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Quality Management Systems: ISO 9001

Quality Management Systems: ISO 9001

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Quality Management Systems: ISO 9001

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  1. Quality Management Systems:ISO 9001 By Matthew Felten

  2. Overview • About ISO • What is ISO 9001 • Contents of ISO 9001 • Evolution of ISO 9001 • Impact of using ISO 9001 • Who is all using ISO 9001? • Benefits and Issues of using ISO 9001

  3. About ISO • International Organization of Standards : ISO • Because of the name creating different acronyms in different languages, went with ISO which was derived from the Greek isos, meaning equal. • Began operations in 1947 • Goal to create voluntary international standards • Started with delegates from 25 different countries • Since created over 19,500 international standards • Members in 164 countries

  4. About ISO cont. • Worlds largest developer of International Standards • Standards created from people all over the world • ISO 9001 is used by over a million organizations alone • ISO is a non-government organization • that helps create standards to help both the government sector and private companies. • This creates standards that can be used in a more broad sense • helping both groups with usable standards • Standards usable in organizations both big and small

  5. ISO: International Organization for Standardization

  6. What is ISO 9001 • Quality management standard • Sets the requirements of a Quality management system • Can be used by any organization, large or small • Over a Million companies are certified to ISO 9001 in over 170 countries • Focus on Quality management principles • Strong customer focus • Motivation of top management • Process approach • Continual improvement

  7. Contents of ISO 9001 • Requirements of ISO 9001 • Scope (not audited) • Normative references (not audited) • Terms and definitions (not audited) • Quality management system • Management responsibility • Resource Management • Product Realization • Measurement, Analysis and Improvement

  8. Main Ideology of ISO 9001 • Enhancing customer satisfaction • To increase customer satisfaction quality must be increased • Continually improve the process • By continuing to work on the process so quality can continually be increased. • Both goals work off each other. • Increase in quality increases customer satisfaction • This is done by continuing improvements to ones current process. • Main focus is quality management systems of manufacturing • Major differences between Software production and manufacturing of goods • Note: Focus on the process but not the actual product.

  9. Quality Management System • General Requirements • Determine Process needed for a Quality Management System • Use of the next four requirements to create a usable system • Documentation of a Quality Management System • To help make the process standardized • Implementation of a Quality Management System • The business actually needs to create product with the system. • Maintenance of a Quality Management System • Largest part of the standard

  10. Quality Management System cont. • Documentation Requirements • Quality Policy • Formal statement from management • Linking business, marketing plan and customer needs • A Quality Manual • Scope of Quality Management System • Describes changes to system from recorded data • Control of Documents • Who changed what, what was changed and when it changed • Records from planning, and operations in process • Legible, readily identifiable and retrievable

  11. Management Responsibility • Management Commitment • Need to establish the quality, conduct reviews • Customer Focus • Communicate with customer to establish quality • Quality Policy • Formal statement from management • Responsibility, Authority and Communication • Management representative • Management Review • Planned reviews to find improvements

  12. Resource Management • Human Resources • Correct education, training, skills and experience • Infrastructure • Buildings and workspaces • Equipment – both hardware and software • Supporting Services • Work Environment • Temperature • Noise • Lighting

  13. Product Realization • Planning of product realization • This is the requirements gathering phase of process • Customer-related processes • Requirements and feedback • Design and development • Process for design and development • Waterfall or Agile? • Clearly define design and development stages • Purchasing • Production and service provision

  14. Measurement, analysis and improvement • Customer Satisfaction • Internal audits: checking on the quality management system • Control of nonconforming product • This is looking at products that were not of acceptable quality • Software projects over budget, past deadlines • Analysis of data • Customer satisfaction • Conformity of the product compared to requirements • Trends in the process, ways to fix or prevent these trends • Improvement • Corrective and preventive actions

  15. Auditing • How do you become registered in ISO 9001? • Audit by internal staff trained for this process • Audit by external certification body • Audits are to ensure reviews and improvements are happening • ISO has no part in any of this • Companies not connected to ISO do all accreditations • ISO simply develops the standards • 1994 standard asked if you followed what the manual said? • 2000 standard asked if it is a good process, or can it be done better?

  16. Evolution of ISO 9001 • ISO 9001:1987 • First version of ISO 9001 • Structured off British standard BS 5750 • ISO 9001:1994 : • Changes for preventative actions • ISO 9001: 2000 : • Included upper management • Add standard 9002 and 9003 to 9001 • ISO 9001: 2008 : • No major additions, just explanations • ISO 9001: 2015

  17. Impact of ISO 9001 • Advantages • Optimization can decreases company expenses • Increase communication • Management control • Increase customer satisfaction • Disadvantages • Can be expensive to become accredited • Massive amounts of documentation • Initial time investment is large • Note: Being accredited is optional, some companies may fallow ISO9001 but may not actually be accredited.

  18. 2012 Report • At least 1,101,272 as of December 2012 • Certificates issued in 184 countries • Top three countries for certificates • China • Italy • Spain • Top three countries for growth • Spain • China • Romania

  19. Questions

  20. References • Video - http://www.youtube.com/watch?v=AYBVTeqKahk • About ISO - http://www.iso.org/iso/home/about.htm • About 9001 - http://www.iso.org/iso/iso_9000.htm • 9001 contents - https://www.iso.org/obp/ui/#iso:std:iso:10001:ed-1:v1:en • Cont. - http://dent.ksu.edu.sa/fportal/sites/default/files/iso_9001_2008_fourth_edition.pdf • Evolution – www.kcg.com.sg/history-iso9000.html • ISO9001:2015 - http://www.nsai.ie/ISO-9001-2015-Revision-Update.aspx • Past Data – www.iso.org/iso/survey2009.pdf • 2012 report – www.iso.org/iso/iso_survey_executive-summary.pdf • Advantages - http://www.inc.com/encyclopedia/iso-9000.html/1 • Manufacturing vs. Software - http://www.oskarsson.se/useful_info/ISO9000/Ch2.htm