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QA in Brief - ISO9001 2015 Update #13

Kevin Stretton - Friday, January 29, 2016

The revised quality concepts

 

Within the 2008 framework mandating a documented quality management system companies were required to demonstrate how they controlled:-

 

  Internal auditing

  Policy & objectives

  Quality manual & procedures

  Preventive action

•      Records

 

It’s important to note that internal auditing, policy objectives and preventative action are inter-connected with each other and closely linked to continual improvement methods.

 

However, with changes to the 2015 version all of these requirements have been reorganised and so your organisation has a unique opportunity to adapt creatively to those changes while demonstrating control of risk.

 

Areas to consider are:-

 

  Context of the organisation compared with its community and industry sectors

  Decisions made or based on evidence and facts, not opinions

  Engagement of people (external to and within the organisation)

  Evaluating the organisation’s performance

  Improvement

  Increased customer focus

  Leadership (not just management commitment)

  Managing relationships

  Operations – how they are structured and controlled

  Planning

  Process based controls and thinking (no matter what industry sector you are in)

  Support mechanisms

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