Welcome back to the second part of this short series on Quality Management System certification for small businesses and start-up companies.
In this 4 part series, I will explain exactly what third-party certification involves, and how you can level up your business through this process.
The standard we will be focussing on is ISO9001:2015, as this is the most popular certified Quality Management System standard worldwide, with an estimated 1 million+ certifications.
Missed part 1? Read it here.
Implementation – Where to begin?
Once it’s been decided that the organisation is going to implement a certified Quality Management System and top management have bought into the project as there is a strong enough WHY (refer to part 1 for more about this), it’s now time to put the wheels in motion with implementation.
Implementing change in business is always easier said than done; sometimes the hardest part is knowing where to start.
The logical place to start in my opinion is by getting hold of the standard and performing a gap analysis to baseline your organisation’s current state. ISO9001:2015 and all other ISO series standards can be purchased online from the ISO web store: https://www.iso.org/standards.html
Before starting the gap analysis you will want to consider creating some form of compliance checklist that is derived from the various sections of the standard – this will help break things down into more manageable sections and serve as a way of recording objective evidence against each requirement based on current conditions.
Whilst performing the gap analysis you may be pleasantly surprised that some of the requirements are already being fulfilled or are partially fulfilled – after all, standards are based on widely accepted best practices.
Identifying gaps can also extend to “knowledge gaps” and it may be worthwhile seeking some training on Quality Management Systems if you have limited previous experience. This could be through a classroom-based course, an online self-paced course or spending time being mentored by somebody more knowledgeable in this discipline.
Once the initial gap analysis has been completed and you have a list of gaps that need to be addressed, it is now time to start putting in place the processes and documentation to do that. This is the part of the journey that involves creative problem-solving and creating solutions that work for the business.
Naturally what works for one business may not work for the other, and there are many variables at play, so it would be difficult for me to explain exactly HOW to address the gaps in a written article like this. I can however put forward 5 common mistakes that must be avoided during this phase…

5 common mistakes that people make during the implementation of a quality management system
Mistake 1: Going it alone
The Quality Management System is something that needs to work for the business and not the other way around. As a result, it is vital to ensure that department heads take responsibility for their own processes and have input into them. Make sure it’s a team effort.
Mistake 2: Focussing on Content over Intent
Contrary to the belief of some people, Quality Management Systems are not just about documentation. One of my pet hates when I was a full-time external Auditor was lengthy documents paraphrasing the standard with no verbiage on how things actually get done – this tells employees and external parties literally nothing and is a complete waste of time. When you are writing documents, make sure to make them personal, make them relevant and above all make them easy to understand!
Mistake 3: Creating too much admin
Seek to use system controls and records as a means of demonstrating compliance rather than asking people to fill in additional forms and spreadsheets. Many modern businesses are using web-based platforms (Monday, Zoho and MYOB to name a few) that have a degree of customisation. Where possible, you should aim to integrate controls into the business system and automate the creation of records. Quality Management Systems that are easy to use and don’t feel like an additional task that has to be performed on top of usual business transactions are typically the most effective.
Mistake 4: Poor selection of KPIs
Within the Quality Management System, there will be a need to measure and monitor key processes to ensure they are working effectively. Again, what is measured is something quite personal and will vary depending on the context of the organisation. Avoid picking key performance indicators that are onerous to measure and provide little added value. Also, be aware of how behaviours can be driven by performance indicators. For example, if there is a target to have no more than ‘X’ number of non-conformities per month, you can almost guarantee people will be doing everything they can to avoid raising non-conformities when things are getting close to the limit – which ironically is preventing problems from being seen and lessons being learned from the root cause analysis that comes with a non-conformity event.
Mistake 5: Thinking it’s a one-time event
This goes without saying really, but the Quality Management System is not something you can set and forget. It should be something intrinsic to the business that is an ever-growing and improving project. Everyone in the business will likely be excited about achieving that initial certification, but ensuring they are able to sustain the new ways of working over the subsequent months and years is the real challenge.
Coming up in Part 3
So there we have just 5 common mistakes I have encountered on my travels and strayed into myself at one point in my career or another. I hope those of you reading can relate to some of these or learn from them as part of your implementation journey.
In Part 3 we will be looking at the next step, which is appointing a certification body to independently certify your system. We will discuss how this process works, how to find a good certification body, and explain a bit more about what goes on behind the scenes in these organisations.
As always, thanks so much for reading and feel free to reach out to me on LinkedIn.
#AssuranceWithAndrew
Connect with Andrew Milner on LinkedIn and find out more about Conflux Technology, the pioneering additive manufacturing and thermal technology company that he works for, by visiting their website: www.confluxtechnology.com