Building Your Own Quality Management System (QMS) for ISO 9001:2015
Building your own Quality Mangement System (QMS) for ISO 9001:2015 is a challenge.
Ensuring ISO 9001 Standards with Liteye Systems
The objective of most manufacturing operations is to deliver a quality product to their customers. This was no different for Liteye Systems, a global technology manufacturer and integrator to military and commercial sectors providing defense systems that protect lives and critical infrastructure. It’s no surprise that the company needed to be certified in ISO 9001.
Consulting Project For ISO 9001 and ISO 27001: 6e Technologies’ Success Story
For companies seeking to improve the quality of their services and products as well as consistently meet customer expectations, ISO certification is the best solution. The process of getting ISO certified can be a daunting task for any organization. However, an ISO consultant helps a company to craft a valuable and successful management system, making …
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Liteye – Doing Things the Right Way
“Other people and companies have goals and objectives. We’re on a mission.” – Dana Newton, Quality Manager
The FDA Joins the Rest of the ISO World
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.
What to do When Your QM Leaves
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 I Expect From My Quality Management System?
Clients often ask, what’s the difference between a good and bad quality management system? A follow-up question usually questions the value of one based on ISO 9001. No one should ever be surprised by such questions. There are good and bad approaches to establishing an organization’s quality management system. – This article will highlight the …
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ISO 9001 and Growth: Everything You Need to Know
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.
Comparing QSR: ISO 13485 and 21 CFR Part 820
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 …
Choose Success Before Software for ISO
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.
