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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.
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.
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.
Maintaining quality standards in disruptive times through internal audits
Youmna Abboud, Quality Assurance and Regulatory Affairs Associate at Zimmer Biomet, Middle East, explains why internal audits are required during the coronavirus pandemic.
Eliminating the costs of poor quality
Vimala Balusamy, CQP MCQI, Quality and Project Management Consultant, India, shares her five steps to help prevent poor quality costs in businesses.
Securing the TISAX label
Raymond Mooney, PCQI, Business Development Manager at TÜV Nord, UK, outlines the requirements and advantages of the TISAX Standard for automotive businesses.
Setting and meeting KPI targets
Paul Vaughan, CQP FCQI, Quality Manager at Siemens Rail Automation, UK, explains the importance of setting key performance indicators (KPIs) for business.