The latest news and updates from cognidox

Why not just use Qualio as your medical device eQMS?

Qualio is an eQMS platform launched in 2012 by Irish entrepreneur Robert Fenton. From small beginnings, his co...

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Medical Device, IVD or SaMD? Medical device regulation explained

  Question for you: is the product you intend to develop a Medical Device, an In Vitro Diagnostic Medical Devi...

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How a QMS supports medical device risk management in ISO 13485

  A QMS should ultimately help guard against customer harm or dissatisfaction, by guarding against the risk of...

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Document Management and Document Control: Is there a difference?

For some companies simply managing their documentation is enough to support their business goals. But others n...

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4 ways to build an ISO 13485 compliant medical device QMS

Are you looking for ways to build and maintain the most efficient, ISO 13485 compliant QMS as your company con...

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What's the difference between a QMS, eQMS and an eDMS?

There are different ways companies can build required quality management systems, from using traditional paper...

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Why not just use Dropbox for your Medical Device QMS?

DropBox is a file sharing platform familiar to millions throughout the world. Once a personal file storage and...

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11 'must have' features of medical device document control software

Inflexible SOPs, complicated interfaces, training and maintenance requirements. Traditional document control s...

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What’s the cost of chaos in a document management system?

Chaotic document management is wasting the time and energy of businesses around the world every year. But in s...

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Why not just use Google Drive for your medical device QMS?

A Quality Management System is a requirement for medical device developers across the globe. But should you bu...

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Moving from paper to a digital medical device Quality Management System

The case for ditching paper-based QMS (Quality Management Systems) can seem like a no-brainer. But faced with ...

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7 Quality Management Principles of ISO 9001:2015 and how to live by them

ISO 9001:2015 and its related quality standards are all based on the ‘Seven Quality Management Principles’ def...

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4 steps to build a simple & effective supplier quality management system

Supplier management needs to be a collaborative and proactive process if it’s going to deepen key relationship...

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Why your company should have a Quality Strategy

I believe that a quality strategy is a vital element to the success of a business. Quality of product and oper...

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Should you use Microsoft software to build your own digital QMS?

SMEs creating a digital Quality Management System (QMS) will often reach for the most familiar tools to build ...

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8 Tips For Documenting SOPs (Standard Operating Procedures)

There are many reasons why an organisation might need to document their SOPs. From training staff and identify...

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Post Market Surveillance for Medical Devices; Why, How & Who?

Post Market Surveillance (PMS) has been elevated in importance by the new MDR and IVDR regulations which will ...

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Good Distribution Practices (GDP) In the Pharmaceutical Industry

Managing the quality of medical products as they are stored and distributed brings with it many challenges. Di...

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Where are you on the Quality Management Maturity Grid?

Of all the quality management ‘gurus’ the late Philip Crosby is one of the most readable. In his book ‘Quality...

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CBD, GMP and GdocP; quality management in the cannabis industry

Around the world different rules apply for the cultivation, manufacture and sale of cannabis and CBD products....

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Organizational knowledge in ISO 9001:2015

  One of the areas included in the ISO 9001 :2015 is 7.1.6 Organizational knowledge. The stated requirement is...

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Compliance Vs. Kaizen; how quality management can be part of your DNA

Companies working in heavily regulated sectors might have been historically slow to change and optimise their ...

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Riding the wave of the med-tech quality management challenge

Time and costs can soon rack up in a med tech device design and development cycle. But those who have installe...

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The evolution of a Quality Management System

A focus on a quality management system shouldn’t just mean a ‘box ticking’ exercise for an organisation. And i...

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Are you developing a medical device?

Are you developing a medical device? And are you certain about that? It might sound like a crazy question. If ...

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How to Build a QMS Your Team Will Actually want to Use

One of the main challenges of implementing a Quality Management System (QMS) is ensuring it is actually used f...

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No more mavericks: Better QA through collaboration

It’s a cliche that good collaboration and teamwork maximises productivity. But in the high tech product develo...

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Is your QMS just for ISO certification?

 Is ISO certification the only reward you’ll receive for jumping through all those QMS hoops? And is it really...

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ISO 13485:2016 - decoding the enigma

Developing medical devices can be a process fraught with challenges. As a startup or established business abou...

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ISO9001 ready with Cognidox – an overview

4 steps to getting ISO9001 ready Achieving ISO9001 compliance can appear daunting, but while it requires a sig...

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A closer look at Document Control for ISO 9001

What is document control? Properly documented information is at the heart of meeting the ISO 9001 standard, an...

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White Paper – How to apply Risk-based Thinking to ISO 9001:2015

For the past several months we've published a series of blog posts on the application of Risk-based Thinking f...

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ISO 9001:2015 – How to apply Risk-based Thinking to Quality Processes [Part XII]

There are twelve posts in this series. To read Part XI, please click here. This is the final part in our serie...

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A gQMS reinforces ISO 9000 Quality Management Principles

When gaining a quality badge is the primary objective, there is a temptation to just think about meeting the m...

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ISO 9001:2015 – How to apply Risk-based Thinking to Quality Processes [Part XI]

There are twelve posts in this series. To read Part X, please click here. If you have been reading this blog r...

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ISO 9001:2015 – How to apply Risk-based Thinking to Quality Processes [Part X]

There are twelve posts in this series. To read Part IX, please click here. In this and the following two posts...

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ISO 9001:2015 – How to apply Risk-based Thinking to Quality Processes [Part IX]

How to apply Risk-based Thinking to Quality Processes - a Summary There are twelve posts in this series. To re...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part VIII]

RISK MANAGEMENT METHODOLOGY FOR QUALITY MANAGEMENT Steps 4-6 in the method There are twelve posts in this seri...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part VII]

There are twelve posts in this series. To read Part VI, please click here.  Steps 1-3 in the method If you hav...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part VI]

  There are twelve posts in this series. To read Part V, please click here. Risk based thinking is the new 'pr...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part V]

SO 31000 Risk management techniques - continued Attributes of a selection of risk assessment tools   There are...

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Visualizing Business Processes - what can go wrong?

Most Quality Control and Quality Assurance methods are concerned with business process mapping as a way of und...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part IV]

ISO 31000 Risk management techniques - continued There are twelve posts in this series. To read Part III, plea...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part III]

ISO 31000 Risk management techniques Attributes of a selection of risk assessment tools If you haven't yet rea...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part II]

ISO 31000 Risk management techniques: A selection of risk assessment tools you might like to consider Part 1 i...

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ISO 9001:2015 - How to apply Risk-based Thinking to Quality Processes [Part I]

Why taking a risk-based approach is a requirement of ISO 9001 Risk-based thinking is a sore point among many Q...

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Graphical QMS, documented information, and the audit process

A gQMS will help with internal and external auditing requirements - leading to ISO certification in less time ...

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The Graphical QMS - how to get value from documented information

Documented information in a Quality Management System (QMS) - and why it's time for a radical overhaul of how ...

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ISO 9001:2015 - The likely impact (Part III)

What 'documented information' is required by ISO 9001:2015? There are twelve posts in this series. To read Par...

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ISO 9001:2015 - The likely impact (Part II)

There are twelve posts in this series. To read Part I, please click here. Risk-based thinking and the resultin...

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ISO 9001:2015 - The likely impact (Part I)

How will the new version affect ISO 9001:2008 registrations? According to BSI, the new standard, ISO 9001:2015...

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Document Control, ISO 9001 and CogniDox DMS

  ISO 9001:2008 is not prescriptive - it provides a framework and good advice but generally leaves it up to th...

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CogniDox and Acrolinx for document quality

At Cognidox, we spend a deal of time talking about quality documents in the context of quality assurance, ISO ...

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Using a Web Archive (WA) document type for a QMS

  Recently we announced a case study with a partner, Primilis, in which they used a CogniDox feature to implem...

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