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 ...

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...

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...

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...

22 Mar 2021

We live in a world of super specialization. There seems to be a degree for every field and then subspecialty and further sub-sub specializations. It is not enough to be a banker anymore but there is a need for specialization in wealth management or mortgages of loans and so on. As the need for specializations and the associated training increases how does one determine the extent of ISO ...

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 ...

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...

16 Mar 2021

ISO 13485 released an updated version of the standard in 2016 but it broke ranks with ISO 9001. In the past the two standards were aligned with the ISO 13485 capturing the additional requirements for the medical device industry. An ISO 13485 overview would reveal that it has retained a lot of the documentation requirements and not left the standard as subjective as the revised ISO 9001:2...

11 Mar 2021

It is said that air travel is statistically one of the safest modes of transportation. The flights that do not land well or go missing make the news more than the 1000’s of those that complete a safe flight. Checklists used in the aviation industry are infamous for how well they assist pilots deal with disasters. However, a lot is to be said for the plane itself, which is built to string...

05 Mar 2021

The short answer is NO. MDSAP is not going to replace ISO 13485 and it is not time to give up your ISO 13485 certification. ISO 13485 MDSAP are two different programs with similar requirements but they do not duplicate each other. MDSAP has the more stringent requirements of the two and companies that are already certified to ISO 13485 will see an increase in the number of audit days onc...