ISO 9001:2008 QUALITY MANAGEMENT
SYSTEMS
AGENDAAGENDA
1. Introduction• What is ISO?• What are the Clauses and benefits?• Quality Management System?
2. Quality Manual3. Elements of a Quality Manual4. How to achieve certification5. Initial Certification Audit6. Advantages & Summary
INTRO
E
very organization would like to improve the way it operates
A quality management system gives you the framework you need to monitor
and improve performance in any area you choose.
I
SO 9001 is the world’s most established quality framework, currently being
used by over ¾ million organizations in 161 countries.
I
t helps all kinds of organizations to succeed through improved customer
satisfaction, staff motivation and continual improvement.
WHAT IS ISO?
I
SO is a standard for Quality
Management System
I
SO 9001:2008 is a model for
a Quality management
system
WHAT IS ISO?
T
he term ‘ISO’ actually stands for
the ‘International Organization for
Standardization’
T
he Organizations short name was
taken from the Greek word “isos”,
meaning “equal”.
ISO FAMILY
I
SO 9000:2005 Consists of 3 areas• ISO 9000:2005 – Quality Management Systems-
Fundamentals and Vocabulary• ISO 9001:2008 – QMS – Requirements (required for
certification) • Management Responsibility• Resource Management• Product/Service realization• Measurement, analysis, improvement
• ISO 9004-2009 – QMS – Guidelines for performance improvement
CERTIFICATION AND REGISTRATION
C
ertification is known as Registration in some countries
A
n Independent, external body has audited an organizations
management system and verified that it conforms to the
requirements specified in the standard (ISO 9001).
I
SO does not carry out certification and does not issue or approve
certificates,
BENEFITS
The major reason why many companies want ISO 9001 certification is that
they want to portray themselves as a worthy company to do business with,
many of them do not really realize the benefits (some direct and others
indirect):
Direct Benefits:
• Improved customer satisfaction;
• Improved quality of products and services;
• Employees satisfaction and more commitment to the organization;
• Better management and a more effective organization;
• Improve relations with suppliers;
• Improved promotion of corporate image.
BENEFITS
Indirect Benefits: It helps companies to
• Review business goals, and assess how well the organization is meeting
those goals;
• Identify processes that are unnecessary or inefficient, and then remove or
improve
them;
• Review the organizational structure, clarifying managerial responsibilities;
• Improve internal communication, and business and process interfaces;
• Improve staff morale by identifying the importance of their output to the
business, and by involving them in the review and improvement of their work.
WHAT IS QMS?
Q
MS – Interconnected processes that are used to
manage a business.
QMS PRINCIPLES
Any organization can
benefit from implementing ISO 9001 as its requirements are underpinned by
8 management principles:
A
customer focused organization
L
eadership
T
he involvement of people
E
nsuring a process approach
A
systematic approach to management
A
factual approach to decision making
M
utually beneficial supplier relations
C
ontinuous improvement.
QUALITY MANUAL?
A Quality Manual is the main, top-level
document which establishes the quality policies
and objectives of an organization.
WHAT WILL A QUALITY MANUAL PROVIDE TO A COMPANY?
Overall it provides evidence of what specific controls are implemented to ensure product/service quality.
Who will benefit ?• Customers• Suppliers• Employees The Company• ISO
A QUALITY MANUAL SHOULD….
1. Address all Quality System elements
2. Contain or refer to quality procedures
“Documentation”
THE IMPORTANCE OF DOCUMENTATION
BENEFITS OF DOCUMENTATION: QUALITY MANUAL
T
he Key is to move towards:
• Consistently repeating the best practices
and
• Improving those processes which are lacking
4 LEVELS OF DOCUMENTS
SO, WHAT EXACTLY DO WE FIND IN A TYPICAL QUALITY
MANUAL?
You might just find things like…
BASIC QUALITY MANUAL OUTLINE
Introduction
Policy and Objectives
Definitions
Quality System
Organization
Authority and Responsibilities
Compliance
Internal Review and Audit
Documentation and Change
Purchasing
Inspection and Testing
Training
1. To prevent risks
2. To detect deviations
3. To correct errors
4. To improve efficiency
5. To reduce costs
6. To meet customer needs
7. To market company
ADVANTAGES OF QUALITY MANUAL
ADVANTAGES OF QUALITY MANUAL
SOME FACTS
I
SO 9001 certification cost is tax deductible(“Cost incurred by a
taxpayer to obtain, maintain, and renew ISO 9000 certification
are deductible as ordinary and necessary business expenses under
section 162 of the Code”)
G
etting Compliance/Certification does increase sales by 4%
C
ustomer satisfaction increase by 8%.
T
he assessment process for achieving certification consists of a two stage
Initial Certification Audit as follows:
S
tage 1 – the purpose of the auditor visit is to confirm the readiness of
the organization for full assessment.
S
tage 2 – the purpose of the auditor visit is to confirm that the quality
management system fully conforms to the requirements of ISO
9001:2008 in practice.
INITIAL CERTIFICATION AUDIT PROCEDURE
Presentation on ISO 9001:2008 importance to our
Internal Teams
Finalize the Internal Auditor which suits to our
Organization.
Set and start implementing the standards and
procedures to comply with ISO.
Target timeline to acquire ISO 9001:2008
certification is JULY 2012.
ACTION ITEMS