Proper implementation of ISO 9001

As an ISO consultant in Malta, I get the opportunity to work with various types of clients, giving me the opportunity to ‘go under the hood’ of various business. Proper implementation of ISO 9001 depends on the character of the business owner – how will are they to improve their business.

Recently I was working with 2 different clients who work within the distribution of Medical Devices in Malta. Both were inspired to get ISO Certified because of the upcoming Medical Device Regulations for Distributors in Malta that will come into force mid next year. However, their approach was completely different. Specifically, their motivation for certification was different.

Management commitment

The new iso standards prioritize the importance of risk management. The way the new standard is designed is created to help management to see the management system as an extension to the business plan. Committed business leaders, do not just look at the proper implementation of ISO, as a way to meet the ISO 9001 certification requirements. Rather they are committed to improvement.


A key element of management commitment is how much time they dedicate to process of ISO certification. One of the clients I’ve mentioned above agreed to set up a weekly recurring meeting – whereby we’d meet every week at the same time to continue our progress on ISO certification. The other client continually postponed meetings as was not (mentally) fully present during the meetings. Moreover, the latter expected to progress to be done on the certification without their input – they wanted me to design their management system, without explaining the intricacies of the operations. Which is naturally impossible.

The aim is to create a management system that is specific to their needs, and that would therefore reflect how they operate their business. I can create a generic management system, based on how other businesses work – but what benefit would that have for their company.


Another key element of commitment is effort. Top business leaders want to roll up their sleeves and really try to improve. They are dedicated to the cause and give the necessary effort to provide all the information that is requested. They put a hand on heart and look beyond the simply meeting the requirements of the standard – but they are committed to improvement.

Proper implementation of ISO 9001

Proper implementation of ISO 9001, therefore, depends on the business owner, and on their consultant. The process to get ISO 9001 certified is an exciting journey for some, and a chore for others.

The most striking difference between these two business owners was that one of the business owners was extremely reluctant to implement any changes within their business. As an ISO consultant, I take pride is making as little changes to my clients as possible – I believe that small changes can lead to big improvements. But to achieve a Proper implementation of ISO 9001, that doesn’t mean that there should be no changes to the management system.

The client who was committed to improvement went ahead and suggest changes for improvement themselves. Sometimes, I had to hold him and advise him that the suggested change would not give the required benefit – and that therefore should not be implemented at once – there were more pressing improvements to implement. I did this, as I do not like implementing many changes at once within my clients’ businesses. I like to keep it to a maximum of 3 changes during a Proper implementation of ISO 9001.

The latter client would then get very excited when we agree on a change that can be implemented to their business. At one point, we said that further information can be gathered right after the commission of equipment is done. Immediately, he got down to it and started scribbling notes on the information that the new form would have. This motivates me to further improve the business of my client. Meetings with such clients rarely finish on time – and I spend more time than anticipated on such clients. And that is completely fine by me – it is the reason why I love what I do!

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