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The process approach to audit – a unicorn?
Published: 6 Dec 2024
A 'process approach' is mentioned in the guidance documents for several standards, but is not defined in terms of implementing an audit of a quality management system. Andy Nichols CQP FCQI takes a closer look at this apparent paradox.
Preparing for unannounced audits of medical devices
Published: 8 Jun 2023
ISO 13485 internal auditor Karandeep Singh Badwal, explains what to expect and how to prepare for unannounced audits of companies with a UKCA or CE-marked medical device.