Scaled Management Systems

ISO9001:2015 Update – Part 1


As we move closer to the introduction of the ISO9001:2015 standard there’s been considerable discussion about the significance of the changes compared with previous versions.

However, the changes aren’t so significant.

Traditionally ‘smart’ organisations have always adopted a ‘risk’ based approach to the management of their total operations as they know & understand the importance of achieving ‘seamless’ cost effective transition of data, information and inputs transformed into a finished product or service. The standard simply provides them with a structure to achieve their objectives.

What are the changes?

So what’s important about the ISO9001:2015 update & your implementation strategy?


  • Will contain 10 major elements in a standardised format with other standards.
  • A focus on risk and risk management supported by –
    • Demonstrable leadership.
    • Management decisions that are based on data or factual evidence.
    • The use of knowledge gathered from across the organisation (not just training)
  • The changes that have been made to ISO9001:2015 involve both reformatting and restructuring of the standard at a high level.
  • The terms goods and services are now used to replace the previous definitions of product and service.
  • Requirements for design and development and measuring equipment have been refined for relevance to the service sector.

The 10 major elements cover 7 broad themes:-

  • Customer focus
  • Leadership
  • Engagement of people
  • Consistency in processes (Process approach)
  • Improvement
  • Evidence based decision making
  • Management of relationships

What are the 10 common elements that will be shared with other risk based standards (ISO14001 & 45001)?

  1. Scope
  2. Normative references
  3. Terms and definitions
  4. Organisational context
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Evaluation of performance
  10. Improvement


  • There is a transition window of 3 years (September 2015 until September 2018).
  • Assess where the business is now both operationally and in terms of compliance with the standard.
    • Which elements of your existing system will transfer easily to the new format?
    • And which elements will need greater work?
  • Plan how the business will transition to the new standard & close any gaps.
    • Resourcing money, people & time
  • Implement the changes & improvements.
  • Monitor the effectiveness and success of the improvements.

Subsequent articles will provide greater detail on the important clauses.