Zero Major NC holds a great value for an organization. A major non-conformance during surveillance or certification audit can risk the certification and put the customer business on hold. It poses great risk to current and future customer orders and businesses. If a company is encountered with major non conformance, the communication goes through the pipeline to the stakeholders and customers. To build a system with zero major non-conformance, a strong Quality Management System is mandate. The only way to have a strong Quality Management System depends on correct implementation and audit strategy.
Kadmar Consultants understands Tier1, 2, & 3 struggles and pains. This blog will help small to large size enterprises (SME) to understand the reason of major non-conformances and how to prevent them. This will help your organization to maintain ISO 9001 Readiness throughout the year while improving real performance.
It shows failure of the Quality Management System (QMS), a system that has cracks and leaks in its foundation. The major reason for these failures is due to:
This reflects the true goal of ISO 9001—not just certification. It helps organization build a strong framework that can achieve competitive edge in this digital era.
Organizations the lacks the understanding and intent of ISO 9001 certification will usually fail as it has a system that works on paper but in actual is not properly executed.
A system developed for external audits only.
A system to help get into the customers entry pool.
Weak internal audits and Management review process.
ISO 9001 readiness reflects the organizations’ ability to meet and exceed customer requirements and demand. A system built on values and transparency. Reflects strong leadership and employee engagement. Employee ownership and empowerment is the key to these organizations.
Most of the time Kadmar gets the question from its client, “Can a system be 100% audit ready throughout the year at any point in time especially for SME enterprises?”. Answer is yes, we understand things and certain failures are sometime bound to happen regardless of carrying out risk assessments, but when you have strong control and backup plan in place your system will have minimal risk impact and will function as plan. Contingency planning helps identify risks and help apply preventive and backup controls in place.
“Do what you say and say what you do”- This aligns ISO 9001 scope with organization scope and that is standardization. All processes should reflect on paper and in actual same flow and activities. Example, Work instruction should reflect an employee’s actual flow of work.
Internal audit is the scorecard of the organization before external or customer audit. It reflects the performance of the organization’s Quality Management System. If carried out in effective way, can prevent non-conformance or defects from arising at first place.
Management Review is a strong performance evaluator and continuous improvement tool of ISO 9001. It accesses risks and opportunities associated with each process and define actions to continually improve it. Strong leadership involvement is one of the biggest factors in achieving zero major NCs.
Carryout risk assessment at each level of the organization, between and within processes. Define actions to mitigate risk and plan to improve continually with zero repeat issues.
Each employee in the organization from top to bottom are required to understand the scope and intend of the standard and how it helps them achieve excellence in their job. Employees are the main pillar of the organization. They are the one who make implementation possible and move it to execution phase. Without employee engagement an organization is a structure without strength—impressive in appearance, fragile. Employees form an organization but if there is no engagement, the organization becomes functionally hollow.
Kadmar Consultants understands the needs and challenges of ISO 9001 and requirement of getting Zero Major NC. We don’t work with you for certification- we work to make your system strong and audit ready throughput the year.
Q: Is zero major Non-Conformance guaranteed in ISO 9001 audits?
No audit can be guaranteed, but strong readiness significantly reduces risk.
Q: Can SMEs realistically achieve zero major NCs?
Yes. SMEs often perform better than large organizations when systems are well aligned.
Q: How early should ISO 9001 readiness begin?
At least 3–4 weeks before the certification or surveillance audit
Q: Are mock audits helpful?
Absolutely. Mock audits are one of the most effective readiness tools.
Ready to unlock true power of ISO 9001 certification and grow business? Contact Kadmar Consultants today to schedule a consulting session or ISO 9001 training program tailored to your organization’s need.
Author: Asma Rashid