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.
Building your own Quality Mangement System (QMS) for ISO 9001:2015 is a challenge.
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.
“Other people and companies have goals and objectives. We’re on a mission.” – Dana Newton, Quality Manager
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.
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.
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 …
What Should I Expect From My Quality Management System? Read More »
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.
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.
Having worked in the ISO industry for over 30 years, at Cavendish Scott we recognize that making a decision about ISO can be a future-altering decision for a company. For many, the future is altered in a good way. For others, the choices made when choosing a consultant can harm a company for years to …
Things to Consider When Hiring an ISO Consultant Read More »
The International Organization for Standards (ISO) developed ISO 9001 to be an overarching standard focused on quality. Specifically, ISO 9001 gives us the standard that specifies requirements for a quality management system(QMS). It is the most popular standard in the series.