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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.
Supporting climate change with audit and assurance
Climate change is a focal point for organisations around the globe and audit has a key role to play in ensuring businesses embrace the challenge. Gillian Karran-Cumberlege, Head of Board Advisory and co-founder, Fidelio Partners, explains why.
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.
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.
Streamlining the audit process
Pedro Medel Reyes, Quality and Compliance Manager at Perforadora México of Grupo México, has streamlined the audit process for his company to improve efficiency. Here, he explains the work which led to him becoming a finalist in the Emerging Talent Award at this year’s CQI International Quality Awards.
Audit SIG attendees and the future of audit
The Chartered Quality Institute’s Audit SIG Conference, in partnership with Inmarsat and sponsored by Société Générale de Surveillance (SGS), took place on September 15 at Inmarsat’s headquarters in London. At the end of the event, delegates and Audit SIG members stopped to share their thoughts on the future of the audit industry and their key takeaways from the event.
The role of quality assurance in the UK energy sector transformation
For Ivan Ericsson, Head of Quality Management at engineering and management consultants Expleo UK, treating assurance as a strategic tool, rather than just a box-ticking exercise, is critical to the future of the UK energy sector.
Achieving accreditation as a small company
Su Chantry, Clinical Director at SKC Occupational Health, outlines her journey to ISO 15189 accreditation.