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 ...

23 Jun 2021

What is ISO 22301? ISO 22301 is an international standard for Business Continuity Management Systems. This standard is designed to protect, prepare for, respond to, and recover from unexpected incidents when they arise. When your organization has a Business Continuity Management System, it is prepared to detect and prevent unforeseen threats. ISO 22301 applies to all organizations ...

31 Mar 2021

Small Passenger vessel
Excerpt below is from White Paper by 'Implementing Safety Management Systems for Passenger Vessels' by Dr. Inderjit (IJ) Arora (QMII), Julius Desilva (QMII) and Captain Lee Boone (USCG, Retired). To continue reading the paper click on link in text. INTRODUCTION All too often, major accidents are the catalyst for change in the maritime industry. Evidence of this is seen in the developme...

29 Mar 2021

Quality! Who does not want it. We read through hundreds and thousands of reviews each day just so we can buy a quality product or service. Even those searching for an ISO 9001 training are looking to identify a training provider that will provide a quality training. ISO 9001 is an international standard set by the International Organization for Standardization (ISO) that defines the fram...

28 Mar 2021

In the aerospace industry a small error in the supply chain can have disastrous consequences to the final product. AS9100 certification in the industry provides third party validation of the processes and organization has put in place to manage the quality of the product/service they deliver. It also helps to provide confidence to customers that they employ a process-based management sys...

27 Mar 2021

AS9110 Process Effectiveness Assessment Reports are used to identify the effectiveness of a process. PEAR was developed to allow audit personnel to systematically evaluate the effectiveness of a process as performed by the organization. It takes the inputs, outputs, actual steps of the process and recourses and controls in account. Turtle diagrams are often sued to depict PEARs. The P...

26 Mar 2021

Subchapter M ushered in a new era for the inland water companied within the US in the towing industry. The need for the regulation was driven by the many accidents that occurred on the inland waters of the US owing substandard vessels and incompetent personnel in use. As companies struggle to meet the requirements of the new regulation, those opting for the TSMS option seek documentation...

24 Mar 2021

ISO 9001 training is a great starting point for those that do not have a good understanding of the ISO 9001 standard and are looking to implement it within their organization. The standard provides the framework for implementing a quality management system and defines requirements around the plan-do-check-act framework. ISO 9001 is also the basis for many other ISO standards such as ISO ...

23 Mar 2021

ISO 13485 sets the requirements for a quality management system for those organizations in the medical device industry. While there are many mandatory regulatory requirements issued by each country related to medical devices, ISO 13485 remains a voluntary standard. The need for certification to the standards stems either from a customer requirement or from a need to market to customers t...

20 Mar 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 ...