ISO 9001 2015 DIS 6.0 Planning Slides
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Transcript of ISO 9001 2015 DIS 6.0 Planning Slides
ISO 9001:2015
Planning – Risks and Objectives
10/21/14 © 2014 Cavendish Scott, Inc.
www.CavendishScott.com
1
Overall Purpose
• Explain the differences between the Planning processes
of ISO 9001:2008 and ISO 9001:2015 DIS
– The Planning process is integral in the establishment and growth
of any Quality Management System (QMS).
– Requirements for Planning include Formal activities for the
planning of risks, opportunities, objectives and changes.
10/21/14 © 2014 Cavendish Scott, Inc.
www.CavendishScott.com
2
2008 vs. 2015 DIS Comparison
ISO 9001:2008 ISO 9001:2015 DIS
5.4 Planning
5.4.1 Quality objectives
5.4.2 QMS planning
6 Planning for the QMS
6.2 Quality objectives and planning to
achieve them
6 Planning for the QMS
6.1 Actions to address risks and
opportunities
6.3 Planning of changes
Significant Differences
The organization shall plan actions to address risks and opportunities and how
to integrate and implement these actions into the QMS and evaluate the
effectiveness of these actions
Requirement to plan changes to the QMS in a systematic manner
10/21/14 © 2014 Cavendish Scott, Inc.
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What has not been changed
• The requirement for the organization to have
objectives that are consistent with the quality policy
and are measureable.
• Ensuring that the integrity of the quality management
system stays intact when changes are made.
• The quality management system is continually
improved.
10/21/14 © 2014 Cavendish Scott, Inc.
www.CavendishScott.com
4
Risks and Opportunities
• The 2008 version requires that preventive actions are
determined and taken to eliminate the causes of
nonconformities in order to prevent their occurrence.
• While 2008 gives the direction that actions need to be
taken, the 2015 draft redefines this and states that
risks for both internal and external issues for
interested parties and their requirements that are
relevant to the quality management system are to be
taken into consideration.
10/21/14 © 2014 Cavendish Scott, Inc.
www.CavendishScott.com
5
External Risks
Some of the sources for external risks that might be
relevant to the QMS:
– Technology,
– Suppliers,
– Customers,
– Changes in statutory or regulatory requirements
• including those of local, state, national or international agencies
10/21/14 © 2014 Cavendish Scott, Inc.
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Internal Risks
• Equipment
• Training of Personnel
• Capacity
• Technology
• Control of processes
• Capability
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Addressing Risks
• Once the risks and opportunities have been identified
the organization needs to:
– Give assurance that the quality management system can
achieve its intended results
– Prevent or reduce, undesired effects;
– Achieve continual improvement
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www.CavendishScott.com
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Planning for risks
• The organization not only needs to plan actions to
address the risks and opportunities that have been
identified but also plan how to:
– Integrate and implement the actions into its QMS
processes
– Evaluate the effectiveness of these actions
10/21/14 © 2014 Cavendish Scott, Inc.
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Taking Actions
• Similar to the preventive action requirements in 2008,
the actions that are taken to address the risks and
opportunities shall be proportionate to the potential
impact on the conformity of products and services of
the organization.
10/21/14 © 2014 Cavendish Scott, Inc.
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Options for risks and opprotunities
• Options to address the identified risks and
opportunities can include:
– Avoiding the risk
– Taking the risk in order to pursue an opportunity
– Eliminating the source of the risk
– Changing the likelihood or consequences
– Sharing the risk
– Retaining the risk by informed decision
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Objectives
• As in 2008, quality objectives must be established at
relevant functions and levels. However quality
objectives for relevant processes are also required.
• Also similar to 2008, quality objectives shall:
– Be consistent with the quality policy
– Be measureable
10/21/14 © 2014 Cavendish Scott, Inc.
www.CavendishScott.com
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Objectives - New
• What’s new for objectives for 2015?
– They shall take into account applicable requirements
– They shall be monitored
– They shall be communicate
– The shall be updated as appropriate
– They shall be relevant to conformity of products and
services as well as the enhancement of customer
satisfaction
– The organization shall also retain documented information
on the quality objectives
10/21/14 © 2014 Cavendish Scott, Inc.
www.CavendishScott.com
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Achieving Objectives
• While planning on how to achieve its quality
objectives, the organization shall determine:
– What will be done
– What resources will be required
– Who will be responsible]
– When it will be completed
– How the results will be evaluated
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Planning of Changes
• When the organization determines the need for
changes to the QMS, the changes shall be carried out
in a planned and systematic manner
• The organization shall consider
– The purpose of the change and any of its potential
consequences;
– The integrity of the QMS;
– The availability of resources;
– The allocation or reallocation of responsibilities and
authorities.
10/21/14 © 2014 Cavendish Scott, Inc.
www.CavendishScott.com
15
Customer Feedback
• ISO 9001:2008 has the requirement to determine,
collect and analyze data in order to determine
customer satisfaction.
– Satisfaction not required to be discussed during
Management Review.
• ISO 9001:2015 DIS has changed the requirement for
customer feedback to be reviewed during
Management Review has changed to the information
of the quality performance, including trends and
indicators of customer satisfaction.
10/21/14 © 2014 Cavendish Scott, Inc.
www.CavendishScott.com
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Significance of Customer Satisfaction
• The significance of the change is that the
determination of customer satisfaction is not made by
an individual based on only the analysis of data, but
instead made in an environment where it can be
discussed by management to ensure that appropriate
decisions are made and actions taken on both the
data as well any anecdotal information that is
available.
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Why Analyze Customer Satisfaction Information?
• Ensure that decisions are made on the complete
customer base and not just individual customers.
• Strategic direction given by management to ensure
that customer satisfaction is not only acceptable but
also improved upon.
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18
Supplier Evaluation
• The ISO 9001:2008 requirement to just analyze data
for suppliers has changed.
• The ISO 9001:2015 requirement is to have the quality
performance, including trends and indicators, reviewed
during the Management Review process for external
providers and other relevant interested parties.
10/21/14 © 2014 Cavendish Scott, Inc.
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Supplier Evaluation (cont.)
• This ensures that the data is analyzed, and that it is
discussed, appropriate conclusions are made, and
actions are taken based on the information that has
been gathered.
• This ensures that the organization considers not only
external providers while reviewing the QMS for its
suitability, adequacy and effectiveness, but other
companies, agencies or individuals that are relevant
and interested.
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Conclusion
• Proposed additional influences will need to be
considered, reviewed and discussed during
Management Review.
• QMS is reviewed by management for suitability,
adequacy, and effectiveness taking into consideration:
– external and internal issues,
– customer satisfaction,
– external providers,
– other relevant interested parties, and
– the strategic direction.
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