Non-conformance is not always a bad thing, especially if it is isolated or infrequent. The ISO 9001 audit methods are a framework for assisting organizations in identifying and correcting their own QMS faults before they cause product quality concerns or waste. However, systemic non-conformances and repeated failures are far more serious.
If your organization has significant non-conformances or systemic patterns of failure, you may face more than mere difficulties with ISO 9001 certification or re-certification. A single lapse may be an isolated incident, whereas a big nonconformity may be a major red flag about your capacity to manage quality successfully.
How to Avoid Non-conformances by Using ISO 9001?
ISO 9001 Audits and customer comments are useful resources for identifying nonconformities. They are, however, not the sole tools for shifting to a proactive and quality-driven culture. A corrective action is taken in response to a QMS failure. It is preferable to start shielding against non-conformance risks right away with best practices to avoid these difficulties in the first place.
- Review of Conduct Management: Conduct a regular management review at least once a year, preferably bi-annually or every quarter. Use these evaluations to delve deeply into product changes, needs, processes, and risks, and plan and implement improvements using a defined system. The basis of continuous improvement is management review.
- Quality Data Analysis: Customer comments and other quality events must be documented and implemented. Feedback is also a great tool for determining trends. Customer feedback, both good and negative, as well as quality metrics, can identify trends in complaints, non-conformances, and deviations. By actively analysing quality data, you may more effectively distinguish between isolated incidents and emerging patterns, allowing you to accelerate root cause investigation.
- Continuous Audit: Internal audits can be undertaken on an ongoing basis to assess the health of processes. Some processes may necessitate more frequent audits. Audits might look into the progress of earlier findings or questions. Most significantly, audits can be a helpful tool for collaboratively discovering opportunities for improvement with staff. Employees closest to the process can collaborate with internal audits to highlight concerns or suggest possibilities for advancement in a quality-driven culture.
- Maximize the Visibility: With an electronic quality management system (eQMS), you can gain greater insight into the non-conformance process. CAPA and NCR are easily lost in the system or buried behind competing priorities when using paper-based approaches. Cloud-based QMS software solutions for overall quality management, on the other hand, create visibility. Using basic, shareable tools, you can make sure that chances for change are rapidly adopted.
Turning Points from Non-conformance into the Quality
Noncompliance with ISO 9001 is not always a bad thing. Many organizations have at least some minor non-conformities. When flaws are detected early on by an employee, during an internal audit, or a management review, they can represent an opportunity. Minor difficulties can be avoided by proactively identifying them.
A holistic, broad approach to risk management is crucial, especially when minor non-conformities have the potential to escalate into major concerns. To fully reap the benefits of an ISO 9001:2015 quality management system, the best way is to protect against non-conformances and related risks. Improve performance through management review, internal audit, data recording, and digital cooperation.
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