QMT Features: March 2014
Out with the old, in with the new
Dr Margaret Rooney, quality assessor at certification body, NQA, looks at the most likely and significant changes to ISO 9001 and the implications for companies seeking to maintain or achieve certification

ISO 9001:2008 is now well on its journey to becoming ISO 9001:2015. Members of the international committee responsible for the update of ISO 9001 and ISO/TC 176 have already seen and commented on the first committee draft of the updated standard.

The international committee has met to consider all comments and I expect the main bones of the last committee draft to remain in place through to the final published version. However, it won’t be until we see further drafts that we will be in a position to completely and accurately predict what the final published version will look like in detail. I expect to see the public draft in April of this year with final publication scheduled for late 2015.

The Need for Change

The world in which we live is changing at a rate never witnessed before, and a lot has changed even since the ISO 9001 standard was last re-written in 2008.  When first published, ISO 9001 was very much about compliance. It is now more and more becoming a standard that organisations reap real and tangible benefits from. Procurement departments no longer accept what a company says in a marketing presentation, they look for further evidence and that evidence is frequently ISO 9001. The history of the standard is firmly set in the engineering and manufacturing industries but increasingly, it is service-based companies seeking certification.

These changes will be very much reflected in ISO 9001:2015. There will be much more emphasis on outsourcing and managing elements of your business that you are not in control of. The use of the word product is expected to be noticeably missing from the updated standard. Instead it becomes ‘goods and services’ recognising that not all organisations buy and sell products.

There are two clauses that I expect will be redrafted in the standard, both of which reflect its manufacturing heritage. The current version is very specific about calibration, but for a high proportion of companies using the standard this is irrelevant. This clause will certainly be redrafted in favour of one which recognises that a measuring device can now be as simple as a survey.

The emphasis throughout the 2015 draft on determination, review, development and provision of goods and services marks a further explicit move from the standard’s engineering and manufacturing origins.

Risk and Processes

A completely new development for ISO 9001 is the incorporation of core text and common terms. These recognise that although different sectors may have their own management system standards, such as AS 9100/AS 9120 for aerospace, there are many elements which they have in common. All future management system standards will have a new high-level structure following key headings, core text relating to generic requirements for any situation and common terminology.

Although all management systems are fundamentally about managing risk, this focus has been somewhat lost in recent years, new standards, particularly ISO 9001:2015, will bring it back.  The introduction of the core text will also place more emphasis on processes. ISO 9001:2000 did place greater importance on processes but the 2015 version will take this further.

As part of certification companies will be expected to determine risk and define processes more clearly. Companies will be expected to define all inputs, outputs and what needs to be measured for every process within its operations; whether that links to the development of a product or the marketing department producing new literature.  Processes have always been part of quality management but have often been developed in a rather patchy manner as they are not always well defined and understood. Linking in with the need for improved processes is the need for quality objectives and planning to achieve them, there will be a greater emphasis placed on this in ISO 9001:2015. Companies will have to determine resources, responsibilities and evaluation of results; this brings ISO 9001 much more into line with ISO 14001.

A Need for Training
ISO 9001:2015 will be the most significant change to quality management in almost twenty years. There is no hiding from the fact that training will be required for everyone involved with quality management systems. Organisations that do not employ a full time quality manager in-house will need to look externally, even the most highly experienced quality managers and consultants will benefit from extra training.

I expect it to be a big education for everyone. My advice to companies, who are at the outset of the certification process or are maintaining their certification on an annual basis, would be, to ensure that those who are central to the company’s quality management standard are trained well in advance of your first audit after the new standard comes into effect. In fact companies should be looking at training now and speaking to their certification body for help.

From now on those involved with a quality management system should be thinking of it in terms of using it to help manage risk. Quality managers need to be analysing and evaluating risk. If you do not see your management system as helping with this, it needs to change.
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