Internal Audit

Internal audit refers to the organized assessment of an organization’s operations, internal controls, and risk management techniques. In the QMS context, this audit evaluates the efficiency of processes, identifies gaps, and ensures the improvement of operations. 

The goal of internal auditing is to help organizations achieve its goals and comply with operational directives. Internal auditing allows identifying preliminary risks and inefficiencies and the areas where the organization can improve compliance and efficiency. 

Internal audits is carried out in accordance with different standards and regulations like ISO 9001:2015, ISO 13485:2016, EU GMP, IATF 16949, etc. All of these standards and regulations set the rules for audit planning, implementation, reporting, training of auditors, and audit recurrence. 

Internal audit is performed by certified specialists who are part of the internal audit team and help maintain objectivity in the auditing process. The auditors must be certified specialists and have relevant experience in applied standards and systems. Auditors’ duties are to assess compliance, collect unprejudiced audit evidence, and report the outcomes to management to support CAPAs.  

Why Perform Internal Audits? 

An internal audit, often labeled as a first-party audit, is an audit carried out by the organization itself or on its behalf. It helps the organization make a self-declaration of conformity. ISO 9001 and ISO 13485 require businesses to have systems that reflect their operations. Clause 9.2 of ISO 9001:2015 and clause 6 of ISO 13485:2016 state that the business “shall” perform audits, thereby making it a necessity to follow the requirements of each standard. Therefore, it can be concluded that local audits are a good management tool to ensure that the system complies with standards. 

Why Are Internal Quality Audits Important in a QMS? 

Internal quality audits are a crucial aspect of a QMS as they ascertain that processes operate as intended and conform to internal procedures, requirements, and industry standards. Internal quality audits help organizations confirm the efficacy of processes, detect non-conformance as it happens, and create accountability amongst departments. 

In essence, internal audits enable the examination of a QMS to achieve ongoing compliance, improve risk mitigation, and prepare for external audits and inspections. 

Internal audits serve as an avenue to ensure continual improvement by providing information regarding inefficiencies, making process gaps obsolete, and preventing potential risks. 

Internal audits offer immediate benefits such as compliance assurance, detection of issues, and superior process control, which over time aids in creating a quality culture throughout. 

Improving Your Compliance 

After completing an internal audit, enterprises must act quickly to close the gaps identified in the audit. Following up with a follow-up audit after the first audit will make the chances of successful external audits higher. You may identify several of the following risks during an internal audit: 

• Reputation risk 

• Operational risk 

• Transactional risk 

• Credit risk 

• Compliance risk 

• Strategic risk 

• Geographic risk 

• Legal risk 

• Vendor concentration risk 

• Cybersecurity risk 

The first step in identifying high-risk areas is an internal audit. Once you have them pinpointed, a remediation plan can be created that would prepare you for a successful external audit.