Liteye - Doing Things the Right Way

April 14th, 2022

“Other people and companies have goals and objectives. We’re on a mission.” – Dana Newton, Quality Manager

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The FDA Joins the Rest of the ISO World

March 23rd, 2022

The FDA has made a statement about a new proposed rule to "incorporate" ISO 13485 into their quality system regulations for medical devices. They have been working on this for 30+ years.

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ISO 27001 Update: What it Means for You

February 21st, 2022

ISO reviews all standards every five years. This change ensures they stay relevant in an ever-changing world. They don't have to make any changes, but they have to review them. And if they do decide to make some changes, that will add a few more years before a new version is released. That is why we typically see standards change in 7-8 years.ISO 27002 is about information security controls. Controls to keep your information secure. They're often thought of as Cyber Security controls, but they...

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What to do When Your QM Leaves

February 16th, 2022

More and more companies realize that their QMS revolves around one person; their Quality Manager. One day, that quality Manager will leave, so how can you set up the system to survive losing a huge key factor in your system. That's what we're going to discuss.

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What Should I Expect From My Quality Management System?

January 18th, 2022

What should a good Quality Management System provide?

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The New Evolution of ISO Lead Auditor Training

October 28th, 2021

We all have a lot of experience of the new normal. We have experience washing our hands, keeping our distance, being at home, living with partners remote working, children experiencing remote learning, and, yes, remote working ourselves. It's not a huge leap to realize that pretty much everything has been delivered remotely, and that includes ISO auditing.

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ISO 9001 and Growth: Everything You Need to Know

October 27th, 2021

ISO 9001 is a system and process management model, and it’s embedded into industry and business. The principles are hard to argue against and fight it as you will, it’s not going to go away.

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Comparing QSR: ISO 13485 and 21 CFR Part 820

March 01st, 2021

The FDA is presently working on transitioning its QSR requirements to ISO 13485. The intent is to coalesce 21 CFR Part 820 with ISO 13485:2016 to harmonize requirements while revamping the regulation, which hasn’t been updated in more than 20 years. As medical device companies increasingly distribute globally, they have had to comply with both requirements, as well as other international requirements. Since international medical device regulators (including the ones in EU, Canada, Australia,...

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Choose Success Before Software for ISO

October 16th, 2020

Clients sometimes ask Cavendish Scott for advice on the best software for ISO. They generally seem to be hoping for a package that will provide the architecture for their standards, so they can simply follow all the prompts, check all the boxes, and thereby pass all their audits.

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Standards Help Wyoming Manufacturers Improve

August 11th, 2020

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