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  • Promulgate-to publish, to proclaim. Propreitary-manufactured and sold only by the owner of the patent, formula, brand name, or trademark associated with the product: proprietary medicine . While ISO defines itself as a non-governmental organization , its ability to set standards that often become law, either through treaties or national standards, makes it more powerful than most non-governmental organizations[ citation needed ]. In practice, ISO acts as a consortium with strong links to governments
  • ISO is not an acronym or initialism for the organization's full name in either official language. Rather, the organization adopted ISO based on the Greek word isos (ἴσος), meaning equal . Recognizing that the organization’s initials would be different in different languages, the organization's founders chose ISO as the universal short form of its name. This, in itself, reflects the aim of the organization: to equalize and standardize across cultures. ISO also publishes Technical Reports, Technical Specifications, Publicly Available Specifications, Technical Corrigenda, and Guides. International Standards are identified in the format ISO[/IEC][/ASTM] [IS] nnnnn[:yyyy] Title , where nnnnn is the number of the standard, yyyy is the year published, and Title describes the subject. IEC for International Electrotechnical Commission is included if the standard results from the work of ISO/IEC JTC1 (the ISO/IEC Joint Technical Committee). ASTM is used for standards developed in cooperation with ASTM International .
  • Member bodies are national bodies that are considered to be the most representative standards body in each country. These are the only members of ISO that have voting rights. Correspondent members are countries that do not have their own standards organization. These members are informed about ISO's work, but do not participate in standards promulgation. Subscriber members are countries with small economies. They pay reduced membership fees, but can follow the development of standards.
  • ISO documents are copyrighted and ISO charges for copies of most
  • Certification body-ANSI/BSI. Certification to an ISO 9001 standard does not guarantee any quality of end products and services; rather, it certifies that formalized business processes are being applied. Although the standards originated in manufacturing , they are now employed across several types of organizations. A "product", in ISO vocabulary, can mean a physical object, services, or software .
  • The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs. The quality policy is understood and followed at all levels and by all employees. Each employee needs measurable objectives to work towards. Decisions about the quality system are made based on recorded data and the system is regularly audited and evaluated for conformance and effectiveness. Records should show how and where raw materials and products were processed, to allow products and problems to be traced to the source. You need to determine customer requirements and create systems for communicating with customers about product information, inquiries, contracts, orders, feedback and complaints. When developing new products, you need to plan the stages of development, with appropriate testing at each stage. You need to test and document whether the product meets design requirements, regulatory requirements and user needs. You need to regularly review performance through internal audits and meetings. Determine whether the quality system is working and what improvements can be made. Deal with past problems and potential problems. Keep records of these activities and the resulting decisions, and monitor their effectiveness (note: you need a documented procedure for internal audits). You need documented procedures for dealing with actual and potential nonconformances (problems involving suppliers or customers, or internal problems). Make sure no one uses bad product, determine what to do with bad product, deal with the root cause of the problem and keep records to use as a tool to improve the system.
  • Iso

    1. 1. ISO
    2. 2. What is a standard? <ul><li>Standards are written guidelines which help to do things, or make things, more efficiently or more safely. </li></ul><ul><li>They are written through a formal prescribed process which involves consultation with relevant bodies and reaching consensus across all interested parties so that the final document meets the needs of business and society. </li></ul><ul><li>All standards take the form of either: specifications, methods, vocabularies, codes of practice or guides. </li></ul>
    3. 3. What is ISO? <ul><li>International Organization for Standardization. </li></ul><ul><li>An International-Standard setting body. </li></ul><ul><li>Founded on 23 February 1947. </li></ul><ul><li>promulgates worldwide proprietary industrial and commercial standards. </li></ul><ul><li>headquarters in Geneva, Switzerland. </li></ul><ul><li>non-governmental organization. </li></ul><ul><li>two official languages, English and French. </li></ul><ul><li>ISO has 158 (of 195) national members. </li></ul>
    4. 4. About… <ul><li>Name and abbreviation. </li></ul><ul><li>main products are the International Standards. </li></ul><ul><li>ISO also publishes Technical Reports, Technical Specifications, Publicly Available Specifications, Technical Corrigenda, and Guides </li></ul><ul><li>International Standards are identified in the format ISO[/IEC][/ASTM] [IS] nnnnn[:yyyy] Title </li></ul><ul><li>( IEC for International Electrotechnical Commission) </li></ul><ul><li>- the std. is a work of ISO/IEC JTC1 (the ISO/IEC Joint Technical Committee). </li></ul>
    5. 6. <ul><li>ISO documents are copyrighted. </li></ul><ul><li>Not Open source. </li></ul>About…
    6. 7. List of some ISO Standards <ul><li>ISO 1 Standard reference temperature for geometrical product specification and verification </li></ul><ul><li>ISO 1000 SI units and recommendations for the use of their multiples and of certain other units </li></ul><ul><li>ISO 9000 Quality management system in production environments </li></ul><ul><li>ISO 9001 Quality management </li></ul><ul><li>ISO 10006 Quality management — Guidelines to quality in project management </li></ul><ul><li>ISO 14001 Environmental management standards </li></ul><ul><li>ISO/IEC 20000:2005 IT Service Management System (based on BS15000) </li></ul><ul><li>ISO 31000 — Risk Management </li></ul><ul><li>ISO/IEC 80000 — Quantities and Units </li></ul>
    7. 8. ISO 9000 <ul><li>ISO 9000 is a family of standards for quality management systems. </li></ul><ul><li>maintained by ISO. </li></ul><ul><li>administered by accreditation and certification bodies. </li></ul><ul><li>Companies are &quot;ISO 9001 certified&quot; or &quot;ISO 9001 registered&quot;. </li></ul>
    8. 9. ISO 9000 series of standards <ul><li>includes:- </li></ul><ul><li>ISO 9001:2008 Quality management systems – Requirements (also – 9000 series like 9002, 9003) </li></ul><ul><li>ISO 9004:2000 Quality management systems - Guidelines for performance improvements </li></ul><ul><li>ISO 9001: Version includes – </li></ul><ul><ul><ul><li>1987 </li></ul></ul></ul><ul><ul><ul><li>1994 </li></ul></ul></ul><ul><ul><ul><li>2000 </li></ul></ul></ul><ul><ul><ul><li>2008 </li></ul></ul></ul><ul><li>ISO 9001:2000 combines the three standards 9001, 9002, and 9003 into one, called 9001 </li></ul>
    9. 10. ISO 9001:2008 Quality management systems — Requirements <ul><li>Page iv: Foreword </li></ul><ul><li>Pages v to vii: Section 0 Introduction </li></ul><ul><li>Pages 1 to 14: Requirements </li></ul><ul><ul><li>Section 1: Scope </li></ul></ul><ul><ul><li>Section 2: Normative Reference </li></ul></ul><ul><ul><li>Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000) </li></ul></ul><ul><li>Pages 2 to 14 </li></ul><ul><ul><li>Section 4: Quality Management System </li></ul></ul><ul><ul><li>Section 5: Management Responsibility </li></ul></ul><ul><ul><li>Section 6: Resource Management </li></ul></ul><ul><ul><li>Section 7: Product Realization </li></ul></ul><ul><ul><li>Section 8: Measurement, analysis and improvement </li></ul></ul>
    10. 11. ISO 9001:2008 Quality management systems — Requirements <ul><li>The standard specifies six compulsory documents: </li></ul><ul><li>Control of Documents (4.2.3) </li></ul><ul><li>Control of Records (4.2.4) </li></ul><ul><li>Internal Audits (8.2.2) </li></ul><ul><li>Control of Nonconforming Product / Service (8.3) </li></ul><ul><li>Corrective Action (8.5.2) </li></ul><ul><li>Preventive Action (8.5.3) </li></ul><ul><li>Also, Quality Policy & Quality Manual </li></ul>
    11. 12. Summary of ISO 9001:2008 in informal language <ul><li>See also, </li></ul><ul><li> </li></ul>
    12. 13. Questions?