Team spirit

After achieving ISO 13485 and 9001 in under six months, product design consultancy IDC knows how to take the pain out of what can be a complicated process. Swap the red tape for simplicity, says IDC’s engineering director, Julian Swan, as he shares his experience of avoiding the pitfalls and striving for best practice

Six months may seem like a tight timescale to many companies, but having a well established process focused on medical device quality is half the battle and can make the road to certification easier. Having refined such a process over 40 years, IDC found that the approach became a natural progression towards formal certification. 

Even so, the pitfalls remain and there are certain routes that can make the process dramatically easier. It may seem obvious, but engaging a whole company approach is essential.  Keeping the quality process simple makes change more palatable internally and much easier for everyone to get involved when they’re busy with day-to-day tasks.

Getting commitment from everyone in the company is essential, from the top down. As an SME we were able to involve the directors through to administrators, so we could establish the best ways of doing things. After all, it is the staff who are using the quality system, so it makes sense that they have a say in the best way of doing things.

For IDC, the quality process was not just about being procedural but about how it could further benefit its design process for clients. By establishing open communication and short weekly quality certification meetings for the whole company, IDC was able to focus on improving their existing process by taking onboard feedback from staff.  The team was motivated to contribute by reward and recognition, which also encouraged feedback from all.

Another essential parameter for success is to seek the guidance of an external consultant who specialises in supporting companies to gain ISO certification. It’s easy to think you can go-alone on this, but the investment of a consultant is worthwhile in terms of time and to establish a process that follows best practice. It’s the same reason our clients come to us. Even now that we have achieved certification we still retain our external consultant, MDM, to give us a regular health check to keep on top.

IDC’s biggest challenge came when rolling the quality system out across other businesses within the organisation. The company has a base in Shanghai, IDC China, and also a well-established model making and prototyping business, UK-based IDC Models. 

Whilst the process was complicated by geographical distance, the benefits have outweighed any issues. IDC Models now holds a rareposition in the market as a UK prototyping company offering ISO 13485 for batch production, with the same being true of its China office providing product design and development services with such a stamp of regulatory approval which is still unusual in the country.

This is an achievement in itself, but when you consider that we were managing the quality process for Shanghai from IDC in the UK, it speaks volumes about the benefits of tight communication throughout the process.

For companies still wavering about whether to take the plunge for ISO accreditation, perhaps examining the benefits abroad as well as at home is prudent.  IDC China has benefited greatly from quality certification.  Interestingly, the structured approach that the quality process demands has become a real asset for China where its clients naturally lean towards contracts and frameworks within business. 

With increasing levels of medical product development in China, the quality process has added rigorous standards which have proved vital for Chinese clients looking to develop products for global markets. Additionally, the fact that both IDC and IDC Models in the UK, as well as IDC in China, now offer a standardised quality process means that clients can invest with the same level of confidence at either location, whether they are British clients taking advantage of the Chinese design services or vice-versa.

By letting our team take ownership of the process, we are now in a position where we all take a more analytical approach and are constantly asking ‘is this the best way?’.  We are tuned into regularly re-evaluating the way we work, and this can only be a good thing for our clients as we move forward in a process of continual review and improvement.