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 ID: 677304
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Slide1
Quality Management Systems: ISO 9001
By Matthew FeltenSlide2
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 9001Slide3
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
i
sos, 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 countriesSlide4
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 smallSlide5
ISO: International Organization for StandardizationSlide6
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
improvementSlide7
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 ImprovementSlide8
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.Slide9
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 standardSlide10
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 retrievableSlide11Slide12
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 improvementsSlide13
Resource ManagementHuman Resources
Correct education, training, skills and experience
Infrastructure
Buildings and workspaces
Equipment – both hardware and software
Supporting Services
Work Environment
Temperature
Noise
LightingSlide14
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 provisionSlide15
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 actionsSlide16Slide17
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?Slide18
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 Slide19
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.Slide20
Top 10 Countries for ISO 9001 Certificates - 20091
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
23400Slide21
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
RomaniaSlide22
Questions Slide23
ReferencesVideo -
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