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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.
A psychologist, a quality guru and a president walk into a bar…
Published: 14 Apr 2023
Andy Nichols CQP FCQI takes a closer look at why audit checklists can be a polarising subject.
How QMSs can ensure safety in medical devices
Published: 11 Jan 2023
Karandeep Singh Badwal, Director of QRA Medical and an internal auditor for ISO 13485, outlines some of the common mistakes found in the quality management systems for medical devices.
The importance of gap assessments in auditing
Published: 11 Jan 2023
Conducting a gap assessment is a vital first step when implementing a new management system or integrating one with an existing system. IRCA Lead Auditor Andy Lau explains the steps that must be taken to ensure conformance with certification body standards.