The latest news and updates from cognidox

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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