however, they should be in a position to be impartial and objective. Evidence-based approach: Evidence must be verifiable and be based on samples of the information available.Ĭompetence level may be measured by training, participation in previous audits and experience in conducting audits.Independence: Auditors must be independent of the activity being audited and be objective.Professional care: Auditors must exercise care in accordance with the importance of the task they perform.Fair presentation: Audit findings, conclusions and reports reflect truthfully and accurately the audit activities.Ethical conduct: Trust, integrity, confidentiality and discretion are essential to auditing.The following principles relate to auditors: It also allows auditors working independently from one another to reach similar conclusions when auditing in similar circumstances. This requirement is unchanged from the requirements of ISO 9001:2008 Clause 8.2.2 – Internal Audit.Īuditing relies on a number of principles whose intent is to make the audit become an effective and reliable tool that supports your company’s management policies and policies whilst providing suitable objective information that your company can act upon to continually improve its performance.Īdherence to the following principles are considered to be a prerequisite for ensuring that the conclusions derived from the audit are accurate, objective and sufficient. To meet statutory and regulatory requirements.To explore opportunities for improvement.To determine the effectiveness of the implemented system in meeting specified objectives (quality, environmental, financial).Ensuring compliance to the requirements of internal, international and industry standards & regulations, and customer requirements.Your organization will likely conduct internal audits for one or more of the following reasons: Our Internal Audit Procedures & Checklists is proven to work.

Iso 13485 internal audit checklist