The FDA will release a draft guidance this month on how it will interpret International Organization for Standardization (ISO) audit reports when determining its inspection priorities for device makers, an agency director says. Under the FDA Amendments Act, which reauthorised the Medical Device User...

Hello all, I'm sure most of you will be aware that a new version of the ISO 9001 standard is earmarked for release later this year, being called ISO 9001:2008, which will update the current ISO 9001:2000 standard. Have you read or heard about any of the changes? Please share with other members your...

The new British standard (BS) for business continuity is set to become an international standard, driven by demand for supply chain security as global interdependencies increase, says IBM. Robin Gaddum a consultant at IBM business continuity and resiliency services said, BS 25999 will be of value in...

To support the take-up of the new business continuity standard BS25999, IT Governance Limited has published Business Continuity and BS25999: A Combined Glossary as a new addition to its Pocket Guide series. This Pocket Guide presents a standard, common set of terms that can be used to discuss business...