ISO 9001:2015 vs.

ISO 9001:2008
Main changes

Presenter: Strahinja Stojanovic

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 What are the main differences between
the 2008 and 2015 revisions?

If you already implemented a QMS

according to ISO 9001:2008

… you can save a lot of time if you

approach this transition systematically.

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 Although changes cause much
stress, they are opportunities for
improvement.

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Agenda

• What has stayed the same

• What is not mandatory any more
• Main differences
• New structure
• Context of the organization
• Risk-based thinking
• Main challenges
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What has stayed the same

• PDCA Cycle
• Quality principles
ISO 9001:2008

• Quality Policy

ISO 9001:2015
• Quality Objectives
• Internal audit
• Corrective actions
• Management review
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What is not mandatory any more

• Quality manual
• Management representative
• Preventive action

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Main differences

New structure

Context of the organization

Documented information

Risk-based thinking

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New structure

1 Scope 6 Planning

2 Normative references 7 Support

3 Terms and definitions 8 Operation

4 Context of the
9 Performance evaluation
organization

5 Leadership 10 Improvement
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Context of the organization

• How to define it
• External interested parties
• Determining the scope of the QMS
• The QMS and its processes

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Risk-based thinking

• What should be taken into account

• What method to use
• Do we need to document it?

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Main challenges

• Application of risk-based thinking

• Determining context of the organization
• Auditing according to the new version
• Estimation of time and effort needed for
transition to the new version
• Changes related to the documentation

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Conclusion

The new version of the standard

gives more freedom; use it to your
advantage.

Instead of being stressed about it,

create better distribution of
responsibilities and authorities and
bigger involvement of top
management
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Q&A

Strahinja Stojanovic
 Thank you!
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