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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.
ISO 9001 in healthcare: Certifying a service, not a product
Published: 6 Apr 2023
What are the challenges of becoming certified to ISO 9001 in the healthcare sector? Denis Foley CQP MCQI explains.
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.