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...

28 Feb 2021

FMEA or Failure Mode Effects Analysis has been in use since the 1940s. It was primarily used in the aerospace industry to start with and then slowly made its way into the automotive sector where it gained popularity. In 2019 a change was made to the FMEA methodology used and AIAG (The US Automotive Group) and VDA (the German counterpart) issued a new FMEA handbook that changed the method...

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 Feb 2021

The word quality means different things to different people. To companies it often means delivering a conforming product/service to a customer aka meeting their requirements. To achieve this conformity consistently successful companies, implement quality management systems. Rather than re-invent the wheel, ISO 9001 is often selected as the standard to use to set up a quality management s...

08 Feb 2021

The ISM Code was ratified and brought into effect to improve the safety of shipping. With this was ushered in new era for the maritime industry. The ISM code was launched with the intent of getting companies to self-regulate and proactively mange risks. Companies that have embraced the ISM Code and not solely viewed it as a paperwork burden have reaped the benefits of the ISM code. Compa...

21 Feb 2020

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ISO 9001 internal auditors play a critical role in the success of the system. ISO 9001 internal auditors provide inputs to Top Management for continual improvement of the system. Internal audits, given the nature, can be more detailed and as such usually go into depth considering the limited scope of the audit. For audits to add value internal auditors should be trained in identifying th...

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...