This article is particularly relevant to organizations seeking to develop or transition a quality management system to the ISO 9001:2015 standard.

There has been much ballyhoo about the latest ISO 9001 standard placing more emphasis on risk and no longer mandating requirements for a quality manual and documented procedures. In the meantime, certain other new or enhanced requirements have appeared with little fanfare. One of those is clause 6.3 - Planning of changes. The 2008 edition of the standard referred to planning for changes in several places – notably in the sections on document control, QMS planning, and management review. However, the topic is now given its own sub-clause with undoubtedly greater emphasis being placed on it.

Planning for change

As the context of an organization changes over time, there will be a need for its management system to also change. This is necessary in order to adapt to new circumstances, and maintain a viable strategic direction. Changes may be triggered by external factors (political, economic, social, technological, environmental, or legal), or internal factors (performance, resources, or culture). Changes might include:

  • A new process, product or service.
  • Changing a process, product or service.
  • Outsourcing a process, product or service.
  • Discontinuing a process, product or service.

At a more granular level, changes to process inputs, controls, outputs etc. might include:

  • New materials / components.
  • New process method / technology.
  • New measuring tools / techniques.
  • New supplier.
  • New / changed documentation.
  • New / changed record-keeping methods.
  • Enhanced competency / training / licencing requirements.

Whatever the changes to your QMS and its processes might be, they need to happen in a controlled manner in order to best take advantage of new opportunities, while managing any risks. When planning changes, you might consider:

  • The purpose of the change, and any potential consequences it may have
  • Controls to maintain the integrity of the QMS
  • The availability of resources e.g. people, infrastructure, facilities
  • Allocating or re-allocating responsibilities and authorities

There is a whole consulting industry servicing organizational change management, and there is a good reason for that - It can be a notoriously difficult thing to do well - particularly when considering significant changes in large and complex organizations. On the other hand, we shouldn't go off at the deep end and attempt to micro-manage every little detailed change that occurs in every process - no matter how insignificant that might be. A balanced approach is needed to give the greatest cost / benefit ratio. Some changes will justify careful management, while others may not. In prioritising change management activities, you might consider:

  • The consequences of the changes
  • The likelihood of those consequences occurring
  • The impact on your customers, other interested parties, and your quality objectives
  • ·The effectiveness of relevant QMS processes
  • Other factors

Where a project management approach is considered to be justified, change management activities might include:

  • Appointing a project manager
  • Establishing opportunities, objectives, milestones, and metrics
  • Identifying / managing risks to success of the project
  • Establishing a team with defined responsibilities and accountabilities for tasks within the project
  • Producing and updating a time line / Gantt chart
  • Communications with team members and others to be consulted / informed
  • Conducting reviews at periodic intervals or milestones / report to top management
  • Training people
  • Implementing a pilot or test run of the change
  • Implementing the change

Every organization transitioning from old to new standard will need to analyse the new requirements, then consider any gaps in their compliance, and what is needed to address those gaps.

Acknowledgements:

This article is based on an extract from Quality Manager Toolkit – available in Qudos 3 software and Qudos Club

Change ahead image courtesy of mrpuen and FreeDigitalPhotos.net


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