fbpx

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 …

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 …

ISO 22000 Certification – Food Safety Management

Certification to ISO 22000 Certification – Food Safety Management, is a major milestone for aspiring companies within the food industry. In a previous post, we have already discussed the various management systems that exist within the ISO family. In this post, we will go deeper into what ISO 22000 Certification – Food Safety Management really …

Sales Procedure as per ISO 9001 requirements

One of the most intense activities to do during an ISO 9001 implementation is to define the procedures of the business. In this blog, you will learn on how to create the Sales Procedure as per ISO 9001 requirements. Through this blog, we will take the following two examples to explain how the same requirement …

Vision, Mission and KPIs

When thinking of starting any business process re-engineering activities, we need to think about the vision, mission and KPIs for the organization. It is said that “if you don;t have a destination, you can never get lost”, and naturally the inverse also applies. Therefore, before starting any major improvement works within an organization, it is …

How do I prepare for an ISO Audit?

As part of implementing and maintaining an ISO Management System, an Internal Audit and External Audit are required. So, how do I prepare for an ISO Audit? Luke Desira‘s background had led him to have a very different approach to ISO Certification. His first job was at a multi-national corporation employing 45,000 people, and his …

Management Review Meeting for ISO 9001

The Management Review Meeting for ISO 9001 could possibly be the primary source for continual improvement. First of all, I’d like to explain the difference between data and information: Data – raw numbers. For example, a filled in customer feedback form (or 15 of them) – stacked on top of each other. Information – processed …

Risk Management in ISO 9001

Risk Management in ISO 9001 is defined as “the effect of uncertainty” on business objectives. Risk is about dealing with uncertainty. Anything that can have an impact on the strategic direction of a business, can be considered as a risk. If we have no objectives, we are not doing anything. If we have an event without …

How long does it take to get ISO Certification?

ISO Certification is increasingly becoming important for forward-looking business who are seeking to structure and grow their business. The first consideration that most business owners consider when seeking such a certification is “How much does it cost to get ISO Certified in Malta?”. Like with any other investment that is to be made, the exact …

ISO 15189 – Medical laboratories

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 …