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Preparing for unannounced audits of medical devices
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…
Andy Nichols CQP FCQI takes a closer look at why audit checklists can be a polarising subject.
ISO 9001 in healthcare: Certifying a service, not a product
What are the challenges of becoming certified to ISO 9001 in the healthcare sector? Denis Foley CQP MCQI explains.
How QMSs can ensure safety in medical devices
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
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.
ICP's ongoing journey to innovation
The team from the Federal Authority for Identity, Citizenship, Customs & Port Security in the UAE – named as one of two Quality Organisation of the Year winners at this year’s International Quality Awards – was also a finalist for the Digital Innovation Award.