ISO 9001:2015 - some useful advice from Chamber Member SQMC

31st January 2017

Director and resident Quality Manager at the Scottish Quality Management Centre, Karen MacKenzie, offers some advice for Chamber members gearing up to implement (or transition their current Quality management system to) ISO 9001:2015.

OK, so ISO 9001:2015 has been with us now for around 18 months, and is becoming well established. As a UKAS Certificating Body Auditor, a Management Systems Consultant and a trainer of auditors to IRCA approved level, I’ve had a fair amount of involvement with it, particularly drawing up transition plans for companies.

This has made me aware of the need for someone just to say: “what are the main things we have to do, and what’s involved in them?” So here’s a starter for 10. Bear in mind this is not the absolute in transition requirements, but it will give you a good start.

Firstly, start looking at the context of your organisation: what sphere does it operate in? Are you in the widget manufacturing industry, or in the window replacement industry? Or the training and development industry?

What might impact on your business: change of government? Stakeholder withdrawal of funds/support? Environmental or Health and Safety legislation? A lack of competent staff? Competitors developing new products and leaving you behind?

And what are the internal and external influences on the business? Some will be the same as I’ve just mentioned, but also there are things like lack of succession planning; increase in logistical delivery costs; etc.

Start working on this at Senior Management level because your quality management system (which is really a business management system) is going to carry you through this whole process.

So when you appreciate your sphere, and understand your business’s determining influencers, you will see clearly the impact all this has on business goals, direction, and then on Quality objectives.

For instance, if you’re setting a business objective to increase sales by 5%, some Quality objectives must go with it, such as achieving the increase with zero defects or no increase in re-work. Or, perhaps achieving your goal within the same timeframe, but with fewer non-conformances.

You can then start looking at risks in relation to all of this. If – within the newly-identified context of your organisation – you want to set a goal to increase sales by 5%, what would the risks be? What are the views of the shareholders – will they support this? Can you afford it? Are you geared up for it? Do you have sufficient numbers of trained personnel, equipment, tools, logistical support, etc. to achieve it? Will it impact on other areas of the business?

"When you appreciate your sphere, and understand your business’s determining influencers, you will see clearly the impact all this has on business goals, direction, and then on Quality objectives."

This will take you to determining the roles, responsibilities, resources, process methodologies, monitoring and measuring activities, inspections, checks and balances you need to keep tight control of the processes to see if they deliver the 5% increase efficiently and effectively.

One measure of control that you’ll need to tighten up on is any externally-supplied product or service of subcontract activity. As any of these feed into your end product or service, you are obliged to set the control measures on these externally-sourced goods or services, to ensure they are delivered in accordance with your management system and your agreement with the customer. So there’s no harm in doing a ‘root and branch’ review of these activities, and getting them up to scratch.

Another area to have a good look at is your internal audit process. Is is based on the areas of most importance? The high-risk areas where issues occur, be they complaints, non-conformances, credit notes issued, re-work, high scrap levels, etc. (of course you need to be monitoring and measuring to know this!) So these areas should be up for audit much more frequently than others, and the audit programme should be ever-changing in accordance with what is raising its head as important at any given time. Those areas that have had ‘importance status’ will fall away as corrective action kicks in and they recede into the background.

Obviously, there is a lot more, but I suggest if you get started on these, you’ll be well on your way.

However, if you find this too daunting and would like some support, then don’t hesitate to get in touch with me or my fellow consultants at SQMC for on-site or remote support. I’ve just been working with a client in Dubai by telephone. Among other things we exchanged news that he was feeling the cold at 25 degrees Celsius, whilst I was suffering the tropical ‘balminess’ of Leven’s 4 degrees!

Find the Scottish Quality Management Centre online at

Enlightening ISO 9001:2015 Awareness workshops are available at SQMC (headquartered within Dunfermline’s Carnegie Conference Centre) every six weeks.

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