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InfoQ Homepage News Getting your Quality Management System Used

Getting your Quality Management System Used

Creating and maintaining a Quality Management System (QMS) can be difficult, certainly when organizations have multiple product lines where different regulations and standards are applicable. When an organization adopts agile the QMS is usually impacted. Changes in the QMS will need to be deployed to govern compliance while at the same time agility needs to be increased in the organization.

Willem van den Biggelaar will talk about how to design, deploy and maintain an efficient and effective QMS at the QA&Test Conference in Bilbao, Spain which will be covered by InfoQ. His presentation can be downloaded from his website: Help: Our Quality Management System is not used!

InfoQ did and interview with Willem about the benefits of having a QMS, dealing with multiple regulations, assuring adherence to a QMS, how a QMS can support agility and deploying a QMS in an agile way.

InfoQ: In your view what is a QMS? What are the benefits of having one?

Willem: A QMS is the documented set of agreements about the way of working within a company. Without this agreement each design project and/or production team works according its own insights which can lead to a wide variation in the quality of products and inefficient work.

InfoQ: Can you name some of things that often go wrong when organizations are deploying a QMS?

Willem: Problems that I often see in organizations with Quality Management Systems are:

  • The idea that writing it down is enough.
  • Only performing initial deployment
  • All deployment by the quality person, feeding the idea that the QMS is his/hers responsibility

InfoQ: From a governance point of view a QMS must assure that applicable regulations are being met. Do you have good practices when dealing with multiple overlapping or conflicting regulations or regulations from different standardization bodies?

Willem: You can make a cross matrix to check if all regulations are “in”. I always try not to split up (make separate) procedures but sometimes it can be more convenient. An example is a work instruction to bring a medical device to the market and a work instruction to bring machinery to the market.

I have not seen any conflicting regulations yet as in principal they all want the same: are you in control

InfoQ: What can you do to assure that a QMS is followed and adhered to in an organization?

Willem: First you need to do proper deployment. Next, check if QMS is followed by official audits and "non official" audits (like listening to people talking in the coffee corner). You need to re-deploy if issues are found.

InfoQ: How can you validate a QMS to see if it supports an organization in reaching it's goals?

Willem: You can’t by validating as I described it (piloting) but you can by measuring on the processes. E.g. By means of GQM (Goal Question Metric) method

InfoQ: If an organization is adopting agile or lean processes would they still need a QMS?

Willem: Yes! You always have output so you need templates. You always want a common way of working so you need procedures or work instructions.

InfoQ: What kind of changes are needed to a QMS to support agility?

Willem: Agility is just a way of working, so write down how you do it and put it in your QMS. I have seen organizations who keep agile development outside their QMS. It became a work instruction in each of their projects. That is not needed and can be ineffective.

InfoQ: Could you develop and implement a QMS using an agile approach, e.g. in iterations in stead of a big bang deployment?

Willem: Of course, certainly if you don’t know the exact requirements at the start. You could also develop it while the first project is already running, e.g. the first increment should deliver the requirements and the project management processes.

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