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Quality Management Systems: ISO 9001. By Matthew Felten. 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. About ISO. International Organization of Standards : ISO
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Quality Management Systems:ISO 9001 By Matthew Felten
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
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
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
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
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
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.
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
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
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
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
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
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
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?
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
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.
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
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