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Iso nand nabl

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6th sem b pharma QC,QA
pharmaceutical quality assurance
Quality Management System
Introduction to ISO 9000
Eight Quality Management Principles
ISO 9000 Series
Advantages
Clauses
Introduction to ISO 14000
Standards under ISO 14000 series
NABL accreditation ( National Accreditation Board for Testing and Calibration Laboratories)
Function of NABL
Process of NABL


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Iso nand nabl

  1. 1. ISO 9000 AND 14000 NABL ACCREDITATION Himanshu Kamboj Assistant Professor
  2. 2. Contents • Quality Management System • Introduction to ISO 9000 • Eight Quality Management Principles • ISO 9000 Series • Advantages • Clauses • Introduction to ISO 14000 • Standards under ISO 14000 series • NABL accreditation ( National Accreditation Board for Testing and Calibration Laboratories) • Function of NABL • Process of NABL
  3. 3. Quality Management System • A quality management system (QMS) defines and establishes an organization's quality policy and objectives. • It also allows an organization to document and implement the procedures needed to attain these goals. • 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. • 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
  4. 4. Introduction to 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 eight management principles on which the family of standards is based.
  5. 5. • Originally published in 1987 by the International Organization for Standardization (ISO), a specialized international agency for standardization composed of the national standards bodies of 90 countries. • ISO 9000 is a series of Quality Management System (QMS) standards, provide guidance and tools for companies and organizations, to ensure that their products and services consistently meet customer’s requirements, and for consistent improvement in quality.
  6. 6. Eight Quality Management Principles Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision- making Mutually beneficial supplier relationships
  7. 7. Customer focus • Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements, strive to exceed customer expectations, assess customer satisfaction and customer relationships
  8. 8. Leadership • Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment within the organization. • Establish a vision and direction for the organization • Set demanding goals • Model organizational values • Establish trust • Train and empower employees • Identify employee contributions
  9. 9. Involvement of people • People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit. • Ensure that people’s skills are used and valued • Make people responsible • Enable participation in continual improvement • Evaluate individual performance • Facilitate learning and sharing of knowledge • Enable open discussion of problems and constraints
  10. 10. Process approach • A desired result is achieved more efficiently when activities and related resources are managed as a process. • Supervise activities as processes • Assess the capability of activities • Identify linkages between activities • Prioritize improvement opportunities • Organize resources effectively
  11. 11. Improvement • Improvement of the organization's overall performance should be a permanent objective of the organization. • Develop organizational performance and capabilities • Align advanced activities • Empower people to make improvements • Measure improvement consistently • Celebrate the improvements
  12. 12. Evidence-based decision making • Effective decisions are based on the analysis of data and information. • Guarantee the accessibility of accurate and consistent data • Use suitable methods to analyze data • Make decisions based on analysis • Balance data analysis with practical experience
  13. 13. Relationship management • An organization and its external providers are interdependent and a mutually beneficial relationship enhances the ability of both to create value. • Identify and select suppliers to manage costs, optimize resources, and create value • Establish relationships considering both the short and long term • Share expertise, resources, information, and plans with partners • Collaborate on improvement and development activities • Recognize supplier successes.
  14. 14. • These standards provide guidance. • Tools to ensure products and services meet customer’s requirements. • Quality is consistently improved.
  15. 15. ISO 9000 Series • Explains fundamental quality concepts and provides guidelines for the selection and application of each standard ISO 9000 • Model for quality assurance in design, development, production, installation and servicing. ISO 9001 • Model for quality assurance in the production and installation of manufacturing systems ISO 9002
  16. 16. • Quality assurance in final inspection and testing. ISO 9003 • Guidelines for the applications of standards in quality management and quality systems. ISO 9004 ISO 9000 and ISO 9004 are guidance standards. They describe what is necessary to accomplish the requirements outlined in standards 9001, 9002 or 9003.
  17. 17. Advantages  Quality is maintained,  ISO registration also has a significant bearing on market credibility as well.  Opportunity to compete with larger companies  More time spent on customer focus,  Confirmation that your company is comitted to quality,  May facilitate trade and increased market opportunities,  can increase customer confidence and satisfaction.
  18. 18. • Quality Management System • Management responsibility • Resource management • Product realization • Measurement, analysis and improvement Clause 4 Clause 5 Clause 6 Clause 7 Clause 8 Clauses The requirements of the standard are specified in following clauses of the standard:
  19. 19. • Quality Management Clause ▫ General requirements ▫ Documentation requirement ▫ Quality manual ▫ Control of records and documents • Management responsibility clause ▫ Customer focus ▫ Quality objective ▫ Quality policy ▫ Quality management system planning ▫ Management representative ▫ Internal communication
  20. 20. • Resource management requirement clause ▫ Competence, awareness and training ▫ Infrastructure ▫ Work environment • Product realization requirement clause ▫ Planning of product realization ▫ Customer related process ▫ Customer communication • Measurement, analysis and improvement clause ▫ General requirements ▫ Monitoring and measurement customer satisfaction Internal audit ▫ Analysis of data ▫ Continual improvement
  21. 21. ISO 14000 • Environmental management • Help organizations to work within healthy environment • Help to meet the challenge of climate change • Develop 570 international standards
  22. 22. Standards under ISO 14000 series • ISO 14001: Set criteria for EMS • ISO 14010: Standards about auditing • ISO 14020: Standards about environmental labeling • ISO 14030: Standards on environmental performance evaluation • ISO 14040: Standards on environmental life cycle assessment
  23. 23. Advantages  Creates a more efficient, effective operation  Increases customer satisfaction and retention  Reduces audits  Enhances marketing  Improves employee motivation, awareness, and morale.  Promotes international trade  Increases profit  Reduces waste and increases productivity  Common tool for standardization  Enables to meet the requirements of an internationally uniform quality system.  Motivates the employees and develops pride in them for achieving excellence.
  24. 24. THANK YOU

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