Basic of Iso 9001b
Basic of Iso 9001b
Basic of Iso 9001b
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ISO 9001 is an outline for a
Quality Management System
When you build your Quality Management
System based on ISO 9001:2008, you will be
managing your organization as a system of
interrelated processes.
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Quality Management System
Criteria
An International Group of Business
and Quality Professionals determined
criteria.
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The ISO 9001 Standard
The standard outline the requirements for the Quality
Management System in sections 4 through 8 of ISO
9001. Take a look at the sections of the standard
outlined below.
Section 1: Scope
Talks about the standard and how it applies to
organizations
Section 2: Normative Reference
References another document that should be used
along with the standard, ISO 9000:2008, Quality
Management Systems-Fundamentals and Vocabulary
Section 3: Terms and Definitions
Gives a few new definitions
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The ISO 9001 Standard
Section 4: General Requirements
Gives requirements for the overall Quality Management
System
Section 5: Management Responsibility
Gives requirements for Management and their role in
the Quality Management System
Section 6: Resource Management
Gives requirements for resources including personnel,
training, the facility and work environment
Section 7: Product Realization
Gives requirements for the production of the product or
service, including things like planning, customer related
processes, design, purchasing and process control
Section 8: Measurement, Analysis and Improvement
Gives requirements on monitoring processes and
improving those processes
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The ISO 9001 Standard
The requirements cover everything from how you
plan your processes, to how you carry them out,
measure them and improve them.
The standard calls your production processes
"Product Realization". This is where you are actually
making your product or delivering your service.
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The Benefits of ISO 9001
Having an effective Quality Management System,
(QMS) in place leads to many improvements in an
organization.
ISO 9001 is a proven foundation for an effective
QMS. Whether you decide to Register your
organization, or just build an ISO 9001 QMS for the
internal benefits, you will improve your
organization.
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The Benefits of ISO 9001
Internal Benefits include:
• Increased productivity
• Less scrap and rework
• Increased employee satisfaction
• Continual improvement
• Increased profits
Marketing Benefits include:
• An internationally recognized QMS
• Increased opportunities in specific
markets
• Increased customer satisfaction
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What will ISO 9001 do for your
employees?
• Established a Quality
Policy and Quality Goals,
and
• Designed a Quality
Management System to
control how processes are
performed
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QUALITY POLICY
Purpose
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QUALITY POLICY
The President and Top Management may decide
to change the Quality Policy only when the
organization attains the goals and
aspirations expressed or they are no longer
relevant or sufficient.
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QUALITY POLICY
Based on the above commitments and aspirations.
Your Organization developed a formalized quality
management system to assure that the quality of
the products we manufacture, and services we
provide to our external customers meet and/or
exceed their expectations in a safe and
environmentally conscious manner.
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QUALITY POLICY
Your Organization posted the Quality Policy
throughout the organization in English. General
orientation training explains and discusses the
Quality Policy meaning to new employees.
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Quality Goals
Quality goals are
established to support
the quality policy. They
are measurable, specific
goals. As you meet the
goals, new goals can be
set.
()
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Documented
Quality Management System
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Management Responsibility
Once Management has established the Quality Policy and
Objectives, they must continually improve the effectiveness of
the QMS.
Management will:
• Review the Quality Policy
• Collect and analyze data
about the performance of QMS
processes
• Hold Management Review
Meetings to assess
opportunities for improvement
and need for changes
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Management and the Customer
Management must make sure that systems have
been established to determine and meet customer
requirements.
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Your organization must continue to
provide the resources necessary:
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Human Resources
Employees are a resource
Employees must be qualified and trained for the job they are
performing.
• The facility
• Equipment
• Layout
• Workspace
• Support services
• Heat
• Vibration
• Noise
• Humidity
• Light
• Cleanliness 26
Product Realization:
The processes in your organization that actually
result in the product or service that goes to your
client.
These include:
• Design and Development
• Customer related processes
• Purchasing
• Production and Service
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Product realization processes
must be planned
There are things that need to be determined as
you set up your quality management system and
as you implement new processes.
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Processes must be controlled
A well controlled process will be performed
consistently day to day, employee to employee.
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Make sure that you are using a
controlled copy of the documentation
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You must manage processes related to your
customers to make sure you are determining their
requirements and meeting those requirements
• Identify requirements
• Review the requirements
• Establish customer communication
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Design and Development
If you design product, you must control your design and
development process. The process must include:
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To maintain quality, meet customers'
requirements and prevent mistakes,
your product and materials must be
clearly identified throughout production
and delivery.
• Identify it
• Verify that it is suitable for use
• Protect it
• Record and report any lost, damaged or
unsuitable product to the customer
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To maintain product quality during handling,
storage and delivery, it is your responsibility
to:
• Follow preservation
requirements
• Follow handling instructions
to prevent damage
• Follow packaging requirements
to maintain product quality.
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Work instructions identify measuring and
monitoring requirements
• Equipment used for measuring and
monitoring is calibrated to make sure
that measurements are accurate.
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Measure, Analyze and Improve
To meet the requirement of continually
improving the QMS, your organization will
carry out inspection, testing, measurement,
analysis and improvement processes.
Customer Satisfaction
• How does the customer perceive your
performance in meeting requirements?
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Internal Audits measure and
monitor how well the QMS is being
followed.
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When product or material does not meet
requirements it must be controlled to
make sure it does not get to the client.
• It must be clearly
identified
• It must be dispositioned
Reworked
Regraded
Scrapped
Accepted as is (by concession)
by the customer
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Corrective and preventive action systems
should be used by all employees to address
problems and potential problems.
Corrective Action:
Preventive Action:
When you see something that may cause a problem, fix it and
prevent the problem from happening.
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Welcome to the
Basics of ISO 9001:2008
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