- Preparing for ISO 9001:2015 audits requires understanding of what elements an extenal registrar auditor will ask in key areas such as organizational context, risks and opportunities, and how the QMS integrates with business processes.
- Reading this article which provides advice for internal/external auditors can be helpful audit preparation.
- It advises auditors to focus on how organizations manage changes, capture and use knowledge, and plan to achieve quality objectives.
- In addition to audit preparation, answering these questions can also ensure that the QMS is not just a compliance tool but a strategic asset that drives continuous improvement and overall business success.
When preparing for an ISO 9001:2015 audit, auditors must focus on several critical areas to comprehensively evaluate an organization’s Quality Management System (QMS). One key question concerns the “context of the organization,” which involves understanding internal and external factors influencing the company’s strategy and goals. This context and identifying interested parties and their requirements form the foundation for assessing risks and opportunities, which is central to the ISO 9001:2015 standard.
Another essential aspect is how the organization plans and achieves its quality objectives. Auditors should examine the specific actions, resources, responsibilities, and timelines that have been put in place to meet these objectives. Additionally, understanding how the QMS is integrated into the broader business processes is crucial. This integration reflects the shift of ISO 9001 from a pure quality management standard to a strategic management tool that influences every part of the business.
Managing change and capturing organizational knowledge are also vital components of the audit. ISO 9001:2015 emphasizes proactive planning for changes and learning from past experiences to improve future outcomes. Auditors should seek evidence that changes are effectively managed and that lessons learned from successes and failures are documented and used to enhance the QMS. By focusing on these areas, auditors can help ensure that the QMS meets the standard’s requirements and drives continuous improvement and business success.
Key question areas are:
- What can you tell me about the context of your organization such as goals, purpose, strategies, etc.
- Who are your interested parties (i.e. customers, investors, communities in which you are based) and what are their requirements?
- How do you capture and use knowledge to aid continuous improvement?
- What risks and opportunities have been identified, and what are you doing about them?
- What are your quality objectives and what plans are in place to achieve them?
- How has your QMS been integrated into your operational/business processes?
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