Wilkshire Consulting Blog

At Wilkshire Consulting, we often meet organizations that proudly earned ISO 9001 certification — only to struggle, stall, or fail during their first surveillance audit. The pattern is surprisingly consistent. The initial certification audit goes well. The certificate is issued. Celebration follows. Then, somewhere between Month 6 and Year 1, momentum fades. Processes drift. Leadership attention shifts. Documentation becomes outdated. By the time the surveillance audit arrive

(A Wilkshire Consulting Long-Form Guide) Management Review is one of the most scrutinized — and frequently misunderstood — requirements in ISO 9001. Many organizations treat it as a once-a-year meeting designed to “check a box,” but auditors expect something very different. A strong Management Review isn’t just documentation. It’s evidence that leadership is actively engaged in the Quality Management System (QMS) and using data to make informed, strategic decisions. At Wilks

At Wilkshire Consulting, one of the most common things we hear after an ISO 9001 audit is: We didn’t expect those findings.” The reality is that most ISO 9001 nonconformities are predictable and preventable . Certification bodies see the same issues repeatedly across industries — from manufacturing and construction to service providers and IT organizations. Understanding where companies typically fail gives you a powerful advantage. In this article, we’ll walk through the mo

At Wilkshire Consulting, we often tell clients: Leadership sets the direction, but Support builds the foundation. In ISO 9001, Clause 7— Support —is where the organization’s strategy and systems come to life. It ensures that people, resources, communication, and knowledge all work together to sustain a high-performing Quality Management System (QMS). Without strong support structures, even the best-designed processes can fail. Clause 7 ensures that your organization has the i

When organizations pursue ISO 9001 certification, they often focus on documentation, audits, and process control. But one of the most critical—and sometimes underestimated—requirements lies at the very top: leadership . ISO 9001:2015 places strong emphasis on leadership because a Quality Management System (QMS) can only be effective if senior management actively drives its success. Clause 5, titled “Leadership,”  sets the tone for how an organization aligns its strategy, cult

When it comes to implementing ISO 9001:2015, Clause 8 Operation is where strategy becomes action. While earlier clauses establish the framework of your Quality Management System (QMS)—like leadership, planning, and support—Clause 8 focuses on the actual delivery of products and services . This is the heart of quality management: ensuring the processes you’ve carefully planned are controlled, consistent, and capable of meeting customer requirements. Understanding this clause

For more than three decades, ISO 9001 has been the world's most recognized Quality Management System (QMS) standard, helping...

When organizations think of ISO 9001:2015, calibration may not be the first topic that comes to mind. Yet, calibration is one of the most...

Equipment maintenance might not always be the first thing people think of when discussing ISO 9001, but it plays a vital role in ensuring...

As technology continues to reshape how businesses operate, ISO standards are evolving to meet the demands of a digital-first economy....