Preparing for Change and Risk

Shirley Kennedy, simpleQuE Project Manager. Learn more about Shirley here.

Shirley Kennedy, simpleQuE Project Manager. Learn more about Shirley here.

The simpleQuE team is preparing for the ISO changes and recently attended NQA’s overview of the draft changes to ISO 9001:2015 and ISO 14001:2015.

The major revisions of both standards are due by September and will incorporate this high level structure divided into 10 sections:

  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


What stands out in the ISO 9001:2015 draft?

  • It’s all about the risk

Risk is defined as the effect of uncertainty on an unexpected result and is referred to explicitly in some sections, and is more implicit across a wide range of the standard.  Process risk…product risk…behavioral risk…identifying risks and the actions to address them – so risk becomes critically important in the development, implementation and maintenance of management systems. The risk management requirements replace ‘preventive actions’. 

  • Less prescriptive on documentation

‘Documented information’ replaces both ‘documented procedure’ and ‘records’. – “The organization shall maintain documented information [procedures] to the extent necessary to support the operation of processes and retain documented information [records] to the extent necessary to have confidence that the processes are being carried out as planned.” So there may be more flexibility in determining which procedures exist and there is no requirement for a formal Quality Manual.

  • Responsibility expands for the company’s leadership

‘Management Representative’ goes away, but the leadership responsibilities and authorities are expanded in an integration of QMS and business processes. Understanding the business’ internal and external factors, the needs of interested parties in the business, the company’s processes, and the associated risks, all should drive leadership to set appropriate goals and take actions.

There’s so much more than what we’ve listed. SimpleQuE offers free Executive Overviews along with a full range of training for your organization.

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