Part of any quality management system (QMS) or environmental management system (EMS) is checking to see if you are really doing what you claim. Accountants do that for your finance department. Quality Control does that for your product. Internal auditors do that for your management system. I’m often asked “why can’t I hire someone outside to come and do audits for us?” While that sounds logical, it’s kind of like saying “why can’t I stop brushing my teeth and have the dentist clean them for me?” It would get pretty scary in between visits.

Sunday, 25 October 2009 17:05

What is ISO 13485 & why do I need it?

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ISO 13485:2003 lists the International Standards Organization requirements for  quality management systems for medical devices.  Like many of ISO's 17,500 different standards, ISO 13485 takes the core quality management concepts of ISO 9001:2008 and adapts them to the medical device industry. 

The ISO technical committee for this standard took input from the Global Harmonization Taskforce and from food and drug agencies around the world, to ensure that those who pursued 13485 certification would be well-positioned to meet the requirements of a variety of medical device regulatory bodies  – a true benefit to those designing, manufacturing and marketing anything to the medical device industry.

Friday, 30 October 2009 17:03

Why do root cause analysis...

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I'm often told "We fix the cause of any complaints or returns - isn't that the same thing?"  Unfortunately there is a dramatic difference between an immediate correction to a failed product or service and doing root cause analysis to help you make lasting corrective actions which will prevent recurrence.

Whether the failure is related to a product or service, fixing the  surface cause of the individual occurrence (e.g., rework the part, replace the document, or call and clarify the miscommunication) may relieve the pressure temporarily, but it doesn’t really find out why it happened.  And the problem with quick fixes is they often turn out to be short-term, which leaves you open to repeat failures.

Monday, 09 November 2009 16:58

The Purpose of Quality Objectives

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My auditor says we need Quality Objectives.  What are they and why do we need them?


There are all types of quality objectives – from top management strategic objectives, to in-line production objectives. In each case the goal is to create continual improvement within the QMS by identifying something to shoot for and then measure how you are doing against the objective.  Set by top management at relevant levels within the company, quality objectives are an expression of how the company intends to achieve its quality policy.  Quality objectives should be measurable, specific, and communicated, since employees need to understand how they contribute to them.  Quality objectives should not be limited to product quality, but be goals designed to help drive continual improvement of the entire Quality Management System (including resources, staffing, sales & marketing, production, measurement, analysis and improvement).


In our changing economy, staying the same is not an option – Strategic measurable quality objectives help everyone catch the vision and have specific targets to work towards.  One last reminder - to keep employees engaged and contributing, remember to measure progress against your objectives, and communicate status updates -- and find fun ways to recognize progress.

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