Key Takeaways
- Regular ISO internal audits help companies get certified and create a culture of continuous improvement.
- Staying up-to-date with standards, managing documentation, and monitoring CAPA are the challenges of ISO internal auditing.
- Digital audit tools tackle these challenges with features like training and audit checklists, audit scheduling, centralized data storage, and analytics dashboards.
ISO internal audits are essential for ensuring that an organization’s processes and management systems align with ISO standards. These audits not only confirm compliance but also increase the probability of getting ISO-certified, which can directly contribute to the bottom line and build your reputation.
This blog post will explore the significance of ISO internal audits, the steps to conduct them, and the potential challenges companies face.
What is an ISO Internal Audit?
An ISO internal audit, aka ISO first-party audit, is a systematic assessment conducted within a company to evaluate how well its processes and management systems conform with the chosen ISO standards. They are carried out independently by the company’s internal team or outsourced to external auditors.
Besides assessing ISO compliance, internal audits also help identify areas of improvement, nonconformances, opportunities for continuous improvement, and ways to improve the effectiveness of your systems and processes.
Which ISO Standards Recommend Internal Audits?
Although most standards recommend internal audits, clause 9.2 of the following ISO standards mentions internal audits explicitly:
- ISO 9001:2015 for Quality Management Systems
- ISO 14001:2015 for Environmental Management Systems
- ISO 45001:2018 for Occupational Health and Safety Management Systems
Why is it Important for Companies to Conduct ISO Audits Internally?
Internal audits help companies prepare for external assessments conducted by certification bodies. They also ensure businesses stay ISO-compliant during the certification period.
By conducting internal audits, organizations can verify that they have met all the requirements for their chosen ISO standards. Furthermore, they can identify and resolve gaps and nonconformances that could cause delays in certification.
What are the Focus Areas of ISO Internal Audits?
The following 9 areas are assessed during ISO internal compliance audits within a company:
- Governance and Risk Culture: Assess governance culture and risk management systems.
- Process Adherence: Review SOPs against the ISO requirements, identify deviations, and verify processes and maintenance practices.
- Employee Competence and Training: Assess employee knowledge base and training modules and address gaps in skills.
- Documentation Control: Verify documentation systems for accessibility and accuracy.
- Risk Management Practices: Check assessment, mitigation, monitoring, and reporting methods associated with risk management.
- Performance Metrics and Objectives: Review performance metrics and check if they adhere to business objectives.
- Corrective and Preventive Actions: Evaluate the effectiveness of the CAPA in finding the root cause of problems and timely correction.
- Supplier Management: Audit supplier vetting process and verify compliance with vendor requirements.
- Continual Improvement Initiatives: Find areas of improvement, introduce innovation and best practices, and monitor progress.
How to Prepare for an Internal ISO Audit?
While conducting ISO internal audits for certification, focus on ensuring that any compliance issues or gaps are discovered and rectified before the external assessment.
Once your organization is ISO certified, internal audit frequency should be set by considering process feedback data, customer feedback, the impact of process performance on customer satisfaction, etc. Additionally, you might want to account for organizational changes, risks, and opportunities.
Regardless of the internal audit plan, you need to fulfill the following ISO internal audit requirements before conducting the audit:
- Select Competent Auditors: Ensure the selected auditor is well-trained to audit internal ISO standards against which they are performing the audit. This translates to thoroughly reviewing the clauses of standards in detail.
- Develop Internal Audits Schedule: Determine the frequency of audits based on the area of assessment and its impact. Share the schedule in advance with all stakeholders, giving them time to prepare.
- Study Previous Audit Findings and CAPA: Allow auditors to familiarize themselves with previous audit findings and corrective actions, their status, and their impact.
- Prepare ISO Internal Audit Checklists: Depending on the items to be verified, prepare your audit checklist for the ISO standard against which you’re conducting the audit.
👉 Useful Resource: ISO Internal Audits Checklists
Here are free checklists to audit internal ISO standards:
→ ISO 14971 Checklist
→ ISO 45001 Audit Checklist
→ ISO 9001 Internal Audit Checklist
→ ISO 14001 Internal Audit Checklist
→ ISO 14001 Self-Assessment Checklist
→ ISO 9001 Checklis for Self-Assessments
→ ISO 22000 Internal Audit Checklist (Food Safety)
» ISO Audit Checklists: Fully customize the above checklists or create your own with GoAudits’ 14-day FREE trial!
ISO Internal Audit Process: How to Conduct ISO Internal Audits Effectively?
Now that you know how to prepare for the audit, let’s look at the steps involved in conducting an ISO self-assessment:
1. Review Audit Objectives and Required Logistics
Before starting the audit, review its objective and scope with the auditor. Address their queries/doubts related to standards or audit practices. Recheck the logistics – checklists, tools, software, etc., required for an efficient audit.
You may want to inform the auditee about the date, scope, and objective. This heads-up helps workers ensure availability and prepares them to answer audit questions.
2. Conduct the Audit
Begin the audit with an opening meeting where the inspection team reiterates the purpose, scope, and process to the auditees. Then, they may proceed with examining processes, documents, and records.
This includes observing activities, interviewing staff, and reviewing documentation to gather evidence of non-conformance. You may want to apply audit best practices like taking photos, adding notes/comments, etc.
Throughout the audit process, auditors must remember the goal is to find areas of improvement and not assign blame. This ensures employees are comfortable discussing processes and potential issues and suggesting improvements.
3. Report Findings
Now is the time to compile all your findings, which include audit scores, noncompliance data, photos, notes/comments, etc., into a report. Once the report is ready, you need to share it with all the stakeholders to review it and suggest corrective actions.
Manual reporting can take several hours and is prone to error. Therefore, it is best to automate workflows and reporting using ISO audit software.
Automate Reporting: Generate customized standard reports and share them with your team with a click.
4. Management Review and Analysis
At this stage, the leadership reviews the audit reports and conducts further analysis to spot trends and recurring problems.
The issues and nonconformities found during the audit are typically assorted into three buckets – principal non-conformity, trace non-conformance, and possibilities of enhancement. Corrective action plans are chalked out, and priority is assigned to each non-conformance.
Analytics Dashboard: View overall business performance, see historical trends, identify improvement areas, and more.
5. Implement Corrective Measures
Develop a plan to implement and monitor the corrective actions. This involves assigning tasks to members within or/and outside the organization, taking regular follow-ups, accommodating unprecedented hiccups like absenteeism, reassigning tasks, etc. The ultimate goal is the on-time completion of corrective actions.
Corrective Action Software: Assign, monitor, and ensure efficient corrective action implementation.
6. Follow-up and Verification
Schedule follow-up audits to verify the correct implementation of the remedial measures and assess their impact. It helps companies know if the applied measures are effective in addressing the concerns, or if they need to change their POA.
Common Challenges of Meeting Internal Audit ISO Standards
Although regular internal audits strengthen ISO compliance and further the vision of continuous improvement, implementing them in practice can be a struggle.
The first and foremost challenge is understanding and staying up-to-date with ISO standards. Your success in compliance is directly proportional to your team’s knowledge of ISO standards. However, each standard has many clauses that require deep understanding and are updated at regular intervals. Thus, companies need to implement rigorous training programs to train their employees.
ISO compliance has rigorous documentation requirements. Managers need to maintain documents which include SOPs, templates, audit reports, and training records, which becomes challenging without a centralized platform.
Another challenge is monitoring the impact of corrective actions. Organizations need to verify that implemented measures prevent recurrence and drive continuous improvement. Without follow-up, the entire internal audit process loses some of its effectiveness in achieving ISO compliance.
Streamline Your ISO Internal Audits With GoAudits
GoAudits offers functionalities required to streamline, automate, and scale your internal ISO audit process. With GoAudits, you can:
- Create efficient internal audit schedules
- Manage multiple ISO standards through checklists
- Automate creating reports and sharing them with your team
- Store documents on the cloud to access them easily anytime
- Develop custom and easy-to-update digital ISO training checklists
- Implement corrective actions and assess their impact on compliance
With a rating of 4.8 stars on Capterra, GoAudits is trusted by some of the biggest names across industries.
» Customer Success Story: How businesses leverage GoAudits to maintain regulatory standards and compliance.