“Other people and companies have goals and objectives. We’re on a mission.” – Dana Newton, Quality Manager
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...
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.
What should a good Quality Management System provide?
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.
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,...
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.