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ISO 9001:2015 differs substantially from the preceding 2008 standard especially in its emphasis of a risk-based approach to quality management, effective communications and extension of processes into the supply chain.

People often ask us:

  • How do I extend my quality management system out to third parties in my supply chain?
  • In simple, practical steps, how do we implement a risk-based model of quality management?
  • How can Q-Pulse help us comply with ISO 9001:2015?

If you are an Ideagen customer using Q-Pulse, the good news is that you already have the tools you need to comply with ISO 9001:2015. There are various options touched on in this blog that you can read about in more detail in the next email showcasing the related Technical White Paper, “Prepare and Align: System Readiness for ISO 9001:2015”.

We share the view of the CQI and IRCA that ISO 9001:2015 makes a material difference and we encourage all our customers to embrace the new standard and reap the operational and strategic benefits that flow from it:

  • Efficiency and productivity benefits;
  • A culture of reporting, learning and sharing;
  • Strengthening and protection of brand and reputation;
  • A substantial reduction in non-conformances, undesirable events and failures of every type;
  • Business resilience (deriving in part from the risk based approach to suppliers).

Several configurations of Ideagen software products can be deployed to help you comply with ISO 9001:2015. These include the following options:

  • Using the Document Management System in Q-Pulse to implement risk-based policies and procedures and then controlling these using the CAPA module.
  • Improving analysis and communication about risks and applying highly visual risk assessments to events using the Q-Pulse Incident Management System (IMS).
  • Extending your Q-Pulse QMS to manage compliance of third parties including suppliers.
  • Full implementation of a risk based approach to quality management using the risk modelling and management capabilities of a solution based on Q-Pulse and Gael Risk.

Ideagen quality, compliance and risk management products Q-Pulse and Gael Risk offer a complete solution to achieving ISO 9001:2015 compliance. The approach and degree of process automation you choose can be partial, stepped or complete. Whatever your choice, the Ideagen Customer Experience and Professional Services teams are available to help you every step of the way.

Ideagen's Gordon McKeown
Written by

Gordon Mckeown

Stop trying to manage compliance using spreadsheets and email.