ISO13485 Compliance

I have been blogging about ISO9001 over the past couple of weeks, where does ISO13485 fit? ISO13485 is the standard for medical manufacturers.  It extends ISO9001 to an extreme.  It requires all of the procedures identified in ISO9001, and then adds more.  If you are not sure if you need a procedure written for some…

ISO9001-2015 Compliance

In a Quality Progress publication, Syed Hasan Jaffrey discussed the benefits of being ISO9001 compliant… He says that being ISO9001-2015 compliant is good for your company for many reasons. Benefits Of the many benefits of ISO 9001: 2000, these are the three most significant: It provides a framework for a well-organized QMS [quality management system].…

ISO9001-2015 Compliance

In an earlier blog, I put forth the idea that a company is a collection of processes.  If your intent is to be ISO9001 compliant, you will be creating that collection of processes… Being ISO9001-2015 compliant is good for your company for many reasons. Sales Many of your customers will select their vendors from those…

Process Management in PLM

PLM and business process management… Business process management is a topic too large for a single blog.  I would like to point out 2 key areas of process management that should receive special attention. Touch point with your customer Nordstrom In my last blog, I mentioned Nordstrom’s customer service.  They have determined the best way…

More Processes to Manage

Last week I addressed PLM and the processes it can manage… This week, let’s talk about some other important processes that can be easily managed by your PLM software. Risk Management ISO9001-2015 added risk management to their compliance list.  It seems obvious that companies should address risk management – They may, but not routinely. Risk…

PLM & Process Management

I see a Company as a collection of processes… These processes can be as simple as generating a purchase request or as complicated as an engineering change request and everywhere in between. Purchase Request Process An employee may have a need for an item that doesn’t exist within his company.  They will fill out a…

PLM & Culture Change

Companies taking on a PLM project will encounter culture change. Implementing new software means that the user community will need to use that new software and using that new software may require them to change their daily routine.  Many people don’t like change and a bad attitude of just one person can impede or destroy…