ISO 14971 – Content Deviation #3 Economic Considerations of Risk Reduction

Home / News, Views & Updates / Monthly Archives: April 2014

ISO 14971 – Content Deviation #3 Economic Considerations of Risk Reduction

During the process of harmonisation of ISO 14971: 2007 as an EN standard, it became apparent that the standard did not comply with all the requirements of the Medical Devices Directives (MDDs), namely 90/385/EEC, 93/42/EEC and 98/79/EC. Seven discrepancies were identified; these ...

Read More

ISO 14001 CONTINUAL IMPROVEMENT SURVEY 2013

The International Standards Organisation (ISO) committee responsible for ISO/TC 207/SC1 carried out a survey of the environmental management system standard ISO 14001 in 2013. This survey sought to gain information from users in relation to the standards current benefits and...

Read More

Gauge R&R and Attribute Agreement Analysis as it Applies to Non-Measurement Assessments

Many organizations now undertake Gauge R&R studies on their measuring instruments. However, the facilities now available for undertaking similar studies for non-measurement type instruments, such as Go/No-Go gauges, are less well known. Strictly speaking, the term “Gauge R&...

Read More

What are the Hidden Skills of a Project Manager?

With the increased attention given to leadership in today’s business community, one could argue for the simple substitution of the expression project management with project leadership. You are right to think this but we must also understand there are so many other hidden s...

Read More

Blog Sign up

Sign up to receive the latest industry and company news direct to your inbox.