Adapting to the New Normal: Third-party Audits.

Damien Tiller, CQP MCQI, IRCA Lead PQMS and QMS Auditor, highlights the way the SOC® Service Organizations: Trust Services Criteria Report could overcome the difficulties inherent in remote auditing. Many organisations have switched to remote audits during their vendor selection and due-diligence auditing phase. For some organisations, especially those within the life sciences industry, this…

Lack of Engagement from Top Management

In our latest dilemma, Chris Achillea, UK Head of Compliance at Integral, UK, explains how quality managers can encourage senior teams to take ownership and more responsibility for their management system(s).  Dilemma The quality manager for a national service delivery organisation has scheduled a formal quarterly management review meeting for the senior team to attend….

​Top Tips for Problem Solving with ISO 9001:2015

David Finney, CQP MCQI, founder of The Energy of Conversation and trainer in coaching and auditing, shares his top tips for problem solving, while meeting the requirements for ISO 9001:2015. I’ve been training professionals in coaching and auditing skills for many years. When I discuss internal issues arising in business I constantly come across the…

Influencing Objectivity and Integrity in Audits

William Rankin, CQP FCQI, Management System and Audit Manager at Inmarsat, UK, takes a look at how quality managers and internal auditors can work together to ensure objectivity and integrity is achieved during audits. Dilemma A medium-sized pharmaceutical company, with a global presence, recently appointed a new managing director (MD) to turn around a period…

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. Businesses around the world have been disturbed and had to revise their yearly plans, due to the coronavirus pandemic. The healthcare industry, in particular, witnessed a shift in its priorities, mostly by…

Maintaining Independence for Internal Audits

Andy Nichols, CQP MCQI, Program Manager at Michigan Manufacturing Technology Center, US, explains how internal auditors can achieve the independence requirements of ISO 9001.  One of the most frequently misunderstood and debated requirements of the ISO 9001:2015 requirements for Internal Audits (9.2.2) is the idea that auditors are ‘independent’ of the work being audited. It’s…

Performing Remote Audits

Ana Mariano, Management System Consultant at Rosehall Management Consultants, Philippines, explains the benefits of remote audits and the skills required to execute them correctly. The coronavirus pandemic has forced many organisations around the world to step back and look at a revolutionary transformation that is impacting the quality profession – Industry 4.0. The Fourth Industrial…

Remote auditing: A 360-degree perspective

Dean Blevins, CQP MCQI, Product Quality Specialist at Almac Group reveals what was discussed at the latest CQI Northern Ireland branch event on remote auditing.  On Tuesday 5 May 2020, the CQI’s Northern Ireland branch hosted an online webinar called ‘Remote Auditing – A 360 Degree Perspective’. The branch event, which was open to all CQI and IRCA members, proved to be…

Auditing for Cost Improvement

Jeff Monk, CQP FCQI, Managing Director of auditing training and consultancy firm, Jemo International, shares his simple steps to help organisations curtail costs and improve business performance through audits. Many senior executives view quality as an overhead cost, necessary but not profit making. This article is based on work that we, Jemo International – a global…