Lecture 4 Flashcards
What is a Quality Management System (QMS), and what are some examples?
A QMS is a system that documents processes, procedures, and responsibilities to achieve quality policies and objectives. Examples include:
ISO 9001:2015: Incorporated into Pharmaceutical Quality Systems, requires supplier certification.
ISO 14001: For environmental management.
ISO 45001: For occupational health and safety
What is ISO 9001:2015, and what does it achieve?
ISO 9001:2015 sets the requirements for a quality management system. It helps businesses improve efficiency, customer satisfaction, standardize procedures, monitor defects, and conduct annual management reviews.
What are the seven Quality Management Principles (QMPs) of ISO 9001:2015?
Customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision-making, relationship management.
Give an overview of the ISO 9001:2015 Standard.
ISO 9001:2015 provides standardized requirements for a QMS. It promotes the process approach for improving QMS effectiveness and enhancing customer satisfaction. It is structured in 10 clauses and focuses on the process approach, PDCA (Plan-Do-Check-Act), and risk-based thinking.
What are the leadership requirements in ISO 9001:2015?
Leadership must ensure the Quality Policy and objectives are established, integrate QMS into business processes, provide necessary resources, ensure the QMS achieves intended results, and support the effectiveness of the QMS by engaging people.
Explain the following: a) the process approach, b) risk-based thinking, and c) PDCA.
a) Process Approach: Integrates processes as a complete system, defining interrelated activities to achieve intended outputs.
b) Risk-Based Thinking: Addresses risk to improve process outputs and prevent undesirable results, maintaining the effectiveness of the QMS.
c) PDCA (Plan-Do-Check-Act): A management cycle for continuous improvement. Plan: Set objectives. Do: Implement. Check: Monitor and measure. Act: Take action to improve.
Why do biopharmaceutical or pharmaceutical companies implement ISO 9000 Certification?
To adhere to regulations, ensure a standard QMS is in place, verify and validate manufacturing/services, improve operations, and enhance overall performance.
What do the following acronyms stand for, and explain their use? a) PDCA, b) ISO, c) PQS.
a) PDCA: Plan-Do-Check-Act, a management method for continuous process and product improvement.
b) ISO: International Organization for Standardization, develops standards to ensure quality, safety, and efficiency.
c) PQS: Pharmaceutical Quality System, a formalized system required by regulation, providing a model for an effective QMS based on ISO standards.
