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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.
Benefits and challenges of remote conformity assessment
Dr Nigel H Croft CQP FCQI, examines the benefits and challenges of the digitalisation of conformity assessment and quality infrastructure systems.
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.
Workplace best practice at South American IT consultancy, Hexacta
Hexacta, finalists for Quality Organisation of the Year at the CQI’s 2022 International Quality Awards, uses best practices in the workplace, alongside state-of-the-art technologies, to ensure the highest standards of quality across more than 130 live projects.
Conformity assessment: Setting the standard
In this interview, Warren Merkel, Vice President of Policy at the ANSI National Accreditation Board, explains the reasons behind the update to ISO/IEC 1706:2022 Conformity assessment – Code of good practice, and its impact on the work of quality professionals.
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.
ISO 9004:2018 – little known but highly useful
Carew Hatherley, Managing Director of IT consulting company IQM Group, examines how the scoring system of ISO 9004 can be used for a different style of reporting or analysis.
Breaking down language barriers
Quality Engineer Benjamin Clifford, who works for DISCO Corporation in Japan, was a finalist in the Emerging Talent category at this year’s CQI International Quality Awards. Here, he explains his journey into auditing, and how a multi-lingual auditing programme is improving standards in his organisation.