ISO 9001:2015 FRAMEWORK

 

Auditor Training for ISO 9001:2015 for compliance 

via 

adopting proper systematic approach and protocol 

 

Lets dive  into the critical process of auditing for ISO 9001:2015. As auditors, key role is to help  organizations maintain  quality management systems (QMS),for that  the essential steps of auditing – from pre-assessment until the  final report  is handover. 

Let’s break down the entire audit process into several key stages:

1. Pre-assessment & Planning

Before we start the actual audit, pre-assessment and planning set the foundation for success. The goal here is to establish a clear scope and objectives of the audit. When auditing a company certified to ISO 9001:2015, we look at how their processes align with the standard. In the automotive industry, the focus will often include elements related to product traceability, supplier management, and regulatory compliance.

Steps in Pre-assessment:

Understand the Scope: Identify what areas, processes, or departments will be audited.

Collect Relevant Documents: Review previous audit reports, quality manuals, procedures, and records.

Communicate with Key Stakeholders: Ensure that the auditee understands the audit objectives, and clarify any expectations from management.

Create an Audit Plan: This plan should outline the schedule, key areas of focus, and resources required. Always ensure that the audit plan is aligned with ISO 9001:2015 requirements.

2. Conducting the Audit

Host: The heart of the audit lies in its execution. The objective is to verify that the processes meet the ISO 9001:2015 standard and that the organization consistently produces components that meet customer and regulatory requirements.

Here’s how to structure your audit:

Opening Meeting: The audit begins with an opening meeting. This is where you introduce the audit team, review the audit plan, and set expectations with the auditee. It’s also an opportunity to clarify any final questions before you begin.

Evidence Gathering:

Interview Staff: Speak with employees at different levels, from operators on the shop floor to top management, to understand how they are implementing the QMS.

Review Documents and Records: This includes inspection reports, production logs, calibration records, and customer feedback. Documentation is key in industries like automotive manufacturing.

Observe Processes: Ensure that actual practices align with documented procedures. In this case, you'd be particularly interested in product conformity, supplier control, and handling non-conformances.

Take Notes and Record Findings: Focus on evidence of conformity or non-conformity. A well-documented finding will help you generate a clear audit report later.

3. Reporting & Generating Findings

After conducting the audit, the next step is to organize your findings into a formal report. Here’s where the role of the auditor becomes that of a clear communicator.

Non-Conformities: Clearly outline any gaps between the company’s practices and the ISO 9001:2015 requirements. It’s important to classify findings as either major or minor non-conformities, or opportunities for improvement.

Conformities and Best Practices: Don’t forget to highlight areas where the company excels. This is particularly important in industries like automotive, where demonstrating best practices can strengthen supplier relationships.

Key Elements of an Audit Report:

Executive Summary: A high-level overview of the audit, including the overall conformity to ISO 9001:2015.

Detailed Findings: Each non-conformance should be listed along with its associated evidence.

Recommendations for Improvement: Offer practical advice that can help the company address non-conformities and enhance its QMS.

4. Closing Meeting & Presentation

Host: Once the audit report is ready, the closing meeting is where you present your findings to the auditee and top management. This is a critical moment to ensure transparency and encourage action.

Presenting Audits observation findings tactfully:

Be clear and objective in your presentation. Explain both positive findings and areas for improvement.

Allow time for the auditee to ask questions or provide clarifications.

Discuss next steps, including timelines for corrective actions and opportunities for follow-up.

Handling Feedback: During this meeting, it’s important to listen to the auditee’s perspective, particularly if they wish to contest any findings. Be open to discussion but maintain objectivity.

5. Handover of Audit Report for Management Review

Finally, the audit report is handed over to management for review.

 Management review is a crucial aspect of ISO 9001:2015, ensuring that top leadership is actively involved in maintaining and improving the QMS.

Ensure Accountability: Clearly assign actions for addressing non-conformities. Management should commit to timelines and resources for corrective action.

Monitor Follow-Up Actions: Auditors may be called back for a follow-up audit to verify the implementation of corrective actions.

Final Thoughts

As auditors, our role is not just to find problems but to provide value by helping organizations like yours maintain a robust QMS. 

By following a structured approach to pre-assessment, planning, conducting the audit, and reporting, you ensure that the company not only complies with ISO 9001:2015 but also enhances its operations and product quality – critical when you’re supplying automotive components to major car manufacturers.

Keep tap on next blog: where we’ll dive deeper into corrective actions and continual improvement in QMS. Until then, keep striving for excellence in your audits and quality management practices!