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What are the ISO 9000 standards?
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What are the main ISO 9000 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?
Documentation Requirements
Customer, Statutory and Regulatory
Requirements
Section 4.2
Document Control Procedure
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ISO 9001:2008 Quality Management System
requirements:
Section 5: Management Responsibility from our Manual
Management Responsibility Section 5 ISO9001:2008
ISO 9001:2008 Clause Our Procedure
Internal Communication
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ISO 9001:2008 Quality Management System
requirements:
Section 7: Product Realisation from our Manual
Product Realisation Section 7 ISO9001:2008
ISO 9001:2008 Clause Our Procedure
11
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ISO 9001:2008 Quality Management System
requirements: Section 8: Measurement, Analysis
and Improvement from our Manual
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What are the ISO 9001:2008 Quality
Management System document requirements?
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What are the ISO 9001:2008 Quality
Management System requirements?
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What are the ISO 9001:2008 Quality
Management System requirements?
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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. It is a
requirement to keep records of these activities
and monitor their effectiveness.
Preventive Action (8.5.3)
The ISO9001:2008 standard requires that you
need to take Preventative Action to eliminate
potential causes of problems. It is a requirement to keep
records of these activities and monitor their effectiveness.
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What are the ISO 9001:2008 Quality
Management System requirements?
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What are the ISO 9001:2008 Quality
management 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 customer requirements
- Design and development inputs relating to product requirements
- Results of design and development reviews and actions
- Results of design and development verification and actions
- Results of design and development validation and actions
- Results of the review of design and development changes
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 standards exist
- Validity of the previous measuring results when the measuring equipment is
found not to conform to requirements
- Results of calibration and verification of measuring 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?
Customer
focus
Mutually
beneficial
supplier Leadership
relationships
Factual Quality
approach to Involvement
decision Management of people
making
Principles
Continual Process
improvement approach
System
approach to
management
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Why is customer satisfaction included in ISO
9001?
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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?
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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 their requirements.
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How will the implementation of the
ISO9001:2008 standard help us?
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