Quality Management Systems: ISO 9001 BY MATTHEW FELTEN.
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Transcript of Quality Management Systems: ISO 9001 BY MATTHEW FELTEN.
Quality Management Systems: ISO 9001BY MATTHEW FELTEN
OverviewAbout 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 ISOInternational 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
ISO: International Organization for Standardization
What is ISO 9001Quality 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 9001Requirements 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 9001Enhancing 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 ResponsibilityManagement 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 RealizationPlanning 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 improvementCustomer 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
AuditingHow 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 9001ISO 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 9001Advantages
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.
Top 10 Countries for ISO 9001 Certificates - 2009
1 Chine 257076
2 Italy 130066
3 Japan 68484
4 Spain 59576
5 Russian Federation 53152
6 Germany 47156
7 United Kingdom 41193
8 India 37493
9 USA 28935
10 Korea, Republic of 23400
2012 ReportAt 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
Questions
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