1. What is Quality Management System (QMS)?
A QMS is a formalized system that documents processes, procedures, and responsibilities for achieving quality obiectives.
2. Why is QMS important for an organization?
It ensures consistent quality, enhances customer satisfaction, meets compliance requirements, and improves efficiency.
3. What are the key components of QMS?
Policy, objectives, processes, documentation, continual improvement, audits, and management review.
4. What is ISO 9001?
It's the international standard for QMS that helps organizations meet customer and regulatory requirements.
5. What is the difference between Quality Assurance (QA)and Quality Control (QC)?
QA focuses on preventing defects, while QC identifies and corrects defects
6. What is a Corrective and Preventive Action (CAPA) in OMS?
Corrective Action deals with eliminating the cause of detected issues, while Preventive Action aims to prevent future occurrences.
7.How does risk management apply to QMS?
It helps identify potential risks, evaluate their impact, and establish measures to mitigate them.
8. What is a Non-Conformance Report (NCR)?
It documents instances where products or processes fail to meet required standards.
9. How do audits contribute to QMS?
Internal and external audits verify compliance, identify gaps, and drive continuous improvement.
10. What is the role of leadership in QMS?