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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 …

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 …

The first step enterprises must do for ISO Certification

When thinking about getting ISO certified, business owners ponder about the first step enterprises must do for ISO Certification. Granted, suppliers or customers might be asking you to get certified, and you would want to know more about what it really means to get certified. But the whole process might be dauting, and you might …

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 …

ISO 9001 Internal audit for SMEs in Malta

ISO 9001 Internal audit for SMEs in Malta might be a daunting task for some, or an exciting experience through which you actively improve your business. ISO 9001 is a voluntary international quality management standard that forward thinking companies implement within their company to structure their processes.  For a company to make a return on …