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www.9001manual.com
What is ISO?
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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 is the history of ISO 9001?
• ISO 9001:1987
Model for quality assurance in design, development, production, installation, and servicing
was for companies and organizations whose activities included the creation of new products.
Had the same structure as the UK Standard BS 5750 unfortunately the emphasis tended to be
placed on conformance with procedures rather than the overall process of management.
• ISO 9001:2000
Combination of the three standards 9001, 9002, and 9003 into one, called 9001. Design and
development procedures are required only if a company does engage in the creation of new
products. Introduced the concept of process management. Required the involvement of
Senior Management in order to integrate quality into the business system and avoid
delegation of quality functions to junior staff. Required measurement of the effectiveness of
tasks and activities. Expectations of continual process improvement and tracking customer
satisfaction were defined.
• ISO 9001:2008
Introduces clarifications to the existing requirements of ISO 9001:2000 and some changes
intended to improve consistency with Environmental Management Standard ISO 14001:2004.
The standard is now practical and business improvement focused. It is completely different to
the original standard which was discredited in some areas as a paper exercise.
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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 .
4.1 Introduction
QM001 Quality Management System
4.2 Documentation
QM002 QMS Manual Summary
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ISO 9001:2008 Quality Management System
requirements:
Section 5: Management Responsibility from our Manual
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ISO 9001:2008 Quality Management
System requirements:
Section 6: Resource Management from our
Manual
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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 Document Number Our Procedure
7.1 Planning
QM012 Contract Review
7.2 Customer Related Processes
7.3 Design and Development QM013 Design and Development
7.4 Purchasing, Orders and Purchasing, Orders and
Verification of Purchased QM014 Verification of Purchased
Materials Materials
7.5 Operational Control
7.5.1 Production
QM015 Production
7.5.2 Validation of Processes
7.5.3 Identification and
QM016 Identification and Traceability
Traceability
7.5.4 Customer Property QM017 Customer Property
QM018 Preservation of Product
7.5.5 Preservation of Product QM019 Despatch and Distribution
QM020 Maintenance
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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 Document Number Our Procedure
8.1 General
QM023 Measurement and Monitoring
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction QM024 Customer Satisfaction
8.2.2 Internal Audit QM025 Internal Audit
8.2.3 Monitoring and Measuring Monitoring and Measuring QMS
QM026
QMS Processes Processes, Analysis of Data
8.3 Control of Non-Conforming Control of Non-Conforming
QM027
Product Product
8.4 Analysis of Data Monitoring and Measuring QMS
QM026
Processes, Analysis of Data
Corrective Action, Preventive
QM028
8.5 Corrective Action, Preventive Action and Improvement
QM029
Action and Improvement Crisis Management
QM030
Product Recall
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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?
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What are the ISO 9001:2008 Quality
Management System requirements?
The standard specifies six compulsory documents:
Internal Audits (8.2.2)
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What are the ISO 9001:2008 Quality
Management System requirements?
The standard specifies six compulsory documents:
Control of Nonconforming Product / Service (8.3)
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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?
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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 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?
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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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What is Continual Improvement?
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ISO 9001:2008 Process Approach to
Management
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ISO 9001:2008 Process Approach to
Management
What is a process?
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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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ISO 9001:2008 Process Approach to
Management
What are the benefits “process approach”?
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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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What are the requirements for auditors?
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What are the main benefits to be derived
from implementing an ISO 9000 quality
management system?
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What are the benefits of using the ISO 9001
standard?
The management of an organization should be able to view the adoption of the ISO9001
Quality Management System standards as a profitable business investment, not just as a
required certification issue:
The discipline of the standard drives the connection of quality management systems
to organizational processes
The disciplines involved give improved organizational
performance, via:
- Using the 8 Quality Management Principles
- Using a "process approach"
- Commitment from senior management
- Using measurable objectives
- Focus "continual improvement" and "customer satisfaction"
- Measurement of the quality management system effectiveness
- Assessing resource requirements
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How will the implementation of the
ISO9001:2008 standard help us?
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How will the implementation of the
ISO9001:2008 standard help us?
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How will the implementation of the
ISO9001:2008 standard help us?
It Improves performance :
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How will the implementation of the
ISO9001:2008 standard help us?
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How will the implementation of the
ISO9001:2008 standard help us?
It saves you money:
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How will the implementation of the
ISO9001:2008 standard help us?
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How will the implementation of the
ISO9001:2008 standard help us?
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What is the next stage for us?
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