You are part of the Internet of Things (IoT) - like it or not

From military operations to healthcare, children’s toys to appliances, anything that accesses the internet and pulls data from it is considered part of the Internet of Things (IoT). How many 'Things' in your business or private life are part of the IoT? Have you even given a second thought to the security risks?
Katie Williard of The Core Solution offers some food for thought if you have not thought too much about it before. Read her article here.
https://www.thecoresolution.com/the-internet-of-things

Survivorship Bias

Published by David McRaney  in 2013, I found this article, Survivorship Bias, on the web while looking for information on a brilliant stats-mathematician by the name of Abraham Wald.

A five to ten minute read, I found the article fascinating with lots of food for thought - challenging what often appears axiomatic. To illustrate a point about survivorship bias, Wald comes into the picture because he was called upon to help determine where additional armour should be placed to increase the chances of WW II British and American bombers and their crews making it back to base after a bombing mission - missions that always included running the gauntlet of heavy anti-aircraft artillery and the consequent heavy loss of aircraft and life. The military examined planes that returned and documented where the most damage was. It looked like this:

Image credit: Nicholas Nunno on LinkedIn

Military commanders wanted to put the thicker protection where they could clearly see the most damage, where the holes clustered. Were they right? No. Read the article to find out why - and why it's time to review many of your obviously correct assumptions about so many things.

Survivorship Bias by David McRaney

https://youarenotsosmart.com/2013/05/23/survivorship-bias/

Blogging terms explained simply

Credit: https://www.facebook.com/WebdesignerDepot

Does ISO 13485 imply that a medical device is proven effective?

I received the following question from someone who viewed my video What is ISO 13485 for medical devices?

If a product has ISO 13485 certification, it means the product is of high quality, trustworthy, and reliable enough to be used as a medical device in any hospital / medical setting - correct?

Does it also imply that its performance or effectiveness is proven too?


Here is my reply...

Remember, it is the organisation, not the product, that is certified. Once the organisation is certified, all product should be manufactured following due process according to the quality management system as laid out in the Quality Manual.

For me, if a medical device manufacturer does not have ISO 13485 certification then they do not warrant a second look. ISO 13485 should be the first requirement for supplier qualification, but certainly NOT the only requirement.

Having ISO 13485 merely gets a manufacturer to first base. It is not a home run. The customer needs to do due diligence to ensure the medical device truly meets all requirements that are critical to quality for their use including, if appropriate, satisfactorily passing a supplier (2nd party) audit.

How can I become an auditor?

How can I become an auditor?

I was asked this question by an environmental engineer who lives and works in a developing country outside of North America and the EU. Here is my response with changes where necessary to preserve anonymity.

Thank you for your query.

I don’t want to over-complicate this and I am not sure how much you already know about auditing. I think it will be safest to proceed as if you do not know much even though, as an environmental engineer, you probably already know quite a lot.

There are 3 types of audit event.

Type 1 (or first party) audits are internal audits conducted by an organisation to assess its own compliance with regulations and conformity to standards.

How do you measure effectiveness of actions addressing risks/opportunities in ISO 9001?

I found the following ISO 9001:2015 question posted on LinkedIn:

9.3.2 e) Effectiveness of actions addressing risks/opportunities.

Anyone care to share how you measure and review the effectiveness of these actions?

So here is my short answer to this question: use Key Performance Indicators (KPIs).

Hopefully you have done something like a SWOT analysis in order to meet the requirements for
6.1 Actions to address risks and opportunities.

SWOT Analysis Chart

Then, following on from that, you would also have some kind of strategic plan for maximising or leveraging strengths and opportunities, and mitigating, minimising or forestalling weaknesses and threats identified in your SWOT analysis. Out of that, again, you would have goals and objectives measurable with Key Performance Indicators (KPIs).

SWOT Analysis --> Strateic Plan --> Objectives with KPIs

Voila!