Highlights of the ISO 9001 Draft International Standard (DIS) Section 10.0 Improvement

1. ISO 9001:2015
Improvement
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2. Overall Purpose
• Explain the differences between the Improvement
processes of ISO 9001:2008 and ISO 9001:2015 DIS
– The Improvement process is integral in the growth of any Quality
Management System (QMS).
– Nonconformity and Corrective Action, and Continual
Improvement processes are included in the Improvement clause
of ISO 9001:2015 DIS.
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3. 2008 vs. 2015 DIS Comparison
ISO 9001:2008 ISO 9001:2015
7.4 Communication
Significant Differences
ISO 9001:2008 ISO 9001:2015 DIS
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective action
x
8.5.3 Preventive action
10 Improvement
10.1 General
10.3 Continual improvement
10.2 Nonconformity and corrective
action
Clause removed
6.1 Actions to address risks and
opportunities (see 6.1.1, 6.1.2)
Significant Differences
Preventive action clause has been removed. 6.1 Actions is used to address
risks and opportunities
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4. What has not been changed
• The organization shall continually improve the
effectiveness of the quality management system.
• When a nonconformity occurs the organization shall
react to it by controlling, correcting it, evaluate the
need for a corrective action, and review the
effectiveness of any corrective actions taken.
• Retain documented information (records) of
nonconformities, actions taken, and the results of
corrective actions
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5. What has been changed
• Preventive action clause has been removed.
– 6.1 Actions is used to address risks and opportunities
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6. Conclusion
• The only significant change to the Improvement clause
of ISO 9001 will be the removal of the Preventive
Action clause.
• Opportunities for improvements will still need to be
determined and actions taken to meet customer
requirements and enhance customer satisfaction.
• Causes for nonconformities will still need to be
determined.
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7. Conclusion
• The determination of the existence of similar
nonconformities, or if they could potentially occur, will
still need to be performed.
• The effectiveness of actions taken will still need to be
reviewed.
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8. We are here to help!
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