If you are looking for some real expert help with how to get ISO 9001 certification, then you couldn't have picked a better article to read; particularly because our guest writer, Mark Braham, is an expert in IS0 9001:2015 (he co-wrote it) and over this three part series, he will explain how you can go about obtaining ISO 9001 certification.
This is the second article from Mark, a CQI category A liaison at ISO/TC176, the international working committee responsible for writing lSO 9001:2015. He is the Chair of the UK national standards body (BSI) and managed QS1 who are responsible for collating and drafting all UK responses to ISO (International Organisation for Standardisation) and UK voting on the standard.
In his first article Mark explored:
In this second article Mark explores:
and
Now, over to the expert...
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Certification to ISO 9001:2015 requires passing an audit to check that your Quality Management System (QMS) delivers on the requirements of the standard as underpinned by the seven Quality Management principles.
These Quality Management Principles (QMPs) are:
QMP 1 – Customer focus: Meeting - and exceeding - your customers' current and future needs is the primary focus of quality management.
QMP 2 – Leadership: Having a unified direction and mission that comes from strong leadership is essential in promoting the right culture.
QMP 3 – Engagement of people: Competent, empowered and engaged people at all levels of your organisation.
QMP 4 – Process approach: Understanding activities as processes that link together and function as a system to yield more effective and efficient results.
QMP 5 – Improvement: Successful organisations have an ongoing improvement focus.
QMP 6 – Evidence-based decision making: Ensuring your decisions are based on the analysis and evaluation of data is more likely to produce the desired result.
QMP 7 – Relationship management: Identifying the important relationships you have with interested parties such as your suppliers – and setting out a plan to manage them – will drive sustained success.
Next I will take a look at the seven QMPs in turn and explore:
In my next article I will look at the remaining three QMPs.
As we explored previously, one of the two core requirements of ISO 9001:2015 is that any QMS must:
Customers are of course king in any organisation; bringing in revenue and paying everyone’s salaries. In addition, they are the best route to new business, since a word of mouth recommendation is the most powerful route to market. These days about 58% of business purchases start with a referral.
It is therefore absolutely key that your QMS at least supports meeting your customers’ requirements (including perceptions) and preferably enhances your customers’ satisfaction.
To meet the requirements of QMP1, you need to show that both your customers and your Quality Management System sit at the heart of your organisation.
This is as much to do with the culture of the organisation, as created by the leadership, as with things that can be ticked off. The auditor will be checking that the Senior Management Team (SMT) are driving customer focus at all key decision points and need to see how your QMS supports this.
Practical ways to demonstrate this to an auditor are to show them your:
The way to get the most benefit from your ISO 9001:2015 certification is to really live the customer focus principle. Ensure that the question being asked is, ‘what else will enhance the experience of our customers?’
The most significant change made in the 2015 update of ISO 9001 is to the Quality Management Principle: Leadership
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In the drafting of ISO 9001:2015, it was recognised that for a QMS to sit at the heart of an organisation and for ‘quality’ to sit there too, the management system must be aligned to the organisation's core strategy; and for this to be the case the strategy must be both clear and supported by the whole leadership team.
An auditor will look to see that the whole SMT are working together to create an environment in which:
Enabling:
Some of this will be behavioural. Some will be systems driven. Some will be about the communication.
All this of course adds up to the culture of the organisation. What an auditor is looking for is an open culture, where everyone is working together, from the top down, to enhance the customer experience. This is of course difficult to quantify, so what an auditor will be looking at is:
They will be reviewing the organisation's quality policy and its values. This is both the written mission and value statements, and the practical ways in which they are implemented, such as:
Focusing on the QMS specifically, they will be looking for one central QMS which has all the policies, processes and resources in one place to deliver:
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The ISO 9001:2015 thinking here is to change the mind-set of, ‘quality is the problem of the quality team’. Just as Health and Safety is now understood to be everyone’s responsibility quality also needs to be everyone’s responsibility.
It should also be recognised that the people working for an organisation are its biggest asset.
So, it is key that every organisation employs the right people in roles that match their competencies and abilities. Supported by:
To enable this, everyone needs to be clear about how they contribute to the business objectives and how they can contribute to enhancing customer satisfaction. Of course this can be done in many different ways, but some of the types of things that an auditor will look for are:
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The process approach principle for quality management systems has been around for many years, but hasn’t necessarily been understood or implemented as intended. This is frustrating as the approach can deliver far more value than it often has in the past.
Process mapping can and should be about predicting the results of change – not just an exercise to achieve ISO certification.
So how can the full benefits of process mapping be achieved?
The answer is in making your Quality Management System, not just a flat manual, but a 3D model of your organisation.
In order for this to be the case, your quality management systems needs to:
If it does do this, it will clearly show your value stream – the processes which brings in your income – and be a model of how your organisation currently works: the AS-IS.
A Quality Management System which delivers this, can then deliver so much more.
The update of ISO 9001:2015 was to make this clear, as it has so often been misunderstood in the past. Reams and reams of process maps do not add value. A QMS which shows you the potential effects of change before you make them – that adds real value.
So what will an ISO 9001:2015 auditor be looking for?
Well that depends on the type of organisation that you are.
For tiny organisations, a paper based QMS may be sufficient. This of course won’t deliver a 3D model of your organisation, but if there are only two people employed, that won’t be required.
For most organisations however, a cloud based system 'accessible from their intranet' will be most appropriate. Document control will be required for international organisations.
Whatever system your organisation uses, just make sure that it has the capability to model the TO-BE and make changes from both a position of understanding the AS-IS and compare various potential TO-BEs, so that you can implement the best one.
Thank you Mark.
In his next article, Mark will move onto examining the remaining three quality management principles against which every quality management system must comply with in order to achieve ISO 9001:2015; as well as what compliance to each of these principle is intended to achieve and how to demonstrate compliance.
Go straight to part three of this three part blog series now:
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