The Perception of Quality Management Standards: ISO 13485 – a good way of looking at it

quality assurance adviceTo a small business, just starting out, it does always seem a very daunting thing to install a Quality Management system to ISO 13485 or ISO 9001. As I am generally more involved with medical device manufacturers and those businesses associated with medical devices, I will discuss the merits of that particular standard, ISO 13485, rather than the more general one of ISO 9001.

The whole process often begins when a company has just invented a medical device and jumped through all the hoops required to have a product that will stun and intrigue the medical world. At that time, the next step is usually to climb the regulatory mountain to the top to make sure all the distributors across the world will be able to buy it, register it and sell it!!

The first step is likely to be looking at the Medical Devices Directive and beginning to understand that to achieve a classification, and maybe an EC Certificate, you are going to need a 13485 system. At this point you want to run and hide.

However, although this may seem a bit more than you reckoned on, it’s definitely worth doing. “Oh you would say that,” I can hear you reply, but for a small business this will prove to be extremely useful, and it will get you the recognition you will need when you start to sell.

How ISO 13485 systems can help you

To read the ISO 13485 document may seem like reading something the government has put out about tax or VAT, but actually, once it is broken down, the whole thing makes perfect sense and is the structure for an efficient and effective business.

iso 13485 consultingI have installed 13485 systems into virtual companies and have ended up with a company structure that was absent to begin with – which takes shape once the framework is in place. Because it addresses all the main functions that any company has to do, the bones of a company emerges in a 13485 system. When a small business starts up there is usually a rush on R and D and materials and services purchasing, but the systems for customer service, and such things as how to set your next goals and measure your success, are not in the mix at all.

Often, the funds are limited until some revenue is generated, so it is so important to spend your money where it is most cost effective and to measure what you are successful at – and where you are possibly failing should be of interest!!

All systems and procedures that you write, or engage someone to write for you, must, and I cannot stress this enough, must follow the processes that you already have in place or need or want to develop, with just some additions to satisfy the standard. Good advice at this point is essential and well worth paying for to ensure that you get the best out of the system you are obliged to install for the sake of your regulatory needs. There will be some extras, but everything you do must fit your business and must be of use to you as a business. In short, your 13485 system needs to work for you and not the other way round!

Liz Streeter

Liz Streeter is a quality assurance and regulatory affairs consultant who advises on manufacturing, testing and streamlining. She builds operational systems and frameworks to ISO 13485 and 9001 standards.

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2 comments on “The Perception of Quality Management Standards: ISO 13485 – a good way of looking at it
  1. Nick says:

    Right on the button with this article Liz!
    So in addition to being a regulatory requirement, a well-functioning QMS makes good sense from a business and financial perspective. I like the process orientation of the standard that you describe. That has to be good for reducing variation bringing significant financial benefits as a result.

  2. Esther Streeter says:

    I work for one of the virtual companies that Liz refers to and the Quality Management System is a vital framework for the companies smooth running of all operations. I use a lot of the procedures myself and they are extremely useful in guiding me through different situations as they arise as well as performing the normal day to day business tasks. The QMS keeps everything in perfect control so that any member of the company can easily see exactly what is going on at any given time and if changes or improvements are required then they can be easily implemented and put in place for all concerned to adhere to. This particular virtual company is a growing one and the QMS has been designed so that it can grow and expand as and when necessary.

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