PLM & ISO9001

I am currently working with a medical manufacturer to help them implement Teamcenter software so that they can be FDA compliant.  Their focus is ISO13485 [which encompasses ISO9001].  They need to have many procedures in place. Over-simplifying, to be compliant with ISO9001 a company needs to be able to show written documentation as to how…

Manage PLM Implementation Costs

A PLM implementation is extremely complex.  The cost of implementation can be as much as five (5) times the cost of the software. The more you know about what PLM software can and can’t do, the easier it will be for you to understand its complexities and minimize them.  A PLM implementation starts with a…

Process Management in PLM

I began selling PLM software solutions in the late 80’s.  At the time, engineering document management software was very new.  There were only 4 companies selling that kind of software. I had a great deal of success selling to aerospace and defense companies.  As you might imagine, they had hundreds [if not thousands] of CAD…

PLM Adoption…

I have been selling, marketing or consulting in the PLM [Product Lifecycle Management] space since the late 80’s.  Early on, the prospects that purchased and implemented their software saw some good return on investment numbers.  These companies were the early adopters. Those of us in the business expected PLM to become adopted by the main…

Procedures & PLM

I am working with a medical manufacturer to help them get into compliance with ISO13485.  Simply put, ISO13485 provides a list of procedures that you are to have in place.  These procedures are written documents so that you could be compliant without the use of software. Maintaining procedures is complicated enough without adding a person…

Maintaining Compliance…

Whether your company must comply with ISO9001, ISO13485 or other regulations, it is your responsibility to maintain compliance. I have knowledge of one company that, for one reason or another, did not maintain their compliance.  The ‘regulators’ pulled their license to sell their product.  They were not able to renew their compliance for 6 months. …

PLM in the Cloud or…

There are many ways to implement PLM software.  Your PLM software can be installed on a server within your company’s 4 walls, on a server in the ‘cloud’ or in some hybrid manner. When choosing PLM software, you will need a requirements document.  The first order of business is to perform a thorough analysis to…