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