Preparing to be ISO Compliant

As I said last week, ISO calls for your company to have a quality manual that includes documentation of all of your procedures.  As you write your quality manual, you will uncover your requirements for any needed software. Managing Documents A basic user needs the ability to store documents and to retrieve them. Beyond that,…

PLM Software can ease your ISO Audit

As I said last week, ISO calls for your company to have written procedures.  You need to follow those procedures and you need to be able to show that you are following them.  It does not tell you what those procedures need to look like.  It doesn’t tell you how to do your job.  It…

An Introduction to ISO9001-2015

The focus of ISO9001-2015 is the adoption of a quality management system.  Compliance with ISO9001-2015 is a strategic decision for a manufacturing organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. It could also help them get more business because many companies prefer to do business…

ISO & Process Management

Both ISO9001 & ISO13485 stress process management. Business Process Management is a discipline [it is not software].  ISO compliance is accomplished with a centralized, common, collaborative environment that gives you visibility into your quality efforts making you an active participant and a quality champion. ISO calls for your company to have written procedures.  You need…

ISO is about Process Management

Both ISO9001 & ISO13485 stress process management. Competition puts pressure on companies to decrease costs and increase productivity.  Business Process Management [BPM] helps companies improve their organization by analyzing, designing, implementing, monitoring, controlling and modifying their operational business processes. A Software program that includes document management with business process management can provide your company with……

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].…