ISO_Series_of_Quality_Standards_Presentation.pptx

ISO 9000 guidline

1. ISO Series of Quality Standards Presented by: Vaishnav Pawar & Team B.Pharm 4th Year – MET Institute of Pharmacy

2. Introduction to ISO • ISO stands for International Organization for Standardization. • Established in 1947, headquartered in Geneva, Switzerland. • Aims to develop and publish global standards for quality, safety, and efficiency. • ISO standards cover manufacturing, healthcare, IT, food, and pharmaceuticals. • Ensures products and services are safe, reliable, and of good quality.

3. Need and Importance of ISO Standards • Promotes consistent quality and reliability. • Enhances customer satisfaction and trust. • Facilitates international trade and recognition. • Ensures safety, compliance, and performance. • Encourages continuous improvement and innovation.

4. ISO 9000 & 9001 – Quality Management System • ISO 9000 defines fundamentals and vocabulary for quality management. • ISO 9001 specifies requirements for a Quality Management System (QMS). • Focuses on customer satisfaction, leadership, and continual improvement. • Widely used across manufacturing, healthcare, and education sectors.

5. Key Principles of ISO 9001 • Customer Focus: Meeting and exceeding customer needs. • Leadership: Creating unity of purpose and direction. • Process Approach: Managing activities as processes. • Evidence-Based Decision Making. • Continual Improvement of processes and systems.

6. ISO 14000 – Environmental Management • ISO 14000 focuses on protecting the environment and sustainability. • ISO 14001 provides a framework for an Environmental Management System (EMS). • Benefits: Reduces waste, controls pollution, and ensures legal compliance. • Helps pharmaceutical industries manage effluent and environmental impact.

7. ISO 22000 – Food Safety Management • Ensures safety of food products from production to consumption. • Combines HACCP principles with management system approach. • Prevents contamination and enhances consumer confidence. • Useful for food, pharma, and biotech sectors handling consumable goods.

8. ISO 45001 – Occupational Health & Safety • Ensures a safe and healthy workplace environment. • Replaces the earlier OHSAS 18001 standard. • Reduces workplace accidents, improves morale, and boosts productivity. • Demonstrates an organization’s commitment to worker safety.

9. ISO 27001 – Information Security Management • Protects sensitive organizational information from cyber threats. • Ensures confidentiality, integrity, and availability of data. • Focuses on risk assessment and continuous monitoring. • Commonly used by banks, hospitals, IT, and research organizations.

10. ISO 13485 – Medical Devices Quality Management • Designed for organizations involved in medical device production. • Ensures compliance with regulatory and safety requirements. • Emphasizes risk management and sterility in device manufacturing. • Enhances reliability, safety, and patient confidence.

11. ISO Certification Process 1. Gap Analysis – Identify missing requirements. 2. Documentation – Create policies and procedures. 3. Implementation – Apply standards in daily operations. 4. Internal Audit – Evaluate performance. 5. Certification Audit – Conducted by an external agency.

12. Benefits of ISO Certification • Enhances brand reputation and global recognition. • Ensures compliance with international regulations. • Improves process efficiency and reduces errors. • Builds customer trust and opens new market opportunities.

13. Conclusion ISO standards serve as the foundation of quality, safety, and efficiency. They guide industries toward excellence and global recognition. Pharmaceutical and allied sectors greatly benefit from ISO compliance. “Quality is never an accident; it is the result of intelligent effort.” – John Ruskin