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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.
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.
Navigating the rocky road ahead
The European Confederation of Institutes of Internal Auditors has published its annual Risk in Focus report. What are the topics of concern for internal auditors, and how can they support their organisations in key risk areas?
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.
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.
Cognitive bias and its impact on outsourcing
Cognitive biases can have a serious impact on supply chain management when it comes to outsourcing vendors. Krishnan Lakshminarayanan CQP MCQI, a Lead Auditor and Senior Manager at William Hare in India, examines some common examples and looks at how they can be avoided.
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.
Boosting manufacturing recovery with LPAs
At EASE Inc, Chief Executive Eric Stoop says that layered process audits hold the key to greater product quality and a faster manufacturing recovery.
Continuing risk-based audits during a pandemic
Gordon McNeil, IRCA Principal Auditor, has conducted audits globally in a variety of industries, including nuclear, defence, aerospace and civil aviation. He shares his experience and advice on how remote audits can continue to be conducted during the Covid-19 pandemic.