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How do you log and deal with non-conformities so that faulty products don't end up in the hands of customers? ...
How do you log and deal with non-conformities so that faulty products don't end up in the hands of customers? ...
A Trial Master File (TMF) is a comprehensive collection of documents that ensures the conduct of your clinical...
Data integrity is central to the safe development and manufacturing of every life-science product on the marke...
Navigating the complexities of ISO 13485:2016 can seem daunting, but understanding its requirements is crucial...
The case for ditching paper based QMS (Quality Management Systems) can seem like a no-brainer. But faced with ...
In 2008, the ICH Q10 Pharmaceutical Quality System (PQS) guidelines introduced a comprehensive model for an ef...
Cognidox and Qualio are both digital quality management systems (QMS) with a focus on the life science and med...
In medical device development, two critical stages of the design process are often confused: design verificati...
What if you could gain approval to sell your medical devices anywhere in the world, by completing a single, re...
What’s the cost of quality? Can it, like QM guru Philip Crosby argued, really be free? Like most things in bus...
Chip designs are becoming more complex and expensive to develop, verify and validate. Opportunities for fables...
There are many reasons why organisations need to document their SOPs. From ensuring uniformity in end products...
Of all the quality management ‘gurus’, the late Philip Crosby is one of the most readable. In his book ‘Qualit...
SMEs creating a digital Quality Management System (QMS) will often reach for the most familiar tools to build ...
Monitoring and measuring quality of products and services is a key part of any QMS. But how can you be sure th...
How do you transform regular supplier reviews from a box-ticking exercise into a genuinely useful commercial a...
ISO 9001 is the internationally recognised standard for quality management used in many sectors from construct...
There are different ways companies can build required quality management systems, from using traditional paper...
A focus on a quality management system shouldn’t just mean a ‘box ticking’ exercise for an organisation. And i...
Qualio is an eQMS platform launched in 2012 by Irish entrepreneur Robert Fenton. From small beginnings, his co...
A QMS should ultimately help guard against customer harm or dissatisfaction, by guarding against the risk of f...
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...
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...
ISO 9001:2015 and its related quality standards are all based on the ‘Seven Quality Management Principles’ def...
I believe that a quality strategy is a vital element to the success of a business. Quality of product and oper...
Managing the quality of medical products as they are stored and distributed brings with it many challenges. Di...
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...
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 ...
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...
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 have...
There are twelve posts in this series. To read Part V, please click here. Risk based thinking is the new 'prev...
SO 31000 Risk management techniques - continued Attributes of a selection of risk assessment tools There are t...
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 ...
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