Visual Management of ISO 9001 will help to achieve the best out your ISO 9001 Certification. In this blog, I wanted to explain by visually showing you one of the benefits of iso 9001. So what is iso 9001? ISO 9001 is a quality management system that will help you to structure your business in …
Author Archives: Luke Desira
The 10 things that can go wrong when implementing ISO 9001 in your organization
In this blog, I will explain the 10 things that can go wrong when implementing ISO 9001. ISO 9001 is a quality management system that has been developed since 1987 with multiple versions of the standard coming out roughly every eight years. I can say that this standard truly helps companies to improve their operational …
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External Audits by Certification Bodies
External Audits – What to expect? External Audits by Certification Bodies is the last step before ISO Certification. Many companies tend to get excited about this part as they do not feel that they are ever ready for the audit. However, like any other concept within ISO Certification – this is just another angle through …
ISO 9001:2015 – Internal Audit Criteria with examples
This page is dedicated to helping you learn the art & science of internal auditing. It is by no means a comprehensive list but it gives you the basis of ISO 9001:2015 – Internal Audit Criteria with examples. ISO 9001:2015 – Internal Audit Criteria with examples In this first part, I will give some basic …
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Operational Procedures for ISO 9001:2015 Requirements
ISO Certification could easily be described as the most important step you’ll ever do for your business. By Creating Operational Procedures for ISO 9001:2015 certification requirements, you are sure to cater to the most critical elements of your core activities. In turn, by taking a deep dive into these key activities, you are bound to …
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ISO Certification vs ISO Accreditation
ISO Certification vs ISO Accreditation are 2 terms that are somewhat used interchangeably, but that however have 2 very different meanings. So, to explain this difference, let’s start from the foundation of what ISO. What is ISO ISO is the International Organisation for Standardisation and its role within the industry is to create standards covering …
ISO 20121 – Sustainable Events
The ISO 20121 – Sustainable Events, just like other standards within the ISO family, is a voluntary standard. This particular standard aims to make a positive impact on the world we live in. ISO 20121 – Sustainable Events, is a practical tool for managing events so that they contribute to the three dimensions of sustainability: …
Recommendations from Certification Bodies
Recommendations from Certification Bodies are always appreciated by ISO consultants who are willing to learn and grow. The following are some of the suggestions that we have received from certification bodies over time. Customer feedback Given that the focus of an ISO 9001 certification is to improve the reliability of our products and services as …
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Responsibilities for the Quality Representative
Responsibilities for the Quality Representative is something that thriving business owners think about when embarking on a continual improvement project. Most successful business leaders feel that they would be better off to assign the improvement project to one specific person. The Quality Representative has a very intriguing Job Description as will be highlighted in this …
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EUDAMED Registration
In this post, we will go through the information required for EUDAMED Registration and the rationale behind this system. The European Database on Medical Devices (EUDAMED) is an online platform aimed at placing all actors within the Medical Device industry, within EU onto the same platform. Actor, in this context, means any organization that needs …