Professional Documents
Culture Documents
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What are the main ISO9000 standards?
ISO 9000:2005 Quality management systems – Fundamentals and vocabulary.
Covers the basics of what quality management systems are and also contains the
core language of the ISO 9000 series of standards. A guidance document used for
reference to understand terms and vocabulary related to quality management
systems.
ISO 9001:2008 Quality management systems – Requirements
This is the only ISO9000 standard for which certification can be gained.
Intended for use in any organization regardless of size, type or product including
service. It provides a number of Quality Management System requirements which
an organization needs to fulfil to achieve customer satisfaction. It includes a
requirement for the continual improvement.
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What are the ISO 9001 requirements for a
Quality Management System?
• The organisation needs to demonstrate its
ability to consistently provide product that
meets customer and regulatory requirements .
Documentation Requirements
Customer, Statutory and Regulatory
Requirements
Section 4.2
Document Control Procedure
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ISO 9001:2008 Quality ManagementSystem
requirements:
Section 5: Management Responsibility from our
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ISO 9001:2008 Quality Managem ent
System requirements:
Section 6: Resource Managem ent from our
Manu al
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ISO 9001:2008 Quality Managem ent System
requirements:
Section 7: Product Realisation from our Manu al
Product Realisation Section 7 ISO9001:2008
ISO 9001:2008 Clause Our Procedure
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ISO 9001:2008 Quality Management System
requirements: Section 8: Measurement,
Analysis and Improvement from our Manual
Measurement, Analysis and Improvement Section 8 ISO9001:2008
ISO 9001:2008 Clause Our Procedure
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What are the ISO 9001:2008
Quality Management System
document requirements?
ISO 9001:2008 refers specifically to only 6documented
procedures (See next Slide).
Other documentation may be required by an organization in
order to manage the processes that are necessary for the
effective operation ofthe quality management system.
This will vary depending on the size of the organization, the
kind of activities in which it is involved and their complexity.
Our small business manual covers all the basic clauses of ISO
9001:2008 with 9 procedures/documents our ISO9001:2008is
much more detailed and has 30 documents. Both include 14
records.
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What are the ISO 9001:2008
Quality Management System
requirements?
The standard specifies six compulsory documents:
• Control of Documents(4.2.3)
• Control of Records(4.2.4)
• Internal Audits (8.2.2)
• Control of Nonconforming Product / Service (8.3)
• Corrective Action (8.5.2)
• Preventive Action (8.5.3)
• In addition to these ISO 9001:2008 requires aQuality
Policy and Quality Manual
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What are the ISO 9001:2008 Quality
Management System
requirements?
The standard specifies six compulsory documents:
Control of Documents(4.2.3)
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What are the ISO 9001:2008 Quality
Management System requirements?
The standard specifies six compulsory documents:
Corrective Action (8.5.2)
• The ISO9001:2008 standard requires that you take Corrective
Action to rectify non-conformances. Itis a
requirement to keep records ofthese activities
and monitor their effectiveness.
Preventive Action (8.5.3)
• The ISO9001:2008 standard requires that you
need to take Preventative Action toeliminate
potential causes of problems. It is a requirement to keep
records of these activities and monitor theireffectiveness.
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What are the ISO 9001:2008 Quality
Management System requirements?
• ISO 9001:2008 requires a Quality Policy and QualityManual:
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What are the ISO 9001:2008 Quality
ma nagement systems requirements?
The ISO9001:2008 standard has an absolute requirement to maintain the
following records:
•Management Review Minutes
•Training Record
•Product Release Record
•Design and Development Records
- Results of the review of customerrequirements
- Design and development inputs relating to productrequirements
- Results of design and development reviews andactions
- Results of design and development verification andactions
- Results of design and development validation andactions
- Results of the review of design and developmentchanges
•Supplier Assessment Record
* All of these records are provided in our manual packs
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What are the ISO 9001:2008 Quality
Management System requirements?
The ISO9001:2008 standard has an absolute requirement to maintain the following
records:
•Validation Record
•Identification and Traceability Record
•Register of Customer Property
•Calibration Record
-Basis used for calibration or verification of measuring equipment where no
international or national measurement standardsexist
-Validity of the previous measuring results when themeasuring equipmen t is
found not to conform to requirements
-Results of calibration and verification ofmeasuring equipment
•Internal Audit Record
•Records of Non-conforming Product
•Corrective Action Request Form
•Preventative Action Request Form
* All of these records are provided in our manual packs
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What are the 8 Quality
Management Principles?
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Why is customer satisfaction
included in ISO
9001?
"Customer satisfaction" is one of the
main driving criteria for anyorganization.
In order to evaluate if a product meets
customer needs and expectations, it is
necessary to monitor and measure
customer satisfaction. Improvements
can be made by taking action to address any identified
issues and concerns. Your customers will gain confidence
that your products will meet their needs and increase their
satisfaction.
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ISO 9001:2008 Process Approach to
Management
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ISO 9001:2008 Process Approach to
Management
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What is the PDCA cycle?
The PDCAcycle is an established, logical, method that can
be used to improve a process. Thisrequires:
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PDCA
Cycle
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What do you need to do to comply
with ISO 9001:2008?
When initially starting to use ISO 9001, you should
familiarize yourself with the Quality Management
System standards, especially ISO 9000, ISO 9001 and
ISO 9004, and consider theirrequirements.
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How will the implementation
of the ISO9001:2008 standard
help us?
It increases customer satisfaction:
• The structure of ISO 9001 ensures that the needs of the
customer are being considered and met and your company
focus is on constantly increasing customer satisfaction.
• "Customer satisfaction" is one of the main driving criteria for
any organization. In order to evaluate if a product meets
customer needs and expectations, it is necessary to monitor
and measure customer satisfaction. Improvements can be
made by taking action to address any identified issues and
concerns. Your customers will gain confidence that your
products will meet their needs and increase theirsatisfaction. 29