29 Jun 2021

Quality is important in all industries but perhaps more so in the medical industry and for those organizations producing medical devices. Apart from ISO 13485 that defines the requirement for medical device quality management systems, medical device manufacturers have to also comply with the regulations of the country their devices are going to be used within. In an effort to streamline ...

17 Mar 2021

The ISM Code is the International Code for the safe Operation of Ships and Prevention of Pollution, more popularly knows as the International Safety Management Code. The most recent revision of the code was released in 2018 that provides updates to the Resolutions included as amendments to the code. The ISM Code specifies the methods to attain ISM certification. The regulations were dr...

22 Feb 2021

Captain IJ Arora
Exclusions to what an organization does were integral to the ISO 9001 standard prior to the 2015 version update. After all an organization cannot do all the work. Clause 7.1.1 lays the foundation on this thought by accepting that an organization must determine and provide resources. In doing so it determines the constraints and capabilities of the existing resources and what needs to be ...

17 Feb 2021

As MDSAP deadlines draw near companies are asking how to prepare for the MDSAP audit. The most basic step for the success of any management system is to say what you do and do what you say. When the system as documented is captured to reflect the “As-Is” of how it is done then implanting the system leads to conformity at all levels. Auditing Organizations (AOs) that will come to assess...

15 Aug 2020

Maritime image
The ISM (International Safety Management) Code, in itself, is not a magic wand, that will bring safety or prevent pollution. It depends on the organization on how it implements the Code. Safe operation of ships and the prevention of pollution should have been any organization's objective. Yet all over the world owners to save money compromise these objectives. Did not the Titanic on Apri...

30 Mar 2020

eight steps for internal audit
Internal audit programs play an important role in ensuring the success of the system. ISO standards such as ISO 9001, ISO 14001,  ISO 45001 provide the framework for management systems to function using a process-based approach, to achieve customer and other stakeholder’s requirements. Organizations certified to ISO standards, strive to be compliant, efficient and remain certified. Succe...

25 Mar 2020

ISO 9001 certification decline graph
ISO 9001 certification have seen a decline in the past two years per data from ISO. Some say that the standard has gotten too complicated with the introduction of organizational context, risk-based thinking and the removal of mandatory documented procedures. Even a few of QMII’s clients had considered letting their certification lapse as conformity to the new standard was perceived as to...

11 Feb 2020

ISO 14001 Lead Auditor training introduces students to the ISO 14001 standard and its interpretation as well as the skills needed to assess the effectiveness of the environmental management system. ISO 14001 in its 2015 revision introduces the lifecycle perspective. In essence, the standard asks organizations to use a lifecycle perspective when designing/manufacturing their products/serv...

09 Jan 2020

Leadership shaking hands
Who cares about the system?  Management systems need top management commitment to work well, and yet many systems lack the necessary commitment. You may recognize some symptoms.  Policy - ignored.  Objectives  are barely alive. Corrective actions remain open. Managers seem not to appreciate the value of the requirements.  Employees are unsure about the system’s requirements. Proactive i...