What is QMS Quality Management System in pharmaceutical Industry 💊 Interview Questions Trackwise скачать в хорошем качестве

What is QMS Quality Management System in pharmaceutical Industry 💊 Interview Questions Trackwise

What is QMS Quality Management System Question and Answers | ISO 9001 Pharmaceutical Industry Exam Questions covered: Question: What is a Quality Management System (QMS)? Answer: A QMS is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. It helps organizations meet customer and regulatory requirements and improve their effectiveness and efficiency. Question: What is the primary international standard for a QMS? Answer: The primary international standard is ISO 9001:2015. Question: What are the seven quality management principles outlined in ISO 9000? Answer: The seven principles are: customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision-making, and relationship management. Question: What is the purpose of a quality policy? Answer: A quality policy is a statement of an organization's commitment to quality. It provides a framework for setting quality objectives and outlines the organization's intentions and direction with respect to quality. Question: What is the difference between quality control (QC) and quality assurance (QA)? Answer: QA is a proactive process focused on preventing defects, while QC is a reactive process focused on detecting and correcting defects after they have occurred. QA is about "building quality in," and QC is about "checking for quality." Question: What is a "nonconformity" in the context of a QMS? Answer: A nonconformity is a failure to meet a specified requirement. This could be a requirement from a customer, a standard (like ISO 9001), or an organization's own internal procedures. Question: What is the purpose of a corrective action? Answer: A corrective action is taken to eliminate the cause of a nonconformity to prevent its recurrence. It addresses the root cause, not just the symptom. Question: What is the purpose of a preventive action? Answer: A preventive action is taken to eliminate the cause of a potential nonconformity to prevent its occurrence. (Note: ISO 9001:2015 has integrated the concept of preventive action into risk-based thinking.) Question: What is the importance of a "communication plan" for a QMS? Answer: A communication plan ensures that relevant information about the QMS (e.g., policy, objectives, changes) is communicated effectively to all interested parties. Question: What is the purpose of "nonconforming output control"? Answer: It's a procedure for ensuring that products or services that do not meet requirements are identified, controlled, and prevented from unintended use or delivery. Question: What is the purpose of "customer property" control? Answer: This ensures that when a customer's property (e.g., materials, tools, data) is in the organization's care, it is handled and protected appropriately. Question: What is a "process owner"? Answer: A process owner is an individual responsible for the effective functioning and continuous improvement of a specific process within the QMS. Question: How does a QMS help with employee morale? Answer: By providing clear procedures, defining responsibilities, and involving employees in improvement efforts, a QMS can reduce frustration and increase job satisfaction. Question: What is "validation" versus "verification"? Answer: Validation is "Are we building the right thing?" (Does it meet the intended use?). Verification is "Are we building the thing right?" (Does it meet the specified requirements?). Question: How is "improvement" addressed in ISO 9001:2015? Answer: It's addressed through various mechanisms, including management reviews, internal audits, corrective actions, and a focus on continuous improvement. Question: What is the purpose of "release of products and services"? Answer: This clause requires that products and services are not released to the customer until all planned arrangements for verification have been satisfactorily completed. Question: What is the difference between "QMS certification" and "accreditation"? Answer: Certification is a certification body confirming that an organization's QMS meets the standard. Accreditation is an accreditation body (e.g., UKAS, ANAB) confirming that a certification body is competent to perform certifications. Question: What is the final outcome of a successful QMS? Answer: The final outcome is a well-managed organization that consistently provides products and services that meet customer and regulatory requirements, leading to enhanced customer satisfaction and business success.