Showing posts tagged with: QMS

In a global environment, companies are facing countless complex, unique industry challenges. Quality becomes not just a buzzword but a true competitive advantage – companies that deliver the best quality products and services efficiently - succeed.     ISO certification, (be it ISO9001, ISO13485…)  communicates a commitment to quality to both customers and regulators. There are many benefits...

ISO’s standards are created to guide companies in dealing with some of the most demanding challenges of modern business – Quality & Customers. At its core, the ISO system is underpinned by the pursuit of recognizable quality that ties business goals and customer needs. The aim is to make business operations as efficient as possible...

ISO 12651-2 defines a document as "recorded information or object which can be treated as a unit". Err… Yup!... Got it!... Been treating recorded objects as a unit for, well… forever…   Sometimes you just have to admire their creativity! Compliance requests essentials On the more serious side, we’re still talking compliance and for that, there are 6...

When digging deeper into a part where ISO 13485:2016 defines roles,  we can get a headache of how to define QMS management. It might be tricky to come to define Is it a job or is it a role in an organization? A QMS manager is a one-person Job with a very critical role, so we...

Software as an industry is unique in that not only can it be a product it can also be a service. Moreover, it is its own means of production;  Increasingly software can be found in all kinds of products, products that are ever more built to ISO standards, a.k.a. quality standards. And where quality and ISO...

What is a role and how does it connect to processes?   The 2016 edition is much more complicated than the 2003 edition so here is a little help to make things a little more understandable. In ISO 13485:2016 there are many new terms, definitions, and requirements compared with the 2003 edition. "First, a stab of the ISO bureaucrats…...

Differences and similarities between the ISO 13485:2003 and ISO 13485:2016 editions. ISO 13485:2003 only had a few defined terms with clear definitions. However, in the new edition of ISO 13485:2016, sixteen new terms are added with longer definitions. Let's see what are the differences and similarities between the editions. Terms that remained the same Advisory notice - giving...