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The ISO 9000 Standards for Quality Management Systems. ISO stands for “ I nternational S tandards O rganization” The source of ISO 9000 and more than 13,000 international standards for business government and society

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The ISO 9000 Standards for Quality Management Systems

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    1. The ISO 9000 Standards for QualityManagement Systems • ISO stands for “International Standards Organization” • The source of ISO 9000 and more than 13,000 international standards for business government and society • A network of national standards institutes from 140 countries working in partnership with international organizations governments industry business and consumer representatives. A bridge between public and private sectors. • Note: ISO has an excellent website: Alan G Robinson@2002

    2. The ISO 9000 Family

    3. Standards and Guidelines Purpose • ISO 9000:2000 Quality management systems - Fundamentals and vocabulary Establishes a starting point for understanding the standards and defines the fundamental terms and definitions used in the ISO 9000 family which you need to avoid misunderstandings in their use. • ISO 9001:2000Quality management systems – Requirements This is the requirement standard you use to assess your ability to meet customer and applicable regulatory requirements and thereby address customer satisfaction. It is now the only standard in the ISO 9000 family against which third-party certification can be carried.

    4. Standards and Guidelines Purpose(Cont’d) • ISO 9001:2000Quality management systems - Requirements This is the requirement standard you use to assess your ability to meet customer and applicable regulatory requirements and thereby address customer satisfaction. It is now the only standard in the ISO 9000 family against which third-party certification can be carried. • ISO 9004:2000Quality management systems - Guidelines for performance improvements This guideline standard provides guidance for continual improvement of your quality management system to benefit all parties through sustained customer satisfaction.

    5. Standards and Guidelines Purpose(Cont’d) • ISO 19011 Guidelines on Quality and/or Environmental Management Systems Auditing (currently under development) Provides you with guidelines for verifying the system's ability to achieve defined quality objectives. You can use this standard internally or for auditing your suppliers. • ISO 10005:1995 Quality management - Guidelines for quality plans Provides guidelines to assist in the preparation review acceptance and revision of quality plans.

    6. Standards and Guidelines Purpose(Cont’d) • ISO 10006:1997Quality management - Guidelines to quality in project management Guidelines to help you ensure the quality of both the project processes and the project products. • ISO 10007:1995Quality management - Guidelines for configuration management Gives you guidelines to ensure that a complex product continues to function when components are changed individually.

    7. Standards and Guidelines Purpose(Cont’d) • ISO/DIS 10012Quality assurance requirements for measuring equipment - Part 1: Metrological confirmation system for measuring equipment Give you guidelines on the main features of a calibration system to ensure that measurements are made with the intended accuracy. • ISO 10012-2:1997Quality assurance for measuring equipment - Part 2: Guidelines for control of measurement of processes Provides supplementary guidance on the application of statistical process control when this is appropriate for achieving the objectives of Part 1.

    8. Standards and Guidelines Purpose(Cont’d) • ISO 10013:1995 Guidelines for developing quality manuals Provides guidelines for the development and maintenance of quality manuals tailored to your specific needs. • ISO/TR 10014:1998 Guidelines for managing the economics of quality Provides guidance on how to achieve economic benefits from the application of quality management.

    9. Standards and Guidelines Purpose(Cont’d) • ISO 10015:1999Quality management - Guidelines for training Provides guidance on the development implementation maintenance and improvement of strategies and systems for training that affects the quality of products. • ISO/TS 16949:1999Quality systems - Automotive suppliers Particular requirements for the application of ISO 9001:1994 Sector specific guidance to the application of ISO 9001 in the automotive industry.

    10. What Is A Quality System? A system of MANAGEMENT which assures that PLANNINGis carried out such that ALL staff know what is EXPECTED and HOW to achieve the SPECIFIED results.

    11. The Purpose of A Quality System The technical, administrative and human factors affecting the quality of (the company’s) products and services will be under control. All such control should be oriented towards the reduction, elimination and, most importantly, prevention of quality deficiencies ...... the quality management system (should) be appropriate to the type of activity and to the product or service being offered.” ISO 9004

    12. According to Ian Durand • “Less than 1 percent of the small and midsize companies in the U.S. presently have a quality system that comes close to satisfying the requirements of ISO 9001 or 9002.” • “In a survey of 600 companies, less than 10 percent of the cost of registration was spent on the registrars themselves.” • The cost is not for the registrars; it is for the internal work to put the system in place.

    13. Who Is Getting Registered

    14. 9000 And 14000: The Engines Are The Same • Management responsibility • Document control • Corrective action • Internal auditing SAC Do Plan Act Check Audit

    15. The Cost of Quality (COQ) • For most U.S. companies, COQ amounts to between 20% to 40% of sales. In most companies, the cost of poor quality is a large sum, frequently larger than the company’s profits. Frank Gryna • COQ is comprised of: Internal Failure Costs: Scrap, rework, failure analysis, scrap and rework (suppliers), downgrading, 100% sorting inspection, reinsertions/retest, avoidable process losses. External Failure Costs: Warranty costs, complaint adjustment, returned material, cost of concessions, liability, litigation.

    16. The Cost of Quality (COQ) (cont’d) Appraisal costs: Receiving inspection and test, in-process inspection and test, final inspection and test, product quality audits, calibration of test equipment, evaluation of materials inventory. Prevention costs: Training, supplier quality evaluation, quality planning, new-products review, corrective action system, process planning and control.

    17. The Cost of Quality (COQ) (Cont’d) • One local manufacturing has COQ in excess of 50% of sales. • A typical profile: Failure costs .......... 80% of COQ Appraisal costs …….. 15% of COQ Prevention Costs .......... 5% of COQ Do it right the first time!

    18. Quality IS Productivity • There is a direct relationship between productivity and quality. As quality goes up, so does productivity. Quality and productivity are different aspects of the same thing. W. Edwards Deming Manpower is something that is beyond measurement. Capabilities can be extended indefinitely when every one begins to think. Taiichi Ohno • ISO 9000 is really a process improvement standard. It will improve your quality and productivity at the same time. • COQ at world-class companies runs under 1%. The medicine works ... but only if the patient takes it!

    19. [ Insert “Talk about the cost of quality!” ] from Chase + Aquilaro

    20. 1) If a company representative tells you that his company is ISO certified, is he telling you the whole story? 2) Can you be assured that products you buy from a company that is ISO 9000 certified are of the highest quality? 3) Will ISO 9000 certification become a requirement for doing business in Europe within the next year? Yes No Yes No Yes No A Quiz

    21. The Idea Behind The Standards Malcolm Baldrige National Quality Award: Get the process right and the results will follow. ISO 9000: Document your quality system and adhere to what you have documented. Improvement will follow. You can’t hope to get the MBNQA or the Deming Prize if you are not implementing ISO 9000. George Lofgren President Registrar Accreditation Board

    22. The Need For International Standards • Increasing emphasis on process, rather than product. There’s no inspector half as effective as a well-controlled process. • Increasing cost of customer audits: • sometimes more than 1 per week; • all look for essentially same things, except for possible difference in emphasis. • Proliferation of alternative definitions of “quality management systems” could raise costs, hamper production, and hinder trade. • MIL-Q-9858A, FDA Good Management Practices (GMPs), ANSI C1, ANSI Z1.15, AQAP-1, Malcolm Baldrige, European Quality Award, Shingo Prize, Deming Prize, Juran Prize, Ford Q101 criteria, GM Target for Excellence, JUSE TQM program.

    23. need well-implemented quality assurance system in place to prevent defects; • need to be able to prove that was prudent and all reasonable measures were taken. • On the other hand: • discovery can allow lawyers to see exactly what you were and weren’t doing. (Still no established case law.) • A single set of worldwide standards would promote economic cooperation, and reduce protectionism and trade wars. A win-win situation for everyone. • Do it once, do it right, do it internationally. • Lawrence D. Eicher • ISO Secretary General • June 1991 Liability issues if damage occurs and your products are involved:

    24. The International Standards Organization (ISO) • Founded in 1947. 143 member countries. • Purpose: 1) to develop, publish, and promote worldwide standards; 2) to facilitate exchange of goods and services; 3) to foster cooperation in intellectual, scientific, technological and economic areas. • Has staff of 665: 500 are production and services staff; 165 involved in coordination work.

    25. ISO Members 143 national standards bodies, comprising • 93 member bodies • 36 correspondent members • 14 subscriber members

    26. ISO Member Bodies • United States: American National Standards Institute (ANSI) • Great Britain: British Standards Institution (BSI) • Japan: Japanese Industrial Standards Committee (JISC) • France: Association Francaise de Normalisation (AFNOR) • Russian Federation: Committee of the Russian Federation for Standardization (GOSTR) • India: Bureau of Indian Standards (BIS) • China: China State Bureau of Technical Supervision (CSBTS) • Jamaica: Jamaica Bureau of Standards (JBS) • Italy: Ente Nazionale Italiano di Unificazione (UNI) • Brazil: Associacao Brasileira de Normas Tecnicas (ABNT) • South Korea: Bureau of Standards (KBS) Result: ISO is administering a system with 500,000 people in it.

    27. ISO 9000 National Standards Cross Referenced

    28. How New Standards Are Developed Decision made to develop new standard Technical Committee (TC) formed TC develops the new standard, using input from Technical Advisory Groups (TAGs) of each participating member country ISO administers voting process ISO does editing and publishing Any member countries may adopt standard directly

    29. The ISO 9000 Standards ISO ISO TC 176 ANSI USTAG 176 Your Comments

    30. “Product” A mixture of: • Hardware: tangible; discrete assembled product. • Processed material: tangible; bulk. • Software: intangible; intellectual in origin. • Service: intangible. “Product” = all of above, so standard is much broader. ISO 9000 now requires companies to manage much more than it used to!

    31. Who you gonna call? • To get copies of U.S. standards, contact ASQC at: (800) 248-1946, or or ANSI at: (212) 642-4900 or • To get copies of ISO standards, call ISO at: 011-41-22-7490111 or call Global Engineering Documents at: (800) 854-7179 or

    32. Supplier Purchaser DESIGN AND DEVELOPMENT (OLD ISO 9001) • Must use when innovative design services expressed in performance terms are directly part of the contract: specific design for customer • does not apply if you are selling only different configurations to customers: • furniture. • automobiles; Example: If ask for washing machine with special sock-folder, and a trumpet announcement at end of cycle, then 9001 situation.

    33. Supplier Purchaser Purchaser Purchaser Purchaser NOT DESIGN AND DEVELOPMENT (OLD 9002) Off the shelf • For use when selling items built to specifications or when manufacturing to external designs. • For example, walk into washing machine store and • buy one from stock; • order one from catalog configured to your tastes. • Key: Can I ask for innovative custom design?

    34. The Early Driving Force Certification Options When Conforming to Harmonized Standards by Product Category: • Type of Product: Machinery: Non-dangerous machines Manufacturer’s Options: Self-declaration • Type of Product: Machinery: Dangerous machines Manufacturer’s Options: Submit a technical dossier to a notified body to certify compliance with standard or Submit a model for type-examination by a notified body

    35. The Early Driving Force (Cont’d) • Type of Product: Personal Protection Equipment: Simple design Manufacturer’s Options: Self-declaration • Type of Product: Personal Protection Equipment: Complex design Manufacturer’s Options: EC type-examination or Certification by a notified body of EC quality control system for the final product (EN 29002/ISO 9002) or • Certification by a notified body of system for ensuring EC quality of production by means of monitoring (EN 29003/ISO 9003) EC adopted ISO 9000 standards word for word.

    36. Broad EC Directives • Product Liability Directive: A manufacturer of a product is liable, regardless of fault or negligence, if a person is harmed or an object is damaged by a faulty product. • Product Safety Directive: Managers must permanently monitor the safety of their products throughout their foreseeable useful life.

    37. Broad EC Directives (Cont’d) • Service Liability Directive: 1.The supplier of a service shall be liable for damage to the health and physical integrity of persons or the physical integrity of movable or immovable property, including the persons or property which were the object of the service, caused by a fault committed by him in the performance of the service. 2.The burden of proving the absence of fault shall fall upon the supplier of the service. 3. In assessing the fault, account shall be taken of the behavior of the supplier of the service, who, in normal and reasonably foreseeable conditions, shall ensure the safety which may reasonably be expected.

    38. Removing Trade Barriers • There are two kinds of product: regulated and unregulated. • Regulated products are those for which the EU has stepped in to pass Europe-wide directives. They are products that the EU feels have significant and health, safety, or environmental issues associated with them. According to U.S. Dept. of Commerce, regulated products make up some 50 percent of U.S. exports to Europe. • Unregulated products are those for which no specific European-wide directives have been made. • Trade barriers removed by EC laws requiring mutual acceptance and recognition of unregulated and regulated products that meet EU directives and/or the health, safety and environmental concerns of the receiving state.

    39. Which Products Are Regulated • In cases where: Member states have legitimately imposed technical requirements; and Conflicting national rules restrict the free movement of products within the EC; then A product directive is issued. • Some directives have ISO 9001 as an option • Some directives require ISO 9001

    40. More Examples • Construction products: At a minimum, manufacturer’s certification of production quality assurance system (EN 29002 and EN 29003 equivalent) • Gas appliances: EC type-examination and Quality assurance system certification or On-site checks of appliances

    41. More Examples • Non-automatic weighing instruments (commercial scales): EC type-examination and Quality assurance certification ( EN 29002) or EC verification • Telecommunications terminal equipment: EC type-examination or Declaration of conformity with full quality assurance (EN 29001)

    42. More Examples • Medical devices: Various options depending on risk level, ranging up to full quality assurance ( EN 29001) or EC type-examination and Production quality assurance ( EN 29002)

    43. Adopted Product Directives That Reference ISO9000

    44. Adopted Product Directives That Reference ISO9000 (Cont’d)

    45. Planned Product Directives

    46. Important Point • Manufacturers may have to meet requirements of more than one directive e.g. Air conditioners must meet 5 different directives: • machine safety; • pressure vessels; • construction products; • electromagnetic compatibility; • low voltage. • ISO 9000 registration may be a broader requirement than appears at first sight!

    47. A Self-Spawning Process • ISO 9001 and 9002 require procedures to be in place for assuring supplier quality: It is recommended that ISO 9001, ISO 9002 or ISO 9003, as appropriate, be used when purchasing products or services. ISO 9004-2 Guidelines for Service Leads to requiring suppliers to be ISO registered. • Case: Supplier 1: good price, good quality; Supplier 2: good price, good quality, ISO 9000 registered. ISO 9000 registered customer. Who gets the contract?

    48. The Bottom line Virtually every purchase agreement, contract and specification written by European industries, institutions, and governments will likely include a “boilerplate” requirement that mandates a contractors to demonstrate compliance with ISO 9000. John J. Kendrick

    49. Rough Implementation Profile 1. Set up a steering group 2. Review existing procedures against the appropriate ISO 9001-9003 standard requirements 3. Identify what needs to be done 4. Establish a program 5. Define and implement new procedures 6. Compile quality manual 7. Meet with assessment body 8. Submit manual for approval 9. Assessor’s visit 10. Certification Source: ISO 9000 Is Coming, Dupont Electronics.

    50. Getting Registered • A product is certified, a quality system is registered. • When you receive registration, you cannot put the registrar’s logo on your products. • Choose your registrar carefully: • caveat emptor; • not all registrars are accredited by appropriate bodies for • your markets; • different registrars apply the criteria differently; • different registrars have different fees/polices. • Worldwide registration system is still disorganized. BIGGEST PROBLEM WITH REGISTRATION: WHO PAYS THE REGISTRARS