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I worked in one of the large Cambridge-based technology consultancies for many years and was privileged to hav...
I worked in one of the large Cambridge-based technology consultancies for many years and was privileged to hav...
SMEs creating a digital Quality Management System (QMS) often turn to familiar, digital tools to build a solut...
With complexity and costs rising, fabless semiconductor companies need to do all they can to keep their flow a...
What does it mean to 'control documents'? And who needs a formal document control system to manage and optimis...
Writing clear, compliant Standard Operating Procedures (SOPs) is key to quality management in regulated indust...
Document control is a key part of any Quality Management System (QMS) and, therefore, a requirement of ISO 900...
ISO 9001 and ISO 13485 are both internationally recognised quality standards, but they serve different industr...
Managing your document lifecycle is central to achieving ISO 9001 compliance. This guide explains how to struc...
ISO 9001:2015 and its related quality standards are all based on the ‘Seven Quality Management Principles’ def...
Mention ISO 9001 to most people, or tell them that you implement quality systems, and they'll start glazing ov...
For those who need ISO 9001:2015 certification, virtual audits are currently taking the place of face to face ...
In Part 1 of this series we considered the problem of reinvention, the unstructured nature of information, and...
In a previous blog, we wrote that information findability is as worthy a topic for ISO 9001:2015 standards-mak...
Unstructured data present both a compliance risk and a missed opportunity for growing organisational knowledge...
The expense and effort of achieving ISO certification is sometimes regarded as excessive and onerous by SMEs -...
One of the areas included in the ISO 9001 :2015 is 7.1.6 Organizational knowledge. The stated requirement is: ...
Is ISO certification the only reward you’ll receive for jumping through all those QMS hoops? And is it really ...
Many quality managers find that as an ISO audit approaches, their stress levels increase. Are all the procedur...
4 steps to getting ISO9001 ready Achieving ISO9001 compliance can appear daunting, but while it requires a sig...
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 ISO 9001 certification is your goal, it’s tempting to treat it as a box-ticking exercise—doing th...
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...
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...
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 ...
Why taking a risk-based approach is a requirement of ISO 9001 Risk-based thinking is a sore point among many Q...
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...
Information Security Risk Assessments in ISO/IEC 27001:2013 ISO/IEC 27001:2013 aligns with the principles and ...
The short answer is 'A lot more than many professionals currently think'. To start, though, the basic facts: I...
ISO 9001:2008 is not prescriptive - it provides a framework and good advice but generally leaves it up to the ...
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