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Showing posts tagged with: ISO 13485

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Creative Collaboration, Collaborative Compliance

Creative Collaboration, Collaborative Compliance

It’s official, workplace emails are an ineffective tool for managing projects. Don’t confuse Emailing a link to your team as collaboration - that’s ping-pong! And sending your team an email and asking them to either comment or provide input on a file, an idea, a suggestion is like trying to push a wet string. Although email...
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QMS Processes & ISO Compliance (ISO compliance in the business world and QMS processes)

QMS Processes & ISO Compliance (ISO compliance in the business world and QMS processes)

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...
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6 Benefits of ISO Compliance

6 Benefits of ISO Compliance

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...
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QMS Manager: Job or Role?

QMS Manager: Job or Role?

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...
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Understanding Roles & Processes in ISO 13485:2016

Understanding Roles & Processes in ISO 13485:2016

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…...
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ISO 13485:2016 - New terms to take note of

ISO 13485:2016 - New terms to take note of

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...
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ISO 13485:2016 – Creating a Glass Ceiling for Startups

ISO 13485:2016 – Creating a Glass Ceiling for Startups

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 disproportionally impact startups and small companies. Essentially, to properly manage...
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