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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.
Managing the risks of risk assessments
Caitlin McArthur, Audit & Compliance Manager at Sodexo, addresses the many challenges around assessing risk at work.
Eliminating occupational health and safety risks
Occupational health and safety (OH&S) is a must. IRCA Principal Auditor Ravindiran Gurusamy outlines best practice for investigating OH&S incidents.
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?
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.
7 hours
MD-QMS ISO 14971:2019 Foundation (Medical Device – Application of risk management to medical devices)
This course provides a basis for learners who wish to go on to complete CQI and IRCA Certified MD-QMS Auditor Training courses
The High Level Structure is dead. Long life to the Harmonised Approach?
Horacio Martirena, a CQI technical assessor, IRCA Lead Auditor and Independent Consultant in management systems, outlines the development of the Harmonised Approach and the issues it addresses, and what it needs to resolve.
Dealing with time pressures
In our latest dilemma, find out how to avoid delays with audits and ensure they’re delivered within the audit plan’s designated timeframe.
Auditing Santa's Workshop
With Christmas soon approaching, Hussain Ali, CQP MCQI, Quality Manager at Jacobs Engineering, explains how an audit at Santa’s Workshop taught him how to deliver more efficient audits during and after the festive season.
Process automation and the quality professional
Richard Seddon, Managing Partner at Process Management International (PMI), UK, explains why quality professionals need to embrace process automation tools in this digitally advanced era.