Iso basic and 9001
- 1. TOPIC: ISO PART -I BY Mr.DIPANKAR NATH. M.PHARM(PHARM.CHEMISTRY),GATE(2009),GPAT(2011) ASSISTANT PROFESSOR. DEPARTAMENT OF PHARMACEUTICAL ANALYSIS . HIMALAYAN PHARMACY INSTITUTE,MAJHITAR,EAST SIKKIM.
- 2. INTRODUCTION: ISO is a name used for the International Standard Organization is the worlds largest developer and Publisher of International Standard. Formed in 1947 in Geneva, Switzerland . The International Organization for Standardization (ISO) is an independent, non- governmental international organization with a membership of 162 national standards bodies. The three official language of the ISO are English, French, and Russian. The main Concept is to determine characteristics of the management practices that must be standardized.
- 3. Objectives: To provide products that is customer focused or oriented. To produce products that meets customers requirements. To enhance customer satisfaction for the products and their trust in it. To enhance quality management. To enhance effective and efficient products design and development Difficulties: Many countries initiated and implemented their own National Quality Policies. Two main features: Internal Quality audit at predetermined level. Continuous monitoring of quality system.
- 4. Benefits: ISO International Standards ensure that products and services are safe, reliable and of good quality. For business, they are strategic tools that reduce costs by minimizing waste and errors, and increasing productivity. They help companies to access new markets, level the playing field for developing countries and facilitate free and fair global trade ISO Popular Standards: ISO 9000 - Quality management ISO 14000 - Environmental management ISO 45001 - Occupational Health and Safety ISO 27001 - Information security ISO 26000 - Social responsibility ISO 50001 - Energy management
- 5. ISO 3166 - Country codes ISO 4217 - Currency codes ISO 639 - Language codes ISO 22000 - Food safety management ISO 20121 - Sustainable events ISO 13485 - Medical devices ISO 31000 - Risk management ISO 37001 - Anti-bribery management systems ISO 8601 - Date and time format
- 6. Quality Management System: A quality management system (QMS) defines and establishes an organization's quality policy and objectives. 1. It also allows an organization to document and implement the procedures needed to attain these goals. 2. A properly implemented QMS ensures that procedures are carried out consistently, that problems can be identified and resolved, and that the organization can continuously review and improve its procedures, products and services. 3. It is a mechanism for maintaining and improving the quality of products or services so that they consistently meet or exceed the customer's implied or stated needs and fulfill their quality objectives.
- 7. ISO 9000 The ISO 9000 family of standards is related to quality management systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements. ISO 9000 deals with the fundamentals of quality management systems, including the seven management principles on which the family of standards is based. The seven quality management principles are : QMP 1 – Customer focus QMP 2 – Leadership QMP 3 – Engagement of people QMP 4 – Process approach QMP 5 – Improvement
- 8. QMP 6 – Evidence-based decision making QMP 7 – Relationship management
- 9. QMP 1 – Customer focus The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations. Key benefits • Increased customer value • Increased customer satisfaction • Improved customer loyalty • Enhanced repeat business • Enhanced reputation of the organization • Expanded customer base • Increased revenue and market share
- 10. QMP 2 – Leadership Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization’s quality objectives. Key benefits • Increased effectiveness and efficiency in meeting the organization’s quality objectives • Better coordination of the organization’s processes • Improved communication between levels and functions of the organization • Development and improvement of the capability of the organization and its people to deliver desired results. QMP 3 – Engagement of people Competent, empowered and engaged people at all levels throughout the organization are essential to enhance its capability to create and deliver value.
- 11. Key benefits • Improved understanding of the organization’s quality objectives by people in the organization and increased motivation to achieve them. • Enhanced involvement of people in improvement activities. • Enhanced personal development, initiatives and creativity. • Enhanced people satisfaction. • Enhanced trust and collaboration throughout the organization. • Increased attention to shared values and culture throughout the organization. QMP 4 – Process approach Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system.
- 12. Key benefits • Enhanced ability to focus effort on key processes and opportunities for improvement. • Consistent and predictable outcomes through a system of aligned processes. • Optimized performance through effective process management, efficient use of resources, and reduced cross-functional barriers. • Enabling the organization to provide confidence to interested parties as to its consistency, effectiveness and efficiency. QMP 5 – Improvement Successful organizations have an ongoing focus on improvement. Key benefits • Improved process performance, organizational capabilities and customer satisfaction • Enhanced focus on root-cause investigation and determination, followed by prevention and corrective actions
- 13. • Enhanced ability to anticipate and react to internal and external risks and opportunities. • Enhanced consideration of both incremental and breakthrough improvement. • Improved use of learning for improvement. • Enhanced drive for innovation. QMP 6 – Evidence-based decision making Decisions based on the analysis and evaluation of data and information are more likely to produce desired results. Key benefits • Improved decision-making processes ability to demonstrate the effectiveness of past decisions. • Improved assessment of process performance and ability to achieve objectives. • Improved operational effectiveness and efficiency. • Increased ability to review, challenge and change opinions and decisions.
- 14. QMP 7 – Relationship management For sustained success, an organization manages its relationships with interested parties, such as suppliers. Key benefits • Enhanced performance of the organization and its interested parties through responding to the opportunities and constraints related to each interested party. • Common understanding of goals and values among interested parties. • Increased capability to create value for interested parties by sharing resources and competence and managing quality-related risks. • A well-managed supply chain that provides a stable flow of goods and services.
- 15. ISO 9000 Series ISO 9000 ISO 9001 ISO 9002 ISO 9003 ISO 9004 Explains fundamental quality concepts and provides guidelines for the selection and application of each standard Model for quality assurance in design, development, production, installation and servicing. Model for quality assurance in the production and installation of manufacturing systems Quality assurance in final inspection and testing. Guidelines for the applications of standards in quality management and quality systems ISO 9000 and ISO 9004 are guidance standards. They describe what is necessary to accomplish the requirements outlined in standards 9001,9002 or 9003.