Similar to ISO 9001, ISO 15189 Medical laboratories is a Quality Management System. The salient difference is that the latter gives requirements that are specific to medical laboratories. Another standard that is also relevant to medical laboratories is ISO 17025. The main difference between the 2 standards is that: ISO 15189 sets out the guidelines for…
Handling your suppliers within your value chain in a systematic fashion is extremely critical to ensure a high-quality product or service. Supplier Management for ISO 9001 Certification is an easy requirement of the ISO 9001 standard that does not require too much effort from your end – and yet that will leave long-lasting benefits to…
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…
In this page, you will get a complete overview to learn the ISO 9001 Certification Requirements. Here we will assume that you are very familiar with the benefits of implementing an ISO Certification and that you understand Why ISO Certification is important. Step 1: Get an overview of the Clauses for Certification Step 2: Know…
Recently, I have been asked by one of my clients to produce a Building Maintenance Report for ISO 27001 Certification. Given that apart from being an ISO Consultant, I am a Mechanical Engineer I am competent and authorised to created such reports. Through this blog post, I wanted to share with you the salient elements…
The Medical Device Regulations for Distributors came into force in mid-May 2021 (after being postponed by 1 year due to Covid-19). Through this regulation, the European Union has streamlined the various fragments of regulations of directives and regulations that previously existing. The idea behind this regulation is to define the level of standard for the…
Corrective actions and non-conformities in ISO are the way that we track mistakes that happen within our organisation. In previous blog posts, I have mentioned multiple times that an ISO Certification does not mean that a company has perfect products and service and that no mistakes are done. An ISO 9001 Certification means that a…
Business process re-engineering might be a pandora’s box for anyone who has never looked into the subject. But in reality, it is very simple. Basically, it debunks the concept of “never change a winning team”. In business, and in life, we must continually strive to improve our position. Whether going backwards or forwards, in life…
The 7 Types of Waste in a Business are not an idea that has been around for long. On the contrary, for the past year, lean principles have only been used for manufacturing companies. However now, with the rise of businesses, due attention is being given drive improvement through the management system of companies. Introduction…
There are many reasons why ISO Certification is important, and even though there are many benefits of ISO 9001 certification, it all boils down to one thing, as we will see below. At the outset, I’d like to make it clear that I do not believe that a mere quality certification improves the quality of…