Benefits of an ISO 9001 Quality Management System
1
What is ISO 9001
An international standard that defines requirements for establishing a quality
management system to control and manage your processes to better serve your
customer.
Other documents in ISO 9000 family:
•
ISO 9000;2005 fundamentals and vocabulary
•
ISO 9001:2008 Quality Management systems – Requirements
•
ISO 9004:2009 Managing for the sustained success of an organization
•
ISO 19011;2011 Guidelines for auditing management systems
•
ISO 10014:2006 Guidelines for realizing financial and economic benefits
•
ISO 10003:2007 Customer satisfaction – guidelines for dispute resolution external
to organizations
2
ISO in brief
•
•
•
•
•
•
ISO is the International Organization for Standardization. ISO has a membership of some 160*
national standards bodies from countries large and small, industrialized, developing and in
transition, in all regions of the world.
ISO’s portfolio of over 18600* standards provides business, government and society with practical
tools for all three dimensions of sustainable development : economic, environmental and social.
ISO standards make a positive contribution to the world we live in. They facilitate trade, spread
knowledge, disseminate innovative advances in technology, and share good management and
conformity assessment practices.
ISO standards provide solutions and achieve benefits for almost all sectors of activity, including
agriculture, construction, mechanical engineering, manufacturing, distribution, transport, medical
devices, information and communication technologies, the environment, energy, quality
management, conformity assessment and services.
ISO only develops standards for which there is a clear market requirement. The work is carried out
by experts in the subject drawn directly from the industrial, technical and business sectors that
have identified the need for the standard, and which subsequently put the standard to use. These
experts may be joined by others with relevant knowledge, such as representatives of government
agencies, testing laboratories, consumer associations and academia, and by international
governmental and nongovernmental organizations.
An ISO International Standard represents a global consensus on the state of the art in the subject
of that standard.
3
10 good things ISO standards can do for SMEs
1. Standards help you compete on a level playing field with bigger enterprises
2. Standards open up export markets for your products and services
3. Standards help you discover best business practices
4. Standards drive efficiency in your business operations
5. Standards add credibility and confidence for your customers
6. Standards open new business opportunities and sales
7. Standards give you the competitive edge
8. Standards make your brand name internationally recognized
9. Standards help your company grow
10. Standards enable a common “language” to be used across an industry sector
4
ISO Facts
•
Over 1,000,000 companies certified to ISO 9001 around the world
•
The standard celebrated its 25th anniversary in 2012
•
ISO 9001 is recognized around the world
•
Companies certified represent a variety of fields and industries
•
Companies as small as one person have been certified
5
Benefits of ISO 9001
•
Improvement in the way an organization does business
•
Satisfied customers by meeting their requirements
•
Increased market share
•
Compete globally
•
Minimize waste, scrap and rework
•
Increase customer confidence
•
Improve the bottom line of the business
6
Benefits of ISO 9001
Customers and users benefit by receiving the products and services that are:
• Conforming to the requirements
• Dependable and reliable
• Available when needed
• Maintainable
Owners and investors benefit by:
• Increased return on investment
• Improved operational results
• Increased market share
• Increased profits
• Mandatory internal audits & reviews
People in the organization benefit by:
• Better working conditions
• Better process flow and control
• Increased job satisfaction
• Improved health and safety
• Improved morale
Society benefits by:
• Fulfillment of legal and regulatory requirements
• Improved health and safety
• Reduced environmental impact
• Increased security
7
Model of a process based quality management system
8
Quality Management Principles
The Standard is built upon eight fundamental principles of
quality management, embedded into its various requirements.
•
•
•
•
•
•
•
•
Customer focus
Leadership
Involvement of people
Process approach
Systems approach to management
Continual improvement
Factual approach to decision making
Mutually beneficial supplier relationships.
9
Quality Management Principles
1 Focus on customers.
A successful organization does this. It's critical to understand what your customers want, what they
need and meet their requirements. You also need to have ways of keeping in touch with how they
perceive your performance, that is how well they (not you!) think you've met their requirements.
2 Provide leadership
Leaders provide clear direction to an organization, pointing the way and being clear about its purpose
(or mission/vision/whatever-you-call-it). They should encourage and develop a culture and
environment in which people do what needs to be done to satisfy customers. Leadership isn't telling or
directing people, it is leading them.
And the culture required is one that goes beyond just 'doing the work' to underpinning how people
think and talk and behave: the culture of the organization.
3 Involve people at all levels
The most effective way to achieve quality is by involving people across all levels of the organization.
Everyone contributes to the success (or otherwise) of an organization and has a part to play in it, as well
as a responsibility for quality.
Whether the word quality appears in their job title is quite immaterial.
10
Quality Management Principles
4 Take a process approach
Efficiency is better achieved when things are managed as processes, rather than as individual tasks
or separate departments.
A process is a sequence of related activities, organized to achieve a particular purpose.
11
Quality Management Principles
Another
Example of a
Process
12
Quality Management Principles
5 Adopt a systems approach to management
This means understanding what a management system is, its various parts and how you
want it to work. It also means having consistent ways to do and manage things, rather
than ad hoc 'making it up' and/or just being reactive.
6 Continually improve
Always aim to do better. Make improving what you do or make a permanent objective.
7 Make decisions based on facts
Use suitable information / facts / data when making decisions -- as opposed to
opinions, feelings, knee jerk responses, snap reactions, 'gut instinct' etc.
To do this, you need to decide first what data you will need, collect it, and
analyze/review it.
8 Aim for relationships with suppliers that are of mutual benefit.
An organization and its suppliers depend on each other. Work with your suppliers
wherever possible, so that you can both benefit.
13
Structure of an ISO 9001 QMS
ISO 9001:2000 Standard - clause headings:
0.
Introduction
1.
Scope
2.
Normative Reference
3.
Terms and Definitions
4.
Quality Management System
5.
Management Responsibility
6.
Resource Management
7.
Product Realization
8.
Measurement, Analysis and Improvement
The first 4 ( 0 to 3 ) clauses do not provide
any requirements for a QMS. They just
provide background information: like
purpose, concepts, principles used - (like
Process Approach, PDCA) etc.,
14
Structure of an ISO 9001 QMS
The remaining five clauses numbering 4 through 8 provide the control requirements that a QMS must implement. The
following is a summary explanation of these 5 major clauses or elements of the ISO 9001:20000 standard. Each major
clause has several sub-clauses. Collectively, these 5 clauses set out the requirements for your QMS.
Clause 4 - Quality Management System - sets requirements to identify, plan, document, operate and control QMS
processes and to continually improve QMS effectiveness.
Clause 5 - Management Responsibility - sets requirements for top management to demonstrate its leadership and
commitment to develop, implement and continually improve the QMS.
Clause 6 - Resource Management - sets requirements to determine, provide and control the various resources needed
to operate and manage QMS processes; to continually improve QMS effectiveness; and to enhance customer
satisfaction by meeting customer requirements.
Clause 7 - Product Realization - sets requirements to plan, operate and control the specific QMS processes that
determine, design, produce and deliver an organization’s product and services.
Clause 8-Measurement, Analysis and Improvement - sets requirements to plan, measure, analyze and improve
processes that demonstrate product and QMS conformity and continually improve QMS effectiveness.
The overall objective of your QMS must be to enhance customer satisfaction by meeting their requirements. This
objective can be achieved by using the ISO 9001 requirements to control your QMS processes and by continually
improving QMS effectiveness.
15
Key Requirements for an ISO 9001 QMS
•
Documenting your system
“Do What you say: say what you do”
Accurate definition of a process or requirement
Can be in multitude of forms:
Procedure
Flowchart
Graphic Illustration
Production router
Electronic media
16
Key Requirements for an ISO 9001 QMS
•
Control of documents
Approval for adequacy
Changes and revision status
Availability
Legible and identifiable
External origin
Standards
Specification
Customer documents
Statutory requirements
Obsolete documents
17
Key Requirements for an ISO 9001 QMS
•
Records
Represent evidence of fulfillment of requirements
Essential for internal auditing
Key to tracking and trending
Used for solving problems
Input to Management Review
•
Management Review
A periodic review of data relating to your organization including evaluation
and analysis for the purpose of improvement, innovation and sustained
success.
18
When ISO 9001 is implemented in an organization:
Well defined and documented procedures improve the consistency of output
Quality is constantly measured
Procedures ensure corrective action is taken whenever defects occur
Defect rates / issues decrease
Defects / issues are caught earlier and are corrected at a lower cost
Defining procedures identifies current practices that are obsolete or inefficient
Documented procedures are easier for new employees to follow
Organizations retain or increase market share, increasing sales or revenues
19
10 good things ISO standards can do for SMEs
Statements from leaders of businesses around the world
20
10 good things ISO standards can do for SMEs
1. Standards help you compete on a level playing field with bigger enterprises
“ Canadians tend to be shy. We don’t market ourselves well internationally. We don’t have the
aggressiveness of our foreign competitors. So when we go up against tough competition, we
can let our standards certificate speak for us. It gives us credibility.”
Doug Smith
President
Conematic Heating Systems
Canada
Conematic Heating Systems is a privately owned company and has a long list of certificates
verifying its conformity to technical standards. Conematic has been working towards certification
to ISO 9001, the world’s most recognized quality management system standard.
21
10 good things ISO standards can do for SMEs
2. Standards open up export markets for your products and services
“ The payoff for engaging in standards work is greater than many small business people realize.
Standards are both important and interesting. For a company like Baltic Safety, it’s essential to
get involved with the working groups so we can get started early with our planning for future
designs and production methods. Globalization means that ISO standards are key for any
company that hopes to succeed in export markets.”
Per Frode
CEO
Baltic Safety Products
Sweden
Baltic Safety Products is the largest manufacturer of lifejackets and buoyancy aids in Europe.
22
10 good things ISO standards can do for SMEs
3. Standards help you discover best business practices
“ The high technical level of our activity must be based on a sound methodology, on
personnel experience and on rigorous project management. ISO 9001 and ISO 9004 helped us
in building up processes to manage all these aspects coherently and unambiguously from
design, up to deployment and customer help, which is deeply appreciated by our national and
international customers.”
Franco Nava
Owner
TW_TeamWare
Italy
TW_TeamWare is an engineering company based in Milan (Italy) specializing in design and
production of electronic devices and systems.
23
10 good things ISO standards can do for SMEs
4. Standards drive efficiency in your business operations
“Without standards I would have had to close down… Not taking part (in standardization) would
have cost me my company and my livelihood… What does it cost me if I do not get involved and
others define rules that are out of line with my needs, interests and experiences, but which I have
to comply with because they are laid down in a standard ? Hence, it is best to join in right at the
start.”
Martin Denison
Managing Director
Scuba Schools GmbH
Austria
Scuba Schools Tauchausbildung GmbH (Scuba Schools Dive Training Ltd.) is registered in Vienna
and specialises in training recreational divers and diving instructors and in producing training
materials.
24
10 good things ISO standards can do for SMEs
5. Standards add credibility and confidence for your customers
“In addition to achieving higher customer confidence levels and better customer retention, our
vendor selection process has also improved. For example, potential vendors are invited to make
changes to their businesses to be in line with ISO 28000 requirements, such as improving their
document control, restricting access to certain areas to authorized personnel only,
and enhancing security at their premises by installing CCTV cameras. Only vendors whose
business processes are aligned to ISO 28000 will be selected to work with us. This ensures that
our customers will receive consistently good service.”
P. Sivanesan
Warehouse Manager
Union Services
(Singapore) Pte. Ltd
Singapore
Union Services provides customers with the full spectrum of logistics services and solutions to
bridge the supply chain to their clients and vendors.
ISO 28000 Standards - published in 2007. It set the requirements for a management system to ensure the
security of a supply chain.
25
10 good things ISO standards can do for SMEs
6. Standards open new business opportunities and sales
“The implementation of a quality management system and use of Kenya standards in my
production has resulted in technology transfer, opening of new business opportunities and
improved sales of my products. I urge small companies to embrace the use standards in order to
upgrade the quality of their products and access both local and export markets.”
Moses Maina
Director
Moselli Industries Ltd
Kenya
Moselli Industries are manufacturers of quality powder soaps and other cleaning product, and
sole distributors of Hyproclean products (Italy) in Kenya.
26
10 good things ISO standards can do for SMEs
7. Standards give you the competitive edge
“ Basically, I was prompted into finding out more about ISO 9001 because many of our competitors
were starting to publicize the fact that they complied with it. Now that we can do the same, we are
finding that we are attracting lots of business from larger companies that want the reassurance of
dealing with a firm that can demonstrate it complies with appropriate standards. A lot of businesses
choose to trade with companies that comply with recognized standards ahead of those that don’t –
especially in a trade like ours, where we deal with lifesaving devices.”
Mike Chilman
Managing Director
MC Fire Protection
United Kingdom
MC Fire Protection is an Oxfordshire-based business which supplies and maintains fire safety
equipment, and provides fire risk assessments and consultancy services.
27
10 good things ISO standards can do for SMEs
8. Standards make your brand name internationally recognized
“ Taking part in standardization work on nanotechnologies allows our company to have access to
standardization developments. Furthermore, this gives us opportunity to join in and defend
current and future interests of Spanish industry. Participating in both national and international
standardization committees is a key matter for our company. We are in a time of strong
international growth and this participation will allow us to adapt our products to future
international regulations.”
Julio Gómez
CEO
Avanzare
Spain
Avanzare is a SME supplier of nanomaterials and nanotechnology based solutions.
28
10 good things ISO standards can do for SMEs
9. Standards help your company grow
“We have the certainty that the reconnaissance achieved by the Métron Acústica
and the growth of our company in these past eight years are directly bonded to the
commitment of always working in compliance with the ISO and ABNT standards,
thus assuring the quality and the satisfaction of our customers.”
Eng. Krisdany Vinícius
S. M. Cavalcante
Partner/Technical Director
Métron Acústica Engenharia e Arquitetura Ltda.
Brazil
Métron Acústica Engenharia e Arquitetura Ltda.is a service provider in acoustics and
vibration.
29
10 good things ISO standards can do for SMEs
10. Standards enable a common “language” to be used across an industry sector
“ As the provider of Masterspec construction specification systems, we and our clients use a
range of standards to enable a “ standard ” approach to be applied to project design and
documentation. Standards provide a common “ language ” for our industry by defining the
quality benchmarks that products and building work have to comply with. For our clients’ own
clients, Standards clearly show that the end product – usually a building project – will meet
minimum standards of health, safety and performance.”
Rolf Huber
Chief Executive
Masterspec, Construction
Information Limited
New Zealand
Construction Information Limited is New Zealand’s market leader in providing specification
systems and supporting software for the construction industry
30
10 good things ISO standards can do for SMEs
http://www.iso.org/iso/news.htm?refid=Ref1443
Foxit Reader PDF
Document
31