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Navigating ISO 9001:2015 Audits: A Comprehensive Guide

Qualityze
18 Apr 2024
Navigating ISO 9001:2015 Audits: A Comprehensive Guide

Creating a flawless Quality Management System (QMS) aligned with the latest amendment in the ISO 9001:2015 standard is crucial. However, it is not enough per se. The next critical step is navigating the ISO 9001:2015 audit—a comprehensive assessment that determines whether your QMS effectively translates into consistent quality or deviates from regulatory standards. This blog discusses the strategies such as audit automation and use of artificial intelligence in auditing to conquer your audit efficiently and confidently.

Understanding the Why and What of Audits

The primary purpose of an audit is to verify the effectiveness and efficiency of your QMS. Audits ensure you're on the right track, adhering to the standard requirements, and eventually delivering exceptional products and services. The audit's true value lies beyond the mere pass-and-fail outcome. Use the auditor's findings as a springboard for continuous improvement. Analyze identified non-conformities and leverage them to strengthen your QMS and identify areas for optimization.

There are two main types of audits: internal and external. Internal audits are self-assessments conducted by your own trained personnel. These proactive measures help identify and address potential gaps before an external audit. External audits performed by an accredited certification body determine whether your organization officially merits ISO 9001:2015 certification.

Comprehensive step by step-by-step guidance

(1)  There Is No Text Without a Context: Understand your organization's context. What are your internal and external factors? Who are the interested parties? Contextual awareness sets the stage for effective quality management.

(2)  Risk-Based Thinking: ISO 9001:2015 audit embraces risk-based thinking. Identify risks, assess their impact, and integrate risk management into your processes. It's not about avoiding risks but pre-empting and managing them strategically. Integrating artificial intelligence in auditing can modernize the process, eliminating manual errors. In our times, artificial intelligence, thanks to its language processing abilities and the capacity to mimic human speech, has changed the business world. Leveraging artificial intelligence in auditing ensures a flawless, cost-effective, and efficient result.

(3) Requirements and Expectations: Stakeholders matter. Understand their requirements and expectations. Customer satisfaction depends on consistently meeting their requirements.

(4)  Dynamics in Context, Interested Parties, and Risks: These elements interact dynamically. Consider how changes in context affect stakeholders and risk profiles. Adaptability is key.

Practical Audit Techniques

(1)  Planning: Prepare meticulously. Define audit objectives, scope, and criteria. Identify competent auditors and allocate resources. You can also use a QMS system to automate audit. Audit automation is capable of identifying non-adherence to regulatory bodies’ requirements and suggest corrective measures to mitigate risks arising from noncompliance. Whether you automate auditing or use humans for the purpose, you must have a flawless plan and risk-proof strategies to achieve your set objectives. A well-structured plan ensures a smooth audit journey.

(2)  Conducting the Audit: Gather evidence objectively. Evaluate processes against ISO 9001:2015 audit requirements. Identify nonconformities and opportunities for improvement. Engage with process owners and employees.

(3)  Reporting: Communicate audit findings. Highlight strengths and areas for enhancement. Your report guides corrective actions and drives continual improvement.

Let's revert to our internal and external audits discussion and shed more light on them.  

Internal vs. External Audits

Internal audits are your organization's self-evaluation tool. You can leverage the power of audit automation for internal audits. or train a team auditors, independent of the processes they assess, who can closely scrutinize your QMS. This proactive approach helps identify and address gaps before an external audit.

Data brings home the importance of internal audits. A 2023 study by the American Society for Quality revealed that organizations conducting regular internal audits experience a 42% reduction in non-conformities during external audits. 

External audits conducted by an accredited certification body are the final step to achieving ISO 9001:2015 certification. These rigorous audits verify whether your QMS meets the standard requirements and functions effectively within your organization. Earning certification signifies your commitment to quality, boosts customer confidence, and opens doors to new markets. A 2022 PWC report highlights that 87% of global businesses consider ISO 9001 certification a valuable tool for gaining a competitive edge. 

Related Article: Key Differences between ISO 13485 and ISO 9001 for Medical Devices

Breaking Down the External Audit Process

The external audit typically unfolds in two stages:

Readiness Review – The first stage is an initial assessment that evaluates your QMS documentation, ensuring alignment with ISO 9001:2015 requirements. It's similar to a pre-flight check, ensuring you're well-prepared for the in-depth Stage 2 audit.

Certification Audit – The second stage, certification audit, is a comprehensive evaluation that delves into the practical implementation of your QMS. Auditors interview personnel, observe processes, and review records to verify if your system delivers the promised quality outcomes.

Charting Your Path: Preparing for Success

Preparation is crucial to a smooth audit. Here are some key strategies to consider:

Embrace a Culture of Quality: Cultivate a culture of a company-wide understanding of the importance of ISO 9001:2015 and its contribution to quality. Thorough knowledge of the ISO 9001:2015 requirements is crucial. Invest in training your team and ensure everyone understands the standard clauses and their application within your organization.

Assign an Audit Champion: Designate a dedicated individual to oversee the audit preparation process. The person will be responsible and accountable for documentation review, internal audit schedule, and uninterrupted communication with the certification body.

Review Your Documentation: The audit will assess how effectively your QMS is documented. Modernize your documentation process, ensuring it's clear, concise, and readily accessible—update procedures to reflect current practices and eliminate outdated and irrelevant information. Ensure your QMS document management reflects the latest revision of ISO 9001 (2023) and accurately reflects your current practices.

Conduct Internal Audits: Schedule regular internal audits to identify and address any deviations from the standard. The proactive approach allows you to rectify issues before the external audit arrives.

Build a Capable Audit Team: Assign qualified internal auditors who thoroughly understand the standard and your organization's QMS.

Conduct Mock External Audit: Conduct a mock audit to sensitize your team to the audit process, reducing anxiety and ensuring a smooth experience.

The Big Day: What to Expect During the Audit

The external audit typically involves an opening meeting, document review, on-site observation of processes, and a closing meeting. The auditor will assess your QMS based on the standard's requirements and identify non-conformities.

Addressing non-conformities:

There is no need to panic if and when non-conformities are identified. The key is to demonstrate a commitment to continuous improvement. Develop corrective action plans (CAPs) outlining steps to address the issues, prevent recurrence, and ensure ongoing compliance.

Beyond the Audit

The audit result might be certification, a request for corrective actions, or even non-certification. Regardless of the outcome, view it as a valuable learning opportunity. 

Here's how to proceed:

Certification—Celebrating Commitment: Earning certification spotlights your dedication to quality. However, maintaining it necessitates continuous improvement through ongoing internal audits and management reviews.

Corrective Actions – A Chance to Refine and Reform: Identify the root cause of any non-conformities identified during the audit. Implement corrective actions and demonstrate their effectiveness to the certification body.

Non-Certification—A Stepping Stone: Analyze the auditor's feedback to pinpoint areas for improvement. Address the shortcomings, strengthen your QMS, and reschedule the audit.

Why Are Audit Indispensable to A Company's Success?

Enhancing Business Performance

(1) Beyond Compliance: ISO 9001:2015 isn't just about ticking boxes. It's about enhancing business performance. Optimize processes, reduce waste, and boost efficiency. Align ISO requirements with strategic goals.

(2) Customer Satisfaction: Delight your customers. Exceed their expectations. A satisfied customer is a loyal one. ISO 9001:2015 can be used as a tool to enhance customer focus.

(3) Quality Improvement: Continuous improvement is the heartbeat of ISO 9001:2015. Learn from lessons, adapt, and evolve. Data-driven decisions lead to excellence.

Parting Shot

The ISO 9001:2015 audit is not a one-off event but a crucial step in your organization's quality management journey. By understanding the audit process, implementing effective preparation strategies, and embracing the outcome – positive or corrective – you can ensure your QMS delivers consistent quality, propelling your organization towards excellence.

FAQs

What is the ISO 9001:2015

ISO 9001:2015 is a widely accepted standard that defines the criteria for an effective quality management system (QMS). It enables businesses of any size and type to demonstrate their capability to consistently deliver quality products and services that comply with customer expectations and regulatory requirements. Adhering to the 2015 framework can enhance performance, simplify operations, and increase customer satisfaction.

How does ISO 9001 work

ISO 9001 defines the steps to set up, implement, maintain, monitor, and continually improve a quality management system (QMS). This involves determining the organization's context, leadership, and planning. The QMS also addresses resources, competence, awareness, communication, and documented information. Once a plan is in place, processes are implemented and controlled to meet customer requirements. The organization then monitors measures, analyzes, and evaluates the performance of its QMS. Continual improvement is a major focus of ISO 9001, so the results of these evaluations are used to refine the QMS.

What are the types of audits

There are two main types of audits for ISO 9001:

Internal Audits: Your team conducts internal audits to proactively assess your quality management system (QMS). They identify areas for improvement before external audits. Think of it as a self-evaluation to catch issues early.

External Audits: These are generally performed by an independent certification body to verify that your QMS meets ISO 9001 standards. Passing an external audit leads to certification, demonstrating your commitment to quality and boosting customer trust.

What is the QMS process audit

A QMS process audit is likely an audit that focuses on evaluating the effectiveness of the processes within a quality management system (QMS). It would typically involve examining things like:

  • Whether the processes are documented and followed correctly
  • Whether the processes are effective in meeting their objectives
  • Whether there are any opportunities for improvement

A QMS process audit is to identify areas where the QMS could be improved so that organizations can:

  • Improve the products and services quality
  • Reduce costs, and Increase customer satisfaction.

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