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

12. 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

13. 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

14. 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

15. 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

17. 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?

18. 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

19. 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.

20. Top 10 Countries for ISO 9001 Certificates - 2009 1Chine257076 2Italy130066 3Japan68484 4Spain59576 5Russian Federation53152 6Germany47156 7United Kingdom41193 8India37493 9USA28935 10Korea, Republic of23400

21. 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

22. Questions

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