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…
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…
“Individuals play the game, but teams win championships”Bill Parcells As in sport, the same rules apply to business. Collaboration is the glue that binds teams. Collaboration is different people executing together on the same issues, cooperatively whether communicating through Chat, Voice, Video or email. But…
QMS manager job or role is a common question when medical device companies start implementing ISO 13485 and defining responsibilities within their quality management system. A QMS manager is usually a dedicated position with a critical role in maintaining regulatory compliance, so we recommend you to keep…
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…
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…
Your email address is the proverbial key to the internet. No email address, no account at Facebook, no streaming, no whitepapers, no downloads. Whether you use Gmail, Yahoo, AOL or a host of others, you need an email account because it’s your ID on the…
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…
May 2016 was a dark period for medical small companies and startups, it was the day the ISO created a glass ceiling for Medical Startups. A glass ceiling! Yes, because ISO13485:2016 essentially puts a glass ceiling on medical start-ups with a daunting new array certification requirements that will…
An innovative approach to tackle the challenges of modern business – Management Through Quality™ qmsWrapper is a smart management software that effectively avoids adding another layer of management by encouraging team-based collaboration compliance. qmsWrapper is for any company needing a powerful, unified platform to help the…
