Only 6 weeks till September 2015 when the new version of ISO 9001 will be published


The impending update to ISO 9001 is the first major revision since 2000. This blog, and the ones to follow, are about the major changes you will see in ISO 9001:2015.

Significant Change – Context of the Organisation

The contents of this clause are new. Unlike the old standard, the new one expects you to understand your organisation’s context before you establish your quality management system, which makes a lot of sense. You are asked to consider the external and internal issues (positive and negative) that are relevant to the strategic direction of your organisation, and to think about how these issues could both impact the quality management system AND how your quality management system could support your organisation’s strategy.

This means that management systems can no longer be held at arm’s length. To meet the requirements of clause 4 they need to form part of the strategic direction of your organisation thus helping to raise the standards to the level of the boardroom and align management. It also increases the likelihood that organisations will develop unique management systems that address their particular needs and requirements.

Significant Change – Process Approach

Section 0.3 of ISO 9001:2015 introduces the concept of a process-based quality management system and clause 4 explains what to do. A process approach to quality management systems was first introduced in ISO 9001:2000. Indeed the process approach was one of the eight quality management principles upon which ISO 9001:2000 was based. But what is it? To answer that we first need to define a process.

There are many definitions out there, and they are all fairly similar, but the one I like best defines a process as a “Set of activities that interact with one another. Processes use resources to transform inputs into outputs. They are interconnected because the output from one process often becomes the input for another process.” (LM Franco, 1997).

Organisations have, for example:

  • Marketing processes
  • Design processes
  • Sales processes
  • Purchasing processes
  • Service delivery processes
  • Manufacturing processes
  • Complaint handling processes
  • Communication processes
  • Training processes.

The list goes on and on, especially when you consider that these processes can be broken down into smaller processes.

The requirements for this process approach to quality management systems were not clearly spelt out in either the 2000 or 2008 versions of ISO 9001. The new standard changes this. It clearly specifies what is expected. For example it says you must identify:

  • Your business processes, the responsibilities for the activities within these processes, and who is to be held accountable for each process.
  • The inputs the processes need and the outputs they will provide.
  • The resources the processes require in order to thrive.
  • How process performance will be measured and monitored.
  • The risks to product, service and customer satisfaction if the process doesn’t work.
  • How you can improve your processes (and then do so).

The list is quite extensive. While most of these requirements could be inferred from various parts of the previous standards, the clearly articulated concentration of them in a single clause means that they cannot be overlooked.

So to answer the question I posed at the beginning of this section – a process based quality management system uses a systematic approach to manage and control how its quality policy is implemented and how its quality objectives are achieved. A process based management system is a network of interrelated and interconnected processes. Each process uses resources to transform inputs into outputs. Since the output of one process becomes the input of another process, processes interact and are interrelated by means of such input-output relationships. Together, these process interactions create a single integrated process based quality management system.

If you’d like some guidance or need a sounding board please email me at Alternatively, visit my website where you’ll find free information to download.

All the best – Liz