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Common mistakes found in the quality management systems for medical devices.

How QMSs can ensure safety in medical devices

Published: 11 Jan 2023

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.

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.

Conformity assessment: Setting the standard

Published: 11 Jan 2023

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

Published: 11 Jan 2023

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.

Breaking down language barriers

Published: 3 Oct 2022

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.