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ISO 9001:2008 Overview and Orientation Training

ISO 9001:2008 Overview and Orientation Training. AGENDA. ISO Background (Optional) Internal Audits and Registration Audits Quality Management Principles Purpose of ISO 9001:2008 ISO Family of Documents Important Notes Key Documents ISO 9001:2008 Clauses Process Model.

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ISO 9001:2008 Overview and Orientation Training

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  1. ISO 9001:2008Overview and Orientation Training

  2. AGENDA • ISO Background (Optional) • Internal Audits and Registration Audits • Quality Management Principles • Purpose of ISO 9001:2008 • ISO Family of Documents • Important Notes • Key Documents • ISO 9001:2008 Clauses • Process Model

  3. Background & History Part I

  4. Lack of Consistency • From the beginning, everyone has done their own “thing” when it came to standards • Variability country-to-country and industry-to- industry • Nations and industries have taken different approaches • Formal versus informal • Enforceable versus voluntary • Specific versus generic • Lack of agreement often led to trade barriers by nations, industries, and special interest groups

  5. Lack of StandardsA Barrier to International Trade • As early as the 1950’s, lack of uniform standards was recognized by political leaders and world economists as a barrier to growing international trade • Evolution of the European Community began to focus additional attention on the lack of uniform standards in the 1970’s

  6. Need For a Common Approach • Bring harmony to international trade by supplying a set of standards that are universally accepted • Enhance free movement of goods • Provide a set of standards applicable for contractual purposes between suppliers and customers • Establish consistent quality practices across international boarders • Provide a common language or set of terms • Independent party verification of the organization’s quality management system • Provide structure for the growing international emphasis on quality

  7. International Organization for Standardization • ISO was originally derived from the Greek root word ISOSmeaning equal • Today ISO stands for the International Organization for Standardization. ISO is not an abbreviation • ISO, historically is an international standards writing organization • ISO is a world-wide federation of national standards bodies • The U.S. is a member body (American National Standards Institute [ANSI] is the U.S. representative) • ISO maintains thousands of different standards, such as those for photography, and screw threads

  8. Creation of ISO 9001 • ISO Technical Committees (TCs) author standards • Draft standards (from TCs) are approved by member nations • International Standards exist to serve many diverse industry needs • TC176 was established in 1985. Its goal was to create a generic standard for Quality Assurance Systems • British Standard BS5750 modified and proposed as ISO 9001 • With input from U.S., Canadian, Military and other standards • ISO 9001 approved in 1987 by member bodies • First revision approved in 1994 • Second revision approved in 2000 • Third revision released in November 2008

  9. TC176 Set Out to Create a Document that: • Outlined commonly accepted requirements for quality assurance • Documented a common sense approach • Was not industry specific • Was not intrusive • Had organization wide impact • Provided tools for: • Cost reduction • Continuous improvement • Effective management control

  10. Registration Audits Drive Quality Improvement • Provides discipline • Established a baseline measurement • Causes an ongoing, organization-wide quality system analysis • Targets areas for corrective action • Provides feedback to management demands/management attention • Causes continuous improvement

  11. Impact of Conformance • Conformance is to a well defined system that is accepted internationally • Verification of the Quality Management System (QMS) on a regular basis by the audit process • Documented/defined practices that promote consistent results • Provides a benchmark for evaluating ongoing QMS effectiveness • Evidence of a documented QMS to show to customers • Enhanced employee involvement within a clearly defined system • Better trained workforce • A “preventive” attitude is instilled within the organization • Customers are more receptive to forming customer/supplier relationships

  12. Introduction and Orientation to ISO 9001:2008 Part 2

  13. Quality Management Principles(from ISO 9001:2008) Eight quality management principles have been identified to facilitate the achievement of quality objectives. • Customer focus: organizations depend on their customers and therefore should understand current and future needs, should meet customer requirements and should strive to exceed customer expectations. • Leadership: leaders establish unity of purpose, direction and the internal environment of the organization. They create the environment in which people can become fully involved in achieving the organization’s objectives. • 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 maximum benefit.

  14. Process approach: a desired result is achieved more efficiently when related resources and activities are maximum benefit. • System approach to management: identifying, understanding and managing a system of interrelated processes for a given objective contributes to the effectiveness and efficiency of the organization. • Continual improvement: a permanent objective of the organization is continual improvement. • Factual approach to decision making: effective decisions are based on the logical or intuitive analysis of data and information. • Mutually beneficial supplier relationships: the ability of the organization and its suppliers to create value is enhanced by mutually beneficial relationships.

  15. Purpose of ISO 9001:2008 • To assist organizations in the establishment and achievement of sound quality practices • To provide methods for organizations to achieve and demonstrate quality performance to customers • To provide organizations with a practical Quality management System model that can be integrated with existing or future management systems • ISO 9001:2008 shares management system principles with the ISO 14000 series of quality assurance • The ISO 9001:2008 and ISO 14001 management model will likely provide the basis of any future Health and Safety Standard proposed

  16. ISO 9001:2008 Is… • Written in such a way that it applies to all types and sizes of organizations • Independent of cultural, social or geographic conditions • Used for registration purposes as required by customer or market conditions • Not intended to increase or change the legal obligations of organizations • Not intended to create non-tariff trade barriers

  17. Some Important Notes • ISO 9001:2008 does not establish absolute requirements for quality performance • Adoption does not require or guarantee optimum quality outcomes • ISO 9001:2008 does require management commitment to an internally generated and implemented quality policy

  18. The ISO 9000 Family of DocumentsStatus as of August 2011 DocumentDateTitle ISO 9000 2005 Quality Management Systems- Fundamentals and vocabulary ISO 9001 2008 Quality Management Systems Requirements ISO 9004 2009 Quality Management System Guidelines for Performance Improvement ISO 10001 2007 Quality Management- Customer Satisfaction ISO 10002 2004 Customer Satisfaction- Guidelines for Complaint Handling in Organizations ISO 10003 2007 Customer Satisfaction – Dispute Resolution ISO 10005 2005 Guidelines for Quality Plans ISO 10006 2003 Quality Management Guidelines for Quality Management Projects ISO 10007 2003 Quality Management System Guidelines for Configuration Management

  19. Supporting Standards DocumentDateTitle ISO/TR 10013 2001 Guidelines for Quality Management System Documentation ISO 10015 2001 Guidelines for Training ISO 13485 2003 Medical Devices- Requirements for Regulatory Purposes ISO 14001 2004 Environmental Management Requirement ISO/TS 16949 2009 Quality Systems Requirements – Automotive ISO 17025 2005 Requirements for the competence of testing and calibration ISO 19011S 2008 Guidelines for Management Systems Auditing ISO 27001 2005 Information Security Management System Specification ANSI Z1.4 2003 Sampling procedures and tables for inspect by attributes

  20. Key Documents • Quality Management Systems – Fundamentals and vocabulary • Quality Management Systems – Requirements • Quality Management Systems – Guidelines for performance improvement 14001 Environmental Management System Requirements

  21. ISO 9001:2008 Causes • Clause 1: Scope • Clause 2: Normative Reference • Clause 3: Terms and Definitions • Clause 4: Quality Management System • Clause 5: Management Responsibility • Clause 6: Resource Management • Clause 7: Product (Service) Realization • Clause 8: Measurement, Analysis, and Improvement

  22. Continual Improvement Of The Quality Management System Customer Requirements Customer Satisfaction Management Responsibility Resource Management Measurement, Analysis and Improvement Output Input Product Realization Product Key Value-adding activities Information Flow The Process Model is the Basis for the Standard

  23. The Contents of ISO 9001:2008 Part 3 • Please refer to the ISO:9001-2008 standards for the actual text of requirements

  24. Required Procedures • 4.2.3 Control of Documents • 4.2.4 Control of Quality Records • 8.2.2 Internal Audit • 8.3 Control of Nonconforming Product • 8.5.2 Corrective Action • 8.5.3 Preventive Action

  25. Required Plans • 7.1 Planning of realization processes • 7.3.1 Design and/or development planning (not currently part of LGS scope) • 7.5.1 Plan and carry out production and service • 8.1 Measurement and monitoring activities

  26. Required Records • Record of management review • Record of education, experience, training and qualifications • Record of review of customer requirement and follow-up actions • Record of design and development input • Record of design and development review • Record of design verification actions • Record of design validation actions • Record of the results of the review of design changes • Record of the evaluation of suppliers • Record of the unique identification of the product • Record of lost, damaged or unsuitable customer property Record of the basis of calibration used when no traceable standards exist • Record of the results of calibration • Record of internal audits • Records of the authority to release product • Record of the nature of nonconformities and subsequent actions • Records of the results of corrective action • Record of the results of preventive action

  27. Required Reporting • Reports to top management on the performance of the QMS including needs for improvement • Reports to customers of unsuitable customer property • Reports on the results of internal audits • Reports on the results of internal audit verification activities

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