ISO

1. ISO INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

2. I.S.O. or ISO? • ISO is not an acronym, but was derived from a Greek word “isos” meaning “equal”. The relation to standards is that if two objects meet the same standard, they should be equal. • The International Organization for Standardization is a voluntary organization whose members are recognized standard authorities, each one representing one country. • The American National Standards Institute (ANSI) is the United States Representative to ISO. • ISO Main Headquarters in located in Geneva, Switzerland.

3. Some History • (AQAP) Allied Quality Assurance Publication..WW11. A series of publications on everything from production efficiency to selection of suppliers. • AQAP Series was adopted by the UK Ministry of Defense for the British Arms Forces. • A trickle down effect was more organizations began to require Quality Assurance Programs from their Suppliers. • 1979 British Standard (BS) 5750 adopted based largely on the AQAP Series. The British version addressed the diversity issues emerging in the requirements for different organizations.

4. More History • BS 5750 was so effective, it was adopted with very little changes by ISO in 1987 as ISO 9000. • The formation of the European Union and the perception that it (ISO) was required in order to do business with Europe, lead to the widespread acceptance of the ISO series.

5. MIL-Q-9858 & MIL-I-45208USA • ONE SIZE FITS ALL APPROACH • NO ALLOWANCE FOR INNOVATIONS-PROCESS MATURITY • POTENTIAL CUSTOMER COST SAVINGS LOST • DETAILED DESIGN SPECS REPLACED WITH PERFORMANCE-BASED SPECS. • IN 1996, THESE MODELS WERE SUPERCEDED WITH ANSI/ASQC Q-9000 SERIES

6. Commercial- Military Integration 1994-Acquisition Reform • Reduce total ownership costs • Reduce acquisition time • Promote standardization of materials, facilities,and engineering practices to improve military readiness

7. Defense Standardization Program • Gov’t unique specifications were a barrier to commercial-military integration • Cancelled or inactivated thousands of documents • Greater reliance on the use of non-government standards

8. Every ISO Member Body is responsible for: • Informing potentially interested parties in the country of relevant international standardization opportunities/initiatives • Ensuring that a concerted view of the country’s interest is presented during international negotiations leading to standards agreement • Providing their share of financial support for the central operations of ISO, through the payment of membership dues • Representing vendors, manufacturers, consumers, professionals and government of it’s country

9. Other Members • Correspondent Member-usually an organization in a country which does not yet have a fully developed national standards activity. Do not take an active part in the technical and policy development work, but are kept fully informed about the work of interest to them • Subscriber Membership-established for countries with very small economies. Subscribers members pay reduced membership fees that nevertheless allow them to maintain contact with international standardization.

10. How is it financed? • Membership dues-80% • Sales of Standards and other Publications-20% • Subscriptions are expressed in units and calculated in Swiss francs • Factors affecting dues: gross national product (GNP) and Value of imports and exports • Others expenditures: Voluntary time and travel for approx. 30,000 experts (several hundred million Swiss francs per year)

11. Who does the work? • A highly decentralized hierarchy of some 2850 technical committees, subcommittees and working groups. Hence the 30000 experts. The premise is that equal partners come together in the resolution of global standardization problems • Qualified representatives of; industry research institutes government authorities consumer bodies international organizations from all over the world

12. The Goal of ISO • Enhanced product Quality and Reliability at a reasonable price • Improved health and safety and environmental protection and reduction of waste-(ISO 14000) • Greater compatibility and interoperability of goods and services • Reduction in the number of models and thus, reduction in costs • Increased distribution efficiency and ease of maintenance • Simplification for improved usability

13. ISO and WTO • Strategic partnership-common goal of promoting free and fair global trading • WTO agreements require underpinning by technical agreements (ISO) • ISO recognized by WTO for special technical support in relationship to new and expanded WTO programs

14. Regional Partners • ISO has recognized regional standards organizations representing: • Africa • The Arab Countries • Commonwealth of Independent States • Europe • Latin America • The Pacific area • South-East Asia Nations

15. ISO Film Speed Code-among photographic equipment standards, it has been adopted worldwide to make things simpler for the user Telephone & Banking Cards-standardization of the format means that they can be used worldwide Internationally Standardized Freight Container-air, sea railways,highways packages interface efficiently. Other standardized documents identifying sensitive or hazardous cargoes making international trade cheaper, faster and safer. Paper Sizes-With ISO 216, standard paper sizes allow economies of scale with cost benefits to both producers and consumers Symbols for Automobile Controls-well designed symbol conveys a clear cut message in a multi-lingual world. These symbols are displayed in automobiles over the world, no matter where they were produced. 12,000 International Standards-more than 300,000 pages in English and French with terminology provided for other languages Others: Automobile bumper heights, sizes and colors of road signs, hygiene and toxicity in the food industry, nut /bolts combinations, light measurement in photography, child resistant packaging,standards for monitoring the state of the environment and standards for safety of machinery and protective clothing (Some) ISO “Achievements”

16. ISO 9000 Series • ISO 9001-applies to organizations that design, develop, produce, install and service product (Tenergy Water, for instance) • 20 sets of Quality System Requirements (Elements) • ISO 9002-applies to organizations that produce, install and service product • 19 sets of Quality System Requirements (Elements) • ISO 9003-applies to organizations that assure Quality through Final Inspection and Testing. • 16 sets of Quality System Requirements (Elements) (missing 4.4, 4.6, 4.9 and 4.19)

17. What exactly is ISO 9001? • A series of Standardized Quality System “Frameworks” which are designed to detect and prevent Quality problems. • There are 20 Elements in the ISO 9001 Standard. Each element outlines Quality issues which the company is required to address as part of the Quality System in order to be certified or compliant.

18. 1. Management Responsibility 2. Quality System 3. Contract Review 4. Design Control 5. Document and Data Control 6. Purchasing 7. Control of Customer Supplied Product 8. Product Identification and Traceability 9. Process Control 10. Inspection and Testing 11. Control of Inspection, Measuring & Test Equipment 12. Inspection & Test Status 13. Control Of Nonconforming Product 14. Corrective & Preventive Action 15. Handling, Storage, Packaging, Preservation & Delivery 16. Control of Quality Records 17. Internal Quality Audits 18. Training 19. Servicing 20. Statistical Techniques The Elements

19. 4.1 Management Responsibility • Commitment • Overall Plan • Steering Committee • Quality Objectives • Management Review • Appoint a senior executive ( The management Representative) to manage the quality system and give him/her the necessary authority to maintain it

20. Management Responsibility 2 • Define a Quality Policy. Policy should describe company’s attitude towards Quality • Identify and provide resources for people to manage, perform and verify Quality System work • Define Quality System responsibilities; insure Quality System personnel have the authority to carry out these responsibilities and ensure that interactions between these personnel are clearly specified. Document this well. • Define a procedure that Senior Managers can use to review the effectiveness of the Quality System

21. 4.2 Quality System • Develop the Quality System • A manual that describes it • Procedures, processes that are consistent with Quality Policy • Quality plans to show how you intend to fulfill quality system requirements • Develop plans for product, processes, projects and Customer Contracts

22. 4.3 Contract Review • Determine Requirements • Procedure to ensure that all contractual requirements are acceptable before agreement to provide product to customer • System for documenting review of customer contracts and sales orders • Procedure to amending contracts and ensuring changes are communicated throughout the organization

23. 4.4 Design Control • Procedures to control the design and development process • Identify groups involved and communication methods • Procedure to control design outputs • Design outputs at all stages verified • Design modifications-how are changes implemented? • Design inputs identified, documented, reviewed, flaws and deficiencies are resolved

24. 4.4.1 General 4.4.2 Design and development planning 4.4.3 Organizational and Technical Interfaces 4.4.4 Design Input Design Output Design review Design verification Design validation Design Changes Design Control 2

25. 4.5 Document & Data Control • Develop procedures to control quality system documents, records and data • Procedures to review, approve and manage all quality system documents, records and data • Procedures to control changes to documents and data

26. Supplier Selection-based on capability, performance history Customer Requirements Flowdown Ensure P.O.’s document precisely what to buy Purchase Order change control Procedures to verify the acceptability of purchases to you and the Customer List of Approved Suppliers-procedure to add or delete from the list Use of approved Suppliers 4.6 Purchasing

27. 4.7 Control of Customer Supplied Product • Correct & undamaged when received • Record & report to Customer damage, etc. • Traceable ownership • Identification and Use • Protect and Maintain (how & who) • Dispose as Customer directs

28. 4.8 Product Identification and Traceability • Identify and document products at every step from purchase through all stages of handling, storage, production, delivery, installation and servicing • Prevent product mixing • Trace product or product batches by means of unique identifiers and record keeping

29. 4.9 Process Control • Develop procedures to plan, monitor and control production, installation and servicing processes • Develop a record keeping system that monitors and controls process personnel and equipment • Insure that all important processes qualities are monitored and recorded

30. 4.10 Inspection & Testing • Quality Plan-decide where, when and how-(incoming, in-process and final inspections) • How records are maintained • Identification (Acceptance/Rejection) • Disposition (Acceptance/Rejection) • Procedures to ensure product meets all requirements prior to shipping

31. 4.11 Control of Inspection, Measuring & Test Equipm’t • Develop procedures to control, calibrate and maintain inspection, measuring/test equipment (hardware and software) • Ensure measurement equipment is appropriate, effective and secure • Calibration procedures for all quality measuring and test equipment

32. 4.12 Inspection & Test Status • Identify conformance status-accept/reject at all points of production process • The test status of the product is documented and respected throughout the production, installation and service process

33. Prevent from unintended use Documented Identify and segregate Disposition by qualified personnel (MRB) Observe contractural or regulatory limitations Identify root cause of defect Record of dispositions Reinspect/retest after rework and repair 4.13 Control of Nonconforming Product

34. 4.14 Corrective and Preventive Action • Implement at root cause of defect • Identify effectivity-date, lot, batch • Identify responsibility for the problem • Commensurate with the magnitude of problem and risks encountered • Anticipate problems-preventive action • Ensure effectivity of corrective/preventive actions

35. 4.15 Handling, Storage, Packaging, Preservation & Delivery • Methods to prevent damage or deterioration through all stages of production • Designate storage areas • Periodic assessment of material in storage • Identify shelf-life sensitive items • Protect to destination when required

36. 4.16 Control of Quality Records • What records are “Quality Records”? • How long to retain, where, how? • Define storage conditions • Customer availability • Hard copy or electronic media • Protect from unauthorized access and subsequent alteration

37. What we say we do Measure performance of the Quality System Scheduled events performed by qualified auditors independent of their functions Objective evidence Report to management for review Discuss with auditee Timely and appropriate corrective action Follow up for effectiveness 4.17 Internal Quality Audits

38. Identify needs Who to train? Who will provide the training? How will training be provided? Quality system training What is training schedule? How will training effectiveness be measured? What training records will be generated? 4.18 Training

39. 4.19 Servicing • Installation • Returned product-not defective • Technical information • Trained personnel • Procedures, materials, equipment • Train customer personnel

40. 4.20 Statistical Techniques • Establish, control & verify process capability • Measure product characteristics • Defined by qualified personnel • Documented procedures

41. WHY DO WE NEED IT? • can be Customer driven. • Inspires more confidence in products and services that conform to the same standards • Improves internal controls • Increases employee involvement • provides a competitive edge

42. Benefits for me? • Potential increase in business volume which means job stability • Outlet for ideas affecting Quality • More control of your job • Decrease in uncertainty of expectations • Less stress

43. Does it change how we do things? • No, in most cases. It means we document what we are already doing. • “Document what you do and do what you say you do.” • There would be some areas that will require written procedures to meet certain specific requirements.

44. Create procedures that meet the ISO Model for a Quality Management System Train internal auditors to perform system audits. Independent third party audit conducted by a Registrar for certification Maintain quality system. Audited every six months to remain certified The Process(in a nutshell)

45. ISO 9001:2000 Process Model

46. ISO 9001:2000 • Why are standards being revised? • What are the major changes? • What do we do now?

47. When will it happen? • Final standard release is scheduled for December 15, 2000. • In three (3) years from the actual publication release, ISO 9002 and ISO 9003 and all associated guidelines will be history. • ISO 9001 Quality Management Systems will have to be amended to comply with the new standard.

48. Why the need for change? • ISO required 5-year standards review • Difficult for small businesses • Oriented towards manufacturing • Proliferation of guideline standards • Need to reduce documentation

49. Some Changes • ISO 9001-ISO 9002-ISO 9003 (3 Stds) will become ISO 9001:2000 (1Std) • 20 Sections(Elements) Structure will become main 5 Sections based on 8 Principles • From a Quality Management System to a Business Management System

50. Process oriented/continual improvement Increased emphasis on role of Top Management Consideration of legal and regulatory requirements Establishment of measurable objectives/planning Determination of training effectiveness Measurement and analysis of system performance (process and product) Monitoring of information and customer satisfaction dissatisfaction Increased attention to resource availability KEY NEW REQUIREMENTS