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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• What has stayed the same

• What is not mandatory any more

• Main differences

• New structure

• Context of the organization

• Risk-based thinking

• Main challenges

Agenda

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What has stayed the same

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• PDCA Cycle

• Quality principles

• Quality Policy

• Quality Objectives

• Internal audit

• Corrective actions

• Management review

ISO

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ISO

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• Quality manual

• Management representative

• Preventive action

What is not mandatory any more

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New structure

Context of the organization

Risk-based thinking

Documented information

Main differences

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1 Scope

2 Normative references

3 Terms and definitions

4 Context of the

organization

5 Leadership

6 Planning

7 Support

8 Operation

9 Performance evaluation

10 Improvement

New structure

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• How to define it

• External interested parties

• Determining the scope of the QMS

• The QMS and its processes

Context of the organization

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• What should be taken into account

• What method to use

• Do we need to document it?

Risk-based thinking

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• 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

Main challenges

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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

Conclusion

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Strahinja Stojanovic

Q & A

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